The Vaccine Adverse Event Reporting System (VAERS)

"Notes" "Symptoms" "Symptoms Code" "Vaccine" "Vaccine Code" "VAERS ID"
"VAERS ID Code" Adverse Event Description Adverse Events After Prior

Vaccinations
"COVID-19" "10084268" "COVID19 (COVID19 (JANSSEN))" "1203" "1111699-1"
"1111699-1" "Patient developed symptomatic COVID infection with symptoms
starting 3/13, was admitted to the hospital for respiratory failure on 3/16 and
expired on 3/18/21" "No prior vaccinations for this event."
"1167886-1" "Patient vaccinated against COVID-19; received COVID-19 Janssen
vaccine on 3/10/2021. Patient developed symptoms last week of March. Called
Provider with symptoms and then presented to the hospital (admitted on 4/1/2021).
Tested for COVID and found to be positive. 4/1/2021. Patient declined, admitted
to ICU on 4/3/2021. Patient died on 4/4/2021. Chief Complaint: HPI: Patient is
a 79 y.o. yr. old female who presents today for COUGH (has had cough for a little
over a week) and FEVER (on and off for about a week)Patient was seen due to feeling
ill for over week. Patient states that she was trying to fight it on her own but
symptoms have been progressing. Patient has felt feverish no known fevers. Has
had a persistent now worsening cough. Patient is feeling very tired and weak due
to being sick for over week. Patient does live alone. Patient is coughing which is
productive with sputum. Patient is eating and drinking well. No N/V/d. No loss
of taste or smell. No recent ill exposure.; Has had covid vaccine. Patient did
get the Johnson and Johnson vaccine over a month ago. Patient is feeling very
fatigue; Having feverish/chills. Patient is taking OTC nightquil which is no
longer helping. Patient does see oncologist for her CLL. DISCHARGE DIAGNOSIS: 1.
Deceased 2. COVID-19 with hypoxia 3. Asthma 4. Anemia DETAILS OF HOSPITAL STAY:
PRESENTING PROBLEM: COVID-19 HOSPITAL COURSE: Patient is a 79 year old female who
was admitted on 04/01/2021 for COVID-19 pneumonia with complications of hypoxia.
Patient's symptoms of cough and shortness of breath have been present for
approximately 2 weeks. It was noted that 1 month ago she did receive the Johnson &
Johnson vaccine. Upon admission patient was treated with azithromycin, Rocephin to
cover for secondary bacterial infection. She was not a candidate for remdesivir
due to the length of her symptoms. She was started on Decadron, as well as gentle
fluids due to tachycardia for approximately 12 hours. During the night of 4/2-4/3
patient progressively declined requiring more oxygen she was transferred to the
intensive care unit. Patient was a do not resuscitate continued decline and after
exacerbating all treatment options patient was switched to comfort care earlier
this evening. Pronounced dead at 6:45 a.m." "No prior vaccinations for this
event."
"1208583-1" "Chills, Fever,fatigue. Tested positive for COVID on 3/22 and
died on 3/29" "No prior vaccinations for this event."
"1218602-1" "colonic necrosis 62 yo woman history of prior L occipital CVA
and DVT on Xarelto presented to Hospital on April 6 with mental status changes.
Patient was noted to be in severe metabolic acidosis, renal failure and shock.
Chest x-ray showed interstitial infiltrates and she tested positive for SARS-CoV2.
She required intubation and mechanical ventilation. CT brain showed
encephalomalacia and atrophy, no new changes. She was transferred on April 8. She
was given IV bicarb for persistent metabolic acidosis. Initially she was only
treated with steroids, then antibiotics were added for fever and persistent
hypotension. She started to spike fevers up to 40. Abdominal CXR ordered prior
to MRI, showed possible pneumatosis. A follow up CT April 13 abdomen/pelvis was
done which shows colonic pneumatosis, with air in the SMV, portal vein, air in the
liver. No thrombocytopenia; platelets on April 13 were 310k, as low as 260 on April
8." "No prior vaccinations for this event."
"1222868-1" "According to POC the resident was transferred to the hospital on
4/8/2021, due to low pressures, high pulse and cough. They certify death by COVID
19, because it affected the lungs." "No prior vaccinations for this event."
"1266936-1" "Employee developed a fever and chills on 01-Apr-21 which he
managed with Tylenol. Symptoms resolved as per patient who contributed the symptoms
as a result of the J&J vaccine. On 10-Apr-21 he developed a cough and requested a
day to rest. On 11-Apr-21, he went to Hospital to be evaluated by the physician
who ordered some labs which were normal. He was then advised to complete PCR swab
and was notified on 12-Apri-21 that his test is positive. As per the protocol, all
COVID-19 positive individuals must report to the Health Center within 24 hours of
notification and complete 10 days home isolation. During isolation, on 17-Apr-21,
patient developed hemoptysis and difficulty breathing a breathing and notified his
supervisor who called 112 for an ambulance. He was transferred to Hospital.
Evaluated and started treatment for pneumonia and was transferred to Hospital on
18-Apr-21. His condition started declining on 21-Apr-21 as he became hypoxic and
tachypneic and was subsequently sedated and intubated. As he became HD unstable,
Levophed and Vasopressin were started and reached maxed doses. On 25-Apr-21 Dr.
from the hospital called and stated that patient expired at 0830." "No prior
vaccinations for this event."
"1266953-1" "It was reported that patient had been experiencing difficulty
breathing, walking and delusions as per his fiancT . Fiance notified Manger that
they sought medical attention earlier in the morning on 1-Apr-21 at the Clinic and
they refused to evaluate patient beyond performing a PCR swab test so, they went
back to their apartment. An SMS notification was sent on 1-Apr-21 indicating that
patient was COVID-19 positive which was not seen by patient or fiance who reported
the result to Mgmt. on 6-Apr-21. He was contacted by patient's friend and advised
him the patient was sick, not able to walk, and having difficulty." "No prior
"1267883-1" "Cardiac Arrest about an hour after being injected." "No prior
"1270605-1" "His brother reporting that he got the vaccine, the following day
he was coughing. The coughing caused him not to be able to sleep and was weak due
to that. He could feel his throat closing and he was having a hard time breathing
and he called his brother who told him to call 9-1-1. He was taken to Medical
Center 4/17/2021, diagnosed with possibly COVID. He was admitted to the COVID
ward and he died on 4/26/2021. The doctor that pronounced him was . Cause of
death diagnosis. Hypoxic respiratory arrest, COVID 19" "No prior vaccinations
for this event."
"1271243-1" "Symptoms of fever, nausea, and weakness started 3 days following
vaccination. Denies any exposure to COVID positive person. Presented to local
emergency department on 3/27/21 with nausea, fever, chills, dizziness, and
confusion. Due to patient's condition, he was transferred to larger facility for
further management. Patient was admitted to hospital and subsequently transferred
to ICU on 4/17/21. He was intubated at that time. Patient went into multisystem
organ failure and died on 4/18/21." "No prior vaccinations for this event."
"1273691-1" "Patient tested positive for COVID 19 on 03/21 after a symptom
onset of 03/19/21. She was admitted to the hospital on 03/24 and passed away 04/19.
Cause of death is listed as multi-organ dysfunction secondary to hemorrhagic shock,
other contributing factors: COVID-19 pneumonia." "No prior vaccinations for
this event."
"1285561-1" ""The patient presented with chest pain around 5 pm on 4/4/21.
Patient reported ""pain came out of nowhere."" Patient reported pain was non-
exertional and non-positional. He described it as ""a constant burning sensation""
located in the center of his chest with radiation upwards toward his jaw and
shoulders, bilaterally. He was transferred to COVID unit, became hypotensive,
hypoxic was seen by house MD. Lung exam crackles bilaterally. IV fluids stopped,
patient was given 40 mg Lasix, Morphine 2 mg and started on a small dose
nitroglycerine drip. POX 70s, low 80s so Bipap ordered. Patient developed v tach
and arrested, resuscitated, defibrillated, received multiple meds, intubated by
anesthesia, transferred in ICU on Levophed and Epinephrine. Arrested in ICU.
Lines were placed by ICU team, arrested again in ICU. Was maxed out on 4 pressors,
despite CPR, pulse could not be obtained, patient was pronounced dead 4/6/21 at
3:31am. 1. Triple vessel CAD 2. Moderately severe LV dysfunction with and EF 30% 3
The recent NSTEMI is secondary to the occlusion of the SVG-OM1. There is a large
thrombus in the SVG which makes PCI of this vessel unlikely to be successful. 4
The native OM1 is chronically occluded. It may be possible to attempt to open this
with CTO techniques, however, at this time continued medical treatment. 5.
Perclose"" "No prior vaccinations for this event."
"1295200-1" "Pt received Covid-19 vaccine on 3/19 then presented to ED with
fever and shortness of breath on 3/23 admitted to the hospital found to be COVID
19+ and requiring 2L oxygen via NC. Treated with dexamethasone, remdesivir and
empiric antibiotics. Following admission, O2 requirement increased, received
tocilizumab then required transfer to the ICU on 3/29. On 3/31 developed right
leg ischemia, underwent thrombectomy and heparin infusion then on 4/1 patient
intubated due to increased need for respiratory support and had bilateral chest
tubes placed, post-intubation course complicated by shock with AKI requiring
pressor support, prolonged encephalolpathy. On 4/24 with worsening shock,
hypoxemic resp failure, AKI requiring pressors and CRRT with broad spectrum
antibiotics and resumption of stress dose steroids, the family was transitioned to
comfort measures and passed away on 4/29." "No prior vaccinations for this
event."
"1296197-1" ""Wife reports patient was vaccinated on 3/30/21. She stated
patient only had blurred vision following vaccination which lasted a about 2 days.
On 4/4 family members visited and it was noted that 1 member tested positive for
Covid on 4/5/21 and her spouse was home sick on 4/4/21 and was later positive on
4/5/21. Around 4/5/21 patient began having more frequent episodes of delusion and
confusion. Speech slurred and slouched in chair. Patient would be demanding when
asking for water when water was in his hand. Talking to her but looking at the
ceiling. She stated she thought he was having ""mini strokes."" Increased
weakness with standing. Slid to floor multiple times from chair. She reports loss
of appetite and trembling. Saw MD on 4/12. ""Could hardly breathe."" MD ordered
doxycycline and an inhaler. Patient to Hospital on 4/13/21. Diagnosed with Covid
on 4/13/21 via PCR. Discharged from hospital to Skilled Nursing Facility on
4/16/21. Sent back to Hospital on 4/18/21 and passed away on 5/1/21. Wife states
that death certificate indicates ""Utonic Hypercapnic respiratory failure,
acute/chronic CHF, hypoxemic respiratory failure and HTN, DM, prostate CA and COVID
PNA. No autopsy performed. Medical PCP."" "No prior vaccinations for this
event."
"1302490-1" ""On 4/26/21 The patient presents to our clinic with concerns for
back pain, fever, shortness of breath, fatigue and coughing. We performed a covid19
antigen test which resulted positive. Based on this and his history and examination
we recommended he go straight to the hospital for further evaluation and treatment.
He was admitted to medical center where a PCR was performed and confirmed
positive. He was discharged on 4/29. Per his wife, they felt he was discharged too
soon and he went to another hospital. He passed away 5/10/2021. This report is
being made in regards to the claim by the CDC that ""no one that has been infected
with covid19 4 weeks after having the janssen vaccine has been hospitalized."" This
patient was not only hospitalized but passed away."" "No prior vaccinations for
this event."
"1306869-1" "Brief HPI and Hospital Course: 67 year old male with unknown
past medical history was brought in by EMS as post-cardiac arrest. Patient was
found on unresponsive on sidewalk, possible collapse. ACLS started by EMS, approx
10-15 minutes. Initial rhythm was junctional PEA. Was given 2 epi and intubated by
EMS and had ROSC, Initial ROSC rhythm was SVT which slowed to 90s on its own. On
arrival to ED, left femoral central line placed. Tox screen was positive for
cocaine and ETOH. Was placed on ACS protocol for possible NSTEMI. Tested positive
for COVID19 on admission. Patient required pressor support on admission.
Hypothermia protocol was initiated. Patient was rewarmed per protocol,
normothermic as of 5/5. Brief Narrative of Events leading to Patient's Death:
Patient remained normothermic with persistent septic shock, multi organ failure,
ARDS secondary to COVID19. Multiple attempts to reach family members made by ICU
team and palliative care team daily without answer. Patient made DNR by two-
physician consent. Patient's BP low despite maximum levophed support." "No prior
"1313860-1" "patient received Covid 19 vaccine Johnston and Johnston on
03/13/2021, became positive for covid on 04/13/2021, went to hosp, admitted" "No
prior vaccinations for this event."
"1331122-1" "Patient was vaccinated on 3/31/21. Noted to be positive for
Covid on 4/19/21 and passed away on 5/8/21. Per the lab report, this is the
information for the ordering provider: He had an emergency contact but no
number. Phone number for patient is no longer operational.""No prior vaccinations
for this event."
"1337251-1" "To ED via ambulance for chest pain and shortness of breath.
Decompensated during transport, hypoxic, cyanotic, hypotensive. Intubated in ED.
CTA of chest positive for saddle embolism. 1/2 TPA/heparin given. Admitted to ICU.
Change in mental status, CT of head showed intracranial hemorrhage. Patient had
reportedly been sick about a week or 2 earlier, covid positive PCR on admission to
hospital." "No prior vaccinations for this event."
"1337780-1" "Person died on 5/7/2021 with death note stating acute
respiratory failure with hypoxia, thrombocytopenia." "No prior vaccinations for
this event."
"1343571-1" "Patient received their J&J vaccination on 4/7/2021. The
patient's wife tested positive on 4/12/2021. The patient tested positive on
4/23/2021. The patient presented to the ER with a severe progressive cough
(starting one week prior), worsening shortness of breath, a high fever, chills,
myalgias, and malaise. The patient was diagnosed with COVID pneumonia and ARDS with
hypoxia and given Lovenox, remdesivir, and dexamethasone, tessalon, and Brovana.
The patient was admitted on the 23rd and continued to decline until their eventual
passing on 4/28/2021." "No prior vaccinations for this event."
"1350433-1" "Presented 5/13 to Hospital. Presented to Hospital on 5/13 with
one week of symptoms including cough, dyspnea, diarrhea. COVID-19 testing was
positive on 5/8. Treatments prior to arrival included remdesivir and
dexamethasone, started 5/13. She was also placed on pulse dose steroids 1000
mg/day methylprednisolone given her history of ground glass lung opacities in 2018.
Progressed to high-flow nasal cannula, then BiPAP on 5/14, and was intubated on
5/17. Paralysis and proning initiated. Transferred to another hospital for
possible VV ecmo candidacy. Patient with severe acute respiratory failure d/t covid
who has failed treatment with the ventilator despite paralysis and proning. CTS
asked to place patient on VV ECMO. 5/20/21 1135am initiated ECMO Patient is a
50yr old female with past medical history of hypertension, asthma, OSA and obesity
BMI 41.5 who presented to hospital on 5/13 with progressive cough and shortness of
breath for about a week. Of note, patient also has a history of respiratory
failure presenting with ground glass opacities on CT scan in 2018 with unclear
etiology despite bronchoscopy and serologic studies which resolved with high dose
corticosteroids. Patient recently tested positive for COVID on 5/8 and received
johnson and johnson vaccine in April. Patient was admitted on 5/13 and treated with
decadron, remdesivir and tocilizumab. Course complicated by progressive
respiratory failure requiring HFNC followed by Bipap and ultimately intubation on
5/17. Due to elevated d-dimer, lower extremity dopplers were obtained which were
negative, however a heparin gtt was initiated. Course further complicated by cold
left lower extremity; arterial duplex demonstrated distal popliteal artery thormbus
extending into the peroneal, anterior tibial and dorsalis pedis arteries. therefore
heparin was switched to argatroban and a HIT panel was sent. On 5/19 patient
continued to decline despite paralytic and pronning. Patient transferred to ICU
for further level of care and VV ECMO evaluation. On arrival patient was started on
veletri; however due to continued respiratory decline a shock call was placed for
VV ECMO and patient cannulated for VV @ 1200. Cannulation was difficult and patient
was felt to have an IVC thrombus as clot was seen going into the ECMO circuit
during cannulation. Post cannulation she developed worsening septic shock and DIC.
She received 2uprbc, 1unit cryo, 1 platelet, 2 FFP, 5 liters crystalloid and 1L
albumin. Blood cultures positive for GPC in clusters. Escalating vasopressors
(Epi/NE/vaso) and ongoing hypoxia family opted to change code status to DNR.
Patient then continue to have worsening hemodynamic instability and went into PEA
and ultimately asystole. She was pronounced deceased at 1815. Family was en route
already due to her instability thus will be notified of her passing once they
arrive. Dr. was notified of patients death." "No prior vaccinations for this
event."
"1351207-1" "73 year old male with PMHx of AFib, CAD, and HTN who presents
with c/o dyspnea that started 4/6/21. Patient states it got to the point where he
could not walk in his house without severe dyspnea. States he was diagnosed with
COVID-19 one week prior. Per chart review he was in our ER 4/3/21 and diagnosed
with COVID-19. At the time he was 95% on room air. His only other symptom has been
diarrhea. He states he received the Johnson and Johnson vaccine one month ago. He
denies any dizziness, chest pain, abdominal pain, n/v, weakness, or numbness. In ER
patient was hypoxic and improved only with BiPAP. Per chart review patient had
cardiac arrest on 11/2020 for 17 minutes. He has a significant cardiac history
consisting of stemi, fem-pop bypass surgery, PVD, CABG x4, AFib post ablation 2017,
V-tach. He was started on therapy with steroids, anticoagulation, and Remdesivir.
He failed to improve and had increasing oxygen requirements. He was eventually
intubated. Due to failure to improve patient was made DNR and eventually expired."
"No prior vaccinations for this event."
"1388920-1" "Contracted COVID-19 ~1 month later, tested positive on 5/16/21.
Died 6/9/2021 at 94 years old. Had CLL diagnosed during final hospitalization,
thought to have caused poor vaccine response and susceptibility to COVID." "No
"1400869-1" "Reported to me by patients niece, who developed similar symptoms
around the same time: Patient developed cough aches, fartigue and shortness of
breath about 8 days after receiving COVID vaccine. After another 10 days of illness
was taken to hospital by ambulance as too weak to stand., and died in hospital
about 5 days later, on or about 5/22/21" "No prior vaccinations for this event."
"1417204-1" "I am the epidemiologist reporting on behalf of patient who
tested positive for COVID-19 via PCR on 5/30/21 after the completion of a full
Janssen vaccine series (Dose 1 on 5/5/21). The patient later died on 6/03/21. Cause
of Death is listed as ?Upper gastrointestinal hemorrhage?.
Comments:=======================nnJune 01, 2021 at 3:07 PM by HD nn6/1 3:06
Supervisor Review completed by HD): ICP needednPT resides at ..nPT admitted to
hospital- as asymptomatic. No dates were provided. shows specimen collected via
hospital on 5/30 and no notes regarding admittance.nClosed as medical
barriers.nnn=======================nnJune 01, 2021 at 2:34 PM by CNA, case is
hospitalized since 5/30. Head of Nursing sent her to hospital for vomiting and is
not currently in the ICU or being treated for any respiratory issues related to
COVID," "No prior vaccinations for this event."
"1418084-1" "Developed s/s of COVID on 4/27/2021, hospitalized, then
transferred to another HCF was inpatient ICU 5/8-6/21 expired 6/21/21" "No
"1420257-1" "hospitalized with respiratory distress and death" "No prior
"1420514-1" "Symptom onset was 12/26/2020, with nausea, fever, chills,
rigors, fatigue, cough, & myalgia." "No prior vaccinations for this event."
"1424154-1" "death 4/24/2021 causes of death listed on death certificate: 1)
Pneumonia Due to COVID 19 2) Acute Respiratory Failure with Hypoxia 3) COVID 19
4) Acute Exacerbation of Chronic Obstructive Pulmonary Disease" "No prior
"1426155-1" "Death: 5/2/2021 Causes of death listed on death certificate:
Covid 19" "No prior vaccinations for this event."
"1427858-1" "COVID-19 symptom onset 4/23, hospital admission date 4/30, died
5/14. Primary cause of death COVID-19 viral pneumonia" "No prior vaccinations
for this event."
"1437342-1" "Death 5/21/2021 Causes of death listed on death certificate 1)
COVID-19 2) ARDS Other: Lung Transplant for cystic fibrosis" "No prior
"Total" "COVID-19" "10084268" "COVID19 (COVID19 (JANSSEN))" "1203"
� �
"COVID-19" "10084268" "COVID19 (COVID19 (MODERNA))" "1201" "0963235-1"
"0963235-1" "Patient diagnosed with COVID on January 9, 2021 after being
exposed to family member that was under quarantine in the same household. Admitted
to the hospital and was discharged on January 14, 2021 with home hospice. Patient
passed away on January 18, 2021" "No prior vaccinations for this event."
"0970930-1" "Pt developed COVID-19 infection, symptoms starting 7 days after
first dose was given. Patient was admitted to hospital on 1/21 after falling
(secondary to weakness) and striking head on toilet. Patient expired due to
respiratory complications of COVID on 1/25." "No prior vaccinations for this
event."
"0975689-1" "Resident vaccinated on 01/06/21 she acquired COVID 19 on
01/10/2021. Resident had multiple co morbidities and was declining prior to the
vaccine. Resident expired on 01/20/2021" "No prior vaccinations for this event."
"0975735-1" "VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21
RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT
EXPIRED ON 01/25/2021" "No prior vaccinations for this event."
"0979841-1" "Pt likely presented to vaccine appt with asymptomatic/early
infection of COVID-19, as he presented 2 days post-vaccination and tested positive
for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of
complications from COVID-19 while in ICU. Date of death was 1/15/2021." "No
"0981945-1" "weakness and fallsNarrative: 95 yo male w/ a PMH significant
for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout,
BPH, chronic knee infection, and DJD who received his first dose of the Moderna
COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to
receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for
weakness and m PCR test on ultiple recent falls (since receiving his first dose of
the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was
admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The
pt initially required supplemental oxygen via low-flow NC, however his oxygen
requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care.
The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the
patient's hospitalization and eventual death, or whether these events occurred from
COVID-19 itself, however this case is being reported the FDA since this vaccine is
under an emergency use authorization (EUA)." "No prior vaccinations for this
event."
"0994778-1" "Resident received the vaccine on 1-22-21 and she was diagnosed
with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms
except feeling weak and she had a decrease in her appetite. She already had a poor
appetite prior. She died on 2-2-21." "No prior vaccinations for this event."
"1020079-1" "Received Moderna covid vaccination 1/14/2021. 1/16/2021 received
report of cough and difficulty breathing. Proceeded to hospital and was diagnosed
Covid+ on testing. Continued to decline, died 1/31/2021." "No prior vaccinations
for this event."
"1020195-1" "Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening
shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal
tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown
for this episode) then readmitted a third time 1/20/2021 for shortness of breath.
Diagnosed covid + at third hospitalization and continued to get worse. He died
1/23/2021." "No prior vaccinations for this event."
"1020724-1" ""Patient sent to the ED or sudden onset of shortness of breath
on 02/02/2021. Per documentation by the MD, the patient had COVID19 ""several weeks
ago"" and the nursing facility felt like he had recovered. A rapid test done in the
ED was negative. When the patient worsened and seemed to be following the same path
as other COVID patients, a send out PCR test was done, which was positive. The
patient worsened and passed away that same day (02/05/2021) I was not made aware
that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021."" "No
"1021926-1" "Passed away; Positive result; A spontaneous report was received
from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine
(mRNA-1273) and developed COVID-19 and passed away. The patient's medical
history was not provided. Concomitant product use was not reported. On 05 Jan
2021, prior to the onset of the events, the patient received their first of two
planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.
On 08 Jan 2021, the patient had a positive COVID-19 test. On 18 Jan 2021, the
patient passed away. No treatment information was provided. Action taken with
mRNA-1273 in response to the events was not applicable. The patient died on 18 Jan
2021. The cause of death was not reported.; Reporter's Comments: This spontaneous
report concerns a female patient who experienced COVID-19 and passed away. The
event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273
vaccine administered and death occurred 14 days after administration of the mRNA-
1273 vaccine. Based on the information provided and the known etiology of COVID-
19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no
definite information on the clinical details of the death, it is difficult to
adequately assess a causal association with mRNA vaccine. Main field defaults to
�possibly related'; Reported Cause(s) of Death: unknown cause of death" "No
"1024539-1" "patient tested positive for covid on 1/29/21. was hospitalized
on 2/8/21 for shortness of breath, generalized weakness, nausea." "No prior
"1024627-1" "covid shot 2/2; feel bad 2/5; covid positive diagnosis - 2/8
s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted went
into DIC per intensivist 2/11 patient died" "No prior vaccinations for this
event."
"1029068-1" "Patient was given vaccine the following day he died ," "No
"1032252-1" "Resident tested COVID-19 confirmed positive a few days after
covid vaccination." "No prior vaccinations for this event."
"1036480-1" "Patient passed away on 2/2/21 after being admitted on 1/31/21
after receiving COVID19 Moderna Vaccine on 1/26/21. On initial report to the
hospital patient reported having a cough for over 2 weeks (starting approx.
1/17/21). He had a postive COVID19 PCR on 1/31/21. Intubated on 1/31/21 and passed
away on 2/2/21" "No prior vaccinations for this event."
"1041200-1" "Patient described feeling nervous, anxious the next morning
(Wednesday) after the vaccine. He later fell in the bathroom after using the
restroom, his legs gave out (his words) and consequently was on the ground for 23
hours before being transported to the hospital. That was Thursday afternoon. He was
diagnosed with COVID-19 on Saturday night and died the following Friday morning."
"1042145-1" "Patient reported feeling weak, fatigue, fever (102), and loss of
appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for
COVID-19 on 2/7/21 (collection date). See following discharge summary from ED:
82 y.o. female who initially presented to the ED with complaint of generalized
weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving
Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with
02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-
90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate
left lung opacities. She was started on empiric ceftriaxone and azithromycin and
admitted to the hospitalist service for further workup and mgmt. During her stay
in the hospital, pt did test positive for Covid 19. She developed rapidly
progressive respiratory failure, felt to be secondary to ARDS. There was also
question of contributing pulmonary edema, however this was refractory to lasix and
thus ARDS was felt to be the most significant factor. She had requested DNR/DNI
status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and
then to BiPAP support. Unfortunately, she continued to suffer greatly with the
BiPAP in place, and therefore made the decision to transition herself to comfort
measures only after visitation from her family. Her other medical issues were
supported as appropriate during her stay, with dextrose infusion for hypoglycemia
and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to
find any documentation regarding how pt was feeling when she received the vaccine
compared to her baseline state of health. thus am unable to say whether the
severity of her illness represents vaccine� enhanced disease or the much more
common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as
result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death:
ARDS due to Covid 19 pneumonia." "No prior vaccinations for this event."
"1044247-1" "Moderna COVID 19 Vaccine: Patient started with symptoms of covid
5 days after first vaccine. She was hospitalized and passed due to COVID 19 on
2/6/21. Patients family informed us when she was due for the second dose." "No
"1047634-1" "Patient was admitted to hospital on 2-9-21 for urinary tract
infection and tested positive for Covid. Developed pneumonia and expired on 2-12-
"1049406-1" "Patient rcvd 1st covid 19 vaccine on 1/26/2021. Patient had
house guests on 1/30/21. Those house guests tested positive for covid on 2/1/2021.
Patient started getting symptoms on 02/2/2021. Patient tested postivie on
2/4/2021. Patient was hospitalized 2/7/2021. Patient passed away on 2/21/21."
"1049963-1" "Found lying face down without respiration or pulse, believed to
be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get
autopsy. Believed to be heart attack secondary to COVID infection, but
unconfirmed. Relative contribution of recent vaccination unknown." "No prior
"1055563-1" "Pt tested positive for COVID-19 on 2/10/2021 and died from
illness related to COVID-19 on hospice at home on 2/18/2021, per care facility."
"1055588-1" "Pt tested positive for COVID-19 on 2/10/2021 and was
hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission,
per caregiver." "No prior vaccinations for this event."
"1055613-1" "Pt tested positive for COVID-19 on 2/10/2021 and was deceased on
2/16/2021 per the caregiver." "No prior vaccinations for this event."
"1055618-1" "Pt tested positive for COVID-19 on 2/10/2021, and was deceased
on 2/16/2021 at." "No prior vaccinations for this event."
"1055629-1" "Pt tested positive for COVID-19 on 2/10/2021, and deceased on
2/12/2021, per caregiver at." "No prior vaccinations for this event."
"1063903-1" "NO SPECIFIC ADVERSE EVENT DUE TO THE VACCINE BUT THE PATIENT
PASSED AWAY 02/10/2021 DUE TO COVID" "No prior vaccinations for this event."
"1067358-1" "1-25-2021- Phone call: pt had cold and cough prior to vaccine.
cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same
and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of
cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level
of distress- leaning forward to breath. appeared ill. diffuse rales throughout both
lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER"
"1069026-1" "Death Narrative: Family was able to be present at bedside
shortly after patient was extubated. Fentanyl bolus given 10-15 minutes prior.
Patient passed away soon after endotracheal tube removed. Time of death 10:14am."
"1080033-1" "COVID symptoms started within 8-9 days of vaccination. No fever,
general not feeling, chills. Turned into very difficult breathing, low oxygen
levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday,
January 27. Died in the hospital Saturday morning, January 30, 2021." "No prior
"1080424-1" ""Narrative: above in section ""Other relevant history"""""No
"1080425-1" "Narrative: Patient with h/o ESRD on HD MWF, HTN presented to ER
on 2/20/21 with worsening dyspnea and GI symptoms; tested positive for COVID-19.
Patient had received first COVID vaccination approx. 9 days prior. Patient admitted
to ICU for treatment of COVID+ PNA. During admission, patient often could not
tolerate removal of fluid during HD d/t tachycardia. He received dexamethasone,
convalescent plasma for COVID. Patient underwent TTE which was notable for septal
wall motion abnormalities and grossly reduced EF. Admission also c/b acute liver
injury, possible cholecystitis, thrombocytopenia, SVT, encephalopathy. Patient then
developed progressive shock and hemodynamic instability on 3/2 and passed away on
"1080427-1" ""Narrative: above in section ""Other relevant history"""""No
"1080932-1" "DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION;
HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X
10 DAYS" "No prior vaccinations for this event."
"1085185-1" "testing positive for COVID; Fever for 3 hours after the vaccine/
High temperature; Joint pain; Severe upper back pain; Headache; A spontaneous
report was received from a nurse concerning a 44-year-old female patient who
experienced fever for 3 hours after vaccination, headache, joint pain, and severe
upper back pain. The patient's medical history was not provided. Products known to
have been used by the patient, within two weeks prior to the event, included
dulaglutide, metformin, empagliflozin, losartan, amlodipine, levothyroxine,
simvastatin, allopurinol, estrogen, colchicine, calcium, zinc, multivitamin and
vitamin C. On 05 Jan 2021, the patient received mRNA-1273 (Lot number 026L20A)
intramuscularly for prophylaxis of COVID-19 infection. On 05 Jan 2021, patient
experienced fever for 3 hours after vaccination. The patient also experienced
headache, joint pain, and severe upper back pain. The patient stated her
temperature was high from 05 Jan 2021 until 09 Jan 2021 when it went down.
Treatment information was not provided. Follow-up received on 21 Feb 2021, from
the patient's husband, included that the patient tested positive for Covid-19 on 09
Jan 2021 and was hospitalized on 11 Jan 2021. The patient never recovered from her
symptoms and the patient died on 02 Feb 2021. Action taken with mRNA-1273 in
response to the events was not applicable. The outcome of the events Coronavirus
test positive was fatal and for headache, joint pain, severe upper back pain and
temperature were unknown. The cause of death was reported as Coronavirus test
positive and autopsy details was unknown.; Reporter's Comments: This case concerns
a 44-year-old female who was hospitalized with a serious unexpected event of COVID-
19 with fatal outcome along with NS unexpected back pain and NS expected fever,
headache, arthralgia. Event onset was 5 days after the first dose of mRNA-1273.
Treatment not reported. Event outcomes fatal. Autopsy results unknown. Based on
current available information and temporal association between use of the product
and the start date of the event, a causal relationship cannot be excluded.;
Reported Cause(s) of Death: Testing positive for COVID" "No prior vaccinations
for this event."
"1088956-1" "Tested positive and had symptoms for Covid-19 . Admitted to
hospital on 2/14/21 in the icu and died in 2/28/21" "No prior vaccinations for
this event."
"1091269-1" "A home dialysis patient who received his first COVID-19
(Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic
and reported no signs of symptom of COVID-19. This patient was diagnosed with
COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The
patient's spouse and son (who lives with them) also tested positive for COVID-19.
This patient developed COVID-19 complications while inpatient including stroke and
mechanical ventilation was required. The patient was made a DNR by family and
removed from mechanical ventilation and expired on 2/26/2021." "No prior
"1094638-1" "Exposure to Covid 19 either on the date of vaccine (2/13/21) or
shortly thereafter. Symptoms of Covid started on Monday (2/15) early morning
following shot. Dr. ordered Covid test on Weds. (2/17). Taken by ambulance to
Hospital, approx. 7 pm on Saturday (2/20) with dehydration, low oxygen levels,
confusion, shaking and cough. Admitted to hospital with threats of ventilator up
until Weds (2/24) when he was intubated, proned and FINALLY given hydration via IV
fluids. He went into kidney failure on Thursday (2/25) and put on dialysis. Other
organs began shutting down and was taken off the ventilator on Friday (2/26) and
did not recover. He passed away just before 4:00 p.m. on 2/26/21." "No prior
"1094868-1" ""Started having confusion at 3#0 a.m. Sunday morning. Unstable
gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks
ago. Had visual hallucinations with seeing ""bugs"" Admitted with positive COVID
and Influenza B diagnosis."" "No prior vaccinations for this event."
"1102722-1" "Patient presented to Hospital ED on 3/14/21 with respiratory
distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in
the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed
by Hospice). The patient passed away on 3/15/2021. Per family patient had recently
received COVID-19 vaccine. Vaccine information verified in portal." "No prior
"1104815-1" "Seen in ED for positive COVID symptoms - discharged with
instructions. Death 1/26/2021" "No prior vaccinations for this event."
"1111389-1" "Cough started on 3/5. Hospitalization on 3/7, Expired 3/16.
Doctor's Death Diagnosis: acute on chronic respiratory failure." "No prior
"1112585-1" "patient diagnosed with covid on 2.18.2021 and died of covid
3.6.2021" "No prior vaccinations for this event."
"1123229-1" "Patient received Moderna Dose #1-01/08/2021 and Dose #2-
02/05/2021. He was admitted to Medical Center on 03/08/2021 with confusion and
decreased O2 sats; date of death was 03/12/2021." "No prior vaccinations for
this event."
"1126683-1" "Death within 60 days of vaccination. Tested positive for COVID-
19 2/8/2021, admitted outpatient to Hospital 2/8-2/10 readmitted 2/13-2/14 with
transfer to Medical Center in with death on 3/2/2021." "No prior vaccinations
for this event."
"1127847-1" "Participant felt flushed, feverish, fatigued with general aches
and dry cough over the weekend after receiving injection, took acetaminophen and
cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on
oximeter check, was sent to the ER. He was intubated in ER and went into
respiratory failure with sepsis due to COVID19. He was treated with tocilzumab,
became paralyzed and DVT in left lower extremity was found. HE required pressors
and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ
failure. His level of cognition decreased until he was no longer responsive and he
died on 2/24/2021." "No prior vaccinations for this event."
"1129951-1" "72 y/o with hx of HTN, Aortic valve replacement, venous stasis
and venous insufficiency of both lower extremities, CAD, AAA, and s/p squamous cell
carcinoma excision in 2019 Upon reviewing the history, here is what we found. 1.
2/27 -- Received send-out covid swabbing/testing- Patient did not disclose this
information when screened for his covid vaccination at the clinic. 2. 3/2, 10:00
AM ? Presented to Covid Vaccination Clinic and received 1st dose of Moderna.
Results of pending covid test were not back at this time, nor did he disclose this
information when screened by nurse prior to vaccination. 3. 3/2, 10:30 PM ? Covid
result came back to lab as positive SARS Co-V 2019 4. 3/3 ? patient called and
notified of result per ED nurse 5. 3/3 ? Pharmacy recommended patient for mAB
infusion (patient did not receive it) 6. 3/6 ? patient presents to ED in severe
respiratory distress, DX of Covid-19 pneumonia & transferred to ICU 7. 3/21 ?
patient dies after 15 day hospitalization in ICU (pt. had received convalescent
plasma x 2 and remdesivir there)" "No prior vaccinations for this event."
"1130111-1" "Patient passed away unrelated to covid vaccine Narrative: The
patient received his first dose of Moderna on 1/14 and he was rushed to the
hospital at 4 am on 1/15. The patient tested positive for COVID and is hospitalized
in the hospital. The patient passed away on 2/8. Cause of death not documented,
possibly due to COVID complication. No indication that death was related to COVID
19 vaccination." "No prior vaccinations for this event."
"1130250-1" "Patient tested positive for Covid on 3/12/21 per hospital
admission notes. Patient was admitted to the hospital on 3/16/2021 with Covid
pneumonia. She passed away on 3/22/21." "No prior vaccinations for this event."
"1135603-1" "temperatures of 38.4�C; dependent on oxygen,adequate level could
not be reached with 10 L oxygen suppply; Respiratory insufficiency; Covid-19;
severe dyspnoea; productive cough; basilar rales; shivering; fatigue; sepsis; SARS-
CoV-2 exposure; A regulatory report (CH-SM-2021-10854) was received from a
physician concerning a 85-years-old male patient who received Moderna's COVID-19
vaccine (mRNA-1273) and experienced events COVID-19 severe dyspnoea (dyspnoea),
productive cough, rales, decreased oxygen saturation, respiratory insufficiency
(respiratory failure), sepsis, fatigue, shivering (chills), temperature of 38.4
degrees Celsius (pyrexia) and exposure to SARS-CoV-2 . The patient's medical
history was Arterial hypertension, Spondylolisthesis, chronic renal insufficiency,
urolithiasis, colon diverticulitis, polymyalgia rheumatica. Concomitant medications
reported was colchicine, allopurinol, acetylsalicylic acid, hydrochlorothiazide
valsartan, calcium carbonate colecalciferol, gabapentin, prednisolone, torasemide,
tramadol hydrochloride, colecalciferol, and zolpidem tartrate. On 21 Jan 2021,
prior to the onset of the events, the patient received their mRNA-1273 (lot batch:
300042460) intramuscularly for prophylaxis of COVID-19 infection. The patient had
a previous exposure to SARS-CoV-2 on 15Jan2021 which was not made known at the time
of vaccination. On 21 Jan 2021, the patient experienced temperatures of 38.4�C
which resolved by 22Jan2021. The practitioner initially suspected a reaction to the
vaccination, however since the fever returned, recommended testing for SARS-CoV-2.
On 22Jan2021, the patient was evaluated at the emergency department with severe
dyspnoea and tested positive for SARS-CoV-2. The patient was experienced shivering,
productive cough, and fatigue with a slightly deteriorated general condition but
was stable and afebrile. The patient had bilateral basilar rales which were
stronger on the right than left. Laboratory tests included elevated infection
parameters, increased creatinine, and elevated D-Dimer levels. Blood gases showed
acute partial respiratory insufficiency. Legionella and streptococcal urine antigen
test as well as the blood cultures were negative. A chest x-ray was done and showed
bilateral peripheral- and basal-predominant interstitial infiltrates. After being
admitted to the hospital, treatment included antibiotics, pulse steroid therapy,
oxygen therapy and remdesivir. The patient became oxygen dependent. On 25Jan2021,
the patient continued to deteriorate and died in the evening. The cause of death
being covid-19 infection. Autopsy information was not provided. Action taken with
mRNA-1273 in response to the events was not applicable. The outcome of the events
was fatal.; Reporter's Comments: This fatal case concerns an 85 Y/O M with exposure
to SARS-CoV-2 was hospitalized with serious unexpected COVID-19, sepsis,
respiratory failure, oxygen saturation decreased, dyspnea, productive cough, rales,
and expected pyrexia, chills, fatigue. Event onset Day 1 after first dose mRNA-
1273. Cause of death COVID-19. Autopsy unknown. Based on current available
information and temporal association between use of the product and the start date
of the event, a causal relationship cannot be excluded.; Reported Cause(s) of
Death: COVID-19" "No prior vaccinations for this event."
"1143895-1" "13th of January received first Moderna shot. 18-19th began to
have headaches 22nd headaches worsened 25th at the doctor's (tested negative nose
swab) home till 28th (28th tested positive for corona after having her first shot
at Advent) stroke symptoms at school 28th Advent did CT scan MRI venous thrombosis
diagnosis, from front to back, hemorrage in the northern hemisphere 29th blood
thinner administered to attempt to drain clot, seizures 31st passed away" "No
"1145531-1" "Pt diagnosed with COVID-19 despite 2 COVID vaccines (first given
1/15/2021. Pt developed respiratory symptoms, including dyspnea, which progressed
over 3.5 weeks and then systemic symptoms of myalgias, malaise. He was admitted
3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required admission to
ICU and died of respiratory failure on 3/28/2021." "No prior vaccinations for
this event."
"1147848-1" "Approximately 3-4 days after her first immunization, patient
became ill. She contacted our triage line 6 days after immunization with report of
chills and weakness. She presented to Medical Center Emergency Room where she was
admitted for hypoxia. She was subsequently diagnosed with COVID by PCR. She
developed respiratory failure, worsening kidney failure necessitating dialysis, c
diff colitis, GI bleed, and acute heart failure. Despite maximal efforts by the
ICU/hospitalist team and specialists her conditioned worsened. She was made
comfort care and died on 2.26.21" "No prior vaccinations for this event."
"1156392-1" ".Mandatory EUA Reporting - Received 2nd Moderna Covid vaccine on
2/26. Admitted to hospital on 3/10 with pneumonia and COVID positive. Patient's son
was living with him and Covid positive. Failed treatment with abx, steroids,
oxygen. Transitioned to comfort care and passed away on day 8 of hospitalization."
"1156579-1" "Per Hospital medical records patient was admitted to hospital
3/14/2021 at 1021. Notes from 3/14/21 indicate patient presented with 1 week of
nonproductive cough. Received chemotherapy 4 days ago. 3 days ago developed fever,
chills, dyspnea, anorexia." "No prior vaccinations for this event."
"1156595-1" "Mandatory EUA Reporting - Patient received Moderna COVID-19
vaccine on 1/4. She was living with someone who was diagnosed with COVID-19 on
1/11. Patient was tested on 1/11 and was negative for COVID-19. Then about 4-5 days
later developed symptoms and tested positive. She was admitted to hospital on
1/20/2021 to medical floor, transferred to ICU on 1/27, and died on 2/5/2021."
"1160236-1" "covid+ Narrative: Patient with diagnosis of chronic respiratory
failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea
secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM,
Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early
1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency,
Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple
joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility
3/27/21 with new onset Afib/further respiratory decompensation requiring
NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4
gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure
secondary to COPD/COVID with daughter at side." "No prior vaccinations for this
event."
"1160237-1" "COVID+ Narrative: Patient administered COVID-19 vaccine
(Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and
was brought by ambulance to tertiary care facility with diagnosis of COVID-19.
Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine
drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021."
"1160722-1" "Patient diagnosed with COVID on 2/21/2021 and subsequently
expired" "No prior vaccinations for this event."
"1161015-1" ""Per RN at Group Home where patient worked, on 3/19/21 he called
the RN with complaints of a ""low grade"" fever (99-100 degrees) but otherwise
reportedly felt fine. He was advised to stay home, was offered Covid testing but
refused. On 3/22/21 the RN received an email from patient's supervisor that he
still felt unwell and reported vomiting and diarrhea. Was offered a Covid test but
refused. -Per patient's friend (a nurse who informed us of the case) various
friends spoke with patient up until the morning of 3/25 and he reportedly had no
respiratory or cardiac complaints. They were unable to reach him the evening of
3/25, nor the morning of 3/26 so sent the police for a well check and patient was
found dead. He lived alone. -Per OSME. Patient did not receive an autopsy but did
have an ""inspection"" which includes an external exam, toxicology and other
testing including Covid testing which was positive. The specimen has been sent for
sequencing. -Of note, Patient worked in a group home that had an outbreak of Covid
in Jan/early Feb. His last exposure to a + person was likely 2/8/21 but possibly
2/10/21. He had a Covid test 2/15/21 that was ""inconclusive"". The test was re-run
(same assay) and was also ""inconclusive"""" "No prior vaccinations for this
event."
"1161042-1" "PATIENT CONTRACTED COVID, DATE OF COLLECTION 3/18/2021, DIED ON
3/21/2021" "No prior vaccinations for this event."
"1161106-1" "CONTRACTED COVID, CONFIRMED 3/17/21, PATIENT DIED ON 3/23/21"
"1179974-1" "pt was diagnosed with covid on 3-29-21 , hospitalized for
pneumonia and respiratory failure and expired on 4-6-21 at Hospital" "No prior
"1180051-1" "Was hospitalized (unsure dates on hospitalization); has no
known pre-existing conditions; symptom onset was 3/3/2021 with fever, chills,
rigors, myalgia, rhinorrhea/congestion, sore throat, cough (wet productive),
nausea/vomiting, headache, loss of smell and taste, and fatigue. Was a household
contact to a known COID-19 case." "No prior vaccinations for this event."
"1182101-1" "Completed Moderna series on 02/12/2021. Diagnosed with COVID-19
on 04/06/2021 and expired from COVID-19 pneumonia on 04/06/2021" "No prior
"1183418-1" "Vaccine breakthrough hospitalization - SOB with O2 sat 50% when
EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and chest pain.
BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID mAb day of
admission, but clinical course worsened. Admitted to Medical ICU for acute
respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on BIPAP
and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed
pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain
DNR/DNI, ultimately she elected to transition to comfort measures only given
worsening hypoxia." "No prior vaccinations for this event."
"1193971-1" "Respiratory failure; Dizziness; Feeling hot; Weakness
generalized; Muscle pain; COVID-19; This regulatory authority case was reported by
a non-health professional and describes the occurrence of RESPIRATORY FAILURE
(Respiratory failure) and COVID-19 (COVID-19) in a 74-year-old male patient who
received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19
vaccination. The occurrence of additional non-serious events is detailed below.
Concurrent medical conditions included Spinal disorder (Degeneration of the spine).
On 20-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced
DIZZINESS (Dizziness), FEELING HOT (Feeling hot), ASTHENIA (Weakness generalized)
and MYALGIA (Muscle pain). On 05-Mar-2021, the patient experienced RESPIRATORY
FAILURE (Respiratory failure) (seriousness criterion death) and COVID-19 (COVID-19)
(seriousness criterion death). The patient died on 05-Mar-2021. The reported cause
of death was Respiratory failure and covid-19, virus identified. It is unknown if
an autopsy was performed. At the time of death, DIZZINESS (Dizziness), FEELING HOT
(Feeling hot), ASTHENIA (Weakness generalized) and MYALGIA (Muscle pain) outcome
was unknown. Concomitant product use was not provided. Treatment
information was not provided. The reporter's contact information was not provided.
Reporter did not allow further contact; Reported Cause(s) of Death: Respiratory
failure; COVID-19, virus identified" "No prior vaccinations for this event."
"1197016-1" "patient was hospitalized with COVID-19 on April 6, 2021" "No
"1229797-1" "Paient was vaccinated on 3/29/2021 with dose 1 of Moderna.
Patient developed COVID symptoms on 4/4/2021 and passed away on 4/16/2021." "No
"1232988-1" "Taken to the Hospital due to COVID-like symptoms (strong cough).
At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin
levels. Dies at the Hospital due to COVID-19." "No prior vaccinations for this
event."
"1233587-1" "Patient received two dose Moderna series of vaccinations for
COVID 19 (1/21/2021 and 2/18/2021). Patient reported to ED feeling weak on
2/20/2021, but was not tested for COVID at that time. Reportedly, patients family
were all tested for COVID and were positive on or about 2/21/2021. The patient was
later admitted to the hospital on 4/13 with COVID. She subsequently expired on
4/14." "No prior vaccinations for this event."
"1241393-1" "Death Narrative: The patient did not have any predisposing
factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient
transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that
day. He was reported to have a reaction to the vaccine including diaphoresis, new
onset afib, and hypotension(vasovagal reaction). He was discharged the next day
with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID
pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure
secondary to COVID-19. Comorbidities include advanced age, obesity, HLD,
atherosclerosis, DM2, HTN." "No prior vaccinations for this event."
"1241403-1" "Death Narrative: Patient tested positive for COVID-19 on
1/25/21 after receiving her first vaccine on 1/8/21. He was discharged from
hospital on 1/26/21 with admitting diagnosis of COVID pneumonia. He did not have
any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug
event. The ADR did not occur at the time of administration of the vaccine nor was
there an ADR that occurred between the observation period and the date of death.
Patient had made it through the COVID infection period but suffered complications
including pneumonitis, lung, heart, and kidney failure requiring high flow oxygen.
He required readmission to hospital for the complications in 3/2021 but ultimately
passed away on 3/24/21 likely due to the multi organ failure complication of COVID"
"1241587-1" "She was a healthcare worker. It was reported to me by her
immediate supervisor that she tested positive for COVID-19 the day after her first
vaccination. She became symptomatic around January 21, 2021. She was scheduled to
return to work on January 29, 2021 but did not come in. She died on February 2,
"1242858-1" "Patient contracted COVID 19 and subsequently expired from
respiratory distress, following completion of the serious of two vaccination shots.
She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to
the lot # info- would have to contact vaccination site to obtain" "No prior
"1246110-1" "Lethargy, weakness, headache; ultimately pronounced on 4/3/2021
at 1310 hours" "No prior vaccinations for this event."
"1247898-1" "Patient had second covid 19 vaccine on 2/2/21 at pharmacy. Was
admitted on 4/6/21 to hospital with Shortness and Breath, Vomiting, and COVID-19
(tested positive on 4/6/21). Patient expired on 4/8/21 @ 1954." "No prior
"1257832-1" "Hospitalized +Covid post vaccination with decreased mental
status" "No prior vaccinations for this event."
"1258269-1" "This pt came in to see me in her normal state of health and then
received moderna #1 here on 4/1. Developed SOB 2 hrs after vaccination. Presented
to ER on 4/2 with hypoxia (80%) and was + for covid. The ER triage notes states ?
C/O SOB, Nausea, vomiting, diarrhea that started yesterday 2 hours after he first
COVID Vaccine?. Notes quote her saying ?I got my vaccine yesterday and I started
to feel short of breath.? She died from covid respiratory failure on 4/23." "No
"1267074-1" "#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented
after sudden onset of chest pain early in morning and found to be covid +. ECG
demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't
have much in it. He was found to be COVID rapid test+ and IGG negative. He was
admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub
noted on physical exam. Cardiology ruled out STEMI, thought maybe viral
pericarditis - but wanted echo done after out of isolation. CTA was planned for AM
on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was
not able to be achieved despite aggressive resuscitation efforts" "No prior
"1267753-1" "Case tested positive for COVID-19 on 12/7/2020; vaccinated on
1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021.
Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall. Case
had altered mental status and fever. Case was found to have an acute CVA." "No
"1268137-1" "Cause of Death A: Acute encephalopathy Cause of Death B: COVID
19 IMMUNIZATION FOLLOWING COVID 19 VIRUS INFECTION Cause of Death Other: Chronic
Schizophrenia" "No prior vaccinations for this event."
"1273804-1" "GI Hemorrhage Covid + Respiratory Failure" "No prior
"1275915-1" "On 3/25/21, patient presented to the ED with several days
history of nausea, vomiting, and upper abdominal pain, and 1 day history of
shortness of breath and wheeze. Patient recently received her first dose of
Moderna COVID vaccination on March 10. Patient's daughter first developed COVID
symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed
nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was
tested positive for COVID several days prior to admission (either the 22 or 23rd,
patient not sure). On the morning admission, patient had significant worsening of
shortness of breath and wheeze. Patient also became significantly more weak and
fatigued, and was eventually brought to ED. Patient reported chills, but denied
headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21
with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21." "No prior
"1282517-1" "Patient visited his doctor/pulmonologist on 3/18/21 and had a
negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid
Vaccine was administered on 3/20/21. Within 10 days he developed a serious
cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating,
lifting his arms and communicating. He was diagnosed with Covid Pneumonia.
Patient had underlying conditions (heart, lung and kidney disease)" "Patient was
hospitalized after a FLU vaccine 5 years ago"
"1285947-1" "Hospitalized and died of COVID-19 after being fully
vaccinated." "No prior vaccinations for this event."
"1286213-1" "Presented to ED on 4/23/21 with weakness, malaise, poor appetite
and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy
infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia.
Patient referred to hospice." "No prior vaccinations for this event."
"1286659-1" "Shortness of breath, hypoxia, + COVID-19" "No prior
"1296384-1" "Client admitted to the hospital on 4/26/2021 with Covid
symptoms, body aches, SOB and chest pain. Diagnosed with Covid -19 pneumonia.
Antigen test positive for Covid-19 on 4/26/2021. Subsequent admission on 5/4/2021
with cardiac arrest secondary to hypovolemic shock from UGI bleed, likely variceal.
Client died 5/5/2021." "No prior vaccinations for this event."
"1296477-1" "Case had COVID-19 in November 2020 as part of an outbreak in the
SNF she lives in. She recovered then received her first COVID-19 vaccination on
1/4/21. She received her 2nd dose of Moderna on 2/1/21. On 4/11/21 she became ill
and was transferred to the hospital where she tested PCR positive for COVID-19. She
continued to decline and was intubated. She died on 4/28/21 while still in the
hospital. The diagnosis on her death summary from the hospital is COVID-19
pneumonia." "No prior vaccinations for this event."
"1303196-1" ""per medical report from hospital- ""presented to emergency room
at outside facility secondary to worsening shortness of breath. The patient states
that about 1 week ago she started feeling ill directly after receiving her first
covid vaccine. the patient states her medical issues actually began approximately 2
months ago when she developed sudden onset positional urinary retention as well as
urinary incontinence and constipation. She states that she thought maybe her known
spinal stenosis had worsened causing her bladder dysfuntion.She states she tries to
sit on a commode or a toilet and is unable to void however when lying flat she has
to wear adult briefs as she has no control over her bladder at all. There is no p""
"1307516-1" "Hospitalized and died due to COVID-19 after being fully
vaccinated. From vital records: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA
DUE TO COVID-19" "No prior vaccinations for this event."
"1307637-1" "Patient received dose 1 on 2/12/2021 and dose 2 on 3/15/2021
from community pharmacy. Tested positive on 4/7/2021. Hospitalized for COVID on
4/19/2021. Discharged on 4/29/2021 to hospice. Passed away on 5/1/2021." "No
"1310651-1" "Patient received Moderna vaccine 3/2/2021 0.5 ml LD IM Lot:
029L20A and Moderna vaccine 3/30/2021 0.5 ml LD IM Lot: 019B21A. The patient was
exposed to an infected person with Covid about 1 week after her second vaccine. She
was admitted to the ICU with severe covid on 4/13/21. She was eventually
transitioned to comfort care and died on 5/6/2021." "No prior vaccinations for
this event."
"1311196-1" "FEVER COUGH FATIGUE HEADACHES" "No prior vaccinations for
this event."
"1313922-1" "PT NO SHOW FOR APPT 5/11 FOR 2ND DOSE -CHECK OF agency system
SHOWS PT REPORTED DECEASED 5/14- CHECK OF database SHOWS PT FOUND DECEASED AT HOMEN
5/14/21- AUTOPSY Completed" "No prior vaccinations for this event."
"1313931-1" "ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department
Last attending ? Treatment team Generalized weakness +4 more Clinical impression
Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency
Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with
? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for
which she wears oxygen at night and as needed, also with a history of leukemia and
obesity who presents to the ED complaining of generalized body aches, fevers up to
103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient
reports that she received her second COVID-19 vaccine approximately 1 week ago.
Tolerated this without any particular symptoms. She has had 2 days of
watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting
earlier today. She is denying any particular abdominal pain. Does believe she
felt her urine burning earlier today but has had no gross hematuria. Denies any
flank pain. No ill contacts although her husband has been at home with a slight
cough. Patient does have a cough presently but it is nonproductive. She is
denying any particular chest pain or subjective shortness of breath. No rash or
unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission
Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment
team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine
Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge
Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present
Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past
medical history of chronic lymphocytic leukemia follow-up that was initially
scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on
2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in
the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough,
fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed
with COVID-19. She had however received a second dose of COVID-19 a week before
and was discharged home due to lack of significant findings on imaging chest x-ray
and lack of requirement for higher oxygen support. She presented to the emergency
via EMS for evaluation of progressive shortness of breath with associated with
fever, chills, headache, persistent shortness of breath, cough productive of thick
clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest
pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently,
she thought she was getting better upon discharge after being kept for about 12
hours in the last ED visit, however she was not feeling well after going to bed
last night and asked the husband to call 911. Upon EMS arrival patient was
saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was
eventually placed on 10 L oxygen support. She was noted to be in significant
respiratory distress during speech. Hospital Course Patient was admitted to
hospital due to shortness of breath, and was found to have severe sepsis on
presentation due to COVID-19 pneumonia. She had evidence of acute on chronic
hypoxic respiratory failure as well. She was started on IV antibiotics, as well as
remdesivir and Decadron at high dose. Unfortunately she continued to have
clinical deterioration, and ultimately required high flow oxygen therapy. She was
then transferred to the ICU, and ultimately required intubation due to severe
profound ongoing hypoxia despite optimal medical treatment. She did not respond to
remdesivir or steroids or antibiotics. Post intubation, she also developed acute
renal failure during the course of her admission. Multiple discussions were had
throughout the hospitalization regarding goals of care, and initially patient and
family wish to be continually aggressive. She received full medical treatment,
including life support, with minimal improvement. Despite being on ventilator for
roughly 5 days, she continued to have severe hypoxia. She was proned, and was
unable to sustain oxygen saturations when supine even for short period. Her renal
function continued to decline as well, and at that point discussion was had with
family regarding goals of care again. They were explained that symptoms continue
to be persistent, and her illness continues to progress despite aggressive medical
therapy. Ultimately decision was made to not pursue dialysis, and to allow the
patient to be kept comfortable and pass away naturally from this infection. She
was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and
acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-
ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen
INDICATION: Nasogastric tube placement, encounter initial Supine portable view of
the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in
the gas-distended stomach. This report was created using Voice Recognition
software. Thank you for allowing us to participate in the care of your patient.
X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No
significant change from the previous examination. END OF IMPRESSION: INDICATION:
Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON:
X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ
central venous catheter are unchanged. Right-sided chest tube is unchanged. There
is a small left pleural effusion. There is diffuse bilateral hazy airspace
opacification. No change from prior. This report was created using Voice
Recognition software. Thank you for allowing us to participate in the care of your
patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW
PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged
patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening
hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray
4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central
venous catheter are unchanged. The right-sided chest tube is unchanged. There is no
pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace
consolidation. There is no significant change. Cardiac silhouette is normal size.
There is calcification of the aorta. This report was created using Voice
patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest
radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal
radiograph of the chest was obtained and compared to the prior study dated
4/13/2021. The heart is at the upper limits of normal. The mediastinum is within
normal limits. Interstitial alveolar opacities are demonstrated bilaterally
consistent with pneumonia. There is an endotracheal tube with the distal end
approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards
the stomach. There is a right jugular central catheter. A right-sided pigtail
catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar
opacities consistent with pneumonia. 2. Lines and tubes in place as described. This
report was created using Voice Recognition software. Thank you for allowing us to
participate in the care of your patient. X-ray Chest 1 View, Portable Result
Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and
time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+
TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR
CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal
tube tip located at the level of the carina. Pigtail drainage catheter tip remains
superimposed over the lateral right mid lung zone. Nasogastric tube enters the
stomach but tip not included on the image. Tip of right internal jugular central
venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally.
Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051
hrs, new consolidation and/or atelectasis in the left lung base. No significant
interval change in scattered patches of ground-glass opacity (GGO) within each
lung. Patient has history of COVID-19. Pleural spaces: Small right apical
pneumothorax (12 mm). New small left pleural fluid collection. No right pleural
fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints:
Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of
the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral
right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to
chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new
consolidation and/or atelectasis in the left lung base. 5. New small left pleural
fluid collection. 6. No significant interval change in scattered patches of
ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS
DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable
Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement
of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect
projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left
thoracostomy tube terminates near the lateral right midlung. No other change.
Extensive
pulmonary infiltrates. Stable life support lines. The previous right pneumothorax
has predominantly resolved, only a thin crescent of air caps the right apex. END OF
IMPRESSION: This report was created using Voice Recognition software. Thank you for
allowing us to participate in the care of your patient. X-ray Chest 1 View,
Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines
as described. There is a small right-sided pneumothorax. Unchanged bilateral
airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and
post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-
ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is
projected over the SVC. There is a small right apical pneumothorax. Endotracheal
tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath
the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally.
Findings do not appear significantly changed from prior. The cardiac silhouette is
normal size. There is calcification of the aorta. This report was created using
Voice Recognition software. Thank you for allowing us to participate in the care of
your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1
VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF
IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening
respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is
acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is
partially excluded. The lungs are adequately expanded. There are large areas of
patchy airspace consolidation bilaterally. Findings have mildly increased in
severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly
enlarged. There is calcification of the aorta. This report was created using Voice
patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT
INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE:
AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021.
FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the
right upper and right lower lobe. No change in the heart, mediastinum, or bony
thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This
report was created using Voice Recognition software. Thank you for allowing us to
participate in the care of your patient. X-ray Chest 1 View - Portable Result
Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute
pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak,
cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON:
6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of
pulmonary arteries. This is stable. There is no focal consolidation or effusion.
This report was created using Voice Recognition software. Thank you for allowing us
to participate in the care of your patient. Transthoracic Echo (tte) Complete
Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021
10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart
Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D,
Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is
normal in size. Ejection Fraction 55% (normal range 50-70%). All wall
segments showed normal motion. Mild concentric LVH.
Trivial aortic regurgitation. No additional significant valvular
abnormality. No prior study for comparison. Presentation and
History: Indication: The patient presents for evaluation of arrhythmia. The
patient has a history of obesity and chronic obstructive pulmonary disease.
Findings: Procedure Information: Contrast agent, definity, is being given per
protocol without apparent complications. Due to technical limitations in the
assessment of the left ventricle, imaging was performed after the administration of
intravenous Definity echocontrast, as per protocol. Left Ventricle: The left
ventricle is normal in size. There is mildly increased left ventricular wall
thickness. The left ventricular systolic function is normal. The visually
estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall
segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly
normal in size and function by subcostal view. Atria: The left atrium is borderline
dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing
aortic valve with no significant aortic stenosis. Trivial aortic regurgitation.
Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler
analysis. There is no mitral valve stenosis by color flow and doppler analysis.
Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or
insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace
tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels:
All visible segments of the aorta are normal in size. Venous: The inferior vena
cava is normal in size and collapses greater than 50% with inspiration.
Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study
Comparison: No prior study for comparison.
Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-
5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6)
LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-
224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT
Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00
LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial:
5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E:
0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33
E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic
Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn
Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00
RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc:
3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final
electronically signed on 4/11/2021 5:10:04 PM with status of Final
Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative:
PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and
time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness
of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid
TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without
contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed
images were created by the technologist. Radiation optimization: All CT scans at
this facility use at least one of these dose optimization techniques: automated
exposure control; mA and/or kV adjustment per patient size (includes targeted exams
where dose is matched to clinical indication); or iterative reconstruction.
COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy
peripheral ground-glass opacities which can be seen with atypical pneumonia.
Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No
cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta.
Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No
acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-
glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN
ELECTRONICALLY SIGNED BY MD" "No prior vaccinations for this event."
"1317367-1" "U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1, J96.00 -
Acute respiratory failure due to COVID-19" "No prior vaccinations for this
event."
"1322807-1" "Patient was seen by an outpatient provided and was referred to
emergency department due to hypoxis and respiratory distress on 4/27/21. He was
found to by COVID-19 positive at that time. He was admitted to the hospital for
further management. on 4/28/21, his condition declined. He was intubated and
transferred to the ICU. Patient went into severe acute kidney injury and
eventually into multi-system organ failure. He was placed on comfort measures on
and was pronounced dead on 5/15/21." "No prior vaccinations for this event."
"1323550-1" "Patient received Moderna COVID vaccine on 2/1/2021 and
2/22/2021. Pt. presented to Medical center within Health system with weakness and
arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for
COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health
system on 5/2/2021 complaining of SOB. Stated that she has had non-productive
cough for months, but felt it had worsened lately. Pt. found to be COVID positive
with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not
intubated but expired from cardiac arrest/COVID on 5/16/2021." "No prior
"1323673-1" "Subsequently developed respiratory distress and pneumonia after
testing positive for COVID. Pt died due to illness." "No prior vaccinations for
this event."
"1330750-1" "ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours)
Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance
(CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine
Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge
Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021
Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA *
(Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic
stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive
pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes
Coronary artery disease with history of myocardial infarction without history of
CABG Not Applicable Depression Yes History of aortic valve replacement
Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral
vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia
(CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA
(transient ischemic attack) Not Applicable Dementia with behavioral
disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting
Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury)
(CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91]
Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history
of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome
status post pacemaker, aortic stenosis status post valve replacement.Coronary
artery disease status post CABG, CHF, history of peripheral vascular disease,
history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD,
dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia
11/2020 was brought to the emergency room by the family due to worsening confusion
and agitation, as per wife after the patient was discharged back in November in few
weeks patient dementia started to get worse, more confused, more agitated and few
times he was violent to his family members, well for the last few days patient's
wife reported that his confusion was very bad so she decided to bring him to the ED
for further evaluation management. Hospital Course -For the above presentation
patient was admitted to the hospital services, patient was started on oxygen
supplementation, Covid repeat test continue to be positive, started on IV
antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8
patient was found without any spontaneous respiration, patient was pronounced dead
by the RN and CRNP finished the discharge defecate, please refer to RN
documentation for more details." "No prior vaccinations for this event."
"1336774-1" "Patient developed fever, dyspnea and headache on 5/12/2021;
tested positive for COVID-19 on 5/12/2021; patient died on 5/20/21" "No prior
"1337701-1" "64 y.o. female who presented with SOB. She has a history of CAD,
diabetes, CHF, CKD and DVT presents to the ED in respiratory distress. Patient was
brought in by EMS from nursing home. Patient had reported onset of shortness of
breath and respiratory distress over the last 6-7 hours. Patient has O2 sat of 90%
on 6 L. Patient only uses 2 L nasal cannula oxygen all day long. Patient is
coherent and initially was placed on BIPAP but then stated she wanted to go back,
now after ER doc spoke to her she is ok with being admitted but does not want BIPAP
or to be placed in the ICU. She is DNR/DNI. She is working hard to breathe
currently. Patient is unsure if she is making urine at this time. Workup in the ER
revealed AKI on CKD and covid + pneumonia. Patient elected hospice and expired
5/20/2021. It was reported that patient had received vaccines at Walmart." "No
"1337755-1" "Person died on 5/9/2021, with death note listing acute and
chronic respiratory failure with hypoxia, COVID-19, paroxysmal atrial fibrillation,
chronic heart failure with reduced ejection fraction, follicular lymphoma, history
of CABG, hyperglycemia, and type 2 diabetes." "No prior vaccinations for this
event."
"1347160-1" "fall on May 19 and admitted to ER May 22 with subacute R MCA
stroke resulting in obtundation and left sided hemiparalysis. Complicating his
presentation is acute COVID 19 infection with pneumonia along with acute on chronic
systolic congestive heart failure." "No prior vaccinations for this event."
"1347808-1" ""started with c/o ""feels weird in my chest like a pulled
muscle"", few days later slight short of breath with fatigue, May 2 11:45 cardiac
arrest when paramedics placed O2, rounds of CPR and med's, pronounced dead at
hospital after attempts of CPR. Out come on death certificate Bilateral Pulmonary
Thromboemboli. Coroner stated there were multiple PE's in bilateral lungs. Positive
for Covid 19 (Had in Feb, vaccine in April 20)"" "No prior vaccinations for
this event."
"1353962-1" "COVID-19; This regulatory authority case was reported by an
other health care professional and describes the occurrence of COVID-19 (COVID-19)
in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna)
for COVID-19 vaccination. No Medical History information was reported. On
06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced
COVID-19 (COVID-19) (seriousness criterion death). The patient died on 22-Apr-2021.
The reported cause of death was covid-19. An autopsy was not performed. For
mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any
causality assessments. No concomitant products were reported. Action taken with
mRNA-1273 in response to the events was not applicable. ADR description - Covid;
Sender's Comments: Based on biological plausibility, the event is assessed as
unlikely related to mRNA-1273. The event of COVID-19 was consistent with infection
in pandemic set up.; Reported Cause(s) of Death: COVID-19" "No prior vaccinations
for this event."
"1355384-1" "Admitted to the hospital with weakness, fever on 4/14/2021.
Transferred to ICU on 4/17/21 requiring bipap. Intubated 4/25/2021. covid + 4/2/21.
Last vaccine dose completed 3/3/2021. Pt died on 5/15/2021""No prior vaccinations
for this event."
"1357112-1" "Patient developed COVID after vaccination; She is now deceased;
This spontaneous case was reported by a consumer and describes the occurrence of
DEATH (She is now deceased) in a 73-year-old female patient who received mRNA-1273
(Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The
occurrence of additional non-serious events is detailed below. Concurrent
medical conditions included Cancer (previously had cancer twice). Concomitant
products included ATORVASTATIN CALCIUM (LIPITOR), NIFEDIPINE (PROCARDIA
[NIFEDIPINE]), TICLOPIDINE HYDROCHLORIDE (TICLID), OMEPRAZOLE (PRILOSEC
[OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On
22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19
Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced
COVID-19 (Patient developed COVID after vaccination). The patient died on 23-Apr-
2021. The cause of death was not reported. It is unknown if an autopsy was
performed. At the time of death, COVID-19 (Patient developed COVID after
vaccination) outcome was unknown. It was reported that the patient
previously had cancer twice, and her immune system was not what it should have
been. The patient got really, really sick and had COVID at some point after
receiving the vaccine. No corrective treatment was provided. Action taken with
the drug in response to the events was not applicable. Company comment: Very
limited information regarding this event has been provided at this time. Noting the
subject had received 1st dose of vaccine prior to COVID. However, based on the
mechanism of action of mRNA1273, the event COVID is unlikely related to vaccine.;
Sender's Comments: Very limited information regarding this event has been provided
at this time. Noting the subject had received 1st dose of vaccine prior to COVID.
However, based on the mechanism of action of mRNA1273, the event COVID is unlikely
related to vaccine.; Reported Cause(s) of Death: Unknown cause of death" "No
"1364724-1" "Patient received second COVId 19 vaccine on 4/9/21 @ Health
Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and
Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired
on 5/19/2021 at hospital." "No prior vaccinations for this event."
"1366092-1" "COVID-19 pneumonia; Vaccination failure; COVID-19; This
regulatory authority case was reported by a physician and describes the occurrence
of COVID-19 PNEUMONIA (COVID-19 pneumonia), VACCINATION FAILURE (Vaccination
failure) and COVID-19 (COVID-19) in a 72-year-old female patient who received mRNA-
1273 (COVID 19 Vaccine Moderna) (batch no. G26761A) for COVID-19 vaccination.
The patient's past medical history included COVID-19, COVID-19 pneumonia, Kidney
failure chronic and Kidney transplant in June 2015. Concurrent medical conditions
included Insulin therapy, ARDS, Allergy to antibiotic and Diabetes mellitus.
Concomitant products included INSULIN HUMAN (HUMULIN R), ROSUVASTATIN CALCIUM
(XETER), ENALAPRIL MALEATE (EDNYT), ALLOPURINOL (MILURIT), DOXAZOSIN,
ACETYLSALICYLIC ACID, PREDNISOLONE (PREDNISOLON RICHTER), TACROLIMUS (ADVAGRAF),
INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), PANTOPRAZOLE SODIUM SESQUIHYDRATE
(CONTROLOC), FUROSEMIDE, METOPROLOL SUCCINATE (BETALOC ZOK), POTASSIUM CHLORIDE
(KALDYUM) and MYCOPHENOLATE SODIUM (MYFORTIC) for an unknown indication. On 05-
Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna)
(Intramuscular) .5 milliliter. On 16-Apr-2021, after starting mRNA-1273 (COVID 19
Vaccine Moderna), the patient experienced COVID-19 (COVID-19) (seriousness criteria
death and hospitalization). On an unknown date, the patient experienced COVID-19
PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death, hospitalization and
medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness
criteria death and hospitalization). The patient died on 22-Apr-2021. The reported
cause of death was COVID-19 pneumonia, Vaccination failure and covid-19. It is
unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are
provided in parenthesis if available): On 16-Apr-2021, SARS-CoV-2 test: positive
(Positive) POSITIVE. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular),
the reporter considered VACCINATION FAILURE (Vaccination failure) to be possibly
related. No further causality assessments were provided for COVID-19 PNEUMONIA
(COVID-19 pneumonia) and COVID-19 (COVID-19). Treatment medicines were not
provided. Action taken with mRNA-1273 in response to the event was not applicable.
Company comment: Very limited information regarding this events has been provided
at this time.; Sender's Comments: Very limited information regarding this events
has been provided at this time.; Reported Cause(s) of Death: COVID-19 pneumonia;
Vaccination failure; COVID-19" "No prior vaccinations for this event."
"1368648-1" "Died on 1/31/2021." "No prior vaccinations for this event."
"1371177-1" "Patient hospitalized and died after testing positive for COVID-
19. Tested positive on 5/3/2021." "No prior vaccinations for this event."
"1371859-1" ""COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021 patient
admitted through ED for chief complaint of 5 days shortness of air, tested positive
for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021 admitted to
ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021 patient
intubated due to respiratory failure/distress/hypoxia; identified in septic shock.
5/31/2021 went to surgery for left forearm and hand compartment syndrome. 6/3/2021
Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and Verapamil
(intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine Manufacturer:
Moderna Lot #: Clinic Administering Vaccine: ""local church"" - no specific name
was provided, Injection site: Description of event/reaction: Patient does not have
vaccination card and reports not knowing date of first vaccine or exact clinic
location. Date of Hospitalization: 5/24/2021 Reason for clinic visit or
hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if Yes,
date 05/23/2021"" "No prior vaccinations for this event."
"1374761-1" "COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested
positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia,
hypoxia, non-sustained ventricular tachycardia, altered mental status,
cardiomyopathy, septic shock, and multiorgan failure; also tested positive for
haemophilus influenza." "No prior vaccinations for this event."
"1377765-1" "My mother was the patient in question She had a Moderna Covid
Vaccine in Feb/March of 2021. She then had 2 doses of Rituxan on April 28th of
2021. After her second dose of the medication, she tested positive for covid 3
days later. She was hospitalized on May 8th and was not able to recover. She passed
away on May 20th. The Drs at the Hospital in told me the rituxan essentially wiped
the vaccine from her body. The reason I'm reporting this is to warn others in her
position about the possible side effects. My mom had a very false sense of
security." "No prior vaccinations for this event."
"1378451-1" "Unsure, Department followed up on her positive COVID results in
10/2020 and 11/2020. It came to our attention last week that the reason stated for
her death on 5/28/21 was due to COVID. Due to having 2 positive tests late last
fall and then seeing that she had been vaccinated for COVID in March and April
2021, I was instructed to complete a VAERS." "No prior vaccinations for this
event."
"1382262-1" "Patient received first dose of Moderna on 4/15/2021. Patient
tested positive on 4/19/2021 for Covid. Patient admitted to hospital on 4/25/2021.
Patient expired 5/14/2021" "No prior vaccinations for this event."
"1382638-1" "Patient received his second dose of the Moderna vaccine on
5/21/21. On the morning of 5/22/21, patient started having issues with mobility,
heavy sweats, body aches, and headache, although he had no fever and maintained his
sense of smell and taste. Patient was later hospitalized and tested positive for
COVID on Thursday, May 27, 2021. Patient passed away on Friday, May 28, 2021."
"1385943-1" "04/28/2021: Patient transferred from Hospital with shortness of
breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated
episodes of hypoxemia and hypotension - was intubated on mechanical ventilation,
eventually switched to pressure control inspiratory pressure, extubated, had to be
reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension
pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient
placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00
Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory
failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable
bacterial superinfection, Atrial fibrillation with rapid ventricular response,
Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida
tracheobronchitis, Previous history of prostate cancer status post radiation,
dyslipidemia, hypertension present at admission." "No prior vaccinations for
this event."
"1392262-1" "COVID-19; Vaccination failure; inappropriate schedule of
vaccination; This regulatory authority case was reported by a physician
(subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-
19) and VACCINATION FAILURE (Vaccination failure) in a 74-year-old female patient
who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The
occurrence of additional non-serious events is detailed below. The patient's
past medical history included Myeloproliferative neoplasm since an unknown date,
Adipositas, Hypertension arterial and Coronary heart disease. On 20-Mar-2021, the
patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular)
1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine
Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 20-Mar-2021, the
patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate
schedule of vaccination). On 20-Apr-2021, the patient experienced COVID-19 (COVID-
19) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure)
(seriousness criterion death). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT
ADMINISTRATION (inappropriate schedule of vaccination) outcome was unknown. The
patient died on 24-Apr-2021. The reported cause of death was Respiratory failure.
An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided
in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: positive (Positive)
positive and positive (Positive) positive; Ct value = 13 SARS-COV2 lineage B.1.1.7.
For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not
provide any causality assessments. Concomitant medications were not provided.
Treatment information was not provided. Company Comments: This case concerns a 74-
year-old female patient who experienced inappropriate schedule of vaccination and
fatal event of COVID-19 13 days post last dose of mRNA-1273 vaccination. Patient
had significant underlying co-morbidities to include neoplastic disease in addition
to advancing age. Based in biological implausibility, causal relationship between
the reported events and product use is unlikely.; Sender's Comments: This case
concerns a 74-year-old female patient who experienced inappropriate schedule of
vaccination and fatal event of COVID-19 13 days post last dose of mRNA-1273
vaccination. Patient had significant underlying co-morbidities to include
neoplastic disease in addition to advancing age. Based in biological
implausibility, causal relationship between the reported events and product use is
unlikely.; Reported Cause(s) of Death: Respiratory failure""No prior vaccinations
for this event."
"1395420-1" "Patient presented to emergency department for increasing trouble
breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on
3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for
management of COVID-19 infection where she also tested positive for COVID-19. She
was admitted for further management of COVID-19 infection. Her symptoms did not
improve and she was placed on comfort measures on 5/4/2021. Patient expired on
5/5/2021 due to complications from COVID-19 infection." "No prior vaccinations
for this event."
"1395844-1" "pt had 2nd Moderna vaccine on 2/10/2021 lot # 013M20A. Pt
became Ill on 5/10/2021, test covid-19 positive on 5/17/2021 and treated with BAM,
Intubated on vent 6/1/2021 deceased 6/13/2021" "No prior vaccinations for this
event."
"1403521-1" "weak, loss of appetite, pneumonia, ARDS" "No prior vaccinations
for this event."
"1406851-1" "5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female
with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and
HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive
in the ED and was intubated for airway protection. CTA chest with extensive acute
pulmonary embolism with findings of right heart strain. Patient intubated and
sedated, information is obtained from her son, medical staff and medical records.
Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to
slowly be improving until Saturday prior to admission Per son was more tired but
she had worked with physical therapy and HH on Friday. Sunday she was having
difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental
status, unspecified altered mental status type; Pneumonia of left lower lobe due to
infectious organism; Atrial fibrillation with rapid ventricular response (HCC);
Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary
embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory
failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB
(shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial
fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)"
"1410369-1" "Patient received 2nd dose of the COVID-19 vaccine on 2/10/21 and
was considered fully vaccinated two weeks later on 2/24/21. On 6/10/21 patient was
hospitalized with a possible upper GI bleed. Overnight the patient began to have
increased oxygen needs and crackles on auscultation. She was transferred to the
ICU, had an abnormal chest x-ray, and tested PCR positive for COVID-19. The patient
had acute kidney failure and respiratory failure with a DNR and DNI. She expired on
"1410797-1" "Initially had fatigue, diarrhea, and loss of appetite. Tested
positive for COVID 19 on 5/28/21 , during surveillance testing related to a
facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness,
high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back
to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia,
treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On
6/12/2021, went to ED for ischemic stroke. Died 6/13/2021.""No prior vaccinations
for this event."
"1417109-1" "Patient received first dose of Moderna on May 18, 2021. Spouse
came to the pharmacy and informed us that the patient passed away in the hospital
on June 15, 2021. She was diagnosed with COVID-19 during her stay at the
hospital." "No prior vaccinations for this event."
Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died
on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD
and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as:
OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG
DISEASE (ASTHMA/EMPHYSEMA/COPD)" "No prior vaccinations for this event."
Moderna vaccine series (Dose 1 on 2/11 and Dose 2 on 3/11). The patient later died
on 5/13/21 . Cause of Death is listed as ?Intestinal Obstruction?." "No prior
"1420707-1" "Patient presented to ER on 01/18/2021 and stated respiratory
symptoms began on 01/14/2021. Positive Covid test that day. Patient was released
from ER and admitted as inpatient to the hospital on 01/23/2021 and expired of
Covid related symptoms on 02/02/2021." "No prior vaccinations for this event."
"1424014-1" "Death 4/18/2021 Causes of death listed on patient's death
certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis,
Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity"
"1424081-1" "Death 4/7/2021 Causes of death listed on death certificate: 1)
Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4)
Atrial fibrillation Other: COVID 19" "No prior vaccinations for this event."
"1424120-1" "Death 04/23/2021 Causes of death listed on death certificate:
1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension"
cardiac arrest 2) unknown cause Other: COVID 19, CAD, AKI needing HD" "No
"1425911-1" "Death: 04/20/2021 Causes of death listed on death certificate:
1) Covid" "No prior vaccinations for this event."
atherosclerotic heart disease Other: recent Cove at 19, pneumonia, peripheral
vascular disease, hypertension, dementia, extensive squamous cell carcinoma of skin
of scalp, protein calorie malnutrition" "No prior vaccinations for this event."
"1425926-1" "Death: 5/7/2021 Causes of death listed on death certificate: 1)
COVID-19 2) Sepsis 3) Sarcoidosis 4) End stage renal disease Other:
Hypertension, Congestive heart failure" "No prior vaccinations for this event."
"1427108-1" "COVID symptoms began 3/16, positive test 3/19, hospital
admission 3/22, death 4/1" "No prior vaccinations for this event."
"1427795-1" "Died 4/24. Immediate cause of death acute hypoxic respiratory
failure, underlying cause COVID-19 associated respiratory distress syndrome and
COVID-19 viral pneumonia" "No prior vaccinations for this event."
"1431331-1" "Patient received second COVID vaccine on 2/3/2021. Was admitted
to Medical Center on 6/15/21 for generalized weakness and tested positive for COVID
19 on 6/15/2021. Patient was also positive for COVID 19 in November 2020. Patient
expired on 6/26/2021 while hospitalized." "No prior vaccinations for this event."
"1431351-1" "3/7/2021: dysregulated taste, dyspnea, Myalgia, pneumonia,
hospitalized, treated but died" "No prior vaccinations for this event."
"1431502-1" "Patient died of complications due to COIVD-19 illness, which was
4 months after receiving his second dose of vaccine. He was a breakthrough case
that died with full vaccination status for COIVD-19. No one is indicating that the
vaccine had anything to do with this persons' death." "No prior vaccinations for
this event."
"1433471-1" "Died of COVID-19 illness on 05/08/2021" "No prior vaccinations
for this event."
"1433788-1" "Death 5/29/2021 Causes of death listed on death certificate: 1.
pneumonia 2. COVID 19 3. coronary artery disease, hypertensin, Non insulin
dependant diabetes" "No prior vaccinations for this event."
Cardiac arrest 2) Failure to thrive 3) Parkinson's Disease 4) COVID-19 infection
4/2021 Other: Coronary artery disease" "No prior vaccinations for this event."
"1437378-1" "Died of COVID-19 illness on 05/05/2021" "No prior vaccinations
for this event."
"1437443-1" "Death 5/31/2021 Causes of death listed on death certificate: 1.
Autoimmune cold-agglutinin hemolytic anemia 2. COVID 19 3. rheumatoid arthritis,
chronic immunosuppression" "No prior vaccinations for this event."
Hypertensive Heart disease with Heart Failure Diastolic Other: Covid-19" "No
"1440922-1" "ADMITTED TO HOSP AFTER BYSTANDER CPR. COVID TEST AT ADMIT
POSITIVE" "No prior vaccinations for this event."
"1441060-1" "Blood clots in heart with extremely low blood pressure and
shortness of breath. Symptoms suddenly appeared on 04/02/21. Hospitalization and
rehabilitation Until discharge of 05/03/2021. Extremely low blood pressure,
weakness and shortness of breath continued until he was hospitalized again
06/02/2021 He passed away 06/09/2021. He was labeled as Covid 19" "No prior
"1449945-1" ""Vaccination failure; This regulatory authority case was
reported by an other health care professional and describes the occurrence of
COVID-19 and VACCINATION FAILURE (Vaccination failure) in an 85-year-old male
patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. EK9788) for
COVID-19 vaccination. No medical history was reported. The patient's past
medical history included Orthostatic hypotension, Abdominal aortic aneurysm and
Cirrhosis of liver. Concomitant products included PERINDOPRIL ERBUMINE (COVERSUM)
for COVID-19 vaccination, AMIODARONE, ATORVASTATIN, DUTASTERIDE, TAMSULOSIN
HYDROCHLORIDE (DUODART), APIXABAN (ELIQUIS), PANTOPRAZOLE SODIUM SESQUIHYDRATE
(PANTOPRAZOLO), ECHINACEA ANGUSTIFOLIA ROOT, SERENOA REPENS FRUIT, TROSPIUM
CHLORIDE (SPASMO URGENIN), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), LACTULOSE
(DUPHALAC [LACTULOSE]) and PRIMIDONE (MYSOLIN) for an unknown indication. On 10-
Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna)
(Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273
(COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On
12-May-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient
experienced COVID-19 (seriousness criterion death). On an unknown date, the patient
experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion
death). The patient died on 12-May-2021. The cause of death was not reported. It is
unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine
Moderna) (Intramuscular), the reporter considered COVID-19 to be unlikely related
and VACCINATION FAILURE (Vaccination failure) to have an unknown relationship.
Treatment information was not provided. This is a case of lack of efficacy of the
vaccine with an associated adverse event of Covid-19, therefore causal association
between the event is assessed as not applicable.; Sender's Comments: ""This is a
case of lack of efficacy of the vaccine with an associated adverse event of Covid-
19, therefore causal association between the event is assessed as not applicable"";
Reported Cause(s) of Death: Unknown Cause of Death"" "No prior vaccinations for
this event."
"1450098-1" "Patient experienced onset of COVID symptoms 05/26. Tested
positive for SARS-COV-2 by PCR on 06/09. Presented to ER on 06/12/21 c/o cough,
SOB, and hypoxia. O2 sat was 72%. Patient was hospitalized and passed away on
"1454305-1" "Breakthrough resulted in COVID death" "No prior vaccinations
for this event."
"1454319-1" "Breakthrough COVID related death" "No prior vaccinations for
this event."
"1454827-1" "Patient fell down the stairs on 04/18/2021; EMT services found
no pulse upon their arrival to the scene. Patient was transported to hospital and
found to have several broken bones in neck and ultimately died on 04/18/2021 at the
hospital. Patient tested positive for COVID-19 upon admission to hospital, despite
being fully vaccinated. Patient did not have any known symptoms of COVID-19; the
death is not thought to be related to COVID-19." "No prior vaccinations for
this event."
"1454844-1" "Patient admitted to hospital on 04/20/2021 for significant
shortness of breath; patent tested positive for COVID-19 despite being fully
vaccinated against it. Patient died on 04/24/2021. Death Certificate Information:
Part I: Cause of Death: A. Repiratory Arrest B. COVID-19 Part II Other Significant
Conditions COPD; Multiple Myeloma" "No prior vaccinations for this event."
"Total" "COVID-19" "10084268" "COVID19 (COVID19 (MODERNA))" "1201"
� �
"COVID-19" "10084268" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200"
"0934966-1" "0934966-1" "COVID-19; COVID-19; Pneumonia; respiratory failure;
This is a spontaneous report from a contactable consumer. An 80-year-old female
patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an
unspecified route of administration on 02Jan2021 for COVID-19 immunization. Medical
history included Alzheimer's and others. No known allergies. Concomitant
medications included unspecified medications. The reporter's mother in law was
tested for COVID-19 at a nursing facility on 25Dec2020 and she was negative. On
02Jan2021, she received the first dose of Pfizer vaccine. On 04Jan2020, she
developed a high fever, needed oxygen and was positive for COVID-19. Date of death
was 04Jan2021. The cause of her death was listed as pneumonia, respiratory failure
and COVID-19. No autopsy performed. No treatment received. No one knew if the
vaccination contributed to her death. It was hard to know if her death was due to
the administration of the vaccine or it exacerbated the COVID19 symptoms which led
to her death. Since this was unknown, it could have been a possibility. The
reporter wanted to give us this information because we might want to consider
having high risk population, patients with underlying conditions, older population
tested for COVID-19 prior to the vaccination, as this is not currently a
recommendation or a requirement. All is very new and they are all learning so the
reporter wanted to share this information with us. The patient did not receive any
other vaccines within 4 weeks prior to the COVID vaccine. There are medications the
patient received within 2 weeks of vaccination. Prior to vaccination, the patient
was not diagnosed with COVID-19. Since the vaccination, the patient has been tested
for COVID-19. The outcome of the events was fatal. Information about Lot/Batch
has been requested.; Sender's Comments: The association between the fatal event
lack of effect (pneumonia, respiratory failure and COVID-19) with BNT162b2 can not
be fully excluded. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
including the review and analysis of aggregate data for adverse events. Any safety
concern identified as part of this review, as well as any appropriate action in
response, will be promptly notified to regulatory authorities, Ethics Committees,
and Investigators, as appropriate.; Reported Cause(s) of Death: Pneumonia,
respiratory failure and COVID-19; Pneumonia, respiratory failure and COVID-19;
Pneumonia, respiratory failure and COVID-19; Pneumonia, respiratory failure and
COVID-19" "No prior vaccinations for this event."
"0961901-1" "0961901-1" "sick with Covid 19 and died after the vaccination.
Covid positive after the first vaccination; sick with Covid 19 and died after the
vaccination. Covid positive after the first vaccination; This is a spontaneous
report from a contactable physician, based on information received by Pfizer from
Biontech (manufacturer control number: not provided), license party for BNT162B2.
The physician reported similar events for 2 patients. This is the case for the
first of 2 patients. An elderly patient of an unspecified gender received the first
dose of BNT162b2 (COMIRNATY,Lot/Batch Number and Expiration Date unknown), via an
unspecified route of administration on 06Jan2021 at 1 dose form (DF) single dose
for covid-19 prophylaxis. The patient's medical history and concomitant medications
were not reported. It was reported that the physician was a vaccinator of a
vaccination center and on 06Jan2021, 07Jan2021 and 08Jan2021 he had vaccinated 3
elderly residents in a nursing home with the vaccine Corminaty. It turned out that
2 of the elderly residents were sick with Covid 19 and died after the vaccination
in Jan2021. Covid tested positive after the first vaccination in Jan2021. This
patient was vaccinated on 06Jan2021. It was not reported if an autopsy was
performed. Information on the lot/batch number has been requested.; Sender's
Comments: Based on the information available, a possible contributory role of the
suspect products cannot be excluded for the reported event of positive for corona
virus infection for the lack of efficacy of the vaccine. However, based on the
mechanism of action of the vaccine, it is unlikely the patient would have fully
developed immunity for the vaccine to be effective, due to the number of days
passed since the vaccine is given. Case will be reevaluated based on follow-up
information,Linked Report(s) : DE-PFIZER INC-2021043240 same Reporter, same events,
different patient; Reported Cause(s) of Death: Covid-19; Covid-19" "No prior
"0962784-1" "0962784-1" "patient expired 1/15/2021; had been treated as
outpatient for pneumonia, likely COVID-19 but no positive test result in December
2020. PMH diabetes" "No prior vaccinations for this event."
"0976486-1" "0976486-1" "SARS-CoV-2 infection; SARS-CoV-2 infection;
Headache; Nausea; Unwell; Death; This is a spontaneous report received by Pfizer
from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory
authority report number is GB-MHRA-WEBCOVID-202101181401032020 and Safety Report
Unique Identifier GB-MHRA-ADR 24609241. A contactable physician reported that an
83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot
number: EJ1688), via an unspecified route of administration on 06Jan2021 at a
single dose for COVID-19 immunisation. Medical history included frontotemporal
dementia with some motor neurone disease (MND) features, chronic obstructive
pulmonary disease, diarrhea, reflux gastritis. Concomitant medications included
beclometasone dipropionate, formoterol fumarate (FOSTAIR) from 20Oct2020 for
chronic obstructive pulmonary disease, loperamide from 29Dec2014 for diarrhoea,
omeprazole from 01Feb1996 for reflux gastritis, and salbutamol from 19Jun1998 for
chronic obstructive pulmonary disease. Patient previously received SEQIRUS VACCINES
INFLUENZA on 27Oct2020 for influenza immunization. Patient has not had symptoms
associated with COVID-19, not had a COVID-19 test. Patient is not enrolled in
clinical trial. Patient had been feeling well. He attended for his COVID-19
vaccination on 6th January 2021 and when he returned home began to feel unwell,
with nausea and headache. That evening his carers were concerned so they called an
ambulance. The patient tested positive for COVID-19 (SARS-CoV-2 infection) on 7th
January 2021 and unfortunately died on 11th January 2021 in the hospital. It was
unclear if vaccine could have been contributing factor. Reporter was unsure if the
vaccine and death could be connected. The cause of death was unknown. It was
unknown if an autopsy was performed. The outcome of SARS-CoV-2 infection was not
recovered, while for the other events was unknown.; Reported Cause(s) of Death:
Death" "No prior vaccinations for this event."
"0978341-1" "0978341-1" "The patient passed away on 20Jan2021. Cause of death
was not reported.; Corona positive; Corona positive; This is a spontaneous report
from a contactable physician and a consumer received via Regional Authority and
Biontech. An 80-year-old female patient received the first dose of bnt162b2
(COMIRNATY), via an unspecified route of administration on 05Jan2021 at single dose
for COVID-19 immunisation. The patient's medical history and concomitant
medications were not reported. The patient experienced infection of respiratory
tract and Corona (COVID-19 test) positive from 07Jan2021, infection with worsening
of general condition and fever > 38.0 centigrade. The patient passed away on
20Jan2021. Cause of death was not reported (pending for clarification). No
vaccination complications after previous vaccinations and vaccine had not been re-
administered. Outpatient treatment was necessary. It was not reported if an autopsy
was performed. Outcome of the event Corona positive was unknown. Causal relation to
Covid vaccination questionable. Information on the lot/batch number has been
requested.; Sender's Comments: A causal association between BNT162B2 and the
reported events Drug ineffective and COVID-19 cannot be excluded based on a
compatible temporal relation. However, full immunity is only expected 2 weeks after
the second dose. The information currently provided is too limited to make a
meaningful medical assessment. However, per company causality assessment guidance,
the event of death with unknown cause is assessed as related until the cause of
death is clarified and assessed as unrelated. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review appropriate action in
response, will be promptly notified to Regulatory Authorities, Ethics Committees,
and Investigators, as appropriate and analysis of aggregate data for adverse
events. Any safety concern identified as part of this review, as well as any as any
appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees, and Investigators, as appropriate.; Reported
Cause(s) of Death: The patient passed away on 20Jan2021. Cause of death was not
reported." "No prior vaccinations for this event."
"0978343-1" "0978343-1" "Corona Infection; Respiratory infection with cough;
reduced general condition; condition worsened; Corona Infection; This is a
spontaneous report from a non-contactable physician received via Regional Authority
and Biontech. An 87-year old female patient received first dose of BNT162B2
(COMIRNATY, Solution for injection; lot number and expiry date not reported) via an
unspecified route of administration on 05Jan2021, single dose for COVID-19
immunization. Relevant medical history and concomitant medications were not
reported. The patient had no vaccination complications after previous vaccinations.
On 07Jan2021, the patients diagnoses/ suspected diagnosis was Corona infection. On
the same day of 07Jan2021, the patient experienced respiratory infection with cough
and reduced general condition, rapid general health deterioration, and condition
worsened. The patient died 19Jan2021. Course and therapy of the vaccination
reaction: outpatient treatment was necessary, inpatient treatment at the hospital
was necessary but was refused. The vaccination reaction was life- threatening.
Outcome of events was fatal. The patient died on 19Jan2021. The reported causes of
death were corona infection, respiratory infection with cough and reduced general
condition, rapid general health deterioration. It was unknown if an autopsy was
performed. Causal relation to Covid vaccination was reported as questionable.
Information on the lot/batch number has been requested.; Reported Cause(s) of
Death: Corona infection; Corona infection; respiratory infection with cough;
reduced general condition; condition worsened" "No prior vaccinations for this
event."
"0983192-1" "0983192-1" "Patient recevied the COVID-19 vaccine on 1/5/21 by
the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on
1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal
Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L
per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was
unresponsive and without vital signs. Orders were for DNR and CPR was not
initiated." "No prior vaccinations for this event."
"0985367-1" "0985367-1" "TESTED POSITIVE FOR COVID-19 1-7-2021, TRANFERRED TO
HOSPITAL ON 1-18-2021. HE READMITTED TO THE FACILITY ON 1-21-2021 WITH HOSPICE
SERVICES AND EXPIRED ON 1-25-2021." "No prior vaccinations for this event."
"0985527-1" "0985527-1" "COVID-19 + ON 1-13-2021, TRANFERRED TO HOSPITAL ON
1-23-2021 DUE TO HYPONATREMIA" "No prior vaccinations for this event."
"0990314-1" "0990314-1" "Death; positive Covid-19 virus test after
vaccination; positive Covid-19 virus test after vaccination; This is a spontaneous
report from a contactable physician downloaded from the regulatory authority (SE-
MPA-2021-000325 & SE-MPA-1610531706795). An 84-year-old female patient received
bnt162b2 (COMIRNATY; Lot number: EL 1484), intramuscularly in Jan2021 at a single
dose for COVID-19 immunization. Medical history included atrial fibrillation,
Celiac disease, ejection fraction low (35%), type II diabetes mellitus,
hypothyroidism, heart failure, COVID-19. Concomitant medication included
atorvastatin (MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021, cefuroxime
(FURIX), taken from 01Jan2017 to Jan2021, oxazepam (SOBRIL), taken from 01Jan2017
to Jan2021, metoprolol (MANUFACTURER UNKNOWN), taken from 01Jan2017 to Jan2021,
levothyroxine sodium (LEVAXIN), taken from 01Jan2013 to Jan2021, warfarin sodium
(WARAN), taken from 01Jan2011 to Jan2021 and ramipril (MANUFACTURER UNKNOWN) taken
from 01Jan2013 to Jan2021. The patient had a positive Covid-19 virus test after
vaccination and experienced death in Jan2021. The patient had no infection
symptoms but tiredness days before vaccination. The patient was found dead, the day
after vaccination with a suspected cerebro/cardiovascular event. The patient
underwent lab tests and procedures which included COVID-19 virus test: positive in
Jan2021. The outcome of positive Covid-19 virus test after vaccination was
unknown. The patient died in Jan2021. It was not reported if an autopsy was
performed. According to rapporteur, patient is not autopsied.
Cerebro/cardiovascular event is only a suspicion based on patients medical history.
No follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: Unknown cause of death" "No prior vaccinations for this
event."
"0993422-1" "0993422-1" "SARS-CoV-2 infection; SARS-CoV-2 infection; Immune
imbalance; Shortness of breath; This is a spontaneous report received from a
contactable physician by Pfizer from the Medicines and Healthcare products
Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-
WEBCOVID-202101241753594380, Safety Report Unique Identifier GB-MHRA-ADR 24639286.
A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,
lot EJ688), via an unspecified route of administration on 05Jan2021 at single dose
for covid-19 immunisation. Medical history included ongoing endometrial cancer
(Figo stage 3c1), uterine cancer (not ongoing), renal cancer (not ongoing) treated
2006, ongoing type 2 diabetes mellitus (longstanding), obesity (unknown if
ongoing), chronic kidney (unknown if ongoing), cataract (unknown if ongoing),
nephrolithiasis (recurrent, unknown if ongoing) and ankylosing spondylitis (unknown
if ongoing). Patient was not enrolled in clinical trial. Concomitant medications
were not reported. The patient previously received influenza vaccine (split virion,
inactivated) on 01Oct2020 and pneumococcal vaccine polysacch on 03Dec2020 bot for
immunization. The patient experienced sars-cov-2 infection, immune imbalance and
shortness of breath on 06Jan2021. The patient was admitted to hospital on 06Jan2021
and died on 07Jan2021 due to SARS-CoV-2 infection. It was unsure if patient has had
symptoms associated with COVID-19. The patient underwent lab tests and procedures
which included blood test, culture and chest x-ray on unknown date with unknown
results. The patient ad and inconclusive COVID-19 virus test on 06Jan2021. It was
not reported if an autopsy was performed. All the events were considered serious as
important medical events and hospitalization. Only sars-cov-2 infection had a fatal
outcome. No follow up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: SARS-CoV-2 infection" "No prior vaccinations for
this event."
"0994635-1" "0994635-1" "positive COVID-19 test with symptoms; positive
COVID-19 test with symptoms; General physical health deterioration; This is a
spontaneous report from a non-contactable physician downloaded from the Regulatory
Authority. A 80-years-old female patient received the first dose of bnt162b2
(COMIRNATY) vaccine , via an unspecified route of administration on 05Jan2021 at
single dose for covid-19 immunisation . The patient medical history and
concomitant medications were not reported. The patient experienced positive covid-
19 test with symptoms on 07Jan2021. Symptoms included: Upper respiratory tract
infection General physical health deterioration and Fever, lasting for 15 days.
The patient died on 20Jan2021. It was not reported if an autopsy was performed.
Death cause was reported as General physical health deterioration. No follow-up
attempts are possible, information on batch number cannot be obtained.; Reported
Cause(s) of Death: COVID 19; General physical health deterioration" "No prior
"0994858-1" "0994858-1" "Coronavirus infection; Coronavirus infection;
General physical health deterioration; This is a spontaneous report from a non-
contactable physician via Regulatory Authority, downloaded from the Regulatory
Authority-WEB (DE-PEI-PEI2021001369). An 87-year-old female patient received the
first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on
05Jan2021 at single dose for COVID-19 immunisation. Relevant medical history and
concomitant medications were not reported. On 07Jan2021, the patient experienced
coronavirus infection and general physical health deterioration and died due to
coronavirus infection on 19Jan2021. Death cause was reported as coronavirus
infection. It was not reported if an autopsy was performed. The information on the
batch number has been requested.; Reported Cause(s) of Death: Coronavirus
infection" "No prior vaccinations for this event."
"0994885-1" "0994885-1" "Yes- Positive COVID-19 test; Yes- Positive COVID-19
test; Death; sore arm; This is a spontaneous report from a contactable physician.
This is a report received from the Regulatory Authority. The Regulatory authority
report number is GB-MHRA-WEBCOVID-202101222143440710, Safety Report Unique
Identifier GB-MHRA-ADR 24635342. An adult male patient received BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE, solution for injection, lot number:EK4243, expiry date
unspecified), via an unspecified route of administration on 19Jan2021 at a single
dose for COVID-19 immunisation. Medical history included suspected covid-19
(unsure when symptoms started, unsure when symptoms stopped), cardiac LBBB (left
bundle branch block), dilated left ventricle, dilated atrium, dyskinesia septum,
2nd degree heart block, and left ventricular hypertrophy. Patient was not enrolled
in clinical trial. Concomitant medication included ramipril on unspecified date
for left ventricular hypertrophy. In the evening of 19Jan2021, the patient
volunteered and received the vaccine. Sore arm reported only afterwards on
unspecified date in Jan2021. On 20Jan2021, the patient was found dead in bed
(death). The patient underwent lab test which included COVID-19 virus test: Yes-
positive COVID-19 test on unspecified date. Cause of death was unknown. It was
unknown if an autopsy was performed. No follow-up activities are possible. No
further information is expected.; Reported Cause(s) of Death: death" "No prior
"0994886-1" "0994886-1" "Unconscious; positive COVID-19 virus test; SARS-CoV-
2 infection; This is a spontaneous report received from a contactable healthcare
professional from the regulatory authority. The regulatory authority report number
is GB-MHRA-WEBCOVID-202101241937221860 and GB-MHRA-ADR 24639419. A 90-year-old
male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an
unspecified route of administration, on 06Jan2021 at a single dose for COVID-19
vaccination. Medical history included dementia Alzheimer's type and cardiac failure
congestive (CCF). The patient did not have symptoms associated with COVID-19. The
patient was not enrolled in a clinical trial. The patient's concomitant medications
were not reported. The patient experienced SARS-CoV-2 infection on 06Jan2021, which
was reported as fatal. The patient experienced positive COVID-19 virus test on
06Jan2021 and unconscious on 07Jan2021. The patient underwent lab tests and
procedures which included COVID-19 virus test: yes - positive COVID-19 test on
06Jan2021. The clinical outcome of positive COVID-19 virus test and SARS-CoV-2
infection was fatal and of unconscious was not recovered. The patient died on
09Jan2021. The cause of death was reported as SARS-CoV-2 infection. It was not
reported if an autopsy was performed. No follow up attempts are possible;
information about batch number cannot be obtained.; Reported Cause(s) of Death:
SARS-CoV-2 infection" "No prior vaccinations for this event."
"0996674-1" "0996674-1" "SARS-CoV-2 infection; SARS-CoV-2 infection; High
temperature; Dysstasia; Skin discolouration; Tremor; Feeling abnormal; This is a
spontaneous report received from a contactable consumer. This is a report received
from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-
202101241732075000, Safety Report Unique Identifier GB-MHRA-ADR 24639306. An 86-
year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-
19 VACCINE), Lot EJ05536450, via an unspecified route of administration on
07Jan2021 at single dose for covid-19 immunisation. The patient previously
received the firs dose of BNT162B2 on unspecified date with no adverse events.
Medical history included non-tobacco user (Never smoked), dementia with Lewy
bodies. The patient's concomitant medications were not reported. No physical
illnesses. Unsure if patient has had symptoms associated with COVID-19. Patient was
not enrolled in clinical trial. On 08Jan2021 the patient experienced high
temperature, dysstasia, skin discolouration, tremor, feeling abnormal: the patient
could not stand up from his bed, he was grey in skin colour, shaking and he said he
felt terrible. The patient did not go to hospital and was stabilized with oxygen
mask. The events were non serious with outcome of not recovered. On 08Jan2021 the
patient experienced SARS-CoV-2 infection. The patient underwent lab tests and
procedures which included COVID-19 virus test: yes - positive covid-19 test on
20Jan2021. The event SARS-CoV-2 infection was fatal, and the patient died for SARS-
CoV-2 infection on 20Jan2021 at 7.05am. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: SARS-CoV-2 infection" "No prior
"0998175-1" "0998175-1" "Resident vaccinated-1/7/21 Resident covid positive
1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased
"1000275-1" "1000275-1" ""Death unexplained/massive pulmonary embolism in the
context of neoplastic COVID +; Massive stroke related to intracardiac thrombus;
massive pulmonary embolism in the context of neoplastic COVID +/Covid19 PCR
performed: positive/CT scan compatible with covid 19 infection; massive pulmonary
embolism in the context of neoplastic COVID +/Covid19 PCR performed: positive/CT
scan compatible with covid 19 infection; This is a spontaneous report from a
contactable physician downloaded from the Medicines Agency (MA) -WEB, FR-AFSSAPS-
DJ20210104. A 75-year-old female patient received bnt162b2 (COMIRNATY, lot number:
EM0477), via intramuscular on 14Jan2021 at single dose for COVID-19 vaccination.
Medical history included stage IIIB colon adenocarcinoma- (pT3N1aM0) from Aug2020
and unknown if it was ongoing with rectosigmoid resection on 27Aug2020 and
ileostomy closure on 09Oct2020. HTA (arterial hypertension), ACFA (complete
arrhythmia by atrial fibrillation), Non-insulin-dependant diabetes, Dyslipidemia,
Obstructive pyelonephritis in renal colic, Hypothyroidism, right acoustic neuroma
(operated on in 2014 with sequelae facial palsy), and all unknown if they were
ongoing and notion of allergy to iodine. The patient followed in particular for an
adenocarcinoma of the colon treated with simplified LV5FU2 (cisplatin, 5-
fluorouracil, leucovorin) as an adjuvant with a 4th treatment carried out in a day
hospital on 14Dec2020. The patient is non-DPD deficient. The patient lives at home
with her husband, a household helper, a nurse who comes several times a week.
Autonomous for toilet and meals. The report of the day hospitalization of 14Dec2020
mentioned: INTERCURE: G1 asthenia throughout the intercure, improvement in BP,
better general condition. CLINICAL REVIEW: WHO 1-2, BP 117/70 mmHg, HR 102 bpm,
afebrile, 97% AA saturation. Weight 62 kg stable. Normal clinical examination. She
received her cure of LV5FU2. She was hospitalized on 17Dec2020 for a stroke in the
territory of the right posterior cerebral artery, with thrombus in P1, not
revascularized (fall from her bed at 6 a.m., her husband noting a left
hemicorporeal deficit and dysarthria). An MRI is immediately performed which
reveals an ischemic stroke of the posterior arm of the right internal capsule and
of the diffusing right internal and occipital temporal cortex. On the TOF, we find
an occlusion of the posterior cerebral artery from the beginning and an occlusion
of the right internal carotid artery with slow cerebral artery and permeable middle
cerebral artery. EDTSA carried out on 18Dec2020: ""The echo-Doppler anomalies
presented can be compatible either: with an obliteration of the right internal
carotid artery downstream of the portion visualized by echo-Doppler (which is
difficult to assert because on indirect arguments), if this is the case, it looks
old since ''with good replacement of the cerebral arteries via the anterior
communicating artery or with a stenosis of the right siphon without occlusion of
the internal carotid artery explaining the velocities preserved in right MCA"".
Cerebral MRI of 21Dec2020: Ischemic stroke made up of the right posterior
superficial Sylvian territory and the superficial and deep territories of the right
posterior cerebral artery. Recanalization of the right internal carotid artery and
the right posterior cerebral artery of fetal origin. During the stay, she improved
neurologically, with partial regression of motor impairment, total regression of
visual impairment and dysarthria. Upon discharge, she presented a NIHSS score of 2,
with a slight drop in her left upper limb before 10 seconds, and sensitive
extinction. There persist ataxia of the lower limbs and facial paralysis which were
sequelae respectively of an old cerebellar lesion and a neuroma. The patient is
anticoagulated by LMWH tinzaparin sodium (INNOHEP), due to the occurrence of a
stroke under ELIQUIS, her known AF, and the neoplastic context. INNOHEP will be
continued in the long term. She was leaving for her home on 24Dec2020. Patient
finally admitted to Follow-up and Rehabilitation Care on 30Dec2020. Decision with
the patient not to resume adjuvant chemotherapy given the loss of autonomy and an
unfavorable benefit-risk balance. Similarly contraindication to any colonoscopy.
Exploration of an adrenal adenoma accidentally discovered on the control hepatic
MRI. Hypercalcemia on 31Dec2020 prompting the administration of Pamidronate. On
12Jan2021: Positive orthostatic hypotension test. Concomitant medications included
oxazepam (SERESTA) from Dec2020, atorvastatin calcium (ATORVASTATINE ARROW),
tinzaparin sodium (INNOHEP) from 22Dec2020 for Atrial fibrillation, enalapril
maleate (ENALAPRIL EG), calcium phosphate monobasic, magnesium glycerophosphate,
phosphoric acid, sodium phosphate dibasic (PHOSPHONEUROS) from 19Jan2021,
bisoprolol fumarate (BISOPROLOL SANDOZ), pantoprazole sodium sesquihydrate
(PANTOPRAZOLE MYLAN) from Dec2020, dexamethasone from 19Jan2021, sitagliptin
(JANUVIA), amoxicillin, clavulanate potassium (AUGMENTIN) from 19Jan2021,
cinacalcet hydrochloride (MIMPARA) from 12Jan2021, apixaban (ELIQUIS), enalapril
maleate, lercanidipine hydrochloride (LERCAPRESS), esomeprazole, macrogol 3350,
potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), alprazolam.
Notification from a hospital specialist concerning this patient who died as a
result of vaccination with COMIRNATY. Vaccination by COMIRNATY on 14Jan2021 with
good immediate tolerance. The same day realization of a transthoracic ultrasound
which was programmed: LVEF conserved at 50% in SB on an enlarged LV (SIV and PP
11mm) not dilated. Bi-atrial expansion with left atrium 86 ml / m� and right atrium
21 cm�. No increase in left ventricle filling pressures. Central minimal mitral
insuffisiency. Tricuspid aortic valve, mean gradient 2 mmHg. Moderately impaired RV
function, no PH with PAPS estimated at 30-35 mmHg. Breathable dilated IVC. Free
pericardium. Transesophageal echocardiography: Left auricle not free with impaired
emptying rate, no thrombus directly visualized but significant spontaneous
contrast. Bubble test: No patent foramen ovale found. On 15Jan2021: Well
clinically. No headache, no cough, no transit disorder following the Covid
vaccination. Good constants, afebrile. On 16Jan2021: Appearance of a cough. She was
reviewed in hospitalization oncology day on 18Jan2021 for reassessment. CLINICAL
EXAMINATION: WHO 3 with above all significant loss of autonomy. Consciousness
normal, higher functions a little slowed down and tendency to drowsiness. BP 106/67
mmHg, HR 89 bpm, afebrile, 97% AA saturation. Weight 60 kg (-2 kg). Staggering walk
with loss of balance, must hold on to furniture. On 18Jan2021: No fever, no
diarrhea, no other symptom found apart from the cough. Covid19 PCR performed:
positive. On 19Jan2021: blood pressure 140/70 mmHg, pulse 60 / min, respiratory
level: FR at 15 / min, Rhinorrhea, expectorating cough, no dyspnea, no chest pain,
no anosmia or ageusia, asthenia, no headache auscultation with clear reduction of
MV on the left base, elimination of vibrations and dullness therefore: possible
pleural effusion. At the cardio level: no palpitation, no sign of HF, or sign of
DVT, regular auscultation without noticeable breath. At the digestive level: no
diarrhea, no nausea or vomiting, no abdominal pain, palpation within the standards.
Note that the patient does not want to go to intensive care in the event of
deterioration, she does not want intubation. At the end of the morning, episode of
loss of contact with return to full consciousness for several minutes, it is
possible that she was suffering from epilepsy after his stroke with lowering of the
epileptogenic threshold on COVID / fever. No brain imaging. On the other hand, in
view of the saturation: initiation of dexamethasone and AUGMENTIN + realization of
an emergency chest scanner today (on 19Jan2021). CT scan compatible with covid 19
infection (minimal degree of involvement <10%). On 20Jan2021 at 11:30 am the
consultation word mentions: better today, FR at 22 / min, no anosmia or ageusia, no
diarrhea, no dyspnea, no chest pain, no sign of cardiac insufficiency no sign of
DVT or VTE. Auscultation with the same anomalies as yesterday (clear drop in MV in
left base) therefore monitoring. The same day on 20Jan2021, call from a licensed
nurse around 2:35 p.m. for a patient found on the ground, not reactive. Arrival of
the doctor in the room: patient in a state of clinical death, facial cyanosis, no
pulse, no breathing, no heart rate. Total asystole. Time of death recorded 14:45.
Most likely in no flow for 15 minutes. Patient who had refused resuscitation care
yesterday in the event of degradation (refusal of CPR and intubation) so in this
context no resuscitation procedure started. Opinion of the doctor in charge of the
patient since entry into Follow-up and Rehabilitation Care: presence of an
intracardiac thrombus with great certainty according to cardiologists. Possible
cause of death: massive pulmonary embolism in the context of neoplastic COVID +,
Massive stroke related to intracardiac thrombus. Exclusive role of COVID (see
respiratory distress) very unlikely because no major respiratory damage in this
patient, correct respiratory rate and saturation. AF was fairly stable (no recent
ECG either). Unexplained death notified because the participatory role of the
vaccine cannot be completely excluded. The patient died on 20Jan2021. An autopsy
was not performed. No follow-up attempts are possible, no information is
expected.; Reported Cause(s) of Death: massive pulmonary embolism in the context of
neoplastic COVID +; Massive stroke related to intracardiac thrombus; Massive stroke
related to intracardiac thrombus; massive pulmonary embolism
in the context of neoplastic COVID +; massive pulmonary embo"" "No prior
"1000375-1" "1000375-1" "COVID-19 pneumonia/sars-cov-2 infection/dyspnoea,
cough and pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough;
Dyspnoea; This is a spontaneous report received from a contactable physician by
Pfizer from the products Regulatory Agency. The regulatory authority report number
is GB-MHRA-WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR
24651485. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE, lot# EK1768), via an unspecified route of administration on 15Jan2021 at
single dose for COVID-19 immunization. Medical history included cardiac pacemaker
insertion, hypertension, chronic lymphocytic leukaemia, atrial fibrillation, type 2
diabetes mellitus, angina pectoris, prostate cancer, deep vein thrombosis, cardiac
failure. Concomitant medication included allopurinol, atorvastatin, hydralazine,
lansoprazol, isosorbide mononitrate (MONOMIL XL), rivaroxaban for atrial
fibrillation. On 17Jan2021, patient was admitted with shortness of breath/
dyspnoea, cough and pyrexia, he was suspected covid-19 then confirmed having sars-
cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included
COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the
virus at the time of vaccination. He said he didn't have any temperature at the
time of the vaccination. Outcome of event covid-19 pneumonia was fatal, sars-cov-2
infection was not recovered, and the events pyrexia, cough, dyspnoea was unknown.
The patient died on 21Jan2021. It was not reported if an autopsy was performed. The
cause of death was covid-19 pneumonia/drug ineffective. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: COVID-19
pneumonia; COVID-19 pneumonia" "No prior vaccinations for this event."
"1000379-1" "1000379-1" "Chest infection; positive COVID-19 virus
test/suspected COVID-19; positive COVID-19 virus test/suspected COVID-19; This is a
spontaneous report received from a contactable other healthcare professional by
Pfizer from the products Regulatory Agency. Regulatory authority report number GB-
MHRA-WEBCOVID-202101280002382610, Safety Report Unique Identifier GB-MHRA-ADR
24657514. A 100 years old female patient received bnt162b2 (Pfizer-BioNTech COVID-
19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route
of administration on 06Jan2021 at single dose for COVID-19 immunisation. The
patient's medical history heart failure. Patient is not enrolled in clinical trial.
The concomitant medications was not reported. Patient had suspected COVID-19 from
15Jan2021. Onset of chest infection on 15Jan2021, revived the course of
antibiotics. But the course not completed as became too poorly moved to the stage
of end of life. Patient died on 27Jan2021. Lab test included positive COVID-19
virus test on 06Jan2021. The outcome of events was fatal. Unknown if autopsy was
done. No follow-up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: chest infection; positive COVID-19 virus test/suspected
COVID-19; positive COVID-19 virus test/suspected COVID-19" "No prior vaccinations
for this event."
"1010240-1" "1010240-1" "COVID-19 pneumonitis; fever 39 Celsius degree;
Atrioventricular block third degree; Oxygen saturation decreased; drug ineffective;
Radiographic Image of Covid Pneumonitis + Positive PCR Test; This is a spontaneous
report from a contactable pharmacist downloaded from the Medicines Agency (MA)
Regulatory Authority-WEB BE-FAMHP-DHH-N2021-75795. An 84-year-old male patient
received bnt162b2 (COMIRNATY), via unknown route of administration on 11Jan2021 at
single dose for covid-19 immunisation. Medical history was not reported.
Concomitant medications were not reported. The patient experienced drug ineffective
and covid-19 on an unspecified date with outcome of unknown, oxygen saturation
decreased on 13Jan2021, covid-19 pneumonitis on 13Jan2021, fever on 13Jan2021,
atrioventricular block third degree on 13Jan2021. On 13Jan2021 symptom onset. On
15Jan2021 admission with covid pneumonitis (desaturation, fever 39 Celsius degree)
and 3rd degree AV block. The patient died on 19Jan2021. The outcome of the other
events was fatal.Treatment was unknown. The patient underwent lab tests and
procedures which included blood lactate dehydrogenase: unknown results, c-reactive
protein: unknown results, serum ferritin: unknown results on unknown date and
Radiographic Image of Covid Pneumonitis + Positive PCR Test. It was not reported if
an autopsy was performed. Reporter's comment: 11/1 covid vaccine in RVT 13/1
symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius
degree) and 3rd degree AV block. Treatment -Unknown. Evolution of the ADR - Died.
Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of
Covid Pneumonitis + Positive PCR Test. Event assessment: FAMHP/to all
events/unlikely. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Reporter's Comments: 11/1 covid vaccine in RVT 13/1
symptom onset 15/1 admission with covid pneumonitis (desaturation, fever 39 Celsius
degree) and 3rd degree AV block Treatment - Unknown Evolution of the ADR - Died
Examinations - Clinical, Biochemical (CRP, Ferritin, LDH) and Radiographic Image of
Covid Pneumonitis + Positive PCR Test; Reported Cause(s) of Death: COVID-19
pneumonitis; Oxygen saturation decreased; Atrioventricular block third degree;
fever 39 Celsius degree" "No prior vaccinations for this event."
"1010483-1" "1010483-1" "Death in COVID 19, VIRUS positive; Death in COVID
19, VIRUS positive; This is a spontaneous report from a contactable physician
downloaded from the Medicines Agency (MA) Regulatory Authority-WEB (SE-MPA-2021-
001581 and SE-MPA-1611603955343). An 86-year-old male patient received the first
dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly, on 05Jan2021 at
a single dose for COVID-19 immunisation. Medical history included chronic
obstructive lung disease and dementia Alzheimer's type (late onset). Concomitant
medications included oxazepam (OXASCAND) from 2012, memantine (MANUFACTURER
UNKNOWN) from 2016, acetylsalicylic acid (MANUFACTURER UNKNOWN) from 2009,
simvastatin (MANUFACTURER UNKNOWN) from 2009, cyanocobalamin (BETOLVEX) from 2009,
folic acid (FOLVIDON) from 2009, mirtazapine (MANUFACTURER UNKNOWN) from 2012, and
levothyroxine sodium (LEVAXIN) from 2009. The patient had no previous drug
reactions. The patient experienced death in COVID 19, virus positive on 07Jan2021,
which was reported as fatal. The clinical course was reported as follows: Two days
after the vaccination, the patient suddenly desaturated and was sent to a hospital,
where a COVID-19 virus test was taken, which came back positive on 07Jan2021. The
man was treated with high levels of oxygen and parenteral fluid and nutrition, but
his consciousness decreased, and he died after a week in the hospital, reported as
9 days after the vaccination. The physician reported that the patient was probably
already infected, both health care providers and residents had verified ongoing
COVID-19 during that time and the man tested positive 2 days after the first dose
of vaccination. The patient died on 14Jan2021. The cause of death was reported as
COVID-19. It was not reported if an autopsy was performed. The physician reported
that the vaccination in itself is not suspected to have caused the death and does
not suspect aggravated COVID-19 infection due to vaccination.; Reported Cause(s) of
Death: COVID-19" "No prior vaccinations for this event."
"1011130-1" "1011130-1" "Temp of 100.1 and unproductive cough on 1/17; temp
of 100.4 1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on
1/18/2021 Patient passed away on 1/29/2021" "No prior vaccinations for this
event."
"1011492-1" "1011492-1" "1/18/2021- Tested positive for Covid-19. 1/20
Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has
decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed." "No
"1011677-1" "1011677-1" "Lethargic, refusing medications and meals.
1/11/2021- Covid+, poor appetite." "No prior vaccinations for this event."
"1011905-1" "1011905-1" "Ongoing decline overall. Remained on Hospice with
increased lethargy documented on 1/20/21 and progressively worsening thereafter."
"1012021-1" "1012021-1" "Resident on Hospice. 1/18 Hand Shaky. 1/19- Covid
+19. 1/20 Desat 85% on RA, provided 2L O2 supplement= 97% 1/20 congestive cough,
1/28- RR-28;1/29- Hypoglycemia 1/30-NPO. 1/30-resident passed away." "No prior
"1012703-1" "1012703-1" "1/14/2021-0545, blood noted left and right ear.
0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right
and coughing. Increased confusion." "No prior vaccinations for this event."
"1015572-1" "1015572-1" "SARS-CoV-2 infection/COVID-19 disease/reduced
general condition; SARS-CoV-2 infection/COVID-19 disease/reduced general condition;
This is a spontaneous report from contactable physician downloaded from the
Medicines Agency (MA) Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Umm9d, Safety
Report Unique Identifier NO-NOMAADVRE-E2B_00014345. An 87-years-old male patient
received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of
administration on 05Jan2021 at single dose in right arm for COVID-19 immunisation.
Medical history included living in residential institution, recurrent pneumonias,
dementia. Concomitant medication included paracetamol (PARACET) (N02BE01
(unspecified number) reported for paracetamol) for fever. It reported that the
patient experienced SARS-CoV-2 infection on 06Jan2021. The patient had vaccinated
on 05Jan2021. He had reduced general condition on 06Jan2021. COVID-19 outbreak
detected on 07Jan2021 due to positive test in fellow resident. Patient tested
(COVID-19 test) positive on 08Jan2021, alongside several staff members. He
developed COVID-19 disease and died due to COVID-19 on 19Jan2021. The outbreak is
traced back to a staff member, and time of transmission is judged to be prior to
vaccination. Reporting physician assumes no link between vaccination and COVID-19
disease with fatal outcome. Assessment of relatedness reported as no relationship
by reporter. The patient died on 19Jan2021. It was not reported if an autopsy was
performed. Sender's Comment: It is stated in the report that the patient was
infected with COVID-19 before the time of vaccination. The vaccine used is not
live. It can therefore not cause diseases that are vaccinated against or any other
infections. The incident is therefore considered to have no connection with the
vaccine. Information on the lot/batch number has been requested.; Sender's
Comments: Based on the information provided by the reporter, it appears unlikely
that subject vaccine contributed to the event of COVID-19 infection with fatal
outcome. The reported event likely represent intercurrent medical condition in this
elderly 87 year old patient. There is limited information provided in this report.
This case will be reassessed upon receipt of follow-up information. The impact
of this report on the benefit/risk profile of the Pfizer product is evaluated as
part of Pfizer procedures for safety evaluation, including the review and analysis
of aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.;
Reported Cause(s) of Death: SARS-CoV-2 infection/COVID-19" "No prior vaccinations
for this event."
"1016804-1" "1016804-1" "lack of efficacy; corona infection; This is a
spontaneous report from a non-contactable Physician downloaded from the Medicines
Agency (MA) Regulatory Authority-WEB DE-PEI-PEI2021002000. This is a report
received from the Regulatory Authority. An 87-year-old female patient received the
first dose of BNT162B2 (COMIRNATY, batch/lot number: EM0477), via an unspecified
route of administration on 12Jan2021 at single dose for covid-19 immunisation.
Medical history included coronary insufficiency, renal insufficiency, diabetes
mellitus, dementia, gastroenteritis, bloody stool. The patient's concomitant
medications were not reported. Unknown date in Jan2021 after vaccination the
patient developed COVID-19, lasting for unknown. The patient underwent lab tests
and procedures which included COVID-19 PCR test: positiv/positive on 19Jan2021,
diagnosis was confirmed by COVID-19 PCR test. The patient died on 19Jan2021. Death
cause was reported as COVID-19. It was not reported if an autopsy was performed.;
Reported Cause(s) of Death: COVID-19" "No prior vaccinations for this event."
"1016981-1" "1016981-1" "Virologic failure; SARS-CoV-2 infection; SARS-CoV-2
infection; Taking regular medicines for rheumatoid arthritis, received BNT162B2;
Taking regular medicines for rheumatoid arthritis, received BNT162B2; This is a
spontaneous report from a contactable physician. This is a report received from the
Regulatory authority report number GB-MHRA-WEBCOVID-202102021534304120, Safety
Report Unique Identifier GB-MHRA-ADR 24686672 A 76-year-old male patient received
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 09Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical
history included rheumatoid arthritis (Taking regular medicines for rheumatoid
arthritis (or other types of arthritis except osteoarthr..). Patient was not
enrolled in clinical trial. The patient's concomitant medications were not
reported. The patient experienced SARS-CoV-2 infection on 24Jan2021 (also reported
as suspected COVID-19 from 24Jan2021 to 01Feb2021),Virologic failure, serious
criteria reported as death. Not a vaccine reaction as such but unexpected COVID
related death in patient who was vaccinated 2 weeks prior to positive test dies a
week later after positive test. The patient underwent lab tests and procedures
which included COVID-19 virus test: yes - positive covid-19 test on 24Jan2021. The
patient died on 01Feb2021. The outcome of rest events was unknown. It was unknown
if an autopsy was performed. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2
infection; Virologic failure; SARS-CoV-2 infection" "No prior vaccinations for
this event."
"1016989-1" "1016989-1" "Pneumonitis; Drug ineffective; Covid-19; This is a
spontaneous report from a contactable healthcare professional, received from the
Report Unique Identifier GB-MHRA-ADR 24694509. A 80-year-old female patient
received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Jan2021 at single dose
for COVID-19 immunization, via an unspecified route of administration. Medical
history included suspected covid-19 on 17Jan2021. Concomitant medication included
calcium carbonate, colecalciferol (ADCAL D3), amlodipine, atorvastatin, edoxaban,
lansoprazole, losartan, paracetamol, salbutamol, trimipramine. The patient
experienced pneumonitis on 21Jan2021 and the sars-cov-2 test was positive on
21Jan2021. The patient died on 23Jan2021. It was not reported if an autopsy was
performed. Patient was not enrolled in clinical trial. No follow-up attempts are
possible; information about lot/batch number cannot be obtained.; Reported Cause(s)
of Death: Pneumonitis" "No prior vaccinations for this event."
"1019911-1" "1019911-1" "Client was administered the vaccine while
symptomatic (01/25/21) although client did not know he was symptomatic for COVID-
19. He had been exposed to a family member who had tested positive and should have
been in quarantine but wasn't either because it was not felt he was considered a
close contact by his family opinion or his family member never notified public
health of this close contact...?. Clinet had presented to the ED following day
after vaccination for shortness of breath and fatigue and an antigen test showed he
was positive for COVID-19. He was sent home that same day 01/26/21. He was back in
ED on 01/28/21 for worsening symptoms and admitted to hospital and later placed on
ventilator. He passed away on 02/09/2021 (date of death was per his wife)." "No
"1024067-1" "1024067-1" "1/15: Pfizer vaccine dose 1 administered 1/16:
Fever, chills 1/22: Sore throat, coughing w/white phlegm, taking Tylenol and
Mucinex. Fever and chills from 1/16 subsided. Had telehealth consultation with PA.
Per her notes, patient said he gets these symptoms annually, requested for an
antibiotic. PA referred him for a COVID test. Ordered hydrocodone/chlorphen ER
suspension for his cough and an antibiotic. Antibiotic was recommended if symptoms
do not subside. 1/23: COVID test administered 1/25: Reported positive for COVID
1/26: Telehealth session w/PA: she informed patient of his positive test, advised
to quarantine and seek medical help at hospital if symptoms worsen. Patient
reported that his sore throat mostly subsided but is still coughing at night. Said
that the pharmacy didn't receive the prescription order for the antibiotic, so this
was re-ordered. 1/31: Partner found him dead at 8:18AM on his bed. Death
certificate issued by state says cause of death: COVID. Autopsy was not performed.
Buried on 2/9/21." "No prior vaccinations for this event."
"1024157-1" "1024157-1" "7 days after receiving the vaccine, patient suffered
excessive diarrhea and slight coughing. 9 days after vaccine, patient was tested
for Covid 19, and received positive results. Patient was transported to hospital
via ambulance but hospital returned her to the nursing home since chest was clear,
no respiratory issues, and no fever. 10 days after receiving the vaccine, patient
was turned over to hospice care but still in the nursing home. Hospice was called
in to provide better physician advice and access 24/7. 14 days after receiving
vaccine, patient began experiencing excruciating body aches, coughing, low oxygen
levels, and no appetite. 18 days after vaccine, patient died." "No prior
"1025980-1" "1025980-1" "death 9 days after vaccination, asymptomatic until
vaccination date, positive test 3 days following vaccination; death 9 days after
vaccination, asymptomatic until vaccination date, positive test 3 days following
vaccination; This is a spontaneous report from a contactable physician (patient's
son). An 84-year-old male patient received the first dose of the bnt162b2
(COMIRNATY), intramuscularly in the left arm on 21Jan2021 at 84-years-old at 0.3
mL, single for COVID-19 immunization; administered at a nursing home/senior living
facility. Prior to the vaccination, the patient was not diagnosed with COVID-19.
Medical history included hypertension from an unknown date and unknown if ongoing,
allergy to iodine from an unknown date and unknown if ongoing. Concomitant
medications included calcium carbonate, colecalciferol (CALCIMED D3), sertraline
(MANUFACTURER UNKNOWN), olmesartan medoxomil (MANUFACTURER UNKNOWN), omeprazole
(MANUFACTURER UNKNOWN); all taken for an unspecified indication from an unspecified
date to an unspecified date. The patient did not receive any other vaccines within
4 weeks prior to the COVID vaccine. On 24Jan2021, the patient experienced death 9
days after vaccination, asymptomatic until vaccination date, positive test 3 days
following vaccination (Drug Ineffective, Covid-19); which required hospitalization,
and resulted in death. No treatment was received for the adverse events. The
patient was hospitalized for the events for 4 days. The patient underwent lab
tests and procedures which included COVID-19 PCR test nasal swab: positive on
25Jan2021. The clinical outcome of the events: drug ineffective and COVID-19, was
fatal. The patient died on 30Jan2021 due to COVID-19 disease. An autopsy was not
performed. The batch/lot numbers for the vaccine, bnt162b2, were not provided and
will be requested during follow up.; Sender's Comments: Based on the information
currently available, lack of efficacy of the suspected vaccine BNT162B2 (COMIRNATY)
cannot be completely excluded. However, individuals may not be protected until at
least 7 days after their second dose of the vaccine. It is unlikely that the
patient would have fully developed immunity due to the very short time lag (3 days
in this case) between the first vaccine dose and the event onset. Instead, the
positive COVID likely represents the pre-existing infection prior to vaccine use.
Further information is needed for full medical assessment; Reported Cause(s) of
Death: COVID-19 disease" "No prior vaccinations for this event."
"1026141-1" "1026141-1" "death 2/12/21" "No prior vaccinations for this
event."
"1029877-1" "1029877-1" "bothsided pneumonia in the presence of COVID-19
infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of
COVID-19 infection/positive PCR test on COVID-19; This is a spontaneous report from
a contactable physician by Pfizer from BIONTECH. An 82-year-old female patient
received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of
administration on 05Jan2021 at single dose for covid-19 immunisation. The patient
medical history was not reported. The patient's concomitant medications were not
reported. The patient was vaccinated with 1 first dose on 05Jan2021. The vaccines
have not been administered before. The patient had positive PCR test on COVID-19 on
07Jan2021. On 19Jan2021, the patient had progressive worsening of general
condition, bedridden, very weak, nutrition (food and drink) has to be supported and
served, no cough, no fever. On 25Jan2021, hospitalization with further worsening of
general condition and in soporous state. Positive PCR Test on COVID-19 on
25Jan2019. Treatment in hospital from 25Jan2021 to 27Jan2021, Diagnosis: bothsided
pneumonia, epicrisis available. On 28Jan2021, the patient had further worsening of
general condition, very week, sopor, as per relatives' wish palliative care
initiation. The patient experienced bothsided pneumonia in the presence of COVID-19
infection, firstly diagnosed on 25Jan2021. The diagnoses are confirmed as per
hospital epicrisis. The vaccine has not been administered again. The patient died
on 01Feb2021. It was not reported if an autopsy was performed. Without any
relation to COMINARTY has lead to a prophylactic hospitalization and treatment. A
causal relation between course of disease and vaccination is not given.
Information about lot/batch number has been requested.; Sender's Comments: Based on
the information available, a possible contributory role of the suspect BNT162B2
cannot be excluded for the reported positive PCR test on COVID-19 based on the
known safety profile. However the short duration of 2 days since the vaccine first
dose is given it is unlikely patient would have fully developed immunity.; Reported
Cause(s) of Death: bothsided pneumonia in the presence of COVID-19
infection/positive PCR test on COVID-19; bothsided pneumonia in the presence of
COVID-19 infection/positive PCR test on COVID-19" "No prior vaccinations for
this event."
"1029878-1" "1029878-1" ""oxygen saturation 81%; cold; livid discoloration of
acra; respiratory infection with respiratory insufficiency; respiratory infection
with respiratory insufficiency; slightly confused; very weak; COVID-19 PCR test
positive; COVID-19 PCR test positive; This is a spontaneous report from a
contactable physician via local license partner. A 85-year-old male patient
received first dose of BNT162B2 (COMIRNATY) on 05Jan2021 at single dose for COVID-
19 immunization. Medical history and concomitant medications were not reported. The
patient had respiratory infection with respiratory insufficiency on 20Jan2021. On
20Jan2021 patient was in reduced general condition, slightly confused, very weak,
no cough, no fever. On 25Jan2021 positive PCR test (throat swab). On 26Jan2021 very
bad general condition, confused, cold and livid discoloration of acra, oxygen
saturation 81%. Palliative therapy with alleviation of symptoms after consultation
of his daughter. On 27Jan2021 further deterioration of general condition,
temperature 38 degrees Celsius, ""Exitus letalis"" at 5:10 p.m. All events except
COVID-19 PCR test positive required outpatient treatment, hospitalization and was
life-threatening. The patient died on 27Jan2021 at 5:10 p.m due to all events
except COVID-19 PCR test positive. The outcome of COVID-19 PCR test positive was
unknown. Information on the lot/batch number has been requested.; Sender's
Comments: Based on available information, a possible contributory role of the
subject product, BNT162B2 vaccine, cannot be excluded for the reported events of
COVID-19 and suspected LOE. However, based on the mechanism of action of the
vaccine, it is unlikely the patient would have fully developed immunity for the
vaccine to be effective, due to the number of days passed since the vaccine is
given and due to only the first dose was administered. Based on available
information, a possible contributory role of BNT162B2 vaccine cannot be excluded
for the other reported events due to temporal relationship Additional information
is needed to better assess the case, including complete medical history,
diagnostics including chest x-ray and autopsy results, counteractive treatment
measures and concomitant medications. This case will be reassessed once additional
information is available. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
response, will be promptly notified to Regulatory Authorities, Ethics Committees
and Investigators, as appropriate. ; Reported Cause(s) of Death: respiratory
infection with respiratory insufficiency; respiratory infection with respiratory
insufficiency; slightly confused; very weak; oxygen saturation 81%; cold; livid
discoloration of acra"" "No prior vaccinations for this event."
"1029937-1" "1029937-1" "Pneumonia; SARS-CoV-2 infection; SARS-CoV-2
infection; Dementia; Shaking; Encephalitis; This is a spontaneous report from a
contactable consumer. This is a report received from the regulatory authority.
Report Unique Identifier GB-MHRA-ADR 24701055. An 83-years-old male patient
received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EJ1688), via an
unspecified route of administration on 07Jan2021 at single dose for COVID-19
immunization. Medical history included prostate cancer, dementia, myocardial
infarction. Concomitant medication included atorvastatin, bisoprolol, lansoprazol,
ranolazine, temazepam, warfarin for myocardial infarction. Patient has not had
symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The
patient experienced pneumonia (death) on an unspecified date, sars-cov-2 infection
(medically significant) on 15Jan2021 with outcome of not recovered, dementia
(medically significant) on 07Jan2021 with outcome of not recovered, shaking
(medically significant) on 07Jan2021 with outcome of not recovered, encephalitis
(medically significant) on 07Jan2021 with outcome of not recovered. Event
description: Massive and immediate increase in dementia symptoms, hospitalized with
suspected stroke but tests ruled out this. Violent whole body convulsions developed
and became uncontrollable. Treated for potential encephalitis / bacterial
meningitis but again ruled out following test. Treated with antibiotics for
undetermined infection but ongoing deterioration in condition. Developed pneumonia
and contracted corona virus whilst still in hospital and ultimately died 2 week
after admission to hospital with COD listed as pneumonia. No coronavirus symptoms
shown despite positive test. The patient underwent lab tests and procedures which
included sars-cov-2 test: yes - positive covid-19 test on 15Jan2021. The patient
died on 22Jan2021, cause of death was pneumonia. It was not reported if an autopsy
was performed. No follow-up activities are possible. No further information is
expected.; Reported Cause(s) of Death: Pneumonia" "No prior vaccinations for
this event."
"1031189-1" "1031189-1" "COVID 19 symptoms and a positive test was confirmed
on 1/6, employee noted previous exposure to positive family members Narrative:
Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on
1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was
confirmed COVID positive that day. Positive result was reported to employee health
on 1/8/21. Employee Health continued to track employees progress and was informed
of the need for hospitalization on 1/14/21. Course of hospitalization noted the
need for intubation and significant issue with comorbid condition (rheumatoid
arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to
Vaccine vs. COVID infection, but felt it should be reported." "No prior
"1032880-1" "1032880-1" "Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB,
cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN,
former smoker. patient in hospice and died 2/10/2021." "No prior vaccinations
for this event."
"1033102-1" "1033102-1" "Patient received first dose of vaccine on 1/7/21 at
a community Public Health clinic. On 1/29/21 he received a second dose at the
community Public Health clinic. On 2/5/21, the patient presented to the ED with
complaints of shortness of breath worsening over the last 2 weeks. Patient
reported that he had decreased exercise capacity and increased coughing with sputum
production intermittently. Patient reported that he had been feeling chilled, but
no fevers. Patient was admitted and treated with Decadron and Remdesivir. Patient
experienced increased oxygen requirement. Patient was a DNI and did not want to be
on life support. After discussion with the patient and family, patient was moved
to comfort care. passed away on 2/11/21." "No prior vaccinations for this event."
"1035046-1" "1035046-1" "Exitus letalis/ Sudden death unexplained; sars-cov-2
test: positive on 14Jan2021; sars-cov-2 test: positive on 14Jan2021; This is a
spontaneous report from a non-contactable physician downloaded from the regulatory
authority, number DE-PEI-PEI2021002162. This report was forwarded via RA, however
no RA number was provided. A 89-years old female patient received the first dose of
bnt162b2 (COMIRNATY), lot number unknown, via an unspecified route of
administration on 13Jan2021 (at the age of 89-years old) as a single dose for
COVID-19 vaccination. The patient's medical history and concomitant medications
were not reported. The patient experienced exitus letalis on 31Jan2021. Death
cause was reported as Sudden death unexplained. The patient underwent lab tests and
procedures which included sars-cov-2 test: positive on 14Jan2021, sars-cov-2 test:
negative on 27Jan2021. An autopsy was performed and results were not provided.
Outcome of the sars-cov-2 test: positive on 14Jan2021 was unknown. Reporter
comment: Patient in stable general condition. Sender comment: According to the
nursing staff in the home, this is the 12th death in temporal connection with the
Corona vaccination. No follow-up attempts possible. No further information
expected. Information on lot and batch numbers cannot be obtained.; Reported
Cause(s) of Death: Exitus letalis/ Sudden death unexplained" "No prior
COVID-19 test with symptoms; This is a spontaneous report from a contactable other
health professional downloaded from the regulatory authority FR-AFSSAPS-SE20210154.
This reporter reported similar events for two patients. This is the second of two
reports. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot
no. EJ6796), intramuscularly in left arm on 14Jan2021 at single dose for covid-19
immunization. Medical history included cataract (probable cataract of the right
eye), Anterior cruciate ligament tear (Ligamentoplasty of the right anterior
cruciate ligament), ulcerative gastritis, peripheral arterial occlusive disease,
Transmetatarsal amputation (trans metatarsal amputation of the right foot),
pancreatitis chronic, hyperthyroidism, Hypertension arterial, diabetes mellitus,
appendicectomy, Humerus fracture, Blindness, one eye, Tetraparesis all from an
unknown date and unknown if ongoing; Chronic alcoholism from an unknown date not
ongoing. Background included: diabetes complicated by transmetatarsal amputation of
the right foot under insulin; AOMI; HTA (hypertension); probable cataract of the
right eye with blindness of the right eye; Right humeral fracture with braces;
Ligamentoplasty of the right anterior cruciate ligament, appendectomy; Calcifying
pancreatitis; Biological hyperthyroidism; Ulcerated gastritis; Insane syndrome: CT
scan of 27Aug18 which found diffuse encephalic atrophy with old left frontal
ischemic sequelae + per-ventricular leucoaraiosis. Appearance of a motor deficit in
the 2 upper limbs making it difficult to take meals alone from the summer of 2018.
The neurological examination had highlighted a tetraparesis around 4/5 greater with
a more marked deficit in the upper right limb, probably related to humeral surgery
in 2013, associated with advanced peripheral neuropathy, related to diabetes and
cognitive impairment with notable dysexecutive syndrome. Patient institutionalized
around the age of 60 in a context of chronic alcoholism, currently weaned.
Treatment in 2019 included: insulin glargine (ABASAGLAR) 100: 10-0-0; alprazolam
0.5: 0.5-0.5-1; amlodipine 5: 1-0-0; rosuvastatin 5: 0-0-1; boric acid; sodium
borate (DACRYOSERUM) 1-0-1; betamethasone dipropionate; calcipotriol (DAIVOBET) 50:
1-0-1; econazole 1-0-1; latanoprost (MONOPROST) 0-0-1; clopidogrel 0-1-0;
retinol;tocopherol (VITAMIN A) 0-0-1. The patient's concomitant medications were
not reported. The patient experienced covid-19 (death) on 26Jan2021, Symptoms:
dyspnea, fever, asthenia => put on O2. The patient underwent lab tests and
procedures which included computerised tomogram: found diffuse encephalic atrophy
with old left frontal ischemic sequelae + per-ventricular leucoaraiosis on
27Aug2018, motor dysfunction: Appearance of a motor deficit in the 2 upper limbs
making it difficult to take meals alone from the summer of 2018 on 27Aug2018,
neurological examination: had highlighted a tetraparesis around 4/5 greater with a
more marked deficit in the upper right limb, probably related to humeral surgery in
2013, associated with advanced peripheral neuropathy, related to diabetes and
cognitive impairment with notable dysexecutive syndrome on 27Aug2018, Constant
monitoring before injection on 14Jan2021: pulse: 60; TA (Atrial fibrillation):
128/73; Saturation: 95; Temperature: 36.7. Constant monitoring 15 minutes after
injection on 14Jan2021: pulse: 78; TA: 12/7; Saturation: 97; Temperature: 36.1. PCR
(polymerase chain reaction): COVID positive on 14Jan2021. The patient died on
28Jan2021. It was not reported if an autopsy was performed.; Sender's Comments:
Linked Report(s) : FR-PFIZER INC-2021134697 different patient, same cluster of
reports; Reported Cause(s) of Death: positive COVID-19 test with symptoms; positive
COVID-19 test with symptoms" "No prior vaccinations for this event."
COVID-19 test with symptoms; This is a spontaneous report from a contactable other
HCP from the Medicines Agency (MA) Regulatory authority WEB FR-AFSSAPS-SE20210161.
This other HCP reported similar events for 2 patients. This is the first of two
reports. A 78-year-old female patient received first dose of bnt162b2 (COMIRNATY,
Lot#EJ6796), intramuscularly on 14Jan2021 at single dose, left arm for covid-19
immunisation. Medical history included cataract surgery, senile macular
degeneration, Internal carotid endarterectomy from 1988, Alzheimer's disease from
2015, hypothyroidism, Anxiodepressive syndrome, Catarct surgery. The patient's
concomitant medications were not reported. Treatment in Dec2020 included
acetylsalicylate lysine (KARDEGIC) 75mg 1 sachet at noon; paroxetine 20 mg 1 + 0.5
in the morning; mianserine 10mg 2 tablets if needed; diazepam 10 drops at bedtime;
olanzapine 5mg 0.5 -0 -0.5; zopiclone 7.5mg 0-0-1; levothyroxine sodium
(LEVOTHYROX) 100�g 1-0-0; calcium D3: 500mg 1 sachet in the morning. The patient
experienced covid-19 (PCR COVID +) on 18Jan2021. The event was serious as death.
Symptoms reported as dyspnea, fever, fatigue. The patient was put on O2. The
patient underwent lab tests and procedures which included blood pressure (Constant
monitoring before injection): 115/10, blood pressure (Constant monitoring 15
minutes after injection): 11/8, body temperature(Constant monitoring before
injection): 36.5, body temperature (Constant monitoring 15 minutes after
injection): 36.2, pulse rate(Constant monitoring before injection): 80, pulse
rate(Constant monitoring 15 minutes after injection): 84, oxygen
saturation(Constant monitoring before injection): 91, oxygen saturation(Constant
monitoring 15 minutes after injection): 93, PCR covid + on 18Jan2021. The patient
died on 23Jan2021. It was not reported if an autopsy was performed. ; Sender's
Comments: Linked Report(s) : FR-PFIZER INC-2021134701 different patient, same
cluster of reports; Reported Cause(s) of Death: COVID-19 infection" "No prior
"1035310-1" "1035310-1" "Seizure; SARS-CoV-2 infection; SARS-CoV-2 infection;
Chest infection; This is a spontaneous report from a contactable other healthcare
professional. This is a report received from the RA. Regulatory authority report
number: GB-MHRA-WEBCOVID-202102062019418600, Safety Report Unique Identifier GB-
MHRA-ADR 24714675. An 85-year-old male patient received his first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on
06Jan2021 at single dose for COVID-19 immunization. Medical history included lower
respiratory tract infection, hypertension, cerebrovascular accident and atrial
fibrillation unknown if ongoing. Patient had not had symptoms associated with
COVID-19. Patient was not enrolled in clinical trial. Concomitant medication
included prednisolone. The patient experienced SARS-CoV-2 infection on 20Jan2021,
chest infection on 10Jan2021, seizure on 02Feb2021. SARS-CoV-2 infection, chest
infection and seizure. Length of being unwell after the vaccination, not to put
finger on. Then chest infection treated with antibiotics and prednisolone. Had
seizure like episode before completing those medications. Passed away the day after
the episode. The patient underwent lab tests and procedures which included COVID-19
virus test: yes - positive covid-19 test on 20Jan2021. The patient died on
03Feb2021 with SARS-CoV-2 infection as cause of death. The outcome of rest events
was unknown. It was unknown if an autopsy was performed. No follow-up attempts
possible; information regarding batch/lot cannot be obtained; No further
information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2
"1037375-1" "1037375-1" "COVID-19; COVID-19; This is a spontaneous report
from a contactable physician from the Medicines Agency (MA) -WEB FR-AFSSAPS-
MA20210291 . A 93 year-old female patient received the first dose of bnt162b2
(COMIRNATY; Lot # EJ6788) vaccine , intramuscular on 19Jan2021 at single dose for
covid-19 immunisation . Medical history included cerebrovascular accident from ,
osteoporosis , hypertension, gastrooesophageal reflux disease , embolism ,
asthma , stent placement , myocardial infarction and undernutrizion (+++) The
patient's concomitant medications were not reported. The patient was tested
positive to Covid-19 Nasal PCR test on 02Feb2021. The patient died on 03Feb2021
from Covid-19 It was not reported if an autopsy was performed. No follow-up
attempts possible. No further information expected; Reported Cause(s) of Death:
Covid-19" "No prior vaccinations for this event."
"1037617-1" "1037617-1" "Contracted Covid-19 with breathing difficulties;
Contracted Covid-19 with breathing difficulties; This is a spontaneous report from
contactable consumer (patient) and daughter via a company representative. Patient's
daughter was a Health Care Professional. A 95-year-old male patient received
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Jan2021, at single dose, for
COVID-19 immunization. Medical history included underlying heath issues with his
heart (something to do with the valves) and was allergic to mustard. The patient's
concomitant medications were not reported. The patient contracted COVID-19 on an
unspecified date, in Jan2021 and was in hospital on Friday 15Jan2021 with breathing
difficulties. It was reported that he contracted COVID after the vaccine had be
given. However, the patient had been self-isolating and only going to his allotment
in the mornings. He did however have Christmas dinner with his family Christmas
day, with his daughter and son in law who are both active paramedic. They both now
also have Covid and yesterday his daughter moved in with him to take care of him
and she only has mild symptoms. It could be he contracted it at Christmas but the
symptoms didn't show until this week. According to the patient's daughter, the
patient went before to have the Pfizer vaccine and was asked if he had any
allergies, he said he did, he was allergic to mustard. It was reported that the
patient was one of the first people to be asked to get the vaccine he even cycled
to the place and when he got there, they didn't allow him because of his allergy to
mustard. Accordingly, due to that the patient was not given the vaccine at that
time was told that he would be contacted when the AstaZenca one was available. He
had to wait for the Astrazeneca vaccine but ended up having the Pfizer one and
contracted COVID. Reporter stated that if he had it 3 weeks earlier when he was
supposed to would still be alive now. The patient died on an unspecified date, in
Feb2021 due to COVID-19. It was unknown if autopsy was done. Information on batch
number has been request. Follow-up (25Jan2021): New information reported from a
consumer (daughter) via a company representative includes: medical history
(allergic to mustard and additional reporter (daughter). No follow-up attempts are
possible, information about batch number cannot be obtained. Follow up
(11Feb2021): New information received includes: details regarding patient's death
and event's updated.; Reported Cause(s) of Death: COVID-19; Breathing difficult"
"1037865-1" "1037865-1" "respiratory failure from COVID19; presented to the
ER with COVID symptoms and was diagnosed/died on 09Feb2021 from respiratory failure
from COVID19; presented to the ER with COVID symptoms and was diagnosed/died on
09Feb2021 from respiratory failure from COVID19; This is a spontaneous report from
a contactable physician. An 89-year-old male patient received the first dose of
bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration in 10Jan2021 at 12:00 at a single dose for COVID-19 immunization.
The patient's medical history and concomitant medications were not reported. The
patient had no COVID prior to vaccination. The patient received one dose of Pfizer
vaccine on 10Jan2021. The patient was presented to the ER with COVID symptoms and
was diagnosed on 27Jan2021. Patient subsequently died on 09Feb2021 from respiratory
failure from COVID19. It was unknown if autopsy was done. The patient was tested
for COVID post vaccination via nasal swab: covid-19 virus test positive on
27Jan2021. The events resulted in emergency room/department or urgent care,
hospitalization, and patient died. No follow-up attempts are possible, information
about batch number cannot be obtained. No further information is expected.;
Sender's Comments: The Company cannot completely exclude the possible causality
between the reported COVID post vaccination and respiratory failure with fatal
outcome, and the administration of COVID 19 vaccine, BNT162B2, based on the
reasonable temporal association. More information on the underlying medical
condition in this 89-year-old male patient is required for the Company to make a
more meaningful causality assessment. The impact of this report on the
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to RA, IEC,
as appropriate.; Reported Cause(s) of Death: presented to the ER with COVID
symptoms and was diagnosed on 27Jan. Patient subsequently died on 09Feb from
respiratory failure from COVID19; presented to the ER with COVID symptoms and was
diagnosed on 27Jan. Patient subsequently died on 09Feb from" "No prior
"1042049-1" "1042049-1" "Respiratory failure; Pneumonia; covid-19; This is a
spontaneous report from a non-contactable physician downloaded from the Medicines
Agency (MA) Regulatory Authority-WEB. The regulatory authority report number is DE-
PEI-PEI2021001974. An 86-year-old female patient received BNT162B2 (COMIRNATY,
PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 16Jan2021 at single dose for
covid-19 immunization. Medical history included dementia, stroke, and atrial
fibrillation from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced covid-19 on
19Jan2021; the patient also experienced respiratory failure and pneumonia on an
unspecified date, which were serious as they were life threatening, and lead to
death. Details were as follows: covid-19 on 19Jan2021 was noted. Also reported
unknown after vaccination, the patient developed respiratory failure and pneumonia,
reported as lasting until 29Jan2021. The patient was dead and condition was
reported as life threatening. Death cause was reported as respiratory failure and
pneumonia. The patient died on 29Jan2021. It was not reported if an autopsy was
performed. The patient under lab test include covid-19 virus test: covid-19 on
19Jan2021. The batch/lot number for the vaccine, BNT162B2, was not provided and
will be requested during follow-up. Follow-up (15Feb2021): This follow-up is being
submitted to notify that the batch number is not available, follow-up activities
not applicable, information about lot/batch number cannot be obtained. Further
follow-up information will be provided automatically upon availability via MA.;
Reported Cause(s) of Death: pneumonia; respiratory failure""No prior vaccinations
for this event."
"1045017-1" "1045017-1" "COVID-19 aggravated/Fever/ PCR test which turns out
to be positive/ suspicion of bronchitis/ deterioration of the patient's condition;
This is a spontaneous report from a contactable other HCP from the Medicines Agency
(MA) regulatory authority-WEB FR-AFSSAPS-LY20210485. An 88-year-old male patient
received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on
19Jan2021 at single dose, for covid-19 immunisation. Medical history included
chronic bronchitis, autonomy: GIR 1, and living in nursing home from an unknown
date and unknown if ongoing. The patient's concomitant medications were not
reported. Usual treatment not known. On 19Jan2021, in the morning, 1st injection of
bnt162b2, after pre-vaccination consultation. At this time, no symptoms. Stable
state of health throughout the day. On 20Jan2021, faced with the presence of a
fever at the end of the day, he benefits from a PCR test which turns out to be
positive (but the result will not be discovered by the nursing home until
23Jan2021). On 21Jan2021, prescription of antibiotics on suspicion of bronchitis.
In the following days, deterioration of the patient's condition, with several trips
to / from the hospital with return to nursing home as soon as the patient's
condition stabilizes. On 28Jan2021, hospitalization. On 30Jan2021, death. COVID-19
cluster in the facility. The patient underwent lab tests and procedures which
included sars-cov-2 test: positive on 20Jan2021. The outcome of the event was
fatal. The patient died on 30Jan2021. It was not reported if an autopsy was
performed. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19 aggravated/Fever/ PCR test which turns out to
be positive/ suspicion of bronchitis/ deterioration of the patient's condition"
"1047351-1" "1047351-1" "Patient was tested for covid on 2/2/21 with positive
resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed
with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to
ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite.
Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral
lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin,
d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the
patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs
of secondary infection Patient transferred to a different hospital in another
city." "No prior vaccinations for this event."
"1048236-1" "1048236-1" "COVID-19/CT angiogram confirming a picture
compatible with SARS-CoV-2 disease; Diarrhea; Asthenia; Respiratory distress; This
is a spontaneous report received from a contactable pharmacist via agency, the
regulatory authority. Regulatory authority report number CH-SM-2021-11420. An 89-
year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular
on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included
arterial hypertension, dyslipidemia and type 2 diabetes mellitus. The patient's
19Jan2021, diarrhea on 18Jan2021, asthenia on 18Jan2021, respiratory distress on
18Jan2021. The patient was hospitalized for the event from 19Jan2021 to an unknown
date. The events were also fatal. Clinical course: On 17Jan2021 she received the
administration of the first dose of Comirnaty. The next day (18Jan2021) she began
to manifest diarrhea, asthenia and respiratory distress because of which, on
19Jan2021, she presented at the emergency room. Laboratory tests showed an
inflammatory syndrome with C Reactive Protein at 92 mg/L (normal range less than 5
mg/L) and lymphocyte count at 0.6x10E9/L (on 19Jan2021) (normal range 1.50-4.00x10
9/l). On the same day, a SARS-CoV-2 swab is performed, which is positive, a chest
X-ray showing parenchymal thickening in the left mid-basal and right
supradiaphragmatic areas, and a CT angiogram confirming a picture compatible with
SARS-CoV-2 disease. The woman was hospitalized on 19Jan2021 and treated
pharmacologically with dexamethasone (6mg for 7-10 days). On 20Jan2021, respiratory
distress worsens so high-flow oxygen therapy is required. The subsequent course was
unfavorable with progressive deterioration of general conditions and worsening of
the respiratory picture. The woman died of COVID-19 on 22Jan2021. An autopsy was
not done. A causal relationship between Comirnaty and all events was assessed as
being unlikely. Agency assessed this case as serious, results in death. Sender's
comment: COVID-19 infection (confirmed by swab on 19Jan2021), with diarrhea,
asthenia and respiratory distress in a polymorbid elderly woman (89 years old) on
18Jan2021, the day after vaccination with the first dose of Comirnaty (17Jan2021).
At the hospital, laboratory and imaging investigations show a picture compatible
with SARS-CoV-2 disease. The woman dies from the viral infection due to progressive
worsening of her general condition. In the Swiss monograph of Comirnaty it is
reported that the duration of protection offered by the vaccine is not known, since
it is still being determined in ongoing clinical trials, and, as with any vaccine,
vaccination with Comirnaty may not protect all recipients. In particular, it is
reported that subjects may not be fully protected until 7 days after the second
dose of the vaccine. Although the woman did not present with any symptoms at the
time of the first vaccination, the fact that she was not swabbed for COVID-19
before vaccination does not allow us to exclude that the infection was already
ongoing before vaccination. In addition, the timing of the onset of the
symptomatology described here, one day after the first vaccination, speaks against
a causal role of Comirnaty, in agreement with what has been reported in the
monograph, namely the possibility that vaccinated subjects are not fully protected
until 7 days after the second dose (which the woman did not receive) and are
therefore susceptible to COVID-19 infection in the period between the first and
second dose of vaccine. On the basis of these considerations, in the current state
of knowledge, the Comirnaty-COVID-19 causal link is judged unlikely. Note the
rapidity of the lethal event for COVID-19 from the time of onset of symptoms (only
5 days).; Reported Cause(s) of Death: Diarrhea; Asthenia; Respiratory distress;
"1048253-1" "1048253-1" "vaccinated with two doses of Comirnaty/ COVID-19
virus test positive; Diagnosis was confirmed by COVID-19 virus test (result:
positiv/positive, unit: NA); This is a spontaneous report from non-contactable
physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021002548.
A 69-year-old male patient received two doses of bnt162b2 (COMIRNATY), via an
unspecified route of administration on 31Dec2020 (lot number: EJ6796, first dose)
and on 26Jan2021 (second dose, lot number: EK9788) at single dose for covid-19
immunisation. The patient medical history and concomitant medications were not
reported. After vaccination the patient experienced COVID-19 virus test positive on
05Feb2021 and developed Death on 10Feb2021, lasting for unknown. The patient was
dead and was hospitalized. Diagnosis was confirmed by COVID-19 virus test (result:
positiv/positive, unit: NA) on 05Feb2021. It was not reported if an autopsy was
Reported Cause(s) of Death: Lethal outcome/Death; Diagnosis was confirmed by COVID-
19 virus test (result: positiv/positive, unit: NA); vaccinated with two doses of
Comirnaty/ COVID-19 virus test positive" "No prior vaccinations for this event."
downloaded from the Medicines Agency (MA) Regulatory Authority-Web [Regulatory
Authority number ES-AEMPS-746451] from a contactable consumer. A 99-year-old female
patient received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of
administration in the arm, on 05Jan2021, at single dose, for COVID-19 immunisation.
Medical history included ongoing chronic kidney disease, ongoing dementia
Alzheimer's type and atrial fibrillation. Concomitant medications were not
reported. The patient experienced COVID-19 on 19Jan2021. The patient presented
symptoms and was hospitalized due to the event from 01Feb2021. The patient
underwent lab tests and procedures which included COVID-19 virus test: positive on
19Jan2021. The patient died on 09Feb2021 due to the event. An autopsy was not
performed. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-19" "No prior
"1048323-1" "1048323-1" ""sudden death / Death unexplained; acute respiratory
distress; 80% desaturation; agitation without disturbance of consciousness;
Polypnea, thoraco-abdominal rocking, pursed lip; slight edema of the lower limbs; a
sinus tachycardia with a shift in particular in V5-V6; a sinus tachycardia with a
shift in particular in V5-V6; cardio-respiratory failure; Blood pressure still low
at 9/5; Positive COVID test; Positive COVID test (screening as part of a cluster in
the service; disoriented in time and space; Tachycardia around 100 bpm; slight
pallor; This is a spontaneous report from a contactable physician downloaded from
the Agency Regulatory Authority-WEB FR-AFSSAPS-RS20210171. An 83-year-old female
patient received the first dose of bnt162b2 (COMIRNATY, lot/batch number: EJ6788),
intramuscularly on 01Feb2021 at single dose for COVID-19 immunization. Medical
history included hypertension arterial (HTA treated and balanced), cognitive
disturbance (moderate), diabetes mellitus insulin-dependent, hospitalized due to
deterioration of general condition and vomiting revealing cardiac decompensation,
anemic syndrome associated with melena treated by a transfusion of 2 red blood
cells bags and E. coli infection, all from an unknown date and unknown if ongoing.
Concomitant medication included amoxicillin from 12Jan2021 to 18Jan2021 for E. coli
infection. Clinical course: On 12Jan2021, the patient was hospitalized due to
deterioration of general condition and vomiting revealing cardiac decompensation.
The selected decompensation factors are an infection with a cytobacterioligical
urine exam positive to E. coli sensitive to Amoxicillin, treated with amoxicillin 1
g x 3 for 7 days as well as an anemic syndrome associated with melena, treated by a
transfusion of 2 red blood cells bags. Progressive resolution of the cardiological
symptoms and progressive regression of the inflammatory syndrome during
hospitalization. After vaccination, medical observation of 01Feb2021: rather
coherent remarks, but patient disoriented in time and space. No somatic complaint.
Tachycardia around 100 bpm, slight pallor. Clear and symmetrical pulmonary
auscultation. No right or left cardiac insufficiency sign. Physical examination:
Soft, painless calves. Hydroaeric noises ok, abdomen soft, no guarding, no
tenderness. No urinary symptoms. No externalized bleeding observed. 02Feb2021:
Patient partially oriented in time. Blood pressure still low at 9/5, tachycardia at
115 bpm. Stable clinical condition. Cardio-pulmonary auscultation: aortic stenosis,
abdomen soft, no guarding, no tenderness. Positive COVID test (screening as part of
a cluster in the service). Asymptomatic patient. 03Feb2021: good constants, patient
""as usual"". 04Feb2021: without an established cause according to the declarant.
Call for acute respiratory distress with 80% desaturation and with agitation
without disturbance of consciousness. BP 140/80, 145bpm. Polypnea, thoraco-
abdominal rocking, pursed lip. No cyanosis observed. Patient placed under O2 in a
high concentration mask between 10 and 15L allowing correct saturation> 90%.
Crackling in the 2 fields, frothy sputum in a second step, slight edema of the
lower limbs. ECG made finding a sinus tachycardia with a shift in particular in V5-
V6 already present on the previous ECG. Rapid degradation, no improvement after
40mg of furosemide (LASILIX) IV. Then cardio-respiratory failure, start of an
external heart massage, no flow <1min. Initial notice to the resuscitator on call,
resuscitation continued. Non-shockable rhythm, administration of 2x1mg of
adrenaline. Decision not to continue resuscitation after review of the file, after
20min of CPR. Sudden death occurred; death noted at 3:05 am. Coded as ""unexplained
death"" (because death without an established cause according to the declarant)
pending the final hospitalization report for update of the file. The patient died
at 3:05 am on 04Feb2021. It was not reported if an autopsy was performed. The
outcome of events was not recovered. No follow up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: sudden death / Death
unexplained"" "No prior vaccinations for this event."
"1048324-1" "1048324-1" "COVID-19 infection; COVID-19 infection; This is a
spontaneous report from a contactable physician downloaded from the Medicines
Agency (MA) Regulatory Authority -WEB regulatory authority FR-AFSSAPS-RS20210172. A
73-year-old female patient received the first dose bnt162b2 (COMIRNATY, lot number:
EJ6788), intramuscular on 21Jan2021 at SINGLE DOSE for covid-19 immunisation.
Medical history included Cardiac arrhythmia, Dementia with Lewy bodies, Atrial
fibrillation, COPD, Ulcer, Chronic cor pulmonale, Thyroidectomy, Arteriopathic
disease, Hernia hiatal, all from unknown date and unknown of ongoing, Bilateral
pulmonary thromboendarterectomy in 2000, severe dementia from Oct2020, hyperthermia
and sudden desaturation from 31Dec2020. Concomitant medication included warfarin
sodium (COUMADINE). The patient previously received clozapine (LEPONEX) for
dementia, ceftriaxone sodium (ROCEPHINE), amoxicillin clavulanic acid (AUGMENTIN),
and ofloxacin. The patient experienced COVID-19 infection on 03Feb2021 with outcome
of fatal. Clinical course: In Oct2020, the patient presented psychotic symptoms of
severe dementia. Introduction of clozapine. 31Dec2020: episode of hyperthermia and
sudden desaturation. PCR COVID negative. Treatment with ceftriaxone sodium in
probabilistic mode. Switch ceftriaxone sodium to amoxicillin clavulanic acid +
ofloxacin for cutaneous + urinary tract. 14Jan2021: seat lesion on the way to
healing but widening of the orifice of the lesion which is flush with the anus.
21Jan2021: vaccination with bnt162b2. Apyretic patient at 36.5 deg C before
injection. No reaction 15 minutes after injection. Patient under warfarin sodium
(COUMADINE) (not administered on 20Jan2021 in the evening). Long compression at the
injection site, no hematoma. Medical observations following vaccination: 23Jan2021:
INR 2.9 check. 26Jan2021: biologically: Hb 16, 4 g / dL; Leuco 8.7 G / L; platelets
277 G / L. New rise in INR despite reduction in dose of warfarin sodium, new
warfarin sodium treatment regimen. Hemoconcentration, it is recommended that the
patient drink well. 29Jan2021 and 02Feb2021: INR 1.7. 03Feb2021: occurrence of
acute asphyxial febrile respiratory distress on massive PAO, call from the IDE for
acute dyspnea with desaturation below 70 percent. Fever at 38.7 deg C. Stage IV
dyspnea. Rales diffuse in the 2 pulmonary fields. No edema of the MIG. Rapid pulse
+++ BP retained. 03Feb2021: SARS-Cov2 RT-PCR positive. COVID 19 infection GD. Poor
short-term prognosis. Part of cardiac decompensation on AC / AF rapid. The patient
died on 03Feb2021 at 5:15 p.m. It was not reported if an autopsy was performed.;
Reported Cause(s) of Death: COVID-19 infection; COVID-19 infection" "No prior
"1048327-1" "1048327-1" "2019 novel coronavirus infection; Covid PCR test:
positive; Pneumopathy; Dyspnoea; Hypoxia; worsening of the respiratory state,
respiratory distress; hemodynamic instability; appearance of signs of cardiac
decompensation; appearance of signs of cardiac decompensation; left basal pneumonia
treated with antibiotics; This is a spontaneous report from a contactable
pharmacist downloaded from the Medicines Agency (MA) Regulatory Authority-WEB FR-
AFSSAPS-ST20210155. A 90-year-old female patient received first dose of bnt162b2
(COMIRNATY, lot/batch number and expiry date unknown), intramuscular on 05Jan2021
at unknown age at 0.3 mL single dose for covid-19 immunization. Medical history
included atrial fibrillation, Cognitive disturbance, insulin-requiring type 2
diabetes mellitus, hyperthyroidism, anxiety, Chronic renal failure, Decompensation
cardiac, depression, and cardiomyopathy, all from an unknown date and unknown if
ongoing. The patient's concomitant medications were not reported. The patient
experienced pneumopathy on 15Jan2021. On 11Jan2021, the patient had evidence of
dyspnea with moderate hypoxia. On 15Jan2021, the patient had evidence of left basal
pneumonia treated with antibiotics. On 17Jan2021, the patient performed an
antigenic covid test with negative result. On 20Jan2021, the patient had worsening
of the respiratory state with appearance of signs of cardiac decompensation. On
21Jan2021, the patient carried out of a new antigenic Covid test with negative
result and Covid PCR test with positive test. On 22Jan2021, the patient was
worsening of the respiratory state, respiratory distress and hemodynamic
instability. The patient had comfort care in the service. The patient died on
23Jan2021. Seriousness criteria provided for hypoxia, pneumopathy, dyspnea, 2019
novel coronavirus infection and Covid PCR test with positive test was
hospitalization and death. The reporter considered the picture of concomitant
COVID-19 infection to be worsened by vaccination. The patient died for hypoxia,
pneumopathy, dyspnea, 2019 novel coronavirus infection and Covid PCR test with
positive test on 23Jan2021. An autopsy was not performed. Outcome of other events
were unknown. No follow-up attempts are possible. No further information expected.
Information on batch/lot number can not be obtained.; Reported Cause(s) of Death:
dyspnea; hypoxia; Pneumopathy; 2019 novel coronavirus infection; covid pcr test:
positive" "No prior vaccinations for this event."
"1048390-1" "1048390-1" "confusion; hallucinations; increased tone in arms;
tremor; myoclonic jerks; Acute kidney injury; Seizures; Drug ineffective; SARS-CoV-
2 infection; Encephalopathy acute; This is a spontaneous report from a contactable
physician, received from the regulatory authority. Regulatory authority report
number GB-MHRA-WEBCOVID-202102151314380170 , Safety Report Unique Identifier GB-
MHRA-ADR 24765082. A 85-year-old female patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an
unspecified route of administration on 14Jan2021 at single dose for covid-19
immunisation. Medical history included deafness neurosensory, pulmonary embolism,
ischaemic stroke, gingival hypertrophy, hypertension, chronic kidney disease, stage
2 pulmonary sarcoid and liver steatosis, all unknown if ongoing. Concomitant
medications included amlodipine, atorvastatin, bisoprolol, colecalciferol,
edoxaban, famotidine. The patient experienced encephalopathy acute on 24Jan2021 and
was admitted to hospital on 27Jan2021 with few days history of confusion and
hallucinations, tremor, increased tone in arms. Also had Acute kidney injury
(resolved in days with treatment). Developed myoclonic jerks and then seizures on
01Feb2021. Tested positive for covid around a week into admission on 31Jan2021.
Lab data included a suspected covid-19 infection on 06Feb2021. Neurology opinion
sought - unable to perform LP due to agitations and seizures, too unwell by the
time CEPOD available. MRI unable to do due to covid and then deterioration. EEG
showed general slowing, nil specific. Treated with intravenous acyclovir and
ceftriaxone empirically (possible infective cause). Loaded on levetiracetam.
Deteriorating level of consciousness throughout admission. Started on steroids,
however, went to palliative care on 12Feb2021. It was not reported if an autopsy
was performed. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: drug ineffective;
confusion; hallucination; hypertonia; tremor; myoclonus; seizure; covid-19;
encephalopathy" "No prior vaccinations for this event."
"1048391-1" "1048391-1" "unwell; Death NOS; sars-cov-2 infection; sars-cov-2
infection; This is a spontaneous report from a contactable healthcare professional
received from the Medicines and Healthcare products Regulatory Agency (MHRA).
Report Unique Identifier GB-MHRA-ADR 24765674. A 53-years-old female patient
received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot
EJ1688), via an unspecified route of administration on 09Jan2021 at single dose for
covid-19 immunisation. Medical history included learning disorder from an unknown
date and unknown if ongoing reported as severe learning difficulties with self-
harm, low mood and behavioural disorder. Patient was not enrolled in clinical
trial. Concomitant medication included citalopram (unknown manufacturer),
olanzapine (unknown manufacturer), pregabalin (unknown manufacturer), carbamazepine
(TEGRETOL RETARD). The patient experienced death nos on 13Feb2021. The patient
experienced also unwell on an unspecified date with outcome of recovered and sars-
cov-2 infection on 23Jan2021 with outcome of unknown. The events were life-
threatening. The patient underwent lab tests and procedures which included positive
covid-19 test on 23Jan2021. The patient died on 13Feb2021. An autopsy was not
performed. The events were reported as mild non specific malaise. Contact with
carrier positive so screened and found positive. Not acutely unwell when went to
bed, found dead in morning of 13Feb2021. No follow-up attempts are possible. No
further information expected.; Reported Cause(s) of Death: Death NOS" "No prior
"1048626-1" "1048626-1" "Cardio-respiratory arrest; conclusion that she
caught Covid and the vaccine did not protect her/ extreme tiredness/ a slight
cough/ a fever; This is as spontaneous report received from a contactable consumer
downloaded from the Medicine Agency (MA) Regulatory Authority-WEB. The regulatory
authority report number is PT-INFARMED-T202102-951. A contactable consumer
reported that a 92-years-old female patient received 1st dose of bnt162b2
(COMIRNATY), intramuscular on 19Jan2021 at 0.3 mL single for covid-19 immunisation.
There was reference to clinical history in the past of melanoma, stroke, gastric
ulcer, pneumonia and unknown if ongoing. There was a history of allergy to
penicillin. Concomitant medication included esomeprazole, furosemide, clopidogrel.
The adverse reaction, appeared about 6 days after the administration of the first
dose of the suspected drug (25Jan2021), and was initially characterized by extreme
tiredness that led her to eat in the bedroom and a slight cough. After 9 days of
inoculation, a fever developed. The patient died on the 10th day (29Jan2021). The
conclusion was that the patient caught COVID and the vaccine did not protect her
associated with the use of bnt162b2 against COVID-19 (with modified nucleoside), 30
mcg/0.3 ml, concentrate for dispersion for injection, in 1st dose, for active
immunization to prevent COVID-19 caused by the SARS-CoV virus-2, with the dosage of
2 intramuscular doses (0.3 ml each) with an interval of at least 21 days between
each dose. The patient was not previously infected with the SARS-CoV-2 virus,
according to the notifier, the patient was institutionalized and everyone tested
Covid, they were confined to their rooms, the test result was negative. The patient
died of cardiorespiratory arrest. No autopsy was performed. There was no concrete
diagnosis of Covid infection, the notifier said in funeral homes say they would be
treated as a suspect for Covid and, according to information from the institution,
they were also hit hard by this plague. Evolution of adverse reaction was death.
There was no reduction in dosage. The suspected drug was suspended once the
vaccination schedule was incomplete, and the second dose was not administered.
There was no suspicion of interaction between drugs. There is no information on the
specific treatment of the reaction. The events outcome was fatal. No follow-up
attempts are possible, information about batch number cannot be obtained.; Reported
Cause(s) of Death: conclusion that she caught Covid and the vaccine did not protect
her/ extreme tiredness/ a slight cough/ a fever; Cardio-respiratory arrest" "No
"1054698-1" "1054698-1" "THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON
1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT
DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21"
"1055298-1" "1055298-1" "Emergency Room HPI: The patient is a 71 y.o. female
with a PMH notable for COPD, hypertension and anxiety and depression who presented
on 2/6/2021 for evaluation of shortness of breath. Patient presented to our
emergency room yesterday morning from local nursing facility rehab nursing staff
reported that she had had a increased shortness of breath for the last 3 days she
has been diagnosed with COVID-19 on 2-2-2021. Patient has also received both
COVID-19 vaccines. Patient presented to the emergency room with labored
respirations conscious awake and was on a non-rebreather at 15 L. upon arrival to
our emergency room patient's temperature 101.6�, pulse 169, respirations 40 to
blood pressure 142/91 and oxygen saturation 100% on 15 L non-rebreather. Patient
received a chest x-ray that showed chronic emphysema and fibrotic changes in the
lung no acute processes identified. Patient's white count 12.8, glucose 197,
creatinine 1.2, lactic acid 4.6, cardiac enzymes negative, D-dimer 1180, patient
has urine culture pending. Patient has received about 3 L normal saline boluses
patient was having hypotension 86/52. Patient also received IV acetaminophen a
1000 mg IV in the emergency room along with Decadron 10 mg IV piggyback. Patient
was admitted acute care for the need of IV fluids and IV antibiotics for COVID-19
and sepsis 2/12 admit Brief history and initial physical exam: Patient is a 71
year old long-term resident of Rehab and Healthcare. Unfortunately, she contracted
coronavirus (COVID-19) at the nursing home. Her respiratory status started to
decompensate and so she was brought into the hospital. Initial workup showed
significant bilateral pleural effusions and ground-glass opacity of both lungs.
She had a significant supplemental oxygen requirement. She was admitted for
further evaluation and treatment. Hospital course: The patient was admitted and
started on IV Remdesivir. She was given IV Decadron. She was given immune support
vitamins. Despite this, her sepsis worsened. When it became apparent that the
patient was not going to recover, her daughter did make her comfort care only and
hospice was consulted. The patient was found to be appropriate for general
inpatient hospice and was made comfort care. Her requirement for morphine and
Ativan did slowly rise. Eventually, the patient did succumb to her respiratory
failure. Time of death was called at 10:00 p.m. on February 15, 2021 Discharge
Condition: expired. Presume cause of death with cardiopulmonary arrest secondary to
acute respiratory failure secondary to coronavirus (COVID-19) pneumonia
Disposition: Deceased" "No prior vaccinations for this event."
"1055837-1" "1055837-1" "COVID-19; COVID-19; General physical health
deterioration; This is a spontaneous report from a contactable consumer downloaded
from the Agency Regulatory Authority-WEB. Regulatory Authority Report Number: CZ-
CZSUKL-21001043. An 81-year-old female patient received first dose of BNT162B2
(COMIRNATY, Lot number and expiry date unknown) intramuscular on 21Jan2021 at
single dose for COVID-19 immunization. Medical history included ongoing Parkinson's
disease treated for a long time (about 4 years) with partial senile dementia. For
better care, she was placed in a nursing home and the family was satisfied with the
care. According to the attending physician, the patient was in a satisfactory
physical condition, but the mental state was not optimal. Before vaccination, the
patient was tested and COVID-19 PCR test was negative in Jan2021. The patient's
concomitant medications were not reported. On 21Jan2021, the patient was vaccinated
with BNT162B2 vaccine. After a few days in Jan2021, she was placed in isolation
because of Covid-19 positivity. On 11Feb2021 the husband was invited because the
patient got much worse. She was in a desperate state, just wheezing and not
perceiving her surroundings at all. She did not respond to the stroking of her
hands and face and there was no eye contact. She did not recognize her husband or
nephew with his wife. The nurses gave antibiotics in drink, the patient had an
inserted cannula and artificial nutrition. For general worsening of the condition,
the patient was taken by ambulance to the hospital, where she was placed in the
infection department. On 14Feb2021, the patient died due to COVID-19 and general
worsening of the condition. The outcome of the events was fatal. It was unknown if
an autopsy was done. Events were considered as serious with death, medically
significant, hospitalized and life-threatening from regulatory authority. No
follow-up attempts are possible; information about batch/lot number cannot be
obtained.; Reported Cause(s) of Death: COVID-19; General physical health
deterioration" "No prior vaccinations for this event."
"1056153-1" "1056153-1" ""septic shock; multi-organ failure; SARS-CoV 2
infection; acute respiratory failure caused by untyped bacterial pneumonia; acute
respiratory failure caused by untyped bacterial pneumonia; vaccination failure;
This is a spontaneous report from a contactable physician downloaded from the
regulatory authority manufacturer report number IT-MINISAL02-678359. A 63-year-old
female patient received the second dose of BNT162B2 (Comirnaty, Lot No. EJ6797)
intramuscularly on 27Jan2021, the first dose (Lot No. EL1484) was received on
05Jan2021, both at single dose for COVID-19 immunisation. Relevant history induced
Type 2 diabetes mellitus, arterial hypertension, Chronic renal failure under
dialysis treatment, closed fracture of multiple cervical vertebrae since 01Sep2020
(C1-C2 fracture (September 2020) with diver - atlanto-axial flux and compression at
the bulb-medullary passage and on the cervical cord, without neurosurgical
indication due to the high risk-benefit ratio. The patient had Long-term
hospitalization. Relevant concomitant drug included levothyroxine sodium (EUTIROX)
50mcg tablet and epoetin zeta (RETACRIT) 4000 IU / 0.4 ML solution for injection
for Chronic renal failure. Therapy administered in a nursing home included: Eutirox
50mcg, Humalog 6 UI for Diabetes mellitus, Lobivon 5 mg for Hypertension arterial,
catapresan CRTT for Hypertension arterial, Nitrodem 10 mg, Calcium 1cpr, retacrit
4,000 for Chronic renal failure, Rocaltrol 0.25mcg, Omeprazen 20mg, Adalat crono 30
mg for Hypertension arterial, Lantus 12U.I for Diabetes mellitus. 15 days after the
Covid-19 vaccination (II dose), the patient was found to have positive SARS-CoV 2
infection, and arrived in emergency room and then in Intensive T. on 10Feb2021 for
acute respiratory failure caused by untyped bacterial pneumonia, died within 24
hours of septic shock and multi-organ failure (chest x-ray not suggestive of Covid
pneumonia), with onset of respiratory symptoms on 05Feb2021 (reported by doctor).
Treatment therapy included: Resuscitation treatment of the picture Respiratory,
Hemodynamic and Renal (Invasive ventilation, amine-vasoactive, broad spectrum
antibiotic therapy, CVVHDF dialysis treatment). Examinations performed on
admission: Chest x-ray (on 10Feb2021): ""complete opacification of the left
hemithorax is documented as per lung atelectasis. Other more circumscribed
parenchymal thickenings are noticeable on the right. ECHO-lung: diffuse pattern of
B lines bilaterally (left hemithorax greater than right hemithorax), presence of
bilateral pleural sliding without macroscopic signs of pleural effusion. Rapid swab
positive for SARS CoV-2 performed by 118 crew (on 10Feb2021). Upper respiratory
panel filmarray (nasopharyngeal swab) (on 10Feb2021): positive for SARS-COV 2. SARS
CoV 2 PCR rt Positive (nasopharyngeal swab) (on 11Feb2021). FILMARRAY blood culture
panel on 10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on
10Feb2021, culture tests are in progress). FILMARRAY blood culture panel on
10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on 10Feb2021,
culture tests are in progress); complete opacification of the left hemithorax is
documented as from pulmonary atelectasis. Other more circumscribed parenchymal
thickenings are noticeable on the right; SUCCESSFUL; upper respiratory panel
filmarray (nasopharyngeal swab) (10Feb2021): positive for SARS-COV 2; diffuse
pattern of B lines bilaterally (left hemithorax greater than right hemithorax),
presence of bilateral pleural sliding without macroscopic signs of pleural
effusion.; Reported Cause(s) of Death: untyped bacterial pneumonia; acute
respiratory failure; SARS-CoV 2 infection; vaccination failure; septic shock;
multiorgan failure"" "No prior vaccinations for this event."
"1056237-1" "1056237-1" "COVID-19 virus test was positive; COVID-19 virus
test was positive; Patient died on 04Feb2021 with pneumonia; This is a spontaneous
report downloaded from the Regulatory Authority -WEB DK-DKMA-WBS-0032249. The case
was received from a contactable physician via The Regulatory Authority. An 81-
year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for
injection; lot number; EJ679) via Intramuscular route on 03Jan2021 and second dose
(lot number; EJ6136, expiry date; 30Apr2021) via intramuscular route, on 24Jan2021,
and both were at single dose for COVID-19 immunisation. Medical history included
ongoing dementia. Concomitant medications were not reported. The patient underwent
COVID-19 virus test on 26Jan2021 and resulted as positive. On an unknown date in
2021, patient had pneumonia. On 04Feb2021 the patient died due to pneumonia. There
are no other ADRs to COMIRNATY. An autopsy has not been performed. The test was
positive when the patient died. No treatment or medical procedure due to the ADRs
was reported. Seriousness of the event pneumonia was fatal. Outcome of the event
pneumonia was fatal and for other events it was unknown. Causality: The hospital
believes that the patient has died from Pneumonia. The reporting physician does not
believe that there is a causal relationship between pneumonia and COMIRNATY, but he
sticks to reporting the case due to the temporal correlation. No follow-up
attempts are possible, batch number already obtained.; Sender's Comments: The
association between the event fatal pneumonia and lack of effect (COVID-19 virus
test positive) with COMIRNATY use can not be fully excluded.; Reported Cause(s) of
Death: Patient died on 04Feb2021 with pneumonia" "No prior vaccinations for
this event."
"1057082-1" "1057082-1" "Pt admitted to Hospital on 2/8/21 with 2-3 days of
SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time
when the patient received 1st COVID-19 vaccine. Pt had not felt well since
receiving the vaccine and had some changes in taste or smell. He became acutely
worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound
weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During
hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt
and wife discussed goals of care and decided on comfort measure approach. Pt
expired on 2/19/21." "No prior vaccinations for this event."
"1058464-1" "1058464-1" "Pt tested Covid positive 2/8/2021." "No prior
"1059344-1" "1059344-1" "death 2/25/21" "No prior vaccinations for this
event."
"1059621-1" "1059621-1" "1/14/21 - Resident complained of SOB. SPO2 66% on
RA, vs 105/66-96-20 T98.2 O2 administered Pox 97% Binax test revealed (+) COVID
results. Resident transferred to COVID wing. Family (HCP) updated and declined
transfer to hospital Resident continued with fever, hypoxia and lethargy. Family
elected CMO and Hospice notified. Resident died on 1/16/2021 @ 930AM." "No prior
"1061821-1" "1061821-1" "COVID-19; general deterioration in her health
status; Drug ineffective; This is a spontaneous report from contactable consumers
and nurse via other company. A 53-year-old female patient received bnt162b2
(Formulation: Solution for injection), via an unspecified route of administration
on an unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical
history included endotracheal intubation and ongoing mechanical ventilation.
Concomitant medication included macitentan (OPSUMIT) at 10mg once a day for
pulmonary arterial hypertension, selexipag (UPTRAVI, Strength: 800 ug) at 800 ug,
twice a day for pulmonary arterial hypertension. It was reported that patient was
vaccinated with the first dose of COVID-19 vaccine and one week after that began
general deterioration in her health status on an unknown date in Jan2021. The
patient was hospitalised and diagnosed with COVID-19 on 29Jan2021 and shortly after
that had severe dyspnea on an unknown date in Jan2021. The patient was intubated
and sedated on MV(mechanical ventilation). It was reported that patient was
hospitalized since 29Jan2021 until death. The patient died on 04Feb2021. It was not
reported if an autopsy was performed. The outcome of the events was fatal. No
follow-up attempts are possible, information on batch number cannot be obtained.;
Sender's Comments: Based on the temporal relationship, the association between the
event lack of effect (fatal COVID19) with BNT162b2 can not be fully excluded. The
impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to Regulatory Authorities, Ethics Committees, and Investigators,
as appropriate.; Reported Cause(s) of Death: general deterioration in her health
status; COVID-19; severe dyspnea" "No prior vaccinations for this event."
"1061852-1" "1061852-1" "Diagnised by pathologist with COVID-19 but negative
test; Respiratory dysfunction; This is a spontaneous report downloaded from the
Regulatory Authority-WEB [Lareb (LRB) number NL-LRB-00445009] from a contactable
consumer (patient's daughter or son). An elderly male patient received bnt162b2
(COMIRNATY), via an unspecified route of administration, on 28Jan2021, at single
dose, for COVID-19 immunisation. The patient's medical history and concomitant
medications were not reported. The patient was diagnosed by a pathologist with
COVID-19 in Jan2021 but test was negative on 31Jan2021, and experienced respiratory
dysfunction in Jan2021. After events onset the patient underwent lab tests and
procedures which included COVID-19 virus test: negative on 31Jan2021. The patient
died on 02Feb2021. An autopsy was performed and results were not available. Case
summary and Reporter comment: My father was vaccinated on 28Jan2021. Sadly died on
02Feb2021 from the effects of the vaccine, he was chronically short of oxygen and
his lungs stopped functioning. I have come into conflict with the pathologist who
diagnosed COVID-19. What the pathologist didn't know was that my father had been
tested for COVID-19 after the symptoms started. COVID-19 negative test result was
on 31Jan2021. The pathologist, after initial doubts, stayed with his diagnosis of
COVID-19 and said it was not contagious (unbelievable), I myself warned the
nursing home to take measures, but that was according to not need the pathologist.
The pathologist himself reported to the nursing home that the investigation was
still ongoing (various signals, miscommunication). No follow-up attempts are
possible; information about lot/batch number cannot be obtained.; Reporter's
Comments: My father was vaccinated on 28Jan2021. Sadly died on 02Feb2021 from the
effects of the vaccine, he was chronically short of oxygen and his lungs stopped
functioning. I have come into conflict with the pathologist who diagnosed COVID-19.
What the pathologist didn't know was that my father had been tested for COVID-19
after the symptoms started.; Reported Cause(s) of Death: Respiratory dysfunction;
Diagnised by pathologist with COVID-19 but negative test" "No prior vaccinations
for this event."
"1064480-1" "1064480-1" "Bilateral pneumonia; COVID-19; This is a spontaneous
report from a contactable consumer downloaded from the Regulatory Authority-WEB.
This is a report received from the regulatory authority report number is CZ-
CZSUKL-21001001. An 88-year-old male patient received the first dose of the
bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Jan2021 at a
single dose for COVID-19 immunization. The patient's medical history included below
knee amputation on 07Feb2020. Concomitant medications were not reported. On
26Jan2021, the patient experienced COVID-19 (death, hospitalization, medically
significant, life threatening). On an unspecified date, the patient experienced
bilateral pneumonia (death, hospitalization, medically significant). The patient
underwent lab tests and procedures which included SARS-CoV-2 test: positive on
26Jan2021. The clinical outcome of the events: bilateral pneumonia and COVID-19,
was fatal. The patient died on 04Feb2021 due to bilateral pneumonia and COVID-19.
An autopsy was not performed. No follow-up attempts are possible; information
about batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Bilateral
pneumonia; COVID-19" "No prior vaccinations for this event."
"1065049-1" "1065049-1" "COVID-19; This is a spontaneous report received from
a contactable physician, downloaded from the Regulatory Authority NL-LRB-00444454.
A 90-year-old female patient received bnt162b2 (COMIRNATY) (Lot # EJ6134), via an
unspecified route of administration at single dose on 29Jan2021 for covid-19
immunisation. Medical history included ongoing chronic obstructive pulmonary
disease, ongoing emphysema. Concomitant medication included midazolam, morfine.
The patient experienced Covid-19 on 06Feb2021 with fatal outcome. The patient died
on 12Feb2021. The patient underwent lab tests and procedures which included sars-
cov-2 test: positive on 06Feb2021. It was not reported if an autopsy was performed.
The patient died at home using palliative sedation as a result of complications
from Covid-19. Unknown if there was a relationship with vaccination with Comirnaty.
Clinical course as follows: 5 days after vaccination, the patient experienced
symptoms of a Covid-19 infection, 8 days after vaccinations the patient had a
positive SARS COV 2 test and 14 days after vaccination the patient deceased with
palliative sedation. The patient died of complications of a Covid-19 infection. No
follow-up attempts possible. No further information expected.; Reported Cause(s) of
Death: complications of COVID19" "No prior vaccinations for this event."
"1065211-1" "1065211-1" "COVID-19; This is a spontaneous report from a
contactable pharmacist downloaded from the Medicines Agency (MA) regulatory
authority-WEB FR-AFSSAPS-LY20210735. A 90-years-old male patient received the
first dose of bnt162b2 (COMIRNATY; Lot # EJ6795 ) vaccine , intramuscular in the
left arm 19Jan2021 at SINGLE DOSE for covid-19 immunisation . Medical history
included mixed anxiety and depressive disorder, cognitive disorder , Parkinson's
disease, starvation , carcinoid tumour (vertex carcinoid, untreated) , Sars-cov-2
test negative on 18Jan2021, bedridden . The patient's concomitant medications were
not reported. On 25Jan2021 during a systematic COVID-19 screening, the patient
had a COVID PCR test positive: no symptoms presented to date. On 02Feb2021: the
patient presented symptoms such as rapid breathing, fever. he was put under O2.
His condition deteriorated rapidly, he presented with dehydration and a back
pressure ulcer. On 05Feb2021 comfort care were implemented. On 11Feb2021 the
patient died at 8 a.m. The cause of death was Covid-19. Follow up information
cannot be obtained. The patient experienced covid-19 (covid-19) (death) on
25Jan2021. The patient underwent lab tests and procedures which included sars-cov-
2 test: negative on 18Jan2021 , sars-cov-2 test: positive on 25Jan2021 .
The action taken in response to the event(s) for bnt162b2 was not applicable.
Therapeutic measures were taken as a result of covid-19 (covid-19). The patient
died on 11Feb2021. It was not reported if an autopsy was performed.; Reported
Cause(s) of Death: Covid-19" "No prior vaccinations for this event."
"1065267-1" "1065267-1" ""positive COVID-19 test; This is a spontaneous
report from a contactable consumer received from the regulatory authority.
Report Unique Identifier GB-MHRA-ADR 24814558. An 84-year-old male patient
received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration at single dose on 19Jan2021 for covid-19
immunisation . Medical history included amnesia, dementia Alzheimer's type.
Concomitant medications were not reported. The patient experienced positive Covid-
19 test on 25Jan2021. The patient died on 05Feb2021. It was not reported if an
autopsy was performed. The patient had not had symptoms associated with COVID-19.
The patient was not enrolled in a clinical trial. The reporter stated that: ""My
father was ok leading up to the vaccine he was quiet and tired due to boredom of
being locked away in a care home unable to see relatives frequently or go outside
and live a normal life"". No follow-up attempts possible; information regarding
batch/lot cannot be obtained; No further information expected.; Reported Cause(s)
of Death: COVID-19"" "No prior vaccinations for this event."
"1065567-1" "1065567-1" "COVID-19/positive antigen Covid-19 test; became ill;
Sleep excessive/still asleep/she was sleepy; tired; Communication disorder/stopped
communicating by phone; suspected of having another stroke/Suspicion of
cerebrovascular accident; This is a spontaneous report received from a contactable
consumer, downloaded from the Medicines Agency (MA) regulatory authority CZ-CZSUKL-
21001005. A 72-year-old female patient received the first dose of BNT162B2
(COMIRNATY, lot number EL1491) via Intramuscular on 13Jan2021 at single dose for
COVID-19 immunisation. Medical history included: ischemic heart disease,
dysrhythmic form, recurrent stroke with mild residual left-sided finding, last
stroke May2014, endarterectomy bilaterally 1999, ongoing vascular and hypoxic
encephalopathy, ongoing arterial hypertension, type 2 diabetes mellitus since 2006,
now without therapy, ongoing diabetic nephropathy, ongoing diabetic polyneuropathy,
ongoing diabetic retinopathy bilateral and age-related macular degeneration
(practical blindness on right), ongoing dyslipidemia on statin therapy,
thyroidopathy, goitre, effector, dysfunction thyroid, ulcerative colitis, relapse
in May2016, small bowel resection for volvulus with peritonitis in 2005,
cholecystolithiasis, ongoing hepatic steatosis, psoriasis vulgaris, ongoing
psoriatic arthropathy, ongoing vertebrogenic algic polytopic syndrome, ongoing
cerebello-vestibular syndrome, instability with repeated falls, ongoing
polyarthrosis, ongoing postmenopausal osteoporosis, recurrent urinary tract
infections, intestinal resection for volvulus in 2009, trochanter abscess l.dx.
sepses etiologically MRSA, appendectomy, hysterectomy + adnexectomy/
hysterosalpingo-oophorectomy for myomatosis, cataract surgery bilaterally, ongoing
glaucoma, allergies to penicillin (swelling of the face), smoker (3-5 cigarettes
/day). Family history was insignificant. Before the vaccination, the patient was a
lying patient, but she raised her hands and communicated. Concomitant medications
were not reported. Previous vaccination included: against tetanus in Jan2017. It
was reported the next day she stopped communicating by phone/ communication
disorder. The patient was in a nursing home, from where the reporter had
information that the patient was sleep excessive/still asleep. She didn't even say
hello to the phone and stopped moving. Before the vaccination, the patient was a
lying patient, but she raised her hands and communicated. The reporter was
suspected of having another stroke/suspicion of cerebrovascular accident. According
to the reporter, Covid-19 disease was also added. The patient died on 24Jan2021. On
15Feb2021, the attending physician was called: added medical history of the
patient. 48 hours after vaccination, the patient was monitored and no deterioration
was observed. On 17Jan2021 the patient became ill and was very sleepy. An ambulance
was called and the patient was hospitalized. On 16Feb2021, charge nurse was called:
patient was alright at the time of vaccination. No marks of stroke or infection.
She was cooperating, consciousness. On 15Jan2021 she was sleepy and tired. On
17Jan2021 she had positive antigen Covid-19 test. Many patients had similar
symptoms and many of them had antigen Covid-19 positive test. Rales, normal
saturation, normal physiological function. She was transferred to neurological
department after nurse urging. A hospitalisation report was requested. On 24Jan2021
patient died. Outcome of event COVID-19/positive antigen Covid-19 test was fatal,
for other events were not recovered. Autopsy was not indicated. And the reported
cause of death was COVID-19/positive antigen Covid-19 test.; Reported Cause(s) of
Death: COVID-19/positive antigen Covid-19 test" "No prior vaccinations for this
event."
"1065568-1" "1065568-1" "Pulmonary embolism; PCR Covid-19 positive; PCR
Covid-19 positive; Vomiting; aggravated food intake; Eating disorder; Condition
aggravated; This is a spontaneous report from a contactable consumer (patient)
downloaded from the Regulatory Authority-CZSUKL-21001137. An 85-year-old female
patient received bnt162b2 (COMIRNATY), 1st dose on 11Jan2021 and 2nd dose on
01Feb2021, both via intramuscular at single dose for COVID-19 immunisation.
Medical history included ongoing thyroid disorder and patient was on therapy
(psychotropic medicinal products and food supplements) and varicose vein operation.
The patient's concomitant medications were not reported. After 7 days after the
2nd dose, there were some adverse reaction: aggravated condition, vomiting,
aggravated food intake, eating disorder, all on 08Feb2021. She was transferred to
the hospital, where she was diagnosed with massive pulmonary embolism with
saturation 50% on 08Feb2021. PCR Covid-19 was positive on 09Feb2021. PCR Covid-19
positive 09Feb2021. Patient died on 09Feb2021. The cause of death was reported as
embolism lung. Autopsy was done. Autopsy results was not available and will be
informed about autopsy results. No follow-up attempts possible. Batch/Lot numbers
cannot be obtained.; Reported Cause(s) of Death: Embolism lung" "No prior
"1065573-1" "1065573-1" "Covid-19; This is a spontaneous report from a non-
contactable physician downloaded from the Medicines Agency (MA) regulatory
authority-WEB DE-PEI-PEI2021002654. A 54-year-old male patient received bnt162b2
(COMIRNATY) (lot number unknown), via an unspecified route of administration on
12Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included early
childhood brain damage from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced covid-19 (covid-
19) (death, hospitalization) on 13Jan2021. Patient was vaccination with Comirnaty
on 12Jan2021. After 1 day positive PCR test for SARS-CoV2. Symptoms of a Covid-19
infection after 2 days. Stationary admission on 16Jan2021 due to deterioration.
With intake of massively increased Blood sugar (> 900). Patient died on 21Jan2021.
Preliminary autopsy findings included massive pneumonia with microabscesses, staph.
aureus in the tracheal secretion, PCR positive for SARS-CoV2 in almost all organs,
CT pituitary gland 28. Pathologist expresses suspicion of enhanced disease.
Sequencing pending, Antibody determination pending. The patient died on 21Jan2021.
An autopsy was performed. Comirnaty/ Covid-19/ PEI/ C. Inconsistent causal
association. No follow-up attempts are possible. Information about lot/batch
number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia" "No
"1065920-1" "1065920-1" ""never woke up after arrival; Suffered with vascular
dementia; Death cause: Covid/Tested positive to Covid 31Jan, tested due to
increased lethargy; This is a spontaneous report from a contactable consumer. An
85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via
an unspecified route of administration on 22Jan2021 at single dose for COVID-19
immunization. The patient received the vaccine at nursing home/senior living
facility. Medical history included dementia, hypertension, past strokes. The
patient was exposed to asymptotic staff member on or prior to 25Jan2021. The
patient had no known allergy. No COVID prior vaccination. Concomitant medication
included lisinopril. No other vaccine was received in four weeks. The patient was
tested positive to COVID on 31Jan2021, tested due to increased lethargy started
from 26Jan2021. The patient suffered with vascular dementia. She was ambulatory up
to 31Jan2021. The patient was sent to hospice that evening on 31Jan2021 to
quarantine, never woke up after arrival. Palliative Care started 02Feb2021, the
patient expired 12Feb2021. Cause of death was COVID. The patient did not receive
treatment for events. The autopsy was not performed. The outcome of events ""never
woke up, vascular dementia"" was unknown. Information on Lot /Batch Number has
been requested.; Reported Cause(s) of Death: Death cause: Covid"" "No prior
"1066178-1" "1066178-1" "Caller is nephew of patient. Patient was admitted to
Hospital on 2/15/21 with Covid like symptoms and decreased O2 sat. He tested
positive for Covid 2/15/21. Treated with Remdesivir. Patient status continued to
decline and he passed away in hospital 2/22/21 0612." "No prior vaccinations for
this event."
"1067874-1" "1067874-1" "death; COVID-19 positive; low oxygen saturation
levels (79%); throat pain; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority-WEB NL-LRB-00446680 via
Regulatory Authority. A 74-years-old female patient received first dose of
BNT162B2 (COMIRNATY), via unknown route of administration on 04Feb2021 at single
dose for COVID-19 immunisation. The patient medical history was not reported. The
patient's concomitant medications were not reported. The patient experienced death
on 12Feb2021. It was also reported that COVID-19 positive caused patient death.
Three days after vaccination on 07Feb2021, the patient had throat pain. 08Feb2021,
COVID-19 PCR test performed and patient tested positive. On 10Feb2021, COVID-19 PCR
test was positive. The patient was treated with 5L oxygen, but low oxygen
saturation levels (79%) remained on 11Feb2021. Start morphine with restrained
policy. On 12Feb2021, the patient deceased. Outcome of the event other event was
unknown. It was unknown if an autopsy was done or not. No follow-up attempts are
possible; information on batch/lot number cannot be obtained.; Reporter's Comments:
BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine
(Comirnaty): no Death Additional information ADR: 04Feb vaccination. 07Feb arise
sore throat. 08Feb Covid-19 PCR test performed. 10Feb result: positive. 11Feb low
saturation (79%) despite 5 liters of oxygen. Start morphine with restrained policy.
12Feb death BSN available: yes COVID19 Previous COVID-19 infection: disease
symptoms: hospitalization; Reported Cause(s) of Death: Covid 19 positive; death"
"1068549-1" "1068549-1" "2/13/21 Patient had covid like symptoms 2/15/21
Patient admitted to Hospital with covid like sx and decreased O2 sat; tested
positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx
worsened and patient died 2/26/21.." "No prior vaccinations for this event."
"1069329-1" "1069329-1" ""COVID-19 post Infection/COVID-19 respiratory
infection/COVID-19 PCR test on 28Jan2021; COVID-19 post Infection/COVID-19
respiratory infection/COVID-19 PCR test on 28Jan2021; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB via
Regulatory Authority with Regulatory Authority number: AT-BASGAGES-2021-07099. An
88-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for
injection, batch/lot number: EL1491), via an unspecified route of administration on
15Jan2021 (at unspecified age) at single dose for covid-19 immunisation. Medical
history included ongoing Renal insufficiency (NINS), ongoing Polyneuropathy,
ongoing COVID-19, ongoing Coronary heart disease, ongoing Dementia. The patient's
weight was not reported, and height was not reported. No concomitant medication
reported. ""A possible connection between deaths and COVID vaccinations carried out
shortly before is suspected. The people were all vaccinated against COVID-19 on
15Jan2021 (1st vaccination with Comirnaty, batch EL1491), tested positive 4 to 13
days later (one patient 32nd Days later) and died 10 to 20 days after the
vaccination (said patient 37 days later). A comparable number of deaths has not
occurred in the nursing home in recent years."" COVID infection has been
circulating in the home since January. All 12/14 deceased have been tested positive
for Sars-CoV2 by PCR. The patient in this NW report also tested positive for Sars-
CoV2 by PCR (28Jan2021), then died of his COVID infection at the home on 16Feb2021.
On Jan2021 the patient experienced COVID-19 death. The patient's outcome was fatal
for COVID-19. The patient died on 16Feb2021 from COVID-19 respiratory infection.
The patient underwent lab tests and procedures which included COVID-19 PCR test:
Positive on 28Jan2021. The patient died on 16Feb2021. An autopsy was not performed.
No follow-up attempts possible. No further information expected.; Reported Cause(s)
of Death: COVID-19 respiratory infection/COVID-19 post Infection"" "No prior
"1069560-1" "1069560-1" "Hospital course 1/31 ? 2/20/21 1/31 in ED pt was at
home when children noticed his lips were blue, ems arrived and found him to be 50%
on RA, on Non-rebreather pt got to 78%, covid on 01/26 Shortness of Breath 61-
year-old male presents with EMS for evaluation of shortness of breath hypoxia.
History is limited due to the patient's current clinical condition and so is
primarily obtained from EMS. EMS reports that he tested positive for COVID-19 5
days ago. He began developing shortness of breath yesterday and his family called
because his lips and fingers were blue today and he appeared short of breath. On
EMS arrival he had a room air saturation of less than 50% so he was placed on
nonrebreather with improvement in his saturation to 70% and he was transported to
the emergency department. Patient does admit to shortness of breath. He denies
any chest pain. He is noted to have a cast on his left ankle and said that he
broke his left ankle on 23 December but has not had surgery. He denies any new
pain or swelling of the leg. In the ED he was placed on 15L nasal cannula and NRB
mask with improvement in SPO2 to low 90s. Additional work up revealed troponin of
1.35, lactic acid 5.8, and d-dimer 14.4. He received dexamethasone and was placed
on heparin gtt. 1/31 admitted to ICU Acute hypoxic respiratory failure due to
COVID-19 vs heart failure vs PE. CXR with bilateral hazy infiltrates more
pronounced in the bases and left periphery and suspected multifocal pneumonia. At
risk for PE given LLE immobility in the setting of COVID-19 with significantly
elevated d-dimer. RISK of CTA outweighs benefit given AKI and iodine allergy.
Continue with empiric treatment with heparin gtt. Admitted to ICU with SO2 in
60s-70s on 15L and NRB. Attempted 50L 95% FIO2 high flow and nasal cannula. Given
lasix 40mg IV with good diuresis however SPO2 still remained low 80s with RR 40s
and PO2 42 so the decision was made to intubate. Oxygenation improved following
intubation, with further improvement following recruitment maneuver and increase in
PEEP. FIO2 weaned to 90% with SPO2 remaining in mid 90s. Will continue to wean FIO2
as able. ARDS net protocol as much as possible. Consider prone ventilation and/or
epoprostenol if unable to improve . VAP Bundle: HOB >30 degrees; Oral care per
nursing standard and on DVT/PPI prophylaxis Sedation: Target Richmond Agitation and
Sedation Scale (RASS) of 0 to -2 with propofol and fentanyl. Check baseline TG
levels. COVID - 19: Convalescent plasma: Not indicated Steroids: Dexamethasone
6 mg / day for 10 days Remdesivir: Not indicated d/t AKI IL-6 inhibitor: Meets
criteria for tocilizumab Systemic AC: Heparin gtt. No signs of bleeding (Platelets
and Hb stable). Antibiotics: Start 3 and 7 day course of azithromycin and
ceftriaxone, respectively. Elevated troponin Suspect demand ischemia d/t hypoxia;
EKG does not show any ischemic changes AKI: Suspect d/t hypoxia in the setting
of COVID infection. Urine output and electrolytes acceptable. Closed fracture of
left ankle Suffered fracture following a fall on ice in December. Cast was placed
on 12/30 by SOS. He was due to be re-evaluated this week for possible cast removal.
Inhaled epoprostenol started Considered for ECMO but not initiated due to not a
candidate Vasopressors required at times Antihypertensive infusion required at
times severe hypoxia with position changes switched from heparin drip to
enoxaparin prophylaxis 2/20 discharge summary 61 y/o male admitted to Hospital on
1/31 with hypoxia. He was diagnosed with COVID 19 5 days prior to admission, and
had worsening respiratory status. He was intubated after arrival, and was on
ventilator for the entire intervening time, until he was extubated on 2/20 at the
time of transition to Comfort measures only. Prior to developing COVID 19, he
had received his first dose of the Pfizer vaccine, as a member of the school
system. He had a fractured L ankle after a fall on 12/31/20, and had a cast in
place at the time of admission. He received Tocilizumab on 1/31, and underwent
several cycles of prone positioning, beginning on 2/2. He completed a course of
Decadron, he received Ceftriaxone and azithromycin beginning on admission, and
completed a course of these. Anticoagulation with enoxaparin was utilized due to
coagulopathy associated with COVID 19. Vasopressor support was required at times,
as well as diuresis for fluid management. He required high levels of sedation to
maintain ventilator synchrony, and high levels of ventilator support with high
oxygen levels throughout his stay. Tracheostomy was being considered, but family
decided that since he was not going to have good recovery, withdrawal of support,
and allowing death was the appropriate choice for the patient and for them. He
was extubated at 2100 on 2/20/2021. Death was pronounced at 2123 on 2/20/2021.
Children were at bedside." "No prior vaccinations for this event."
"1072559-1" "1072559-1" "COVID-19 PCR test Positive; COVID-19 respiratory
infection; COVID-19 PCR test Positive/COVID-19 respiratory infection; This is a
spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB and received via Regulatory Authority AT-BASGAGES-2021-04882. A 93-
year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number
EL1491), via an unspecified route of administration on 15Jan2021 at single dose for
COVID-19 immunization. Medical history included ongoing COVID-19 Infection.
Concomitant medications were not reported. In Jan2021 the patient experienced
COVID-19 respiratory infection. The patient's COVID-19 PCR test was Positive on
25Jan2021. The patient died on 02Feb2021 from COVID-19 respiratory infection. No
autopsy was done. The outcome of the events was fatal. Relatedness of Comirnaty to
AE assessed by BASGAGES as Unlikely. No follow-up attempts are possible. No
further information is expected. Lot/batch number was provided.; Reported Cause(s)
of Death: COVID-19 respiratory infection" "No prior vaccinations for this event."
"1072763-1" "1072763-1" "The same day that the person was vaccinated he
started feeling dizzy and had difficulty breathing. He was hospitalized from
February 5 to February 23. Patient died in the hospital on February 23, 2021"
"1073452-1" "1073452-1" "death; Since the vaccination, the patient has been
tested for COVID-19/ nasal swab: positive; This is a spontaneous report from a
contactable Consumer received via COVAES portal IL-COVAES-8443f81e-417d-4bfb-8ab8-
e8884c15af83. A 68-year-old male patient received first dose of bnt162b2
(Batch/lot number: Unknown), via an unspecified route of administration, at arm
left, on 03Feb2021 at single dose for covid-19 immunisation. Medical history
included parkinson's disease from an unknown date and was on Parkinson medications.
The patient's concomitant medications included Parkinson medications received
within 2 weeks of vaccination. The patient did not receive any other vaccines
within 4 weeks prior to the COVID vaccine. The patient experienced death on
03Feb2021. The patient was hospitalized for death for 2 days. Prior to vaccination,
the patient was not diagnosed with COVID-19. Since the vaccination, the patient has
been tested for COVID-19. The patient underwent lab tests and procedures which
included nasal swab: positive on unknown date. The outcome of nasal swab positive
was unknown.The patient died on an unspecified date. An autopsy was not performed.;
Sender's Comments: Information provided is limited and does not allow a thorough
medical assessment of this fatal case. Causality cannot be completely excluded for
the ongoing treatment with suspect drug according to Company internal procedure
for cases reporting death cause unknown. The impact of this report on the
benefit/risk profile of the Pfizer drugs is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as well as
any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. ; Reported
Cause(s) of Death: Pfizer vaccine" "No prior vaccinations for this event."
"1075097-1" "1075097-1" "Pt received initial dose on 1/5/21, diagnosed with
COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced
CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated
for pneumonia during this time. Pt was considered terminal status on 1/25/21. She
received second COVID-19 vaccine on 2/15/21. Pt then experienced increased
difficulty eating and taking medications this same day, in addition to
hallucinations she was experiencing. Patient subsequently died on 2/16/21." "No
"1075434-1" "1075434-1" "Death/ Sars-CoV-2 infection positive; This is a
Authority-WEB [AT-BASGAGES-2021-04879]. A 89-years-old female patient received
bnt162b2 (COMIRNATY, batch/lot number: EL1491), via an unspecified route of
administration on 15Jan2021 at single dose for covid-19 immunisation. Medical
history included status after Cervix-Ca (not ongoing Cervix carcinoma). The
patient's concomitant medications were not reported. The patient experienced SARS-
COV-2 test positive on 22Jan2021. The patient died on 27Jan2021 from COVID-19
respiratory infection (also reported the patient experienced death on 22Jan2021).
The cause of death was SARS-COV-2 infection according to death certificate. It was
not reported if an autopsy was performed. The patient's outcome was fatal. No
follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: COVID-19 respiratory infection" "No prior vaccinations for
this event."
"1075435-1" "1075435-1" "COVID-19 respiratory infection; This is a
Authority -WEB AT-BASGAGES-2021-04881. A 91 years old male patient received first
dose of bnt162b2 (COMIRNATY, Lot Number EL1491 and Expiration Date unknown) via an
immunisation. The patient's medical history COVID-19 from unknown date
(continuing). The concomitant medications were not reported. In Jan2021 the patient
experienced COVID-19 and died on 30Jan2021 from COVID-19 respiratory infection. Lab
test included positive COVID-19 PCR test on 25Jan2021. There is no autopsy was
done. The outcome of event was fatal. No follow-up attempts are possible. No
further information is expected. ; Reported Cause(s) of Death: COVID-19 respiratory
"1075436-1" "1075436-1" "COVID-19 pos infection/COVID-19 respiratory
infection; COVID-19 pos infection/COVID-19 respiratory infection; This is a
Authority-WEB AT-BASGAGES-2021-04885. An 85-years-old female patient received
first dose of bnt162b2 (COMIRNATY, lot EL1491), via an unspecified route of
administration on 15Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical
history included exposure to COVID-19 (ongoing COVID infection in patient's
retirement home since Jan2021). The patient's concomitant medications were not
reported. The patient experienced covid-19 pos infection on 28Jan2021. The patient
died on 05Feb2021 from COVID-19 respiratory infection. The patient underwent lab
tests and procedures which included COVID-19 PCR test: positive on 28Jan2021. The
patient died on 05Feb2021. An autopsy was not performed. BASGAGES comment: no
further info available.; Reported Cause(s) of Death: COVID-19 respiratory
"1075437-1" "1075437-1" "Cardio-respiratory arrest; Cardiac insufficiency;
COVID post Infection; This is a spontaneous report from a contactable physician
downloaded from the Regulatory Authority -WEB AT-BASGAGES-2021-04887. A 91-year-
old female patient received 1st vaccination of bnt162b2 (COMIRNATY, lot number:
EL1491) via an unspecified route of administration on 15Jan2021 at single dose for
covid-19 immunisation. Ongoing underlying diseases include polyneuropathy, chronic
pain syndrome, chronic renal insufficiency, cardiac insufficiency. Patient had
COVID-19 (COVID post Infection) in Jan2021. The patient's concomitant medications
were not reported. A possible connection between deaths and COVID vaccinations
carried out shortly before is suspected. The people were all vaccinated against
COVID-19 on 15Jan2021 (1st vaccination with Comirnaty, batch EL1491), tested
positive 4 to 13 days later (one patient 32nd Days later) and died 10 to 20 days
after the vaccination (said patient 37 days later). A comparable number of deaths
has not occurred in the retirement home in recent years. Since 01Jan COVID
infection is circulating in the home. All 12/14 deceased were tested positive for
Sars-CoV2 by means of PCR. The patient of this report is also positive, tested for
Sars-CoV2 by means of PCR (20Jan2021), then on 06Feb2021 patient died in the home.
Patient died on 06Feb2021 from COVID-19 respiratory infection, Cardio-respiratory
arrest, Cardiac insufficiency. Causes of death according to death certificate from
07Feb2021: Cardiovascular arrest, known cardiac insufficiency, status post COVID
positive infection. No autopsy performed. No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: Cardiac insufficiency;
Cardio-respiratory arrest; COVID post Infection" "No prior vaccinations for
this event."
"1075486-1" "1075486-1" "Exitus letalis/dead; COVID-19 rapid POC test
positiv/positive,COVID-19 PCR test positiv/positive; This is a spontaneous report
from a non-contactable physician downloaded from the Regulatory Authority -WEB DE-
PEI-PEI2021002943. This is a report received from the Regulatory Authority. A
85-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number:
EJ6789), intramuscular on 13Feb2021 at single dose for Covid-19 immunisation.
Medical history included coronary heart disease, cardiac insufficiency, heart valve
insufficiency, atrial fibrillation, osteoporosis and herpes zoster all from an
unknown date and unknown if ongoing. The patient's concomitant medications were not
reported. On 23Feb2021 after vaccination the patient developed exitus
letalis/death, lasting for unknown. The patient was dead. The patient underwent lab
tests and procedures which included COVID-19 rapid POC test (result:
positive/positive, unit: NA), COVID-19 PCR test (result: positive/positive, unit:
NA) both on 22Feb2021. An autopsy was not performed. Relatedness of drug to
reaction/event assessed as D. Unclassifiable. No follow-up attempts are possible.
No further information is expected.; Reported Cause(s) of Death: Exitus
letalis/dead" "No prior vaccinations for this event."
"1075636-1" "1075636-1" "1/21/2021 During Covid 19 outbreak on the unit,
resident contracted the virus. 1/21 MD updated on increased weakness, twitching,
fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders
cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and
Influenza swab results received. PCR-Influenza negative, covid-19 positive.
Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2
and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no
hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on
1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began
refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for
Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition
declining and comfort maintained. Meds slowly discontinued. Expired at facility on
"1076452-1" "1076452-1" "SARS-CoV-2 infection; unwell; This is a spontaneous
report from a contactable Physician. This is a report received from the MHRA.
Report Unique Identifier GB-MHRA-ADR 24852738. A 68 year old male patient received
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number:EL0739)
via an unspecified route of administration, on 29Jan2021 at single dose for COVID-
19 immunisation. The patient medical history included: reporter was unsure if
patient has had symptoms associated with COVID-19. Patient was not enrolled in
clinical trial. The patient's concomitant medications were not reported. On
04Feb2021 the patient experienced SARS-CoV-2 infection (death, hospitalization and
medically significant) and unwell (hospitalization and medically significant). The
patient underwent lab tests and procedures which included oxygen saturation
(04Feb2021): 60 % and COVID-19 virus test (04Feb2021): yes - positive COVID-19
test. The patient died on 13Feb2021. The patient had not recovered from the event
unwell at the time of death. It was not reported if an autopsy was performed. The
reported cause of death was SARS-CoV-2 infection. The clinical course was
reported as follows: Patient became unwell on the evening of the day of his covid
jab. Gradually deteriorated and was tested positive for covid on the 04Feb2021. The
reporter saw him at the covid hub on the 4th where his saturations were 60%. He was
sent to hospital where he passed away on the 13Feb2021. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: SARS-
CoV-2 infection" "No prior vaccinations for this event."
"1076464-1" "1076464-1" "tested positive on 16th February/ died directly as a
result of COVID; tested positive on 16th February/ died directly as a result of
COVID; This is a spontaneous report from a contactable consumer reporting on behalf
of her father (patient). A 77-year-old male patient received BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via
an unspecified route of administration on Jan2021 at a single dose for COVID-19
immunization. Medical history included chronic lymphocytic leukaemia (CLL). The
patient's concomitant medications were not reported. The patient received his first
Pfizer COVID vaccine in early January. The reporter returned and both she and her
father (patient who received the vaccine) displayed symptoms of COVID last week
(Feb2021). They tested positive on 16Feb2021. The patient tested positive following
receipt of the Pfizer vaccine. He was a retired general practitioner and currently
shielding. The patient has died directly as a result of COVID, the elderly
gentleman was 77 with underlying, treated CLL and received immunoglobulins on a 3
monthly basis. He was admitted to hospital on Saturday 27Feb2021 as his SATS were
incredibly low and then placed on CPAP on Sunday 28Feb2021. He passed away on the
evening of Monday 1Mar2021. He had received his first dose of the Pfizer vaccine
some weeks ago but not received the 2nd dose. It was not reported if an autopsy was
performed. Information on the lot/batch number has been requested.; Reported
Cause(s) of Death: died directly as a result of COVID; died directly as a result of
COVID" "No prior vaccinations for this event."
"1080404-1" "1080404-1" "Severe fatigue, lethargy observed by family members
on date of discharge from sub-acute nursing care to home 02/03/2021 and
subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy
and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and
loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened
shortness of breath and loss of appetite. Patient requested 911 call on afternoon
of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and
staff reported beginning treatment with dexamethasone and remdesivir. Hospital
staff reported to family that patient had pneumonia, congestive heart failure,
confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and
antibiotics. Patient was transported for care by pulmonary specialist at Hospital
on 02/13/2021." "No prior vaccinations for this event."
"1081820-1" "1081820-1" "COVID-19 aggravated; COVID-19 PCR test positive;
Regulatory Authority, regulatory authority [FR-AFSSAPS-MP20210273]. A 96-year-old
male patient received the first dose of bnt162b2 (COMIRNATY, Lot no.: EJ6788),
intramuscular in the right arm on 21Jan2021 at single dose for covid-19
immunization. Medical history included ischaemic heart disease, cancer of prostate,
and CVA (cerebrovascular accident). The patient's concomitant medications were not
reported. The patient experienced covid-19 aggravated on 02Feb2021. The patient was
vaccinated as part of the COVID-19 vaccination campaign. The patient considered to
be at risk of developing a severe form of COVID-19 disease. It was not specified if
the patient had a history of COVID-19. On 26Jan2021: performance of a positive PCR
test (no variant search) and on 02Feb2021: Onset of symptoms of COVID-19. The
patient was treated in the nursing home. The patient died on 05Feb2021. The cause
of death was COVID-19 aggravated and COVID-19 PCR test positive. The outcome of the
events was fatal. It was unknown if an autopsy was performed. No follow-up
attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID-19 aggravated; COVID-19 PCR test positive" "No prior vaccinations
for this event."
"1081821-1" "1081821-1" "COVID-19 AGGRAVATED; COVID-19 PCR test positive;
Regulatory Authority-WEB FR-AFSSAPS-MP20210274. An 82-year-old female patient
received the first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number:
EJ9788), via intramuscular on 21Jan2021 at single dose in right arm for COVID-19
immunisation. Medical history included dwarfism from an unknown date and unknown if
ongoing, ongoing renal insufficiency, dementia from an unknown date and unknown if
ongoing. The patient's concomitant medications were not reported. Patient was
considered to be at risk of developing a severe form of COVID-19 disease (age).
Patient vaccinated as part of the COVID-19 vaccination campaign. It was reported on
26Jan2021: performance of a positive COVID-19 PCR test (no variant search). On
02Feb2021, onset of symptoms of COVID-19, COVID-19 aggravated. Patient treated in
the nursing home. Duration was reported as 5 days. Evolution: On 06Feb2021, death
of the patient. It was unknown if an autopsy was performed. The outcome of the
events was fatal. No follow-up attempts are possible, no information is
expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; COVID-19
AGGRAVATED" "No prior vaccinations for this event."
"1081822-1" "1081822-1" "COVID-19 aggravated; COVID-19 PCR test positive;
Regulatory Authority FR-AFSSAPS-MP20210275. A 90-year-old male patient received
first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular on 21Jan2021
at single dose in right arm for covid-19 immunisation. Medical history included
ongoing arteritis. The patient's concomitant medications were not reported. On
28Jan2021, the patient Symptoms of COVID-19 appear Covid-19 aggravated was
reported, performance of a positive PCR test (no variant search). Patient treated
in the nursing home. EVOLUTION: On 03Feb2021: Death of the patient. It was not
reported if an autopsy was performed. No follow-up attempts are possible, no
information is expected.; Reported Cause(s) of Death: COVID-19 aggravated; COVID-19
PCR test positive" "No prior vaccinations for this event."
"1081823-1" "1081823-1" "COVID-19 PCR test positive; COVID-19 aggravated;
Regulatory Authority-WEB FR-AFSSAPS-MP20210277. A 78-year-old male patient
received he first dose of bnt162b2 (COMIRNATY; lot number: EJ6788), intramuscular
on the left arm, on 21Jan2021 at a single dose for covid-19 immunisation. Ongoing
medical history included Afib, heart failure, and CVA (cerebrovascular accident).
The patient's concomitant medications were not reported. On 23Jan202, symptoms of
COVID-19 appear/ COVID-19 aggravated. On 25Jan2021: performed a positive PCR test
(no variant search)/ COVID-19 PCR test positive. The patient died on 28Jan2021. It
was not reported if an autopsy was performed. No follow-up attempts are possible,
no information is expected.; Reported Cause(s) of Death: COVID-19 PCR test
positive; COVID-19" "No prior vaccinations for this event."
"1082172-1" "1082172-1" "THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON
2/3 (COUGH AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS
POSITIVE. SHE RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE,
ALBUTEROL MDI, MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON
"1082400-1" "1082400-1" "Patient developed COVID after vaccines. There was
an outbreak at her facility . She ended up with pneumonia and expired on
"1084861-1" "1084861-1" "COVID-19 respiratory infection; This is a
spontaneous report a contactable physician downloaded from the Regulatory Authority
[regulatory authority AT-BASGAGES-2021-04880]. The reporter reported similar events
for 2 patients, this is the 1st of 2 reports. A 90-year-old female patient
received the first dose of bnt162b2 (COMIRNATY, lot number EL1491) via an
unspecified route of administration on 15Jan2021 at a single dose for covid-19
immunisation. The patient's medical history included Heart failure (continuing),
Viral hepatitis B, COVID-19 (continuing). The patient's concomitant medications
were not reported. The patient was positive tested for Sars-CoV2 by means of PCR
(25Jan), on 30Jan2021 21:05 and died in the home from COVID-19 respiratory
infection. The patient was already palliative before COVID-19 and considered as a
terminal patient. No autopsy was done. Causality between the event and vaccine was
assessed as unlikely by the HA. No follow-up attempts are possible. No further
information is expected.; Sender's Comments: Linked Report(s) : AT-PFIZER INC-
2021242520 same reporter, same vaccine, similar events in different patient;
Reported Cause(s) of Death: COVID-19 respiratory infection""No prior vaccinations
for this event."
"1084862-1" "1084862-1" ""SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory
infection/ COVID-19; SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/
COVID-19; This is a spontaneous report from a contactable physician downloaded from
the Regulatory Authority-WEB regulatory authority AT-BASGAGES-2021-04886. A 94-
year-old female patient received bnt162b2 (COMIRNATY, lot/batch number: EL1491) ,
via an unspecified route of administration on 15Jan2021 at single dose for COVID-19
immunisation . Medical history included ongoing breast carcinoma (Mammary gland
right) and Infarct cerebral (ischemic infarction) from an unspecified date and not
experienced sars-cov2-positive infection/ covid-19 respiratory infection/ covid-19
(drug ineffective) (death) on Feb2021. The patient underwent lab tests and
procedures which included COVID-19 PCR test: positive on 05Feb2021. Narrative case
summary and further information was reported as ""possible association between
deaths and COVID vaccinations given promptly before is suspected. The individuals
were all vaccinated against COVID-19 on Jan152021 (1st partial vaccination with
Comirnaty, batch EL1491), tested positive 4 to 13 days later (One patient 32 days
later), and died 10 to 20 days after vaccination (said patient 37 days later). A
similar cluster of deaths did not occur at the nursing home in recent years. COVID
infection has been circulating in the home since 01Jan2021. All 12/14 decedents
have tested positive for Sars-CoV2 by PCR. The patient in this NW report also
tested pos. for Sars-CoV2 by PCR (05Feb2021), then died at the home on 11Feb2021.
"" The patient died on 11Feb2021 from COVID-19. An autopsy was not performed. No
follow-up attempts are possible. No further information is expected. ; Reported
Cause(s) of Death: SARS-COV2-POSITIVE INFECTION/ COVID-19 respiratory infection/
COVID-19"" "No prior vaccinations for this event."
"1084863-1" "1084863-1" "drug ineffective; COVID-19; This is a spontaneous
report a contactable physician reporting on different patients, this is the second
case. The first case report was downloaded from the Regulatory Authority
[regulatory authority AT-BASGAGES-2021-04880]. A elderly patient of an
unspecified gender received the first dose bnt162b2 (COMIRNATY; Lot # EL1491)
vaccine , via an unspecified route of administration 15Jan2021 at single dose for
covid-19 immunisation. The patient medical history and concomitant medications
were not reported. The patient was tested positive to SARS-COV-2 on 16Feb2021 and
died from it on 21Feb2021. It is unknown if an autopsy was carried out. No
follow-up attempts are possible. No further information is expected.; Sender's
Comments: Linked Report(s) : AT-PFIZER INC-2021221786 same reporter, same vaccine,
similar events in different patient.; Reported Cause(s) of Death: Covid-19" "No
"1084890-1" "1084890-1" "symptoms of COVID-19 appeared; symptoms of COVID-19
appeared and performance of a positive PCR test (no variant search); This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority. The regulatory Authority Report Number is FR-AFSSAPS-MP20210276. A 93-
year-old female patient received the first dose of bnt162b2 (COMIRNATY; lot number
EJ6788), intramuscular in the left arm on 21Jan2021 at a single dose for covid-19
immunisation. Medical history included ongoing diabetes, ongoing dementia, and
ongoing Afib. The patient's concomitant medications were not reported. Declaration
made through the national portal, made by a health professional. Patient considered
to be at risk of developing a severe form of COVID-19 disease was yes (age).
History of COVID-19 was not specified. Patient was vaccinated on 21Jan2021 as part
of the COVID-19 vaccination campaign. On 26Jan2021, symptoms of COVID-19 appeared
and performance of a positive PCR test (no variant search). Patient was treated in
the nursing home. On 27Jan2021, the patient died. Accountability made without
prejudice to the elements of investigations which could be carried out within the
framework of legal or amicable compensation procedures. It was not reported if an
autopsy was performed. The events are serious, fatal. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: symptoms
of COVID-19; positive PCR test" "No prior vaccinations for this event."
"1084891-1" "1084891-1" "COVID-19 PCR test positive/ COVID-19 aggravated;
This is a spontaneous report from a contactable physician downloaded from
Regulatory Authority, regulatory authority FR-AFSSAPS-MP20210278. A 77-year-old
male patient received first dose of BNT162B2 (COMIRNATY; lot number: EJ6788) on
left arm, intramuscular on 21Jan2021 at single dose for COVID-19 immunisation.
Medical history included ongoing epilepsy, cerebrovascular accident (CVA) from 2011
to 2013, and dementia. The patient's concomitant medications were not reported. The
patient experienced COVID-19 PCR test positive and COVID-19 aggravated on
25Jan2021. The patient was considered to be at risk of developing a severe form of
COVID-19 disease. The patient was vaccinated as part of the COVID-19 vaccination
campaign. It was also reported that on 25Jan2021, symptoms of COVID-19 appeared.
Additionally on 25Jan2021, performance of a positive PCR test (no variant search).
Patient was treated in the nursing home. On 28Jan2021, death of the patient. The
patient died on 28Jan2021. It was not reported if an autopsy was performed. No
Cause(s) of Death: COVID-19 PCR test positive" "No prior vaccinations for this
event."
"1086537-1" "1086537-1" "acute shortness of breath, immediately transferred
to the hospital; Death NOS; COVID-19 respiratory infection; This is a spontaneous
report downloaded from the regulatory authority-WEB [Regulatory Authority number
AT-BASGAGES-2021-04883] from a contactable physician. An 87-year-old female patient
received the 1st dose of bnt162b2 (COMIRNATY) (lot# EL1491), via an unspecified
route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation.
The patient's medical history and concomitant medications were not reported. The
patient experienced death NOS (death) on 29Jan2021, acute shortness of breath,
immediately transferred to the hospital (death, caused hospitalization on
27Jan2021) on 27Jan2021, COVID-19 respiratory infection (death) on 26Jan2021. The
patient underwent lab tests and procedures which included COVID-19 PCR test:
positive on 26Jan2021. It was not reported if an autopsy was performed. No follow-
up attempts are possible. No further information is expected.; Reported Cause(s) of
Death: COVID-19 respiratory infection; Acute dyspnea; Death NOS" "No prior
"1086566-1" "1086566-1" "Covid-19; Covid-19; This is a spontaneous report
from a non-contactable physician from the regulatory authority-WEB DE-PEI-
PEI2021003038 . A 80-year-old female patient received two doses bnt162b2
(COMIRNATY) , via an unspecified route of administration on 04Jan2021 and 25Jan2021
both at single doses for covid-19 immunisation. Medical history included myositis.
Concomitant medication included immunotherapy with mycophenolate mofetil (CELLCEPT)
for myositis. On 12Feb2021 after vaccination the patient developed COVID-19 and
death on 12Feb2021. Diagnosis was confirmed by COVID-19 PCR test (result: positive)
in Feb2021. Death cause was reported as COVID-19. The patient died on 12Feb2021. An
autopsy was not performed. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19; COVID-
19" "No prior vaccinations for this event."
"1086668-1" "1086668-1" "COVID-19 aggravated; fever between 38 and 39 C;
desaturation (91%); loss of appetite; isolated cough; This is a spontaneous report
from a contactable physician from the Medicines Agency (MA)WEB. The Regulatory
Authority report number is FR-AFSSAPS-RS20210256. A 71-year-old male patient
received the first dose of BNT162B2 (COMIRNATY, lot number: EJ6788, expiration
date not reported), intramuscular in the left arm on 27Jan2021 at a single dose for
COVID-19 immunisation. Medical history included Hypertension arterial, Iron
deficiency anemia, arrhythmia, Diabetes, Delusional psychosis, and hypothyroidism.
The patient's concomitant medications were not reported. The patient is considered
to be at risk of developing a severe form of COVID19 disease (diabetes, heart
disease). The patient experienced COVID-19 aggravated on 05Feb2021. It was further
reported that on 05Feb2021, onset of fever between 38 and 39 C, desaturation (91%),
loss of appetite and isolated cough. The patient was hospitalized on an unspecified
date in Feb2021 due to the events. On 13Feb2021, death of the patient due to
complicated COVID following according to the declaring doctor. It was not reported
if an autopsy was performed. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: isolated cough; COVID-19
aggravated; fever between 38 and 39 C; desaturation (91%); loss of appetite" "No
"1088320-1" "1088320-1" "Pt tested positive for COVID on 2/6/2021. Deceased
on 2/15/21. Not marked COVID death on death certificate." "No prior vaccinations
for this event."
"1088365-1" "1088365-1" "Pt tested positive for COVID on 02/29/2021. Passed
away on 02/25/2021. COVID listed on death certificate." "No prior vaccinations
for this event."
"1088401-1" "1088401-1" "Pt tested positive for COVID on 2/15/21. She passed
away on 02/23/21. Not listed as COVID death on death certificate." "No prior
"1089835-1" "1089835-1" "sudden death/death after vaccination; This is a
spontaneous report from a contactable consumer downloaded from the regulatory
authority-WEB CZ-CZSUKL-21001643. A 78-year-old male patient received his first
dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on
11Jan2021 at single dose for covid-19 immunisation. Medical history included
abdominal pain from 23Dec2020 and patient was admitted to hospital. On 30Dec2020,
the patient was diagnosed with pancreatic tumour. It was decided to not operate.
Stent was applied instead. Three patients from the same room was tested as Covid-19
positive, the patient was negative on 30Dec2020. He might have been Covid-19
positive in Oct2020 (two days fever, loss of smell), but was not tested that day.
On 08Jan2021 the patient had fever, unknown reason. Concomitant drugs were not
reported. The patient experienced sudden death/death after vaccination on
12Jan2021. The event was serious for death, hospitalization, medical significant,
and life-threatening. The cause of death was unknown. According to a physician,
patient was not at terminal stage, preparation for home care with perspective of 3
months. It was not reported if an autopsy was performed. No follow-up attempts are
of Death: unknown cause of death" "No prior vaccinations for this event."
"1091799-1" "1091799-1" "Became COVID-positive, pneumonia, ARDS, hospitalized
for hypoxia 2/21/2021, death 2/25/2021" "No prior vaccinations for this event."
"1094268-1" "1094268-1" "Confusion; shortness of breath; seizure; SARS-CoV-2
infection; SARS-CoV-2 infection; Seizures; Heart rate drop; This is a spontaneous
report from a contactable consumer received from the Regulatory Agency. The
Regulatory Authority report number is GB-MHRA-WEBCOVID-202103061608463700. Safety
Report Unique Identifier GB-MHRA-ADR 24889457. An 85-year-old male patient received
the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Ek4243), via
an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19
immunisation. The patient's medical history and concomitant medications were not
reported. Patient had not had symptoms associated with COVID-19, did not have a
COVID-19, was not enrolled in clinical trial. The patient experienced seizure in
Jan2021 with outcome of unknown , sars-cov-2 infection (death) on 04Mar2021 with
fatal outcome on 04Mar2021, confusion (non-serious) on 23Jan2021 with outcome of
unknown, seizures (non-serious) on 23Jan2021 with outcome of unknown. It was
reported that the patient had a seizure overnight in Jan2021, ended up confused (on
23Jan2021) and short of breathe. He was admitted to hospital and treated with
antibiotics. Patient had 2nd seizure and was treated for further infection. 3rd
seizure just over a week later with continued confusion. Heart rate dropped.
Patient tested positive and passed away. It was not reported if an autopsy was
expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection"
"1094669-1" "1094669-1" "a positive SARS COVID 19 PCR test; COVID-19
aggravated; COVID-19 pneumonitis; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Agency-WEB (FR-AFSSAPS-AM20210427). A 96-
year-old female received BNT162B2 (COMIRNATY), intramuscularly, first dose on
19Jan2021 (Lot number: EJ6788) and second dose on 09Feb2021 (Lot number: EK9788) in
the left deltoid, both at a single dose for COVID-19 immunisation. Medical history
included osteoarthritis knee, coxarthrosis, cataract, venous peripheral
insufficiency, erysipelas, atrial fibrillation (AFib), hand osteoarthritis, and
recurrent fall. The patient was not previously diagnosed with COVID-19. Concomitant
medications included pantoprazole (MANUFACTURER UNKNOWN), rivaroxaban (XARELTO),
zopiclone (IMOVANE), potassium chloride (DIFFU K), pregabalin (MANUFACTURER
UNKNOWN) , furosemide (MANUFACTURER UNKNOWN), trimebutine (MANUFACTURER UNKNOWN),
salbutamol sulfate (VENTOLINE), oxazepam (SERESTA), ramipril (MANUFACTURER
UNKNOWN), and bisoprolol hemifumarate (MANUFACTURER UNKNOWN). The patient
experienced a positive SARS COVID 19 PCR test and COVID-19 aggravated on 13Feb2021,
which caused hospitalization on 13Feb2021 and were reported as fatal. The patient
also experienced COVID-19 pneumonitis in Feb2021, which was reported with
hospitalization and fatal. The clinical course was reported as follows: On
11Feb2021, the patient had an onset of fever and was hospitalized on 13Feb2021
before a positive SARS COVID-19 PCR test. There was clinical degradation
thereafter, initiation of oxygen therapy and unspecified corticosteroid therapy on
14Feb2021. It was also reported that the patient experienced behavioral disorder
and hallucinations from the first dose of the vaccine. The patient underwent lab
tests and procedures which included SARS-CoV-2 PCR test: positive on 13Feb2021. The
patient died on 22Feb2021. The cause of death was reported as COVID-19 pneumonitis.
It was not reported if an autopsy was performed. No follow-up attempts are
pneumonitis" "No prior vaccinations for this event."
"1096600-1" "1096600-1" "Per the patient's spouse and Hospital: The patient
received a rapid COVID test at clinic prior to vaccination, which read negative.
The patient received vaccination on 2/23/21 and the following day (2/24/21) began
to experience breathing difficulties. The patient was admitted to the emergency
room at Hospital on 2/26/21 and diagnosed with hypoxic respiratory failure d/t
COVID-19 (oxygen saturation < 50%). Patient was intubated on 3/2/21. Per Hospital
pharmacist, patient expired on 3/12/21 at 6:40pm." "No prior vaccinations for
this event."
"1099516-1" "1099516-1" "Reduced general condition; COVID-19 respiratory
infection; This is a spontaneous report from a contactable physician. This is a
report received from the Regulatory Authority-WEB. Regulatory authority number AT-
BASGAGES-2021-04874. An 88 years old female patient received the first dose of
BNT162B2 (COMIRNATY, Lot. EL1491) at single dose, on 15Jan2021, for COVID-19
immunisation. Relevant medical history and concomitant medications were unknown.
Post the vaccination, the patient has been tested for COVID-19 and resulted
positive on 19Jan2021. On 22Jan2021, the patient experienced reduced general
condition and died on 30Jan2021. Clinical outcome of reduced general condition and
death was fatal. Cause of death was reported as COVID-19 respiratory infection. It
was unknown if autopsy was done. Relatedness of drug to reaction(s)/event(s) for
Comirnaty to all events, reported as Unassessable/Unclassifiable by BASGAGES. No
Death: COVID-19 respiratory infection; Reduced general condition" "No prior
"1099517-1" "1099517-1" "COVID-19 PCR test positive; Death; This is a
Authority-WEB AT-BASGAGES-2021-04884. A 76-year-old female patient received the
first dose of bnt162b2 (COMIRNATY) (Lot # EL1491), via an unspecified route of
administration at single dose on 15Jan2021 for COVID-19 immunisation. Medical
history included ongoing chemotherapy NOS. Concomitant medications were not
reported. The patient experienced death NOS on 01Feb2021, COVID-19 PCR test
positive on 26Jan2021. The patient underwent lab tests and procedures which
included SARS-CoV-2 test: positive on 26Jan2021. The patient died on 01Feb2021 from
COVID-19 respiratory infection. It was not reported if an autopsy was performed.
Missing info on cause of death and possible underlying diseases. Clinical course
was reportrd as follows: Since 01Jan2021 a COVID infection was circulated in the
retirement home. All 12/14 deceased were tested positive for Sars-CoV2 by means of
PCR. The patient of this AE report was also positive. Tested for Sars-CoV2 by means
of PCR (26Jan2021), on 29Jan2021 in the hospital due to deterioration, died there
on 01Feb2021. No follow-up attempts possible. No further information expected.;
for this event."
"1099628-1" "1099628-1" "COVID-19 aggravated; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB. The
Regulatory Authority report number is FR-AFSSAPS-BR20210398. A 93-year-old male
patient received the first dose of BNT162B2 (COMIRNATY, batch number: EK9788,
expiration date not reported), intramuscular on 11Feb2021 at a single dose for
COVID-19 immunisation. Medical history included Type 2 diabetes mellitus,
cerebrovascular accident (CVA), and dementia. The patient's concomitant medications
were not reported. The declaration was made by a domestic hospitalisation physician
for a resident of a facility for dependent elderly people. Note the absence of a
coordinating physician in this facility. On 01Feb2021, this patient left a
Pneumology department which was the center of a large cluster on that date. PCR
negative at the exit. He was admitted to facility for dependent elderly people. On
03Feb2021, his state of health began to deteriorate and this was initially
attributed to frustration at leaving his home. On 11Feb2021, first injection of the
COMIRNATY was administered with continued deterioration of the general condition.
On 16Feb2021, the patient experienced bronchial congestion, stopping hydration and
PCR COVID positive. On 17Feb2021, the patient experienced COVID-19 aggravated. On
18Feb2021, intervention by the domestic hospitalisation physician for respiratory
deterioration (distress) with agitation and pain which appeared the day before
which included introduction of hyoscine butylbromide (SCOBUREN) and midazolam. On
19Feb2021, death of the patient. In total, the patient probably infected with COVID
before his first vaccine injection, which deteriorated in the days that followed.
The domestic hospitalisation physician cannot rule out a severe form of COVID
following vaccination. It was not reported if an autopsy was performed. No
follow-up attempts are possible, no information is expected.; Reported Cause(s) of
Death: COVID-19 aggravated" "No prior vaccinations for this event."
"1099645-1" "1099645-1" "COVID-19 PCR test positive; COVID-19
aggravated/fever, rapidly worsening; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority-WEB regulatory
authority FR-AFSSAPS-MP20210279. A 101-year-old female patient received first dose
of bnt162b2 (COMIRNATY, solution for injection, lot: EJ6788), intramuscular on left
arm on 21Jan2021 at single dose for covid-19 immunisation. Medical history included
cerebrovascular accident (CVA) from 2013 to 2013 (not ongoing). The patient's
concomitant medications were not reported. On 22Jan2021, the patient experienced
fever, rapidly worsening and COVID-19 aggravated. On 25Jan2021 with PCR test for
COVID-19: positive, no variant testing. The patient died on 27Jan2021 due to COVID-
19 and COVID-19 PCR test positive (reported as severe COVID leading to death). It
was unknown if an autopsy was performed. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: COVID-19
aggravated/fever, rapidly worsening; COVID-19 PCR test positive" "No prior
COVID-19 test with symptoms with fatal outcome/died on 10Feb2021; This is a
Agency-WEB AT-BASGAGES-2021-04888. A 90-year-old female patient received first
dose of BNT162B2 (COMIRNATY, lot number: EL1491), via an unspecified route of
administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical
history included ongoing palliative care palliative and COVID-19 from 07Feb2020 and
ongoing. The patient's concomitant medications were not reported. On 07Feb2021,
the patient experienced positive COVID-19 test with symptoms with fatal outcome.
The patient underwent lab tests and procedures which included COVID-19 PCR test:
positive on 07Feb2021 and COVID-19 virus test negative on 04Feb2021. The patient
died on 10Feb2021. It was not reported if an autopsy was performed. No follow-up
attempts are possible, batch number already obtained. Amendment: This follow-up
report is being submitted to allow appropriate reporting to health authorities.;
for this event."
"1101991-1" "1101991-1" "In ED on 2/25/21 Chief complaint: Patient's daughter
present at bedside stating patient was not vocalizing this morning when she woke
up. Patient's daughter was talking to her and she would orient to her but not
answer any of her questions. EMS called and by the time they arrived patient was
acting her normal self. Daughter states she has had a very difficult time managing
patient's behaviors over the last several weeks and it has been getting more
difficult. Daughter states that over the last several weeks her behaviors have
been worsening and been more difficult to deal with. These include her getting up
at night and sundowning as well as yelling and screaming during the day. Daughter
states that she gets in the shouting matches with the patient during the day.
Daughter breaks down and starts to cry when discussing that she thinks her mother
will need long-term placement as she is having a difficult time dealing with her
behaviors. Of note patient did receive second dose of Covid vaccine yesterday.
-Patient has not been complaining of any symptoms over the last several days and
daughter has not noticed cough or congestion or other signs of URI/illness -No
focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid
positive, incidental finding ? tested so she could go to nursing facility -Patient
asymptomatic -Vital signs stable, afebrile -She does not need treatment at this
time -She will need a repeat Covid test 14 days after the original Covid test prior
to going to SNF -Plan- discharge to skilled nursing facility Discharge summary
Principal Problem: Comfort measures only status Active Problems: Chronic atrial
fibrillation Essential hypertension Dementia with behavioral disturbance
Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis
Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old
female with a past medical history of dementia, likely combined
vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on
2/25/2021 due to behavioral disturbance as well as need for long-term care
placement due to progressive dementia. She did have an incidental positive Covid
test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She
did not require medication or oxygen treatment for COIVD-19. She developed
tachycardia/tachypnea and cough later productive for blood after suctioning
attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's
overall function declined after, and she was refusing/unable to eat or drink. She
was transitioned to comfort care status on 03/03/2021. She eventually slipped
into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was
provided. She had decreased urinary utput and respiratory function indicating
expected progression. She was noted to not have a heart rate on 03/08/2021.
Auscultation did not reveal any breath sounds or heart sounds; unable to palpate
pulse; no pupillary response to light was seen; and patient did not respond to
painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21"
"1104666-1" "1104666-1" "Patient presented with dyspnea and found to have
COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated
and died" "No prior vaccinations for this event."
"1104932-1" "1104932-1" "shortness of breath; PCR test was then made and
turned out positive; Death; This is a spontaneous report downloaded from the
Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021017328. A non-
contactable consumer reported that a 95-year-old female patient received BNT162b2
(COMIRNATY, solution for injection, batch/lot: unknown), via an intramuscular route
of administration on 09Jan2021 at single dose for COVID-19 immunization. Medical
history included ongoing cardiac failure chronic. Concomitant medications was not
reported. Heart failure / the person complained 10 days after vaccination about
shortness of breath and thus directed to the city hospital. The person was from the
beginning of December in quarantine since there was a positive case in the home.
All PCR tests were negative. In the hospital a PCR test was then made and turned
out positive. On 02Feb2021 the person died. The cause of death was unknown. Outcome
of death was fatal and outcome of both events was not recovered. Causality from
regulatory authority: Inconsistent causal association to immunization No
follow-up attempts are needed, follow-up automatically provided by regulatory
authority.; Reported Cause(s) of Death: Unknown cause of death" "No prior
"1104992-1" "1104992-1" "Hypoxia; Vaccination Failure; COVID-19; This is a
spontaneous report from a contactable physician downloaded from the regulatory
authority-WEB. The regulatory authority report number is FR-AFSSAPS-CF20210232.
A 91-year-old female patient received BNT162B2 (COMIRNATY), intramuscular with the
first dose on 08Jan2021 (Lot number unknown) and the second dose in the left arm on
29Jan2021 (Lot number EJ6788) and second dose (Lot number EJ6788) for covid-19
immunization. Medical history included hypertension arterial, dementia, pulmonary
embolism, chronic bronchitis, each from an unknown date and unknown if ongoing.
The patient's concomitant medications were not reported. The patient experienced
covid-19 and vaccination failure on 08Feb2021; the patient also experienced hypoxia
on 14Feb2021. The events were serious as they lead to death. The patient underwent
lab tests and procedures which included polymerase chain reaction (PCR), which was
negative on 02Feb2021; SARS-CoV-2 test which was positive on 08Feb2021. The
clinical course was as follows: the first injection was given on 08Jan2021. The
patient tested positive for COVID-19 on 08Feb2021 (about 10 days after the second
injection), but tested negative for PCR on 02Feb2021. As of 08Feb2021, this
patient presented fatigue without clinical signs (absence of oedema, urticaria,
respiratory and cardiocirculatory failure). On 14Feb2021, the patient's condition
deteriorated. A rapidly settling hypoxia was observed requiring the intervention of
the doctor on duty in emergency. Death occurred within 15-20 minutes after the
hypoxia was detected. Death of the patient occurred before she could be
hospitalised. No search for a viral variant was performed. Hypoxia stop date was
reported as 14Feb2021, with fatal outcome. The patient died on 14Feb2021. An
autopsy was not performed. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Unknown cause of death"
"1107556-1" "1107556-1" "Vaccination failure; Covid-19; respiratory
problems/distress respiratory; Oxygen saturation drop 90%; This is a spontaneous
report from a non-contactable physician downloaded from the regulatory authority-
WEB [DE-PEI-PEI2021003122]. An 81-year-old male patient received bnt162b2
(COMIRNATY, Lot # EM0477) at single dose 1st dose on 05Jan2021 and 2nd dose on
26Jan2021 for COVID-19 immunisation. The patient medical history and concomitant
medications were not reported. The patient experienced vaccination failure, COVID-
19, respiratory problems/distress respiratory and, oxygen saturation drop 90%
lasting for 9 day on 05Feb2021 (32 days after the first vaccination, as reported).
The patient underwent lab tests and procedures which included oxygen saturation:
90% on 05Feb2021. The patient died on 13Feb2021. It was not reported if an autopsy
was performed. Cause of death was reported as COVID-19. No follow-up attempts
possible. No further information expected.; Reported Cause(s) of Death: COVID-19"
"1110746-1" "1110746-1" ""4 am seething breathing, 7 am died; COVID-19
confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test;
Acute deterioration of general condition, no fever; This is a spontaneous report
downloaded from The Regulatory Authority-WEB (DE-DCGMA-21187734). A non-
contactable physician reported that an 88-years-old female patient received the
first dose of BNT162B2 (COMIRNATY, Lot. EM0477) on 02Jan2021, at single dose, for
COVID-19 immunisation. Relevant medical history included cerebral infarction from
on an unspecified date in 2007, acute myocardial infarction on an unspecified date
and unknown if ongoing, diabetes mellitus from an unspecified date and unknown if
ongoing and hypertension from an unspecified date and unknown if ongoing.
Concomitant medication included furosemide (FUROSEMID), amlodipine (AMLODIPIN),
RAMIPRIL AL10 mg, insulin human injection, isophane (BERLINSULIN H BASAL),
bisoprolol fumarate (BISOPROLOL 1A PHARMA), potassium chloride (KALINOR) 1,56 g,
acetylsalicylic acid (ASS-RATIOPHARM) and thiamazole (METHIZOL). On 18Jan2021, the
patient experienced acute deterioration of general condition, no fever. On
19Jan2021, the patient developed breathing difficult described as ""at 4 AM
seething breathing, at 7 AM the patient died"". It was unknown if autopsy was done.
COVID-19 rapid POC test performed on 07Jan2021, on 09Jan2021, on 11Jan2021, and on
12Jan2021, all with negative results. COVID-19 PCR test performed on 13Jan2021 with
negative result. COVID-19 rapid POC test performed on 18Jan2021 with positive
result. Oxygen saturation was at 96 % on 18Jan2021. Clinical outcome of the adverse
event ""COVID-19 confirmed by positive COVID-19 test"" was unknown at time of the
patient's death. Relatedness of drug to reactions/events by Regulatory Authority:
A. Consistent causal association to Follow-up attempts completed. No further
information expected.; Reported Cause(s) of Death: General physical condition
decreased; Breathing difficult"" "No prior vaccinations for this event."
"1110878-1" "1110878-1" "Only received 1st round dosage of COVID vaccination,
he seemed to handle vaccination okay. On January 17, 2021, he tested COVID
positive on a resident screening test done in response to an employee positive case
in days previous to the residents testing. Fifteen days after his first
innoculation,his AM nurse found him non-responsive on early vital checks. Vitals
at that time were normal range. The facility physician was contacted and advised
that he should be taken to Emergency Room at local hospital for further evaluation.
Blood work was taken and ER DR diagnosed Heart enzymes elevated indicating a heart
attack. Advised additional testing should be done, and that monoclonal antibody
treatment wasn't an option due to time lapse since diagnosis of COVID, The option
of comfort care was chosen as the treatment plan." "No prior vaccinations for
this event."
"1112855-1" "1112855-1" "SARS COVID 19; died within a week; Haematemesis;
Agency Regulatory Authority-WEB [regulatory authority number AT-BASGAGES-2021-
09458]. A 76-year-old male patient received his first dose of BNT162b2 (COMIRNATY,
lot number EP2163), intramuscular on 14Jan2021, at single dose for COVID-19
immunisation. The patient medical and concomitant medications were not reported.
The patient experienced haematemesis and SARS COVID 19 on 17Jan2021. On 17Jan2021
the patient was hospitalized. On the same day, in hospital, the patient was found
positive COVID-19 PCR test. The patient was vaccinated on Thursday and was positive
on Sunday, so was probably vaccinated in the incubation period. Previously, he was
never tested positive and tests were carried out very frequently in the affected
nursing home. Patient was hospitalized on 17Jan2021 and died within a week due to
SARS COVID 19 (on unspecified date in Jan2021). The outcome of event haematemesis
was unknown. It was not reported if an autopsy was performed. No follow-up
Death: SARS COVID 19; died within a week" "No prior vaccinations for this event."
"1112896-1" "1112896-1" ""Acute respiratory failure; COVID-19; Fever;
Comirnaty was administered via subcutaneous route; This is a spontaneous report
from a non-contactable consumer downloaded from Regulatory Authority-WEB DE-PEI-
CADR2021015865. An 84-year-old female patient received the first dose of
bnt162b2 (COMIRNATY) (Batch/Lot Number: Unknown) subcutaneous on 09Jan2021 at
single dose for COVID-19 immunisation. The patient medical history and concomitant
medications were not reported. On 21Jan2021 the patient experienced fever, acute
respiratory failure, COVID-19. The outcome for fever and COVID-19 was unknown, the
outcome for acute respiratory failure was fatal. The patient underwent lab tests
and procedures which included SARS-CoV2 test: positive on 21Jan2021. The patient
died on 24Jan2021. An autopsy was not performed. Sender Comment: The current
admission took place in COVID intensive care unit, accompanied by the emergency
doctor. The emergency doctor reports that the patient developed a fever about a
week ago with a known SARS-CoV2 infection. The patient had previously been
vaccinated for the first time on 09Jan2021. A home resident had previously tested
positive for SARS CoV2. When the emergency doctor arrived, the patient was already
respiratory unstable with an SO2 of 50%. After NIV ventilation the saturation was
90%. Upon arrival at our hospital, we saw a cardiorespiratory unstable patient. The
BGA showed global respiratory insufficiency with a pH value of 6.8. Within 5
minutes of her arrival, the patient was gasped and required resuscitation. The
resuscitation remained frustrated. The patient died on 24Jan2021 at 7:19 a.m."".
Causality from Regulatory Authority: Inconsistent causal association to
immunization for all events. No follow-up attempts needed, follow-up
automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Acute
respiratory failure"" "No prior vaccinations for this event."
"1112923-1" "1112923-1" "Severe acute respiratory syndrome; Respiratory
insufficiency; COVID-19/severe acute respiratory syndrome/ respiratory
insufficiency; COVID-19; This is a spontaneous report downloaded from the
Regulatory Authority-WEB (ES-AEMPS-775868). A contactable physician reported that a
86-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route
of administration on 05Jan2021 (first dose, lot EJ6796) at single dose, and via an
unspecified route of administration on 12Feb2021 (second dose, lot unknown) at
single dose for covid-19 immunization. Medical history included being
institutionalized, exposure to COVID-19 from Feb2021 (close contact of confirmed
cases). The patient's concomitant medications were not reported. The patient
experienced covid-19 on 27Jan2021, and severe acute respiratory syndrome/
respiratory insufficiency on 16Feb2021. Ambulance was notified of severe acute
respiratory syndrome associated with coronavirus. The patient underwent lab tests
included COVID-19 PCR test: negative on 22Jan2021, COVID-19 PCR test: positive on
09Feb2021 with antibodies not performed, COVID-19 antigen test: positive on
27Jan2021. Outcome of events was fatal. The patient died on 18Feb2021. It was not
reported if an autopsy was performed. The cause of death included drug ineffective,
COVID-19, severe acute respiratory syndrome, respiratory insufficiency. This
notification also informed that of the possibility of a post-vaccination reaction
event to the second dose that was administered on 12Feb2021. The evaluation after
reviewing and expanding the available information, considered that the verification
of a previous positive Active Infection Diagnostic Test, a positive PCR prior to
the events reported and the clinical judgment of severe acute respiratory disease
associated with coronavirus, allowed establishing a relationship between the
reported event with covid infection in a patient with incomplete immunization. No
Cause(s) of Death: Respiratory insufficiency; covid-19; Severe acute respiratory
syndrome; COVID-19/severe acute respiratory syndrome/ respiratory insufficiency"
from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-
MP20210365. An 89-year-old male patient received first dose of bnt162b2
(COMIRNATY, Batch/Lot Number: EJ6788), intramuscular, in Arm Left on 21Jan2021 at
single dose (reported as 1 DF) for covid-19 immunisation. Medical history
included Hip prosthesis user and COVID-19. The patient's concomitant medications
were not reported. The patient experienced covid-19 aggravated on 26Jan2021,
serious due to resulted in death. Therapeutic measures were taken as a result of
covid-19 aggravated (covid-19). The patient died on 18Feb2021. An autopsy was not
performed. The clinical course was reported as follows: Reporting via national
website from a healthcare professional. Patient considered to be at risk of
developing severe COVID-19. The patient had history of COVID-19. Testing was done
on 26Jan2021. Course of the events: The patient was vaccinated in the framework of
anti-COVID-19 vaccination plan. The first injection was performed with COVID-19
mRNA Vaccine (nucleoside modified) (COMIRNATY), lot #EJ6788 by intramuscular route
in the left arm on 21Jan2021. On 26Jan2021, the patient was diagnosed with
aggravated COVID-19 with fever and oxygen desaturation. On 03Feb2021, oxygen
(unspecified trade name) therapy and IV fluids were given. From 09Feb2021, the
patient presented with appetite loss, refusal of feeding and urinary retention. On
18Feb2021, the patient died. The conclusion was aggravated COVID-19 leading to
death 28 days following vaccination. No other information was available. No FU
attempts possible. No further information expected.; Reported Cause(s) of Death:
COVID-19 aggravated" "No prior vaccinations for this event."
"1114005-1" "1114005-1" ""Tested positive for COVID-19; Exsiccosis; Oliguria;
Gut pain; Pyrexia; Nausea; Appetite lost; Diarrhoea; Hypotension; Unknown cause of
death; BNT162b2 (COMIRNATY), intravenous; This is a spontaneous report from a non-
contactable consumer, downloaded from the Regulatory Authority (regulatory
authority number DE-PEI-CADR2021014173). A 75-year-old female patient received a
single dose of BNT162b2 (COMIRNATY), intravenous, on 09Jan2021, for COVID-19
immunisation. The patient's medical history included ongoing polyarthralgia,
ongoing adipositas, ongoing cardiac valve replacement, ongoing apoplexy, ongoing
atrial fibrillation, Hashimoto-Thyreoiditis, and ongoing hypertension. The
patient's concomitant medications included unspecified anti-hypertensive drug(s).
The patient previously took Phenprocoumon (MARCUMAR) as anticoagulant therapy. On
10Jan2021 the patient experienced gut (abdominal) pain, fever, nausea, loss of
appetite, and diarrhea (described as liquid stool). On 12Jan2021 the patient
experienced deterioration with diarrhea, exsiccosis, and oliguria. On 15Jan2021,
the patient was treated with infusions, and her hypertensive medication was reduced
due to hypotension; the patient was hospitalized. On 16Jan2021, the patient tested
positive for COVID-19. On 16Jan2021 the patient died, however the cause of death
was not provided. No autopsy was performed. The patient had not recovered from
diarrhea, exsiccosis, oliguria, while the outcome of the other events was unknown.
Sender Comment: Arterial hypertension, adipositas, atrial fibrillation,
anticoagulation with Marcumar, condition after cardiac valve replacement,
polyarthrosis, Hashimoto-Thyreoiditis, condition after apoplexy. On 09Jan2021
vaccination COVID-19, on 10Jan2021 abdominal pain, fever, nausea, loss of appetite,
liquid stool, 12Jan2021 deterioration with diarrhea, exsiccosis, oliguria; Therapy
with infusions, reduction of hypertensive medication due to hypotension, on
15Jan2021 Hospitalization, positve test for Covid-19, on 16Jan2021 Exsitus letalis
Causality has been assessed as ""D. Unclassifiable "" for all events by the
Facility. No follow-up attempts needed, follow-up automatically provided by
Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death"" "No
"1114009-1" "1114009-1" "27Jan2021 positive rapid test; Respiratory distress;
This is a spontaneous report from a non-contactable consumer downloaded from the
Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021015257. A 90-
year-old female patient received bnt162b2 (COMIRNATY, lot number unknown), via
intramuscular on 23Jan2021 at single dose for COVID-19 immunisation. The relevant
medical history included asymptomatic COVID-19 from 27Dec2020. Concomitant
medications were not reported. On 26Jan2021 the patient experienced breathing
difficulties and respiratory distress. The patient had rapid test positive on
27Jan2021. The patient died on 31Jan2021. No autopsy was done. The patient
underwent lab test included rapid test which showed positive on 27Jan2021; PCR
smear with unknown results (PCR result is not yet available) on 29Jan2021. The
outcome of the event respiratory distress was fatal, while other events were
unknown. Sender Comment: Presumably the time of infection was 1-2 days before
vaccination, 23Jan2021 first vaccination, 26Jan2021 first symptoms, 27Jan2021
positive rapid test, 29Jan2021 PCR smear, 31Jan2021 died, PCR result is not yet
available. Information about lot/batch number cannot be obtained. No further
information expected.; Reported Cause(s) of Death: Respiratory distress" "No
from a contactable physician via Agency downloaded from the Regulatory Authority
FR-AFSSAPS-MP20210366 A 97-years-old male patient received the first dose of
bnt162b2 (COMIRNATY Batch/Lot Number: EJ6788), intramuscular, administered in Arm
Right on 21Jan2021 as single dose for covid-19 immunisation. Medical history
included starvation, dementia and anaemia macrocytic all unknown if ongoing. The
patient had medical history of COVID-19 and was considered at risk of developing a
severe form of COVID-19. The patient's concomitant medications were not reported.
The patient experienced covid-19 aggravated on 30Jan2021 with fatal outcome. The
patient died on 19Feb2021. An autopsy was not performed. The clinical course of
the events was reported as follows. On 30Jan2021, the patient presented dyspnea,
fever and oxygen desaturation which required oxygen therapy was tested for COVID-19
on 30Jan2021 and was diagnosed with COVID-19 aggravation. The patient then
presented worsening of confusion and agitation, increased crackles heard over lower
lung fields and increase of N-terminal prohormone brain natriuretic peptide,
asthenia and anorexia. Outcome: On 19Feb2021, 29 days after vaccination, the
patient died due to COVID-19 aggravation. Complete file, no further information
available.; Reported Cause(s) of Death: COVID-19 aggravated" "No prior
"1114057-1" "1114057-1" ""COVID-19 respiratory infection; This is a
spontaneous report from a contactable pharmacist downloaded from the Agency
Regulatory Authority-WEB. This is a report received from the Agency, Regulatory
authority report number FR-AFSSAPS-RE20210613. An 81-year-old male patient
received his first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm
Left on 05Feb2021 (Lot Number: EJ6788) as single dose for covid-19 immunisation.
Medical history included acute on chronic renal failure from Nov2020 to an unknown
date, Diabetes mellitus insulin-dependent from an unknown date and unknown if
ongoing, Cold type auto-immune hemolytic anemia from an unknown date and unknown if
ongoing, obesity from an unknown date and unknown if ongoing, bilateral deep vein
thrombosis from Jan2021 to an unknown date. Long-standing treatment included
anticoagulant (unspecified). The patient experienced covid-19 respiratory infection
with fatal outcome on 12Feb2021. Course of the event: On 21Jan2021, a test was
performed and turned out to be negative. On 05Feb2021, the patient received a first
injection of bnt162b2. On 12Feb2021, it was reported ""Highly positive PCR"". The
patient experienced an Apathetic confusional state, ""respiratory distress could
not be corrected"". This was due to SARS-CoV-2 infection progression in context of
multiple underlying pathologies, it was not an adverse event but a lack of efficacy
a week after the injection of the vaccine. The patient was considered at risk of
developing a severe form of the disease ""because of his medical history"". The
patient died on 12Feb2021. It was not reported if an autopsy was performed. No FU
COVID-19 respiratory infection"" "No prior vaccinations for this event."
"1114593-1" "1114593-1" "Rapid deterioration of general condition; resp.
Insufficiency; Unknown cause of death; COVID-19 confirmed by positive COVID-19
test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report
from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB
with regulatory authority number DE-PEI-CADR2021016372. A 69-year-old male patient
received the first dose of BNT162B2 (COMIRNATY), via unknown route of
administration on 31Dec2020 at single dose, and received the second dose of
BNT162B2, intramuscularly in Jan2021 (Lot Number: EK9788) at single dose, both for
COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing
arterial hypertension, ongoing dementia, ongoing multiple vessel coronary artery
disease, and adipositas. The patient's concomitant medications were not reported.
It was reported '10 days after second vaccination positive test to Covid 19. Rapid
deterioration of general condition and resp. Insufficiency in Feb2021,
Hospitalization, ventilation there, died on 10Feb2021'. The patient experienced
unknown cause of death on 10Feb2021 and Positive test to Covid 19 on 05Feb2021. The
patient underwent lab tests and procedures which included SARS-COV-2 test: positive
on 05Feb2021 (also reported as 10 days after second Vaccination). Therapeutic
measures were taken as a result of respiratory insufficiency included treatment
with ventilation. The outcome of events 'COVID-19 confirmed by positive COVID-19
test' was not resolved, of events 'Rapid deterioration of general condition' and
'resp. Insufficiency' was unknown. The patient died on 10Feb2021. It was not
reported if an autopsy was performed. No follow-up attempts needed, follow-up
automatically provided by Regulatory Authority.; Reported Cause(s) of Death:
Unknown cause of death" "No prior vaccinations for this event."
"1117213-1" "1117213-1" "Case tested positive for COVID-19 on 3/1/2021 by
rapid antigen and then again on 3/3/2021 by PCR. Case was admitted to hospital on
3/3/2021 for shortness of breath and occult infection. Case was previously
admitted and discharged from hospital on 2/22/2021 after a lumbar compression
fracture. Case had monoclonal antibody infusions; was afebrile and denied chills,
but had a dry cough. Case was a previous smoker, quit 2 years prior. Case
developed pneumonia. Case required supplemental oxygen." "No prior vaccinations
for this event."
"1121390-1" "1121390-1" "general and respiratory condition deterioration;
SARS-CoV-2 (RT-PCR) was positive/COVID-19 aggravated; discreet edema of lower
limbs; chills; light dry cough; fever; pneumonia to SARS-Cov-2; bacterial
pyelonephritis; infection to Klebsiella Pneumoniae extended-spectrum beta-
lactamases; important septic state; important asthenia; This is a spontaneous
report from a contactable pharmacist downloaded from the WEB FR-AFSSAPS-LY20211184.
A 73-year-old female patient received first dose of bnt162b2 (COMIRNATY),
intramuscular on 29Jan2021 (Batch/Lot Number: EJ6788) at single dose for COVID-19
vaccination. Medical history included heart block atrioventricular, anemia,
arterial hypertension, type 2 diabetes mellitus, hyperparathyroidism secondary,
ongoing chronic renal failure associated with diabetic nephropathy, obesity,
bipolar disorder, sleep apnea syndrome, hyperuricemia, nephroangiosclerosis,
cardio-renal syndrome, with hemodialysis initiated on 10Apr2019, heart disease with
conserved fraction of ejection with multiple episodes of congestive heart failure,
atrioventricular block with pacemaker. SARS-Cov-2 history was unknown. Concomitant
medications included bisoprolol, atorvastatin, valproate semisodium (DEPAKOTE),
risperidone, furosemide, candesartan cilexetil, sevelamer carbonate (RENVELA),
pregabalin (LYRIC), lactulose, paraffin, liquid (MELAXOSE), cinacalcet
hydrochloride (MIMPARA), caffeine, papaver somniferum latex, paracetamol
(LAMALINE), insulin aspart (NOVORAPID), insulin glargine (ABASAGLAR),
acetylsalicylate lysine (KARDEGIC), pantoprazole, calcium carbonate (CALCIDOSE),
zopiclone (IMOVANE), sodium polystyrene sulfonate (KAYEXALATE). On 29Jan2021
patient received a first injection of COVID-19 mRNA Vaccine (nucleoside modified)
(COMIRNATY) for vaccination against SARS-COV-2. On 03Feb2021 patient felt after
dialysis. On 05Feb2021 patient experienced chills, but no fever, with light dry
cough not noticed before. Hemodynamic state was stable. No clinical evidence of
infection was observed, no dysuria, no bowel disorder. No unusual sign on cardiac
examination, but discreet edema of lower limbs. No clinical evidence of pneumonia.
No bowel disorder. The patient presented with important asthenia, but Glasgow score
was 15. Antibiotics by ceftriaxone sodium (unspecified trade name) and gentamicin
(unspecified trade name) were started. On 06Feb2021 SARS-CoV-2 reverse
transcriptase-polymerase chain reaction (RT-PCR) was positive. Later, pulmonary
condition decreased with wheezing and crackles in bases, requiring oxygen therapy.
Direct microscopy and culture of urine disclosed infection to Klebsiella Pneumoniae
extended-spectrum beta-lactamases, requiring a treatment by imipenem (unspecified
trade name) 500mg twice daily. In Feb2021, the patient presented with important
septic state with unwell tolerated fever, and covid-19 aggravated. On 16Feb2021 due
to general and respiratory condition deterioration it was decided to stop active
treatments and to continue comfort care. Patient died on 17Feb2021. In total:
complications of pneumonia to SARS-Cov-2 with (bacterial) pyelonephritis to
Klebsielle Pneumoniae extended-spectrum beta-lactamases. Laboratory work-up: On
05Feb2021: white blood cells 6 x10^9/L, heamoglobin 100 g/L, platelets 152 x10^9/L,
sodium 139 mmol/L, potassium 3.2 mmol/L, bicarbonates 28 mmol/L, creatinine 194
umol/L (usual range not known), liver function was normal, C-reactive-protein 27
mg/L. On 11Feb2021: white blood cells 5.2 x10^9/L, hemoglobin 87 g/L, platelets 132
x10^9/L, creatinine 544 umol/L (usual range not known), increased transaminases
(Aspartate aminotransferase 250 and alanine aminotransferase 195 normal ranges not
available). Additional examination: In Feb2021 thoracic computed tomography
disclosed compatible aspect with SARS-cov-2 pneumonia, with multiple focus of
superinfection of pneumonic appearance. The patient died on 17Feb2021. Cause of
death was bacterial pyelonephritis and COVID-19 pneumonitis, covid-19, infection to
Klebsiella Pneumoniae extended-spectrum beta-lactamases and general and respiratory
condition deterioration. It was not reported if an autopsy was performed. No
Cause(s) of Death: infection to Klebsiella Pneumoniae extended-spectrum beta-
lactamases; general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR)
was positive/COVID-19 aggravated; Bacterial pyelonephritis; COVID-19 pneumonitis"
"1121397-1" "1121397-1" "COVID-19 with symptoms; COVID-19 PCR test positive;
Regulatory Authority-WEB FR-AFSSAPS-PO20211154. A 93-years-old female patient
received bnt162b2 (COMIRNATY) vaccine, dose 2 intramuscular, administered in Arm
Right on 10Feb2021 (Batch/Lot Number: EJ6789) as 0.3 mL, single, dose 1
intramuscular on 20Jan2021 (Batch/Lot number was not reported) as single dose for
covid-19 immunisation . Medical history included hypertension , cardiac failure.
The patient's concomitant medications were not reported. The patient experienced
covid-19 PCR test positive on 18Feb2021 , covid-19 with symptoms on 21Feb2021:
appearance of fever at 39 �C, cough, bronchial congestion and desaturation. Treated
with 5 L O2 and antibiotic therapy. The patient underwent lab tests and procedures
which included pyrexia: 39�C on 21Feb2021 , sars-cov-2 test positive on
18Feb2021. The patient died on 23Feb2021. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information is expected.
Batch/lot number of the first dose cannot be obtained.; Reported Cause(s) of Death:
Covid-19" "No prior vaccinations for this event."
"1122448-1" "1122448-1" "neutropenic sepsis; Neutropenia; cough; SARS-CoV-2
infection; This is a spontaneous report from a contactable consumer. This is a
report received from the Regulatory Agency (RA). Regulatory authority report number
GB-MHRA-WEBCOVID-202103150909596000, Safety Report Unique Identifier GB-MHRA-ADR
24942833. A 69-year-old female patient received first dose of bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jan2021
(Batch/Lot Number EN1185) as single dose for covid-19 immunization. Medical history
included neutropenic sepsis from an unknown date and unknown if ongoing, neoplasm
from an unknown date and unknown if ongoing (Recently had treatment for cancer,
leukemia or lymphoma; radiotherapy or chemotherapy), acute myeloid leukemia from
Jan2016 to an unknown date, acute lymphocytic leukemia from Jan2016 to an unknown
date, stem cell transplant from May2016 to an unknown date, leukemia from Jan2018
to an unknown date (replaced leukemia), stem cell transplant from May2018 to an
unknown date (second stem cell transplant). Patient has not had symptoms
associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant
medications included acyclovir taken for an unspecified indication, start and stop
date were not reported; amlodipine taken for an unspecified indication, start and
stop date were not reported, calcium carbonate (CALCICHEW) taken for an unspecified
indication, start and stop date were not reported; ciprofloxacin taken for an
unspecified indication, start and stop date were not reported, co-trimoxazole taken
for an unspecified indication, start and stop date were not reported; fluconazole
taken for an unspecified indication, start and stop date were not reported;
hyaluronate sodium (HYLO-FORTE) taken for an unspecified indication, start and stop
date were not reported; metoclopramide taken for an unspecified indication, start
and stop date were not reported; ondansetron taken for an unspecified indication,
start and stop date were not reported. Patient had relapsed AML receiving
chemotherapy at home as part of palliative care package. Patient was shielded for
12 months with her husband. Intravenous nurses wearing full PPE were the only other
contacts within the past 2 weeks, prior to that hematology appointment on
27Jan2021, again full PPE worn at all times. Patient was on day 5 of chemo when
nurse measured temperature and recorded as 38.5C therefore sent to emergency on
neutropenic pathway. Neutrophil count 0.0 at clinic and also on admission
05Feb2021. Swabbed positive in Emergency for COVID-19 same day. Admitted to
hospital and treated for neutropenic sepsis. Developed a cough and increased Oxygen
requirement, resulting in continuous positive airway pressure treatment 10Feb2021.
The patient experienced sars-cov-2 infection (covid-19) (death) on 05Feb2021,
neutropenic sepsis (neutropenic sepsis) (hospitalization, medically significant) on
an unspecified date with outcome of unknown, neutropenia (neutropenia)
(hospitalization, medically significant) on an unspecified date with outcome of
unknown, cough (cough) (non-serious) on an unspecified date with outcome of
unknown. The patient underwent lab tests and procedures which included sars-cov-2
test: no, negative covid-19 test on 27Jan2021 and positive on 05Feb2021, neutrophil
count: 0.0 on an unspecified date. Therapeutic measures were taken as a result of
neutropenic sepsis (neutropenic sepsis), cough (cough). The patient died on
15Feb2021. It was not reported if an autopsy was performed. Sadly died 15Feb2021
due to Covid-19. Patient had Covid PCR test and ongoing palliative treatment under
joint care of MRI. Patient was fully shielded from Feb2020. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
SARS-CoV-2 infection" "No prior vaccinations for this event."
"1126490-1" "1126490-1" "COVID PCR coming back positive/Sars-Cov2 infection;
Cholecystitis; This is a spontaneous report from a contactable physician from the
regulatory authority FR-AFSSAPS-RS20210385. An 87-year-old male patient received
first dose of bnt162b2 (COMIRNATY), intramuscular in arm left on 01Feb2021 (Lot
Number: EJ6788) as single dose for COVID-19 immunization. Medical history included
cholangitis from 2020, myocardial infarction from 2011, Dyslipidaemia, Hypertension
arterial, femoral fracture (Patient hospitalized in follow-up and rehabilitation
care since 08Dec following surgery on a femoral fracture), stroke from 2006.
Concomitant medications included glucose, potassium chloride, sodium chloride
(POLYIONIQUE G5, 5% 1L/24h); macrogol 3350, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL PLAIN, reported as Movicol 1 sachet / day); atorvastatin;
enoxaparin sodium (LOVENOX); acetylsalicylate lysine (KARDEGIC); furosemide. The
patient experienced COVID PCR coming back positive/Sars-Cov2 infection complicated
by cholecystitis on 04Feb2021. 01Feb2021: Vaccination with bnt162b2 in the left arm
(first dose). 04Feb2021: in front of a fever and oxygen refereeing, realization of
a COVID PCR coming back positive. This Sars-cov2 infection is complicated by
cholecystitis (presence of a Murphy sign). The thoracic scanner found in the low
sections a possible vesicular wall thickening with lithiasis at the neck and
infiltration to be confronted at the clinic. The opinion with the radiologist finds
a peri-vesicular effusion. Cholecystitis is treated with Ceftriaxone and
metronidazole (FLAGYL) from 04Feb2021 in the evening. 05Feb2021: evidence of
cytolysis (ASAT 201 IU / L, ALAT 221 IU/ L) as well as anicteric cholestasis
( phosphatases alcalines (PAL) 316 IU / L, G-GT at 734 IU / L). Biological
inflammatory syndrome decreasing with the last CRP of 08Feb2021 at 57.1 mg / L. In
terms of Covid, the patient is on 2L of O2 without the need for dexamethasone for
the moment. Transfer on 08Feb2021 for close monitoring Upon entering the service:
Physical examination: Aware and Oriented, Glasgow 15, BP 158/86 mmHg, heart rate 78
bpm, Fever at 38.1 degrees C, 92% saturation under 2L of O2 with a respiratory rate
of 28 / min, no draft, no cyanosis. His pulmonary auscultation found a bilateral
and symmetrical vesicular murmur without added noise. His cardiac auscultation
found regular heart sounds without a perceived breath. His abdominal examination
found a supple, depressible and painless abdomen without pain at the epigastric
level or in the right hypochondrium. He shows no resistance, no contracture, no
Murphy sign. Evolution: Respiratory worsening with the need for the introduction of
8L of O2 associated with increased polypnea; introduction of corticosteroid therapy
with dexamethasone from 09Feb2021 to 17Feb2021. 09Feb2021: Thoraco-abdomino-pelvic
CT scan (to look for pulmonary embolism and abdominal cuts to look for an abdominal
infectious focus in this context of suspected cholecystitis). Sub-optimal quality
injection that does not allow formal pulmonary embolism to be eliminated. No
embolus detected up to the lobe level. Aggravation of bilateral frosted glass
areas, compatible with Covid, involving 30 to 50% of the pulmonary parenchyma. It
was found that the appearance of cholecystitis, with an overall irregular and
laminated wall, with probable rupture of the vesicular fundus seeming to
communicate with a small collection coming into contact with the right colic angle
just under the abdominal wall. Interest of a surgical opinion. An opinion from
digestive surgeons was taken proposing the following management: continuation of
inpatient monitoring; continuation of antibiotic therapy with ceftriaxone and
Flagyl and performance of radiological cholecystostomy. An 8.5F drain was therefore
placed in the gallbladder. 12Feb2021: respiratory worsening; oxygen therapy at 15L
with a high concentration mask and increase in the dose of furosemide to 250 mg /
day. 15Feb2021: The biliary sample during drainage by radiological cholecystostomy
returned positive for Citrobacter Freundii, the antibiotic treatment is switched by
cefepime 2g morning and evening for 5 days. Biologically, the patient presents
hypokalaemia at 3 mmol / L without any sign of ECG, requiring supplementation with
Diffu-K. During hospitalization serum potassium gradually normalized. 17Feb2021:
Introduction of Midazolam 0.1 mg / h h intravenous via infusion pump + Morphine 0.5
mg / h intravenous via infusion pump in front of the discomfort and the non-
regression of the severity of the COVID infection. Increase on 21Feb2021 of
Midazolam to 0.2 mg / h and Morphine to 1 mg / h. 22Feb2021: death of the patient
noted. In total: PCR Sars cov2 positive 3 days after the first dose of COMIRNATY.
Patient died of severe Sars-Cov2 infection, complicated by cholecystitis. It was
not reported if an autopsy was performed. No follow-up attempts are possible. No
further information is expected. ; Reported Cause(s) of Death: COVID PCR coming
back positive/Sars-Cov2 infection; Cholecystitis" "No prior vaccinations for
this event."
"1126834-1" "1126834-1" ""vaccinated 1/13. presented for COVID screening on
1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness,
congestion, poor appetite, coughing. Previous headache and sweating had resolved
by the time she presented. Discharged with isolation instructions. Returned to ED
late on 1/22 with "" right-sided chest pain described as sharp constant 6/10
nonradiating pain localized to the right side of upper chest, shortness of breath
with exertion since this afternoon. She does endorse subjective fevers, with
associated increased coughing which is productive in nature, shortness of breath.""
Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21."" "No prior
"1131557-1" "1131557-1" "COVID-19 disease, symptoms started 3/5/21, deceased
of COVID-19 on 3/14/21" "No prior vaccinations for this event."
"1132474-1" "1132474-1" ""fever; problem with breathing; Sars COV-2 test
positive; the patient died; Sars COV-2 test positive; This is a spontaneous report
from a contactable pharmacist. A male patient of an unspecified age received
bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on
19Feb2021 (Lot Number: EP9598) as SINGLE DOSE for COVID-19 immunisation. The second
dose was scheduled for 12Mar2021 Medical history included arterial hypertension,
diabetes treated with DL HG, respiratory efficiency, full contact, oxygen
saturation 93%; all from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. On 04Mar2021, the patient reported to
the general physician due to high fever that has been going on for several days
(the reporter doesn't know when the fever started). General physician did not
initiate any treatment, he referred the patient to the internal ward of the
hospital. On 05Mar2021, the patient reported to the hospital where SARS COV-2 test
for COVID 19 was performed - the result: positive, the test was performed at 20:59.
The reporter gave the data from the discharge from this hospital: ""patient with
quarantine, headed by the general physician as a fever, claims he had not had a PRC
swab before. A high fever for several days, the primary health care physician did
not start any treatment. The patient was prescribed the following drugs: levoxa,
pyralgina, berodual, neoparin, monitoring with the general physician and he was
sent home. On 07Mar2021 in the morning, the patient had a problem with breathing,
the patient was hit to the hospital in the infectious diseases ward. First, the
patient was connected to oxygen. On 09Mar2021 patient was put on a respirator due
to health deterioration. On 13Mar2021 the patient died. It was not reported if an
autopsy was performed. The outcome of Sars COV-2 test positive, fever and problem
with breathing was unknown.; Sender's Comments: The causal relationship between
BNT162B2 and the events drug ineffective and SARS-CoV-2 test positive, pyrexia,
dyspnoea and patient death cannot be excluded as the information available in this
report is limited and does not allow a medically meaningful assessment. This case
will be reassessed once additional information becomes available. The impact of
this report on the benefit/risk profile of the Pfizer product is evaluated as part
of Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
Reported Cause(s) of Death: the patient died"" "No prior vaccinations for this
event."
"1133428-1" "1133428-1" "Positive molecular swab; COVID-19/dyspnea; This is a
spontaneous report from contactable physician downloaded from the Regulatory
authority-WEB regulatory authority IT-MINISAL02-697591. A 98-years-old female
patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route
of administration on 19Jan2021 at single dose, and the second dose (Batch/Lot
Number: EL0725; Expiration Date: 31Mar2021), via intramuscular administered in left
arm on 09Feb2021 09:52 at 0.3 mL, single for COVID-19 vaccination. The patient
medical history and concomitant medications were not reported. The patient
experienced positive molecular swab on 17Feb2021, dyspnea from 20Feb2021, died
hospitalized in hospital on 20Feb2021. The patient underwent lab tests and
procedures which included COVID-19 PCR test: positive on 17Feb2021. The patient
died on 20Feb2021. It was not reported if an autopsy was performed. Reporter
comment: 1st DOSE TAKEN ON 19Jan2021. Positive molecular swab on 17Feb2021 Died
hospitalized in hospital on 20Feb. Sender comment: 12Feb2021: contacted the
reporter to request a clinical report of death.; Reported Cause(s) of Death:
Positive molecular swab; COVID-19/dyspnea" "No prior vaccinations for this
event."
"1133429-1" "1133429-1" "drug ineffective; positive molecular swab/fever 37.5
� c; This is a spontaneous report from contactable physician downloaded from the
Regulatory authority-WEB regulatory authority IT-MINISAL02-697594. A 92-years-old
female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified
route of administration on 19Jan2021 at single dose, and the second dose (Batch/Lot
Number: EL0725; Expiration Date: 31Mar2021), via intramuscular administered in left
arm on 09Feb2021 09:48 at 0.3 mL, single for COVID-19 vaccination. The patient
medical history and concomitant medications were not reported. The patient
experienced drug ineffective on 13Feb2021, positive molecular swab on 13Feb2021,
fever 37.5 � c on 13Feb2021, admitted and died at the hospital on 21Feb2021. The
Positive on 13Feb2021. The patient died on 21Feb2021. It was not reported if an
autopsy was performed. Reporter comment: 1st dose taken on 19Jan2021. Positive
molecular swab dated 13Feb2021. Admitted and died at the hospital on 21Feb Sender
comment: 12Feb2021: the reporter contacted and the death clinical report requested.
Stop date for events (21Feb2021) No follow-up attempts possible. No further
information expected. Lot/Batch number already obtained.; Reported Cause(s) of
Death: drug ineffective; positive molecular swab/fever 37.5 � c" "No prior
"1135088-1" "1135088-1" "SARS-CoV-2 infection/ COVID +ve; SARS-CoV-2
infection/ COVID +ve; This is a spontaneous report from a contactable physician.
This is a report received from the Regulatory authority Regulatory authority report
number: GB-MHRA-WEBCOVID-202103161715400580, Safety Report Unique Identifier: GB-
MHRA-ADR 24958447. An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 mRNA VACCINE; lot number: EL0739, Expiration Date: not reported) dose 1,
via an unspecified route of administration on 17Jan2021 as single dose for COVID-19
reported. The patient had not had symptoms associated with COVID-19, not had a
COVID-19 test and was not enrolled in clinical trial. The patient experienced sars-
cov-2 infection on 31Jan2021. The patient was hospitalized for sars-cov-2 infection
from 31Jan2021. Admitted to hospital via ambulance on 31Jan2021 and confirmed COVID
+ve. The case was reported as death, hospitalization, medically significant. The
patient underwent lab tests and procedures which included COVID +ve on 31Jan2021.
The outcome was fatal. The patient died on 04Feb2021. It was not reported if an
autopsy was performed and the reported cause of death was SARS-CoV-2 infection.
No follow-up attempts are possible. No further information is expected. ; Reported
Cause(s) of Death: SARS-CoV-2 infection/ COVID +ve; SARS-CoV-2 infection" "No
"1135124-1" "1135124-1" "No event description for this event." "No prior
"1138370-1" "1138370-1" "he started feeling sick day after vaccine with flu
like symptoms, seen in ED 5 days after vaccination, diagnosed with COVID19, About
1 week after that, he was found dead at home on his couch.""No prior vaccinations
for this event."
"1140573-1" "1140573-1" "Dyspnoea; Fever; Ischemic stroke; Saturation at 82%;
Atypical bilateral pneumonitis; probable superinfection of bronchial origin within
the left upper lobe; COVID-19; 10.42 G/L of PNN (neutrophils); did not eat all day;
hyperleukocytosis 11.29 G/L; thrombocytopenia 90 G/L; This is a spontaneous report
received from a contactable physician downloaded from the Regulatory Authority
(RA). The regulatory authority report number is FR-AFSSAPS-RS20210427. An 86-year-
old female patient received the first dose of bnt162b2 (COMIRNATY; Lot Number:
EP9605) intramuscular, administered in Arm Right, on 10Mar2021, as SINGLE DOSE for
covid-19 immunisation. Medical history included cerebrovascular accident from 2020
to an unknown date, coronary artery bypass from an unknown date and unknown if
ongoing, Penicillin allergy from an unknown date and unknown if ongoing,
hyperlipidaemia from an unknown date and unknown if ongoing, caesarean section,
Appendectomy, Carcinoma of tongue from an unknown date and unknown if ongoing, and
ongoing significant speech problems. Concomitant medications included paracetamol,
nebivolol, amlodipine besilate, clopidogrel, levothyroxine sodium (LEVOTHYROX),
pravastatin, calcium carbonate, colecalciferol (CALCIDOSE VITAMINE D), lorazepam,
and paroxetine. On 11Mar2021, emergency services was alerted by neighbours who
have not seen the patient during the day. Patient found lying in bed, dyspneic,
febrile, did not eat all day. On arrival of the emergency services, the patient was
congested, saturated 95% AA (Amino Acids), febrile 39.5 C, FR (fractional
shortening) 56/min. She was hospitalised. Questioning was not very helpful,
significant speech problems since an operation for tongue cancer. According to her
daughter-in-law, patient is usually comprehensible. Emergency examination:
pulmonary auscultation: some crackles in the right base, decrease in vesicular
murmur on the left. Supra-clavicular pull, thoraco-abdominal swing. Polypneic
40/min. Cardiovascular: regular heart sounds, no murmur; no IMO, no jugular turgor;
soft, painless calves. Abdomen soft, depressible, tender in the epigastric region.
Biology: hyperleukocytosis 11.29 G/L including 10.42 G/L of PNN (neutrophils);
thrombocytopenia 90 G/L. Normal blood ionogram, normal renal function. CRP (C-
reactive protein) (< 342.0mg/l) = 2.5, ABG (arterial blood gases): pH 7.44; PO2
(partial pressure of oxygen) 66 mmHg, PCO2 (partial pressure of carbon dioxide) 32
mmHg, bicarbonates 21.7 mmol/l; COVID PCR (Polymerase chain reaction) negative.
Chest CT: no detectable acute proximal pulmonary embolism within the limits of the
examination. Atypical bilateral pneumonitis, potentially suggestive of COVID
involvement (moderate relaxation), with probable superinfection of bronchial origin
within the left upper lobe. Introduction of levofloxacin. On 12Mar2021: clinical
examination: patient is reactive Glasgow 3 with pupils in a reactive mydriasis, eye
rolling; generalized mottling; grazing. Saturation at 82% AA (Amino Acids)
increased to 95% on 15l oxygen. Lung auscultation: bilateral crackles. Emergency
brain scan: systematized left frontal hypodensity suggesting an acute constituted
ischemic focus. In view of the patient's neurological condition and the severe
cardiovascular terrain, it was decided to start palliative care. Dyspnoea, fever
and ischaemic stroke the day after a D1 of COMIRNATY in a frail patient with a long
cardiovascular history; COVID PCR (Polymerase chain reaction) negative but atypical
lung lesions suggestive of moderate COVID involvement with probable bronchial
superinfection. Outcome of dyspnoea, fever and ischaemic stroke was fatal while it
was unknown for the other events. The patient died on 12Mar2021 at 14:30. Causes of
death were reported as dyspnoea, fever and ischaemic stroke. It was unknown if an
autopsy was performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Dyspnoea; fever; ischaemic stroke" "No
"1144356-1" "1144356-1" "Pfizer COVID -19 Vaccine EUA Patient's wife reported
to facility, upon contacting for 2nd dose appointment, that the patient passed
away from COVID-19. This patient did not pass away at facility, as there are no
records of this patient in our EHR. Per patient?s wife, patient was vaccinated on
2/3/21 at the clinic with the initial Pfizer COVID-19 vaccine. The patient passed
away on 2/22/21 from COVID-19 (3 weeks after the initial dose, but prior to the
booster dose). Pfizer/BioNtech NDC# 59267-1000-2 Pfizer/BioNtech Lot # EL9269 Lot
Exp: 05/30/2021 Site: left Deltoid Time of vaccination: 2/3/2021 6:15:53 PM" "No
"1145508-1" "1145508-1" "Patient presented to the ED 2/6/2021 with increasing
SOB and found to have abnormal labs as an outpatient. Patient was found to be
COVID positive on 2/6/2021 as well. Patient was discharged on 2/9/2021 for acute
decompensations diastolic HF. At 2/19/2021 visit with Nephrology, patient found to
have hypervolemic hyponatremia, not responding to oral diuretics and decision was
made to manage as an inpatient. Patient found to have cardiomegaly, mild pulmonary
vascular congestions with small bilateral pleural effusions, EF 59%, severely
elevated pulmonary artery systolic pressure, and had a AKI. Patient did not
improve with diuretic therapy. Hospice and comfort care measures were pursued and
patient expired on 3/1/2021." "No prior vaccinations for this event."
"1146467-1" "1146467-1" "NA- patient refused second dose of vaccine - Patient
condition at time of death Chronic Conditions Renal failure Advanced age 100 y/o
Cardiopulmonary arrest secondary to Covid 19" "No prior vaccinations for this
event."
"1146552-1" "1146552-1" "COVID-19 RESPIRATORY INFECTION; ABNORMAL OXYGEN
SATURATION; POLYPNOEA; MENTAL CONFUSION; FALL; ASTHENIA; This is a spontaneous
report from contactable pharmacist downloaded from the regulatory authority-WEB.
The regulatory authority report number is FR-AFSSAPS-LL20211120. An 86-year-old
female patient received BNT162B2 (COMIRNATY, lot number and expiry date were
unknown, unknown if 1st or 2nd dose), via intramuscular route on 25Feb2021 as a
single dose for COVID-19 immunisation. Medical history included heartburn, GIST
with partial gastrectomy, essential thrombocythemia, diabetes, breast cancer,
osteoporosis with vertebral collapse. Concomitant medications included glimepiride
1 mg, indapamide/perindopril 2/0.625 mg, acetylsalicylate lysine (KARDEGIC 75 mg),
nebivolol 2.5 mg/ day; folic acid 5 mg, anastrozole 1 mg/day. On 04Mar2021 7:00
p.m., the patient referred to the emergency department by her attending physician
for polypnea, 89% desaturation in ambient air and confusion. According to the
patient, asthenia and falls for about 3 days and diarrhea for 2 days (therefore
date of onset of symptoms on 01Mar2021). COVID + Antigen test in the emergency
room. On 05Mar2021, the patient was hospitalized in a COVID unit for COVID +.
Medical treatment included O2 8L / min, lovenox 0.4 x 2 / day, Dexamethasone 6mg IV
per day, antibiotic therapy for extensive pulmonary involvement: Cefotaxime and
Rovamycin. On 06Mar2021, rapid deterioration of the patient's state of health was
reported. At 3h O2 15L / min, at 4 p.m. O2 30L / min. At 7 p.m., the patient's
vital prognosis was engaged, she received comfort care. On 07Mar2021 at 2 a.m.,
death of the patient was reported. Events were fatal. The cause of death was
COVID19. NB: imputability without prejudice to the elements of investigation which
could be carried out within the framework of legal or amicable compensation
procedures. No follow-up attempts are possible, information on batch/ lot number
cannot be obtained.; Reported Cause(s) of Death: COVID19" "No prior vaccinations
for this event."
"1146678-1" "1146678-1" "Patient received 1st dose Pfizer COVID vaccine on
2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose.
Around 3/2/2021, she saw her physician complaining of pain in her arm, which was
attributed to gout. At the time, she also had a nonproductive cough, generalized
weakness and one episode of loose stool. She presented to the emergency room on
3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid
test and PCR. A quantitative test for COVID antibodies was sent out to a reference
lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP,
High Flow Oxygen and ultimately intubation. Was not oxygen dependent before
hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held
due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent
plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for
variants of interest in joint effort between pathology and infectious disease.
Report not yet available." "No prior vaccinations for this event."
"1146787-1" "1146787-1" "death Narrative: Pt has been declining prior to
starting COVID vaccine doses; then he got COVID after first dose (VAER reported);
and then was admitted to hospice for dyspnea, chronic pain, pressure ulcers,
urinary incontinence with foley catheter in place, bedbound, dysphagia." "No
"1149589-1" "1149589-1" "COVID-19 aggravated; COVID-19 aggravated; Anemia;
Lymphopenia; Stage 3 renal failure; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority-WEB, regulatory authority number
FR-AFSSAPS-AM20210581. A 100-year-old male patient living in a retirement home
received first dose of bnt162b2 (COMIRNATY) intramuscular, administered in Deltoid
Left on 21Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation.
Medical history included double inguinal hernia, fracture, closed, colles'
(fracture beam glues left), nasal polyps, venous peripheral insufficiency (lower
limbs), haemorrhoids, oesophagitis ulcerative (stage IV), chronic obstructive
airways disease, hypercholesterolaemia, pyelonephritis, dupuytren's contracture,
shoulder dislocation and pleuritis. Concomitant medications included candesartan
cilexetil (CANDESARTAN CILEXETIL), pravastatin sodium (PRAVASTATIN SODIUM),
pantoprazole (PANTOPRAZOLE), macrogol 4000, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL), paracetamol (DOLIPRANE), hydrochlorothiazide
(HYDROCHLOROTHIAZIDE), prednisone (PREDNISONE). On 21Jan2021, the patient received
his first injection of COMIRNATY. Four weeks after his vaccination, on 09Feb2021,
in front of a pulmonary symptomatology, realization of a PCR SarS-CoV-2 which
returned positive. Support was as follows: amoxicillin, clavulanic acid (AUGMENTIN)
and levofloxacin (LOVENOX). On 16Feb2021, faced with the development of a severe
form of COVID-19, he was hospitalized. The management was as follows: bi antibiotic
therapy with ceftriaxone sodium (ROCEPHIN) and erythromycin, high flow oxygen
therapy (12L/ min). No intensive care. On unknown date, on the laboratory
assessment, anemia at 11.6g/ dL, lymphopenia at 0.93G/ L, stage 3 renal failure
with a clearance of 44.2mL/ min. From 17Feb2021 to 22Feb2021 degradation of the
patient requiring sedation. Patient died on 22Feb2021 due to COVID-19. An autopsy
was not performed. Outcome of the events renal failure, lymphopenia and anemia was
unknown. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: Drug ineffective; Drug ineffective; COVID-19" "No
"1149874-1" "1149874-1" "After the 1st dose, the patient became ill with
COVID-19.; After the 1st dose, the patient became ill with COVID-19.; This is a
Authority-WEB IT-MINISAL02-703039. A 92-year-old male patient received the first
dose of BNT162B2 (COMIRNATY; Lot Number: EJ6790; Expiration Date: 31Mar2021),
intramuscular, administered on the right arm on 24Feb2021 as 0.3 mL, single for
covid-19 immunisation. The patient's medical history and concomitant medications
were not reported. On 14Mar2021, following serious asthenia, the other healthcare
professional was contacted and performed a rapid positive antigenic swab and
transported to the emergency room where positivity was confirmed with a molecular
test. In ER, bilateral interstitial pneumonia was diagnosed and death occurs on
16Mar2021. Therapeutic measures were taken as a result of the event. The patient
died on 16Mar2021. It was not reported if an autopsy was performed. Reporter's
comment: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks
after 1st vaccination.; Reporter's Comments: Onset of Covid 19 with bilateral
interstitial pneumonitis about 2 weeks after 1st vaccination.; Reported Cause(s) of
Death: bilateral interstitial pneumonia; Covid-19" "No prior vaccinations for
this event."
"1151636-1" "1151636-1" "My father received his first Pfizer vaccine on
02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had
shortness of breath. Once arrived at ER, they immediately put him on oxygen.
Vomiting lasted several hours. They tested him for Covid and did a chest x-ray.
Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed
in hospital for 5 days and was then released to nursing home for physical and
occupational therapy. He was very weak and on days experienced what they called
Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to
his apartment, with extended visiting nurse therapy. On 3/10/21, was the first
visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health
Care. She checked his vitals. She said his blood pressure was good, lungs sounded
good and oxygen level was 98. She said he was doing good and that she would not
need to continue to come out and check on him weekly. She left. At 2:30 the same
day, a Physical Therapist from Home Health Care came. She asked him lots of
questions and adjusted my fathers' walker for him. He showed her how he was doing
using the walker. Walked approximately 15-20 feet in his apartment. She checked his
vitals before she left. His oxygen level was now at 91. She had him take a few deep
breathes until his oxygen level was up to 93. She left and said she would be back
on Friday the 12th to begin the actual physical therapy then. Within 10 minutes
after she left my father started shaking uncontrollably and was having difficulties
breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the
way down to 74. They took him to the ER. When getting him out of ambulance he began
vomiting. Vomiting lasted for hours just like when he went to the hospital back in
February. They tried 3 different drugs to control the nausea. They did EKG, chest
and abdomen scans. Was found that he had multiple blood clots and inflammation in
his lungs and a bacterial infection in his blood. After testing, bacteria was found
to be E Coli. Treated him with heparin for clots and antibiotics for infection and
had him on oxygen in nose. Every day thereafter, he felt worse. They switched him
to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early
morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked
him up to a BiPap oxygen machine because his oxygen levels were dropping too low.
We were then told by the lung doctor, that the damage to his lungs was extreme and
that the next step would be to put him on a ventilator and feeding tube. My father
did not want this per his will and his discussion with Dr earlier in the week. Dr
indicated that he would not get better just being on the BiPap machine and we then
chose to have them take him off of the machine because he did not want to go on
life support. My father passed away on Sunday, March 14th around 6:30pm." "No
"1152686-1" "1152686-1" "Respiratory distress, Atrial fibrillation, Acute
Kidney Injury, COVID 19 positive High flow nasal cannula, BiPAP machine,
antibiotics" "No prior vaccinations for this event."
"1153708-1" "1153708-1" "SARS-CoV-2 infection/ Vaccine breakthrough
infection; This is a spontaneous report from a contactable healthcare professional.
This is a report received from the regulatory authority. Regulatory authority
report number GB-MHRA-WEBCOVID-202103231343284950, Safety Report Unique Identifier
GB-MHRA-ADR 25005895. An 82-year-old female patient received first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of
administration on 19Jan2021 at a single dose for COVID-19 immunisation. Medical
history included ongoing dementia (advanced). Unsure if patient has had symptoms
associated with COVID-19. She was not enrolled in clinical trial. The patient's
concomitant medications were not reported. The patient experienced SARS-CoV-2
infection and vaccine breakthrough infection on 01Feb2021. The events were assessed
as serious by HA (fatal and medically significant). Case narrative: The patient
received COVID vaccination 19Jan2021, confirmed COVID positive 01Feb2021. Treated
with antibiotics. Chest x-ray unremarkable. Died 13Feb2021. Cause of death 1)
advanced dementia and 2) COVID-19. An autopsy was not performed. The patient
underwent lab tests and procedures which included COVID-19 virus test: yes -
positive COVID-19 test on 01Feb2021. No follow-up attempts are possible.
Information about lot/batch number cannot be obtained. No further information is
expected.; Reported Cause(s) of Death: Dementia; SARS-CoV-2 infection/ Vaccine
breakthrough infection" "No prior vaccinations for this event."
"1154151-1" "1154151-1" "FALLS, CHEST PAIN, HEMORRAHAGIC CONTUSION, COVID,
PNEUMONIA, HYPOXIC RESPIRATORY FAILURE Narrative: 2/22/2021 Patient presented to
hospital with multiple complaints. He was reporting falls, chest pain, his wife was
diagnosed with Covid. While he was there, he was found to have hemorrhagic
contusion in the right frontoparietal region with minimal surrounding edema, Covid,
pneumonia, elevated troponin. He was accepted in transfer by trauma surgeon Dr. and
arrives with no complaints. 2/26/2021 Patient died after code blue was called Death
Diagnosis: s/p fall with head trauma Focal area right intracranial hemorrhage per
initial CT - serial CT head showing stability Acute hypoxic respiratory failure
secondary to COVID-19 viral illness COVID-19 viral illness Acute chest pain,
improved Elevated troponin, suspected type 2 NSTEMI Elevated D-dimer - V/Q scan
with intermittent probability PE Acute kidney injury on CKD, improving unlikely
that vaccine contributed to patient's death." "No prior vaccinations for this
event."
"1156224-1" "1156224-1" "Patient has a renal transplant; developed fever and
seen in Emergency Ctr.; tested positive for COVID." "No prior vaccinations for
this event."
"1156620-1" "1156620-1" "Mandatory EUA Reporting - Patient received COVID-19
vaccine on 1/12/21 and then tested positive for Covid the same day. Was admitted to
hospital from rehab (resides in rehab for chronic respiratory failure). Patient
deteriorated throughout hospitalization, was transitioned to comfort care, and
"1161302-1" "1161302-1" "Covid-19 Pneumonia; Covid-19 Infection; This is a
spontaneous report from a non-contactable physician downloaded from the Agency
Regulatory Authority-WEB with regulatory authority number DE-PEI-PEI2021003484. An
87-year-old male patient received his first dose of bnt162b2 (COMIRNATY; unknown
lot number and expiration date) at vaccination age of 87-year-old intramuscular on
15Feb2021 as a single dose for covid-19 immunisation. The patient's medical history
and concomitant medications were not reported. It was reported that 13 days
(27Feb2021) after vaccination the patient developed COVID-19 and COVID-19
pneumonia, lasting for 3 days. The patient is dead. The events was reported as
serious with criterion of death. The patient underwent lab tests and procedures
which included COVID-19 PCR test was positive on an unspecified date. It was
reported that the cause of death was COVID-19 pneumonia. The outcome of the events
was fatal. The patient died on 01Mar2021. It was unknown if an autopsy was
performed. No follow-up attempts possible, batch/lot number cannot be obtained.
No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia"
"1161353-1" "1161353-1" "Vaccination failure; Vaccination failure; Urinary
tract infection; This is a spontaneous report from a contactable pharmacist
downloaded from the Agency Regulatory Authority-WEB (regulatory authority number:
FR-AFSSAPS-CN20210903). An 89-year-old male patient received the first single dose
of BNT162b2 (COMIRNATY), via an unspecified route of administration, on 11Jan2021
(Lot Number: EM0477), and the second dose, intramuscular, on 01Feb2021 (Lot Number:
EK9788), for COVID-19 immunisation. The patient was vaccinated with a 25G 25 mm
needle. The patient's medical history included cancer of lower rectum discovered at
the end of 2018, initially treated with concomitant radiochemotherapy, then
discharge colostomy was performed in Dec2019, and finally palliative care from
Jul2020, due to which the patient was in a nursing home. Additional medical history
included complete arrhythmia due to atrial fibrillation, herniated disc,
osteoarthritis, purulent pleurisy, benign prostatic hyperplasis, thoracic aortic
aneurysm operated by custom thoracic endoprosthesis, and popliteal aneurysm. The
patient had no previous history of COVID-19. On 04Mar2021 the patient was
hospitalized following fever and pharyngeal pain. The patient was put in isolation
and a PCR Covid test returned positive for the variant (presence of the N501Y and
A570D mutations of the S gene). There was a progressive worsening with associated
urinary tract infection (ECBU positive for Citrobacter freundii), patient objecting
to treatment. The patient eventually died on 12Mar2021 at 7:05 p.m. It was unknown
if an autopsy was performed. The reported event was 'vaccination failure' with
fatal outcome. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19; Vaccination failure" "No prior vaccinations
for this event."
"1161379-1" "1161379-1" "sars-cov-2 test: contracted (positive); sars-cov-2
test: contracted (positive); Death NOS; deterioration of the general condition as
well as a progressive loss of autonomy; (Urine culture) positive; chills;
hyperthermia at 38 degree C; This is a spontaneous report from a contactable
physician reporting for a patient downloaded from the Regulatory Authority,
regulatory authority number FR-AFSSAPS-TO20211826. An 88-year-old female patient
received bnt162b2 (COMIRNATY), first dose, intramuscular, administered in Arm Right
on 11Feb2021 (Batch/Lot Number: EJ6788) as SINGLE DOSE for covid-19 immunisation.
Medical history included dementia alzheimer's type (severe Alzheimer's type
dementia) and starvation (undernutrition) from an unknown date and unknown if
experienced death nos on 16Mar2021. Clinical course was reported as follows: The
patient received the first injection of the COMIRNATY vaccine on 11Feb2021 and
presented the following day, i.e. 12Feb2021, with hyperthermia at 38 degree C and
chills. She was put on antibiotics, CRP at 15 and ECBU (Urine culture) positive. A
deterioration of the general condition as well as a progressive loss of autonomy
were reported leading to his death on 16Mar2021, i.e. 33 days after vaccination.
The patient underwent lab tests and procedures which included body temperature: 38
centigrade on 12Feb2021, c-reactive protein: 15 on 12Feb2021, sars-cov-2 test:
contracted (positive) on an unspecified date, and ECBU test (urine culture):
positive on 12Feb2021. The patient died on 16Mar2021 (Death NOS). Outcome of the
other events was unknown. It was not reported if an autopsy was performed. No
follow-up attempts possible. No further information expected. Lot number has been
obtained.; Reported Cause(s) of Death: death NOS" "No prior vaccinations for
this event."
"1161667-1" "1161667-1" "SARS-CoV-2 infection; This is a spontaneous report
from a contactable other hcp received from the Regulatory Authority. The regulatory
authority report number is GB-MHRA-WEBCOVID-202103230953268490, Safety Report GB-
MHRA-ADR 25004289. A 93-year-old male patient received bnt162b2 (BNT162B2), dose
1 via an unspecified route of administration on 14Jan2021 (Batch/Lot number was not
reported) at a single dose for covid-19 immunisation. Medical history included
clinical trial participant from an unknown date and unknown if ongoing (RECOVERY,
REGN monoclonal antibodies), It was unsure if patient has had symptoms associated
with COVID-19. The patient's concomitant medications were not reported. The
patient experienced sars-cov-2 infection on 26Jan2021. The patient underwent lab
tests included Covid-19 virus test: positive on 26Jan2021 (Yes - Positive COVID-19
test), polymerase chain reaction (PCR) and chest x-ray (CXR): unknown results.
Therapeutic measures were taken as a result of sars-cov-2 infection. The patient
died on 31Jan2021. It was not reported if an autopsy was performed. Additional
information: Patient received covid vaccine 14Jan2021, admitted to hospital and
tested positive for COVID 26Jan2021. Patient treated with REGN monoclonal
antibodies covid vacs as part of RECOVERY trial. Also treated with dexamethasone
and antibiotics as part of usual treatment. No follow-up attempts are possible;
information about lot/batch number cannot be obtained.; Reported Cause(s) of Death:
"1161668-1" "1161668-1" "SARS-CoV-2 infection/Vaccine breakthrough infection;
SARS-CoV-2 infection/Vaccine breakthrough infection; This is a spontaneous report
from a contactable healthcare professional received from the Regulatory Authority.
The regulatory authority report number is GB-MHRA-WEBCOVID-202103231247133620,
Safety Report Unique Identifier is GB-MHRA-ADR 25005489. An 86-year-old female
patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution
for injection, lot number and expiry date were not reported), via an unspecified
route of administration on 07Jan2021 at a single dose for COVID-19 immunization.
The patient's medical history and concomitant medications were not reported. It was
unsure if patient has had symptoms associated with COVID-19. Patient was not
enrolled in clinical trial. On 31Jan2021, the patient experienced SARS-CoV-2
infection/vaccine breakthrough infection. It was reported that the patient received
COVID vaccine on 07Jan2021. Tested positive for COVID on 31Jan2021 and was admitted
to hospital. Treated with antibiotics and dexamethasone. The reporter assessed the
events as serious (hospitalization and death). The patient underwent lab tests and
procedures which included chest x-ray: unknown results on an unspecified date and
COVID-19 virus test: positive (yes/positive COVID-19 test) on 31Jan2021. The
outcome of the events was fatal. The patient died on 08Feb2021 due to SARS-CoV-2
infection/vaccine breakthrough infection. It was not reported if an autopsy was
performed. No follow-up attempts are possible; information about batch/lot number
cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection/Vaccine
breakthrough infection; SARS-CoV-2 infection/Vaccine breakthrough infection" "No
"1165295-1" "1165295-1" ""COVID-19 aggravated; This is a spontaneous report
from a contactable consumer downloaded from the Agency Regulatory Authority-WEB.
The regulatory authority report number is FR-AFSSAPS-NC20211060. An 80-year-old
female patient received her first dose of BNT162B2 (COMIRNATY, Batch/Lot Number:
Unknown), via intramuscular route in the arm on 25Feb2021 as a single dose for
COVID-19 immunisation. Medical history included cardiac decompensation, and
hypertension in July 2019, obesity, calcified aortic valve, and DTE carotid
atheroma (55%). Concomitant medications included hydrochlorothiazide (ESIDREX),
ginkgo biloba (TANAKAN), losartan potassium (COZAAR), atenolol, and furosemide.
Since 27Feb2021, the patient has presented chills, cough, dyspnea-orthopnea, two
episodes of vomiting, loss of appetite, two coughing up blood (one red and one
black). Cardiology consultation recently does not mention his calcified aortic
stenosis in the report of 26Nov. The patient tested positive for COVID-19 (variant)
on 01Mar2021 while going to the emergency room and then returned home. The patient
consulted again on 02Mar2021 because his condition deteriorated during the day.
Acidosis and hypercapnia were corrected by non-invasive ventilation. The next day,
patient had respiratory deterioration. On 03Mar2021, the patient was referred by
his doctor in emergency. On 03 Mar2021, PH was 7.17 and PCO2 was 87. Patient was
put under non-invasive ventilation. Initial clinical examination showed ""Sym and
bilateral vesicular murmur, bilateral crackles, irregular heart noise, calcified
aortic stenosis murmur, edema of the lower limbs, soft and painless abdo, confused
glasgow scale GSC 14."" CARDIO ADVICE: decompensation which seems to be more due to
COVID than to acute lung edema. CAR BNP (Btype natriuretic peptide) very high.
Summary of management and evolution: Respiratory decompensation on COVID and acute
lung edema (for cardio). Effectiveness of the non-invasive ventilation following a
session of one more hour, control gas PH 7.344, PCO2 52. Patient was still confused
after refusal of care. Serious opinion was made, comfort care. During the first
week of hospitalization, patient was relatively stationary. However, there was
clear deterioration of the disease in the second week of hospitalization.
Unfavorable changes with the death on 15Mar2021. It was not reported if an autopsy
was performed. Conclusion: Covid-19 possibly aggravated by vaccination. Indeed, all
her family circle has tested positive for COVID19 (variant): woman (57 years old,
co-morbidities with cancer right cardiac decompensation, COPD(Chronic obstructive
pulmonary disease), neurodegenerative disease) and the young girl (24 years old).
They did not benefit from the vaccination and remained asymptomatic, except for the
patient. This obviously remains a hypothesis. The pharmacovigilant notes:
Accountability score(s) established without prejudice to the elements of
investigation which could be carried out within the framework of legal or amicable
compensation procedures. No follow-up attempts are possible, information on batch
number cannot be obtained.; Reported Cause(s) of Death: Covid-19 aggravated""
"1165315-1" "1165315-1" "Drug ineffective; confirmed COVID-19 positive
result; Sepsis; This is a spontaneous report from a contactable pharmacist received
from a regulatory authority. The regulatory authority report number is GB-MHRA-
MIDB-ece38980-a6e9-4449-af5e-f32722a8a8ea, Safety Report Unique Identifier GB-MHRA-
ADR 25042533. A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-
19 MRNA VACCINE) intramuscularly on 22Jan2021 (Batch/Lot number was not reported)
at single dose for covid-19 immunisation. Medical history included Type 2 Diabetes
Mellitus, Angina (Ischeamic Heart Disease), perforated duodenal ulcer requiring
surgery and osteoporosis. Concomitant medications included gabapentin,
lansoprazole, simvastatin, sitagliptin, metformin, carbidopa, and co-careldopa.
The patient experienced drug ineffective, confirmed covid-19 positive result, and
sepsis, all from 18Feb2021, which were reported as fatal outcome and causing
hospitalization. The patient was hospitalized for drug ineffective, confirmed
covid-19 positive result, and sepsis from 18Feb2021. Therapeutic measures were
taken as a result of drug ineffective/confirmed covid-19 positive result included
treatment Palliated on 26Feb2021 post admission. The patient died on 26Feb2021.
No follow-up attempts are possible; information about lot/batch number cannot be
obtained.; Reported Cause(s) of Death: drug ineffective; confirmed covid-19
positive result; sepsis" "No prior vaccinations for this event."
"1165558-1" "1165558-1" ""Pneumonia associated with SARS-CoV-2
infection/SARS-CoV-2 infection positive; Pneumonia associated with SARS-CoV-2
infection/SARS-CoV-2 infection positive; This is a spontaneous report from a
contactable Physician downloaded from the regulatory authority RO-NMA-2021-
SPCOV1021 A 74-year-old male patient received bnt162b2 (COMIRNATY), first dose via
an unspecified route of administration on 23Jan2021 (Batch/Lot number was not
reported), second dose intramuscular on 13Feb2021 (Batch/Lot Number: Unknown) both
as single dose for COVID-19 immunisation. Medical history included the patient is
known with: operated clear cell renal cell carcinoma (right nephrectomy), ongoing
chronic renal failure stage 3, ongoing chronic obstructive pulmonary disease
(COPD), ongoing hypertension, ongoing hypertensive nephropathy and fixed nitrogen
retention, ongoing obesity, ongoing type 2 diabetes, ongoing systemic atheromatosis
(aortic and other large vessels), ongoing ischemic heart disease, ongoing stable
angina pectoris, ongoing prostate adenoma, ongoing hepatic steatosis and ongoing
lithiasic cholecystitis. The patient's concomitant medications were not reported.
On 13Feb2021, the patient received the 2nd intramuscular dose of Comirnaty for
active immunisation. On 20Feb2021, the patient developed pneumonia associated with
SARS-CoV-2 infection. As a corrective therapy the patient received Anakinra (400
mg/day subcutaneous, SC) starting with 25Feb2021 up to 01Mar2021, Anakinra (200
mg/day SC) starting with 02Mar2021up to 07Mar2021, Clexane 0.8 ml (2/day SC)
starting with 25Feb2021 up to 08Mar2021, dexamethasone 8 mg intravenous (IV) (2 x 8
mg/day) starting with 25Feb2021 up to 08Mar2021, Controloc 40 mg IV (2 x 40 mg/day)
starting with 25Feb2021 up to 02Mar2021, Quamatel 20 mg IV (2 x 20 mg/day) starting
with 03Mar2021 up to 08Mar2021, levofloxacine 500 IV (1 vial/day) starting with
28Feb2021 up to 08Mar2021, furosemide IV (40 mg/day) starting with 02Mar2021 up to
08Mar2021, hyperimmune plasma 200 ml IV starting with 28Feb2021 up to 02Mar2021,
amikacin IV ( 1000 mg/day) 02Mar2021 up to 08Mar2021, piperacilline/tazobactam 4.5
g every 8 hours IV starting with 02Mar2021 up to 08Mar2021, tocilizumab and
parenteral hydro-electrolytic rebalancing. At a date not specified in Mar2021 by
the rapporteur the patient died. The patient has been tested for SARS-CoV-2
infection (RT-PCR test) on 25Feb2021 and the result was positive. On 01Mar2021,
SARS-CoV-2 neutralizing IgG antibodies (anti-spike) were dosed and result was 554
AU/mL. On 23Jan2021, the patient received his 1st dose of Comirnaty, without
further specification. The patient died on an unspecified date in Mar2021. It was
unknown if an autopsy was performed. The adverse reaction was assessed as ""results
in death"" by the primary reporter. In the reporter's opinion pneumonia associated
with SARS-CoV-2 infection were related to Comirnaty. Sender Comment: The medical
assessor of the Authority requested the investigation of the case at agency to no
result yet. No follow-up attempts are possible. The information about lot number
and expiration date cannot be obtained. Amendment: This follow-up report is being
submitted to amend previously reported information: Updating the listedness of the
events.; Reported Cause(s) of Death: Pneumonia associated with SARS-CoV-2
infection/SARS-CoV-2 infection positive"" "No prior vaccinations for this event."
"1172767-1" "1172767-1" "Patient presented 4/3 stating received Pfizer COVID-
19 vaccine on Monday and began having sympoms about Wednesday. Developed fever by
Thursday and cough/nausea/vomiting by Friday. Cough ongoing and feels like he
should have production but is not able sputum out. The pain is chest is described
as not being able to fully expand his lungs when he tries to inhale. Patient
presented 4/6-DOA" "No prior vaccinations for this event."
"1173177-1" "1173177-1" "confused; cough; diarrhoea; short of breath;
Hypoxia; SARS-CoV-2 infection/ COVID positive; Vaccine breakthrough infection;
General physical health deterioration/ gradual deterioration/ off legs; This is a
spontaneous report from a contactable pharmacist received from the Regulatory
Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-
202103281032444760. Safety Report Unique Identifier GB-MHRA-ADR 25039712. A 91-
years-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration on 20Jan2021 (Lot Number:
EK4243) as single dose for covid-19 immunisation. The patient medical history was
not reported. Patient had not had symptoms associated with COVID-19. Not had a
COVID-19 test. Unsure if patient was enrolled in clinical trial. Concomitant
medication included influenza vaccine reported as a/guangdong-maonan/swl1536/2019
(h1n1)pdm09-like strain (a/victoria/2454/2019 ivr-207), a/hong kong/2671/2019
(h3n2)-like strain (a/hong kong/2671/2019 ivr-208), b/washington/02/2019-like
strain (b/victoria/705/2018 bvr-11), influenza virus strains inactivated, virus
influenza a/california/7/2009 (h1n1) derived strain used nymc x-181, virus
influenza a/perth/16/2009 (h3n2)-like strain used nymc x-187 derived from
a/victoria/210/2009, virus influenza b/brisbane/60/2008 like strain (SEQIRUS
VACCINES INFLUENZA) taken for influenza immunisation on 08Oct2020. The patient
experienced sars-cov-2 infection, confused, cough, diarrhoea, short of breath on an
unspecified date; vaccine breakthrough infection, general physical health
deterioration on 01Feb2021; hypoxia on an unspecified date. The case was reported
as serious with seriousness criteria death, medically significant and
hospitalization. It also reported as the patient experienced COVID positive on
01Feb2021. Since then, had had gradual deterioration. 2 called ambulances prior to
admission, not brought into hospital due to saturating okay. General practitioner
(GP) gave oral antibiotics. On date of admission - confused, off legs and hypoxic.
Cough and feeling short of breath were the main issues, and diarrhoea. Received
azithromycin, ceftriaxone and dexamethasone as per hospital policy. Palliative
management started 08Feb2021 and patient passed away 09Feb2021. The patient died on
09Feb2021 with COVID-19 listed as cause of death. The outcome of event COVID-19 was
fatal, of the other events was not recovered. It was not reported if an autopsy was
performed. Follow-up attempts are completed. No further information is expected.;
"1173211-1" "1173211-1" "COVID-19 test positive; COVID-19 test positive; This
is a spontaneous report from a contactable physician downloaded from the regulatory
authority-WEB [HU-OGYI-176021] received via Regulatory Authority. A 78-years-old
male patient received bnt162b2 (COMIRNATY, concentrate for dispersion injection;
active substance: tozinameran), dose 1 intramuscular on 04Mar2021 (batch number:
ET1831) as 0.3 mL (30 micrograms), single for covid-19 immunisation. Medical
history included chemotherapy unknown if ongoing. The patient's concomitant
medications were not reported. On 18Mar2021, the patient's COVID-19 test was
positive. He had a severe COVID requiring hospital treatment. The patient was died
on 20Mar2021. It was not reported if an autopsy was performed. Sender Comment:
COVID-19 was detected 14 days after first dose of COMIRNATY. Immunity may have not
developed within two weeks after the first dose of vaccine was given.; Reported
Cause(s) of Death: COVID-19 test positive; COVID-19 test positive" "No prior
"1173442-1" "1173442-1" "Sputum; Malaise; Fatigue; covid-19; This is a
spontaneous report from a contactable consumer downloaded from the Medicines
Agency (MA) NL-LRB-00485125 and received via Regulatory Authority (RB). An 86-
year-old male patient received bnt162b2 (vaccine), via an unspecified route of
administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for
covid-19 immunisation. Medical history included ongoing COPD. The patient's
concomitant medications were not reported. The patient experienced covid-19,
sputum, malaise, fatigue all on 01Mar2021 with fatal outcome. The patient underwent
lab tests and procedures which included corona test: positive on 01Mar2021. The
patient died on an unspecified date in Mar2021. It was not reported if an autopsy
was performed. Reporter's comment: No past drug therapy BioNTech/Pfizer vaccine).
BSN available: yes. Confounding factors was COPD. No previous COVID-19 infection:
disease symptoms. No follow-up attempts possible. No further information expected.
Lot/Batch number cannot be obtained.; Reporter's Comments: No past drug therapy
BioNTech/Pfizer vaccine. BSN available: yes. Confounding factors was COPD. No
previous COVID-19 infection: disease symptoms.; Reported Cause(s) of Death: covid-
19; Fatigue; Malaise; Sputum" "No prior vaccinations for this event."
COVID-19 test with symptoms; This is a spontaneous report from a contactable
physician downloaded from the Agency Regulatory Authority-WEB manufacturer report
number FR-AFSSAPS-RS20210587. A 90-years-old male patient received bnt162b2
(COMIRNATY), dose 1 intramuscular on Jan2021 (Lot number was not reported) as
single dose, dose 2 intramuscular, administered in arm left on 11Feb2021 (Lot
Number: EJ6789) as single dose, for covid-19 immunisation. Medical history included
dementia, cerebrovascular accident, myocardial infarction, coronary arterial stent
insertion. The patient's concomitant medications were not reported. 23 days after
the second dose (on 06Mar), patient had respiratory decompensation with dyspnoea
and desaturation. Positive PCR test during hospitalisation. Patient died on
20Mar2021, 37 days after the second dose. It was not reported if an autopsy was
performed. No follow-up attempts possible. No further information expected;
Reported Cause(s) of Death: positive COVID-19 test with symptoms; positive COVID-19
test with symptoms" "No prior vaccinations for this event."
"1174740-1" "1174740-1" "diarrhoea; Urinary incontinence; SARS-CoV-2
infection; SARS-CoV-2 infection; Vaccine breakthrough infection; antitussive
therapy (cough); shortness of breath; This is a spontaneous report from a
contactable pharmacist received from the regulatory authority. The regulatory
authority report number is GB-MHRA-WEBCOVID-202103301347126960, Safety Report
Unique Identifier GB-MHRA-ADR 25051069. An 87-year-old male patient received the
first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0141, via
an unspecified route of administration on 11Jan2021 at single dose for COVID-19
immunisation. The patient's medical history was not reported. Patient has not had
symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not
enrolled in clinical trial. Concomitant medication included influenza vaccine inact
sag 3v (FLUAD) for influenza immunisation on 15Oct2020. The patient experienced
SARS-CoV-2 infection on 07Feb2021, diarrhoea on an unspecified date, vaccine
breakthrough infection on 07Feb2021, antitussive therapy (cough) on 05Feb2021,
shortness of breath on 05Feb2021, and urinary incontinence on an unspecified date.
Case is reported with the seriousness criteria of death. The clinical course was
reported as follows: Patient has had PPM inserted on 02Feb2021. Patient has 2-day
history of 'inability to cough' (as reported) and SOB (shortness of breath) from
05Feb2021. He also developed loose brown diarrhoea and urinary 'leaking.' He was
treated with azithromycin, dexamethasone and ceftriaxone as per hospital policy.
Diarrhoea settled on 11Feb2021. Deterioration despite O2 via CPAP. Patient was
started on palliative medications on 16Feb2021. Patient passed away on 17Feb2021.
It was not reported if an autopsy was performed. Follow-up attempts are completed.
No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2
infection; SARS-CoV-2 infection; diarrhoea; Vaccine breakthrough infection;
antitussive therapy; shortness of breath; urinary incontinence" "No prior
"1174773-1" "1174773-1" "melena; Vaccination failure; Vaccination failure;
Subfebrile; This is a spontaneous report from a contactable physician downloaded
from the regulatory authority-WEB regulatory authority HR-HALMED-300045644. An 83-
years-old female patient received bnt162b2 (COMIRNATY, solution for injection),
dose 1 intramuscular on 20Jan2021 (Lot Number: EJ 6134, lot number not reported) as
30 ug, single; and dose 2 intramuscular on 17Feb2021 (Lot Number: EJ 6790, lot
number not reported) as 30 ug, single; for covid-19 immunisation. Medical history
included patient was a hemodialysis (also reported as dialysis) patient with kidney
failure chronic (also reported as chronic renal failure) from an unknown date to an
unknown date; and patient was in contact with a positive person (ongoing at the
time of the events reported). The patient's concomitant medications were not
reported. It was reported that patient had vaccination failure on 13Mar2021. This
dialyzed patient was admitted to the hospital about 14 days ago for melena
(Mar2021), and was in contact with a positive person in the same room, had died on
13Mar2021, and was subfebrile 2-3 days ago (Mar2021). It was reported that COVID
PCR test results on an unknown date were not available. The events vaccination
failure and subfebrile were reported as medically significant. The outcome of the
event melena was unknown. The patient died on 13Mar2021. The causes of death were
vaccination failure and subfebrile. It was unknown if an autopsy was performed.
Sender Comment: Information on Covid 19 PCR test is not available. No follow-up
Death: subfebrile; vaccination failure; vaccination failure" "No prior
"1180959-1" "1180959-1" ""COVID-19; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority-WEB, regulatory
authority number FR-AFSSAPS-AN20211060. A 96-year-old female patient received
first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: EJ6789), intramuscular on
16Feb2021 on the left arm as single dose for COVID-19 immunization. Medical history
included varicose veins, cognitive disorder, hypertension arterial, venous
insufficiency, and arterial insufficiency coronary; from an unknown date and
unknown if ongoing. In Jan2021, the patient was admitted to the hospital for
general health deterioration. Following discharge, the patient returned weak to the
nursing home. No previous Coronavirus disease 2019 (COVID-19) infection (prior to
the episode described below). The patient was at risk of developing a severe form
of COVID-19 and she did not know if she had allergies/ hypersensitivity. The
patient's concomitant medications included acetylsalicylate lysine (KARDEGIC 75
mg), folic acid (SPECIAFOLDINE), ferrous sulfate (TARDYFERON),lactulose
(unspecified trade name), metoprolol tartrate (LOPRESSOR), perindopril (unspecified
trade name), paracetamol ( unspecified trade name). On 22Feb2021, severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR)
test was performed in the context of a cluster in the nursing room. The PCR
returned positive on the same day. On 26Feb2021 the patient presented with COVID
symptoms with saturation of peripheral oxygen (oxygen saturation) at 60%
(22Feb2021) in ambient air. The patient was not hospitalized due to the pre-
existing general health condition deterioration. On 28Feb2021, at 6:00 a.m., the
patient ate as usual. Death was noticed at the beginning of the afternoon. Severe
COVID-19 was diagnosed in a patient 6 days following vaccination with the first
dose of COVID-19 mRNA Vaccine (nucleoside modified), in the context of a cluster in
the nursing room. The patient became symptomatic ""10 days following vaccination""
and died 12 days after vaccination. The patient experienced covid-19 (death) on
22Feb2021. The patient died on 28Feb2021. It was not reported if an autopsy was
performed. No follow-up attempts are possible. No further information expected.;
Reported Cause(s) of Death: COVID-19"" "No prior vaccinations for this event."
"1180960-1" "1180960-1" "Acute respiratory distress syndrome; cough;
vomiting; asthenia; vaccination failure; PCR positive, variant covid-19 infection;
fever; respiratory discomfort; This is a spontaneous report received from a
contactable physician downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority number: FR-AFSSAPS-BS20210413. This physician reported similar
event for two patients. This is the first of two reports. An 88-year-old female
patient received BNT162B2 (COMIRNATY) first dose (Lot Number: EM0477) on 14Jan2021
and second dose (Lot Number EJ6788) on 04Feb2021; both given intramuscular at
single dose for COVID-19 immunisation. Medical history included arteriopathic
disease, morbid obesity, carotid artery stenosis , osteoarthritis , failure
respiratory, type 2 diabetes mellitus, and heart failure; all ongoing. Concomitant
medications included acetylsalicylate lysine (KARDEGIC); febuxostat (ADENURIC);
furosemide, nebivolol and cetirizine hydrochloride (CETRIZINE). On 01Mar2021 the
patient experienced fever and respiratory discomfort. On 09Mar2021 the SARS-CoV-2
PCR was positive for COVID-19, variant, sequencing in progress. On 10Mar2021the
patient experienced fever, cough, vomiting and asthenia. On 15Mar2021 she was
hospitalized for acute respiratory distress syndrome (ARDS), prognosis live
threatening on 18Mar2021. In total, variant covid-19 infection on 01Mar2021 after a
complete well-conducted vaccination schedule. No conservation condition problem.
The patient died on 21Mar2021. Cause of death was COVID-19 pneumonia, vaccination
failure, fever, cough, vomiting, and Acute respiratory distress syndrome. Autopsy
was not performed. No follow-up attempts possible. No further information
expected. Follow-up (02Apr2021): New information downloaded from the Agency
Regulatory Authority-WEB FR-AFSSAPS-BS20210413 includes updated outcome of events
(fatal). No follow-up attempts possible. No further information expected.;
Sender's Comments: Linked Report(s) : FR-PFIZER INC-2021333550 same reporter,
different patient;AFSSAPS-BS20210414; Reported Cause(s) of Death: vaccination
failure; fever; cough; vomiting; Acute respiratory distress syndrome; COVID-19
pneumonia" "No prior vaccinations for this event."
"1185642-1" "1185642-1" "Vomiting blood; Bloody stool; Generelized discomfort
since vaccination; Melena; Haemodynamic instability; Coffee ground colored
vomiting; positive COVID-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority. Regulatory authority number DK-
DKMA-WBS-0055221. A 82-years-old female patient received the first dose of
bnt162b2 (COMIRNATY), intramuscular on 02Mar2021 (Lot Number: ER2659; Expiration
Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history
included apoplexy cerebral on 2010, ongoing hypercholesterolaemia, apoplexy
cerebral on 2009, ongoing hypertension, ongoing atrial fibrillation, ongoing
urinary tract infection, ongoing renal failure, apoplexy cerebral on 2008, back
surgery, ongoing diabetes mellitus, ongoing dementia, ongoing wheelchair user.
There is no information regarding past medication. Concomitant medications included
rivaroxaban (XARELTO) taken for atrial fibrillation from 2018. The patient
experienced vomiting blood on 02Mar2021, bloody stool on 02Mar2021, generelized
discomfort since vaccination on 02Mar2021, melena on 02Mar2021, haemodynamic
instability on 02Mar2021, coffee ground colored vomiting on 02Mar2021. The ADRs
were reported by the physician as causing acute hospitalisation on 11Mar2021, as
being fatal (all besides from general discomfort) on 11Mar2021 and being life
threatening. No treatment or medical procedure due to the ADRs were reported.
General discomfort was not recovered. Bloody stool, coffee ground vomiting,
haemodynamic instability, melena and vomiting blood were all fatal. Patient died on
11Mar2021. It was not reported if an autopsy was performed. The patient underwent
lab tests and procedures which included sars-cov-2 test: positive on 11Mar2021
(outcome unknown). No follow-up attempts are needed. No further information is
expected.; Reported Cause(s) of Death: Melena; Bloody stool; Coffee ground
vomiting; Vomiting blood; Haemodynamic instability" "No prior vaccinations for
this event."
"1185680-1" "1185680-1" "Vaccination failure; PCR-SARS Cov 2:positive; This
is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority number FR-AFSSAPS-NT20210851. A contactable pharmacist
reported that a 97-years-old male patient received first dose of BNT162B2
(COMIRNATY, Formula-tion: Solution for injection, lot number: EJ6795 and Expiry
date not reported), via intramuscular route of administration on 21Jan2021, as
single dose and second dose of BNT162B2 (CO-MIRNATY, Formulation: Solution for
injection, lot number: EJ6789 and Expiry date not reported), via intramuscular
route of administration on 11Feb2021, as single dose both for COVID-19
immunization. Medical history included Recurrence of inoperable squamous cell
carcinoma of the left cheek with ipsilateral orbital extension initially diagnosed
in 2015, Current functional signs: Complete eyelid occlusion, Extension assessment:
MRI on 14Aug2018: existence of a suspicious left eye-lid tissue infiltration
extending into the temporal and preseptal region, 64mm long in axis, associated
with suspicious left intraparotid lymphadenopathy (11x19mm), Treatments received:
Excision performed in June 2017: incomplete, Peripheral artery disease, trans
metatarsal amputation of the left foot in 2015, Hypertension, AF with cardiac
decompensation, Rhizomelic pseudopolyarthritis, Typhoid fever, Malformation of the
pelvis, Right foot toe amputation, Inguinal hernia, left patella surgery.
Concomitant medication(s) included: potassium chloride (DIFFU K); hydrocortisone
(HY-DROCORTISONE); furosemide (LASIX [FUROSEMIDE]); lorazepam (LORAZEPAM);
nebivolol (NEBIV-OLOL); mirtazapine (NORSET); omeprazole (OMEPRAZOLE); paracetamol
(PARACETAMOL); macrogol (MACROGOL); apixaban (ELIQUIS); budesonide, formoterol
fumarate (SYMBICORT TURBO-HALER) all taken for an unspecified indication, start and
stop date were not reported.It was re-ported that very fragile patient having
presented numerous decompensations of COPD with secondary infections. Greasy cough
with increasing dyspnea since 16Mar2021, with crackling right base: put under
AUGMENTIN with hydrocortisone increase. 2 episode of hematuria described on
16Mar2021. In emergencies: Clinical picture of multi-visceral failure predominant
on the respiratory side in a 97-year-old GIR 3 patient in nursing home with a
history of rhythmic heart disease and locally infiltrating squamous cell carcinoma.
Major respiratory distress without argument for a quickly curable cause in
particular no argument for a pulmonary edema. Background of anti-gene test COVID-
positive the day before In view of the age of the history of autonomy and the
severity of the current clinical picture, after discussion with the family and the
medical and paramedical team, decision of comfort care alone. The patient underwent
lab tests and procedures which included blood creatinine: 278 umol/l on, blood
gases: under mhc: ph 7.31, hypocapnia, normoxia on under MHC: pH 7.31, hypocapnia,
normoxia , blood potassium: 3.7 mmol/l on, blood pressure measurement: 97/44 mmhg
on, blood sodium: 170 mmol/l on, body temperature: 37.4 centigrade on, glomerular
filtration rate: 16 ml / min / 1.73 m2 on, haemoglobin: 14.5 g/dl on macrocytic ,
heart rate: 75/ min on, magnetic res-onance imaging: no values on 14Aug2018
existence of a suspicious left eyelid tissue infiltration ex-tending into the
temporal and preseptal region, 64mm long in axis, associated with suspicious left
intraparotid lymphadenopathy (11x19mm) , oxygen saturation: 93 % on nasal cannula ,
platelet count: 216 10*6/l on, respiratory rate: 40/min on, sars-cov-2 test:
positive on, sars-cov-2 test: positive on. Physical examinations: Glasgow 3,
hypotension, with mottling of the knees, cold ex-tremities Sign of respiratory
distress, polypnea, unencumbered Implementation of comfort care. The outcome of the
events was fatal. The patient died on 27Mar2021. It was not reported if an autopsy
was performed. No follow-up attempts possible. No further information expected."
"1189371-1" "1189371-1" ""Developed lung embolisms and respiratory failure,
and died of the complications.; Lung embolisms; COVID-19; multimorbidity; This is a
spontaneous report from a contactable Physician downloaded from the Regulatory
Authority-WEB DK-DKMA-WBS-0059241. This is a spontaneous case, received on
23Mar2021 from a physician (Internal ID: XMO-A09DA4056C6C4C3A8199155E969CD535) and
a requested follow-up received on 26Mar2021 from the same physician, which
describes the occurrence of Embolism lung (Lung embolisms) and Respiratory failure
(Developed lung embolisms and respiratory failure, and died of the complications)
in a 57 years old female patient vaccinated with COMIRNATY (tozinameran). A 57-
year-old female patient received BNT162b2 (COMIRNATY, Lot #EMO477) via an
immunisation. Relevant medical history included severe multimorbidity/co-morbidity
and living in nursing home, both ongoing. Patient concurrent conditions included:
depression, skin infection (exit site), vitamin B12 deficiency, cardiac disorder,
edema caused by kidney failure, sleeplessness, constipation, pain, bipolar disorder
and type 2 diabetes mellitus. Concomitant medications included oral bisacodyl
(TOILAX) taken for constipation from 23Jul2020 at 10mg 1x/day; oral zopiclone
(IMOVANE) taken for insomnia from 26Jun2020 at 7.5mg 1x/day; oral cefuroxime
(FURIX) taken for oedema from 05Jan2021 at 250mg 1x/day; oral kaliumklorid taken
for potassium supplementation from 05Jan2021 at 2 tablets morning and 1 tablet
evening; oral ascorbic acid taken for vitamin supplementation from 01Sep2020 at 80
mg, 1x/day; oral quetiapine fumarate (QUETIAPIN ACCORD) taken for bipolar disorder
from 25Jun2020 400 mg, 1x/day; oral lactulose (LACTULOSE ORIFARM) taken for
constipation from 14Jun2018 15 mL, 1x/day; oral cyanocobalamin zinc tannate
(BETOLVEX) taken for vitamin B12 deficiency at 1 mg, 1x/day; oral calcium
pantothenate, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine
hydrochloride (APOVIT B COMBIN) taken for vitamin supplementation from 01Sep2020 at
1 DF, 1x/day; oral amitriptyline hydrochloride (AMITRIPTYLIN ""DAK"") taken for
depression from 02Aug2018 at 100 mg, 1x/day; oral oxycodone hydrochloride (OXYNORM)
taken for pain from 30Dec2020 to 13Jan2021 at 10 mg, 1x/day; oral macrogol 3350,
potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for
constipation from 07Oct2020; oral simvastatin (SIMVASTATIN KRKA) taken for
cardiovascular disorder from 06Jun2019 at 10 mg, 1x/day; oral mirtazapine
(MIRTAZAPIN ""ACTAVIS"") taken for depression from 26Jun2020 at 30 mg, 1x/day; oral
tramadol hydrochloride (TRADOLAN) taken for pain from 26Jun2018 at 50 mg, as
needed; oral calcium carbonate, vitamin D NOS (CALCIUM + VIT D) taken for calcium
supplementation from 07Dec2020 at 2 DF, 1x/day; subcutaneous insulin glargine
(TOUJEO) taken for diabetes mellitus from 28Aug2018 at 20 DF, 1x/day; oral folic
acid (FOLIMET) taken for vitamin supplementation from 02Sep2020 at 15 mg, weekly;
cutaneous mupirocin calcium (BACTROBAN) taken for skin infection from 11Nov2020 at
2 DF, 1x/day; oral carvedilol (CARVEDILOL HEXAL) taken for cardiac disorder from
26Mar2013 at 25 mg, 1x/day; oral paracetamol (PANODIL) taken for pain from
07Dec2020 at 4000 mg, 1x/day; oral linagliptin (TRAJENTA) taken for type 2 diabetes
mellitus from 07Jun2015 at 5 mg, 1x/day. The patient was routinely tested for
COVID-19 a few days before vaccination and one day after vaccination, on 08Jan2021,
test result was positive. On 11Jan2021 the patient developed embolism lung (onset
first dose day 4). On 28Jan2021 the patient developed respiratory failure (onset
first dose day 21). The ADRs were reported as being life threatening, resulting in
hospitalisation, and being fatal (28Jan2021). No treatment or medical procedure due
to the ADRs were reported. No autopsy was performed. Reported cause of death was
respiratory failure, lung embolism, COVID-19, multimorbidity (severe co-morbidity).
Only normal confirmation of death was performed post-mortem, findings unknown. Test
results included SARS-CoV-2 test, 08Jan2021, positive; laboratory test, Jan2021,
unspecified, unknown results; diagnostic procedure, Jan2021, unspecified diagnostic
imaging, unknown results. It was unknown if the death was reported to the police
since the reporting physician has not conducted the confirmation of death. The
physician does not wish to report the death to the police. Causality: The
physician comments that she originally hadn't reported the ADRs on her own
initiative and believed the COVID-19 infection compared with severe co-morbidity is
cause of the patient's death. The reason for the late report is that the patient's
daughter has contacted her after the cases regarding thrombosis and AstraZeneca
(ChAdOx1 nCoV-19) was announced in the media, and requested of having the case
reported - despite the patient was vaccinated with Comirnaty. The physician
comments furthermore that she despite of her not believing the vaccine is the cause
of death, she cannot rule it out due to the timeframe from given vaccination to the
lung embolisms and the death occurs. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19; Respiratory failure;
Lung embolism; Multimorbidity"" "No prior vaccinations for this event."
"1198199-1" "1198199-1" "62-year-old male with number of medical problems
that include history of hepatitis-C, history of cirrhosis, history of alcohol
abuse, cocaine abuse, history of diabetes hypertension who has initially presented
to EMS with increasing shortness of breath. Patient suffered cardiac arrest during
his transportation to the emergency room. A CPR was initiated and was given 3
rounds of epinephrine. Most of the history is taken from the ER physician chart
review. ACUTE RESPIRATORY FAILURE SECONDARY TO HYPOXEMIA, COVID-19 , cardiac
arrest, possible anoxic brain damage : Patient is 62-year-old male with
complicated history with history of hepatitis-C, cirrhosis, alcohol use, cocaine
abuse diabetes who presented after having cardiac arrest and possible anoxic brain
damage. Patient was intubated after the arrest. Patient stayed in the hospital
for number of days. Patient was found to have COVID-19 positive. Patient was
found to have diffuse bilateral infiltrate. Patient was started on broad-spectrum
antibiotics including cefepime Flagyl and Decadron. Due to patient's cardiac
arrest patient was started on hypothermia protocol. Patient was rewarming after
that. There was no purposeful movement or neurological recovery. After long
discussion with the family, patient has been made comfort care. Patient was
extubated. Patient expired promptly after that. Family is notified." "No prior
"1199927-1" "1199927-1" "COVID-19/Covid infection, 1 month after the 2nd dose
(complete vaccination schedule); Vaccination failure/Covid infection, 1 month after
the 2nd dose (complete vaccination schedule); COVID-19 pneumonitis; Multiple organ
dysfunction syndrome; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority FR-AFSSAPS-BX20212622. A 70-year-old male
patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EM0477),
administered in arm left on 13Jan2021 as a single dose, then the second dose
(Batch/Lot Number: EJ6789), administered in arm right on 13Feb2021; both
intramuscular as a single dose for COVID-19 immunisation. Medical history included
morbid obesity (BMI 35), oedema of lower extremities, encephalopathy, anal
carcinoma (squamous cell carcinoma of the anal canal), weaned alcoholism, apathy,
venous insufficiency (with lymphedema of the lower limbs) and dysuria (with chronic
urinary retention) from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The patient experienced Covid infection,
1 month after the 2nd dose (complete vaccination schedule)/vaccination failure,
with diagnosis confirmed by PCR (English variant) and images of Covid pneumonia on
chest scanner, rapidly progressing with respiratory deterioration 3 days after the
first signs and death from multiple organ failure 2 weeks after diagnosis.
Description of the effect: 1 month after dose 2, 13Mar: high fever, 14Mar: PCR
positive, 16Mar: desaturation leading to hospitalization in medical service then
transfer to continuing care. Evolution: 29Mar: death of the patient. Update V1:
18Mar: referred to emergency for deterioration of general condition, mottling and
dyspnea. Normal constants arterial pressure at 110, heart frequency at 89,
afebrile, 93% saturation under 2L of O2, Glasgow 15, no deficit sign, no headache,
no focusing sign. Lungs free. Heart noise regular, no congestive signs, no signs of
heart failure. Mild edema of the lower limbs (known lymphedema). Diagnosis of
COVID-19 type pneumonia, English variant. Patient stabilized under 3L of O2 with
glasses. Thoracic CT: COVID-type pneumonia with frosted glass areas with an
impairment estimated at 25%, condensation in bilateral subpleural bands, no image
in favor of pulmonary superinfection. Ectatic aspect of the ascending aorta at 6
cm. Biology: CRP at 29 mg/L, fibrinogen at 7 g/L, D-dimer at 750 ng/mL and
lymphopenia at 0.32 G/L. Mild renal failure with creatinine at 113 umol/L. No ionic
problem. Undernutrition with albumin at 26 g/L and pre-albumin at 0.165 g/L. Normal
liver test. Blood gases: hypoxia at 60 mm Hg, normal capnia and pH. Put on
dexamethasone 6 mg / day and enoxaparin. Hospitalization in medical service. 21Mar:
initiation of treatment with amoxicillin/clavulanic acid. 24Mar morning:
respiratory degradation with 84% saturation under 6L,> 93% under 15L. Marked
asthenia. On auscultation, diffuse crackling, indrawing, polypnea. Arterial
pressure at 122/72 and heart rate at 115. Apyretic. Transfer to continuing care
service. Very hypoxic patient, polypneic at 45/min, setting up FiO2 at 90% under
Optiflow 60 L/min. Glasgow 15. Correct hemodynamics. 28Mar: marked worsening with
multiple organ failure. Patient less and less reactive and communicating. On the
respiratory level, congestion, polypnea, episodes of desaturation, clear tendency
to hypercapnia with respiratory acidosis. OptiFlow shutdown and permanently
switched on non-invasive ventilation. Also, hemodynamic degradation with
hypotension, mottling. Renal function degradation. Hypernatremia and increased
lactates. 29Mar: death at 10:40 a.m. of a COVID + patient with multiple organ
failure. Change in cause of death (multiple organ failure and Covid-19 pneumonia).
The patient was hospitalized for vaccination failure, covid-19, COVID-19
pneumonitis and multiple organ dysfunction syndrome from 16Mar2021 to an unknown
date. The causes of death were reported as COVID-19 pneumonitis and multiple organ
dysfunction syndrome. Therapeutic measures were taken as a result of all events.
The outcome of the events was fatal. The patient died on 29Mar2021. An autopsy was
not performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: COVID-19 pneumonitis; Multiple organ
dysfunction syndrome" "No prior vaccinations for this event."
"1199966-1" "1199966-1" "Vaccination failure; COVID-19; This is a spontaneous
report from a contactable physician downloaded from the regulatory authority,
regulatory authority number FR-AFSSAPS-NY20210628. An 88-year-old female patient
received first dose of bnt162b2 (COMIRNATY; lot number not reported) on 15Jan2021
and second dose of bnt162b2 (COMIRNATY; Lot Number: EK9788) on 04Feb2021 both given
intramuscular as single dose for covid-19 immunisation. Medical history included
ongoing chronic obstructive pulmonary disease, ongoing insulin-requiring type 2
diabetes mellitus, ongoing hypertension, ongoing cardiac failure, and living in
residential institution. Concomitant medications included ipratropium; insulin
aspart (NOVORAPID); paracetamol (DOLIPRANE); terbutaline sulfate (TERBUTALINE
ARROW); amlodipine besilate (AMLOR); zopiclone (IMOVANE); budesonide (BUDESONIDE
ARROW); valsartan (VALSARTAN ARROW). On 28Feb2021, the patient was diagnosed with
COVID infection (variant) in the context of cluster COVID cases in nursing homes.
The patient was hospitalized in 2021 in response to the event. The patient died on
03Mar2021. Cause of death was reported as COVID-19 infection. It was unknown if an
autopsy was performed. Imputability (according to the method): I1 dubious. NB:
Accountability without prejudice to the elements of investigations which could be
carried out within the framework of legal or amicable compensation procedures.
Therapy 1985; 40: 111-8. No follow-up attempts possible. No further information
expected. ; Reported Cause(s) of Death: COVID-19; COVID-19""No prior vaccinations
for this event."
"1200438-1" "1200438-1" ""cardiac arrest; COVID-19 infection; fever (39
degrees Celsius); This is a spontaneous report from a contactable physician
downloaded from a regulatory authority-WEB, regulatory authority number GR-GREOF-
20211826. A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 1
intramuscularly on 09Mar2021 (Batch/Lot Number: EP2166) at 75-years-old as 0.3 mL,
single for COVID-19 immunization. Medical history included chronic dyslipidaemia
from an unknown date and unknown if ongoing, unregulated arterial hypertension from
an unknown date and unknown if ongoing, very high Body Mass Index (BMI) increased
from an unknown date and unknown if ongoing, mild symptoms of infection of the
upper respiratory tract from 05Mar2021 to an unknown date. Concomitant medications
included rosuvastatin (MANUFACTURER UNKNOWN) taken for dyslipidaemia, start and
stop date were not reported. On 09Mar2021, the patient experienced: fever (39
degrees Celsius) (non-serious), cardiac arrest (death, medically significant),
COVID-19 infection (death, medically significant), death (as reported) (death,
medically significant). The clinical course was reported as follows: According to
the reporter, the patient on the day of the vaccination did not report any acute
symptoms while he was providing his medical history, neither any allergies. The
patient just reported the chronic dyslipidaemia treatment. It was the first dose of
the vaccine COMIRNATY and the patient remained in the vaccination center for 15
minutes according to the guidelines; without presenting any symptoms. On 16Mar2021,
the patient's son, called the reporter to declare the death of his father. The
patient's son stated that the patient had a fever the same day of the vaccination
and passed away approximately six hours later. A close relative was found positive
with SARS-CoV-2 on 13Mar2021; and on the day of the report was still hospitalized.
The patient was ""buried after the death certificate from a private physician."" On
18Mar2021, the patient's son was contacted, who was also a physician. According to
the patient's son, his father had unregulated arterial hypertension, dyslipidaemia
and very high Body Mass Index (BMI) (weighed 110 kilograms for over 40 years with
170 cm height). The patient, four days before his vaccination, had mild symptoms of
infection of the upper respiratory tract (mild cough, sniffle and sore throat). On
09Mar2021, the patient was vaccinated and three hours later presented high fever
(39 degrees Celsius). The patient three hours later died. The patient's son stated
that the physician who examined his father told him that he found representative
data of cardiac arrest and the cause of death was cardiac arrest. Three days later,
the patient's wife was found positive with COVID-19 infection and was hospitalized.
According to the patient's son's opinion, his father died from COVID-19 infection,
even though the patient had not tested positive. The patient underwent lab tests
and procedures which included body temperature: 39 Centigrade on 09Mar2021. The
clinical outcome of the events: cardiac arrest, COVID-19 infection, death, was
fatal. The clinical outcome of the event fever (39 degrees Celsius), was unknown.
The patient died on 09Mar2021 due to cardiac arrest, death, COVID-19 infection
(according to the patient's son). It was unknown if an autopsy was performed.
The causality assessment from the a regulatory authority for vaccines was unlikely;
Method of assessment: a regulatory authority causality criteria. No follow-up
attempts are possible. No further information is expected. ; Reported Cause(s) of
Death: COVID-19 infection; Cardiac arrest"" "No prior vaccinations for this
event."
"1200600-1" "1200600-1" "drug ineffective/ positive COVID-19 PCR test; drug
ineffective/ positive COVID-19 PCR test; asthenia and diarrhea; asthenia and
diarrhea; This is a spontaneous report received from a contactable physician
downloaded from the Agency Regulatory Authority-WEB, regulatory authority report
number is IT-MINISAL02-709108. An 84-year-old male patient received BNT162B2
(COMIRNATY), on 23Mar2021 at 08:50 (lot number: ET3620; second dose) at 0.3 mL,
single in the left arm and on 02Mar2021 (lot number: EP2166; first dose), single
dose (as reported); both intramuscularly, for COVID-19 immunization. The patient
medical history included hypertension, ischemic cardiomyopathy, diabetes mellitus,
prostatic hypertrophy (benign), and hyperuricemia. Concomitant medications included
amlodipine besilate (NORVASC, strength: 5 mg) taken for hypertension;
hydrochlorothiazide (strength: 80 mg), telmisartan (strength: 12.5 mg) (PRITORPLUS)
taken for hypertension; metoprolol tartrate (LOPRESOR [METOPROLOL TARTRATE],
strength: 100 mg) taken for ischemic cardiomyopathy; gliclazide (DIAMICRON,
strength: 30 mg) taken for diabetes mellitus; tamsulosin hydrochloride (OMNIC,
strength: 0.4 mg) taken for prostatic hypertrophy (benign); and allopurinol
(ZYLORIC, strength: 300 mg) taken for hyperuricemia. On 23Mar2021, the patient
experienced asthenia and diarrhea. On 26Mar2021, the patient experienced drug
ineffective/ positive COVID-19 PCR test. The patient died on 28Mar2021 due to the
events. It was not reported if an autopsy was performed. Reporter comments: first
dose vaccine lot EP2166 administered on 02Mar2021: no adverse reactions. Symptoms
appeared a few hours after second vaccination therefore I prescribed the COVID-19
PCR test with a positive outcome on 26Mar2021. From my point of view it is not
clinical vaccination failure due to lack of adequate distance from the
administration of the second dose or the result. No follow-up attempts are
possible. No further information is expected.; Reporter's Comments: first dose
vaccine lot EP2166 administered on 02Mar2021: no adverse reactions. Symptoms
appeared a few hours after second vaccination therefore I prescribed the COVID-19
PCR test with a positive outcome on 26Mar2021. From my point of view it is not
clinical vaccination failure due to lack of adequate distance from the
administration of the second dose or the result.; Reported Cause(s) of Death:
asthenia and diarrhea; asthenia and diarrhea; drug ineffective/ positive COVID-19
PCR test; drug ineffective/ positive COVID-19 PCR test" "No prior vaccinations
for this event."
"1200655-1" "1200655-1" "23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos
contact tracking; 20Mar insuff. acute respiratory tract with the need for
hospitalization The Patient resides in a country; hyperbilirubinaemia aggravated;
creatinine: increased; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for pos contact
tracking; 20Mar insuff. acute respiratory tract with the need for hospitalization
The Patient resides in a country; 23Feb I vaccine dose; 11Mar TNF SARS-CoV 2 for
pos contact tracking; 20Mar insuff. acute respiratory tract with the need for
hospitalization The Patient resides in a country; This is a spontaneous report from
a contactable physician downloaded from a regulatory authority-WEB [IT-MINISAL02-
710342]. A 99-year-old female patient received the first dose of bnt162b2
(COMIRNATY, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular,
administered in left deltoid (reported as left shoulder) on 23Feb2021 13:12 as
single dose for COVID-19 immunization. The patient's medical history and
concomitant medications were not reported. On 23Feb2021 the patient had the first
vaccine dose of bnt162b2. On 11Mar2021, TNF SARS-COV 2 for positive contact
tracing. On 20Mar2021, the patient had insuff. acute respiratory tract (Failure
respiratory) with the need for hospitalization as the patient resides in certain
area. Actions taken for the events insuff. acute respiratory tract and TNF SARS-COV
2 for positive included oxygen therapy, hydration, steroids. The patient underwent
lab tests and procedures which included TNF SARS-CoV 2: positive on 11Mar2021,
creatinine: increased on 20Mar2021, and hyperbilirubinaemia aggravated on
25Mar2021. The patient died on 26Mar2021. Cause of death was insuff. acute
respiratory tract and TNF SARS-COV 2 for positive. It was unknown if an autopsy was
performed. The outcome of the events insuff. acute respiratory tract and TNF SARS-
COV 2 for positive was fatal. The outcome of the remaining events was unknown.;
Reported Cause(s) of Death: insuff. acute respiratory tract; TNF SARS-COV 2 for
positive; TNF SARS-COV 2 for positive" "No prior vaccinations for this event."
"1202850-1" "1202850-1" "multiple organ failure with acute respiratory
distress syndrome (ARDS) severe; multiple organ failure with acute respiratory
distress syndrome (ARDS) severe; myocardial astonishment and renal failure on
dialysis; myocardial astonishment with global hypokinesia/myocardial astonishment
and renal failure on dialysis; myocardial astonishment with global hypokinesia;
AFib; arterial hypotension (blood pressure 80/40 mmHg); mottling/Diffuse mottling
of the lower limbs and trunk.; sepsis with fever at 38.9C; PCR COVID19 positive;
PCR COVID19 positive; This is a spontaneous report from a contactable consumer
downloaded from the regulatory authority FR-AFSSAPS-LY20211640. This is a report
received from the Regulatory Authority. A 77-year-old male patient received
bnt162b2 (COMIRNATY), dose 1 intramuscular on 18Jan2021 as single dose (lot
EM0477); and dose 2 intramuscular on 15Feb2021 as single dose (lot EK9788), for
COVID-19 vaccination. Medical history included metastatic renal carcinoma in the
lung, mediastinum and bone treated by left nephrectomy in 2013 and radiotherapy on
pulmonary recurrence, new recurrence of renal carcinoma in 2017 with pleural
involvement initially treated with pazobanib then nivolumab since Jun2018,
pneumocystosis in 2019 treated with bactrim, now on pentamidine for prophylaxis,
chronic renal failure (basic creatinine was 130umol / L), melanoma (operated on in
2016), ischemic heart disease with myocardial infarction (MI) in 2018, hypertension
arterial, complete arrhythmia by atrial fibrillation, Hyperthyroidism (thyroid
overload), and long-term corticosteroid therapy in a context of colitis under
immunotherapy - corticosteroids a priori suddenly stopped suddenly recently.
History of COVID19 was not specified. Concomitant medications included bisoprolol
fumarate (BISOCE), prednisone (CORTANCYL), desloratadine (DESLORATADINE), apixaban
(ELIQUIS), acetylsalicylate lysine (KARDEGIC), furosemide (LASILIX),
metoclopramide, nivolumab, perindopril and pantoprazole. On 19Feb2021, the patient
experienced fever, body aches, chills, headache, digestive disorders. On 21Feb2021,
the patient had a PCR COVID-19 positive. On 22Feb2021, the patient presented to the
emergency room with the persistence of fever and the appearance of rapidly
progressive dyspnea. In the emergency room, a picture of sepsis with fever at
38.9C, mottling, arterial hypotension (blood pressure 80/40 mmHg) which rises after
vascular filling. Oxygen request was at 3 L / min with no sign of respiratory
distress. Thoraco-abdominal CT scan showed COVID19 infection extended to 25% of the
lung parenchyma. Start ceftriaxone and rovamycin + an injection of amikacin.
Hydrocortisone EPS in the face of suspected acute adrenal insufficiency (sudden
stop of chronic corticosteroid therapy). On 22Feb2021: heart rate was 83 bpm, and
76 bpm. On 24Feb2021, heart rate was at 83 bpm. On 25Feb2021, sudden respiratory
degradation and was resuscitation. Respiratory: polypneic at 45 / min, 87%
saturation under non-invasive ventilation (NIV). Hemodynamically: stable except
amine. Patient had diffuse mottling of the lower limbs and trunk and cold ends.
Cardiovascular: tachycardia at 150 bpm and ECG: atrial fibrillation with appearance
of right bundle branch block. Neurologically: Glasgow 15 On the digestive level:
supple and painless abdomen. On the renal level: no urinary functional signs.
Creatinine 137umol / L. Before the sudden onset of distress and the surge of
complete arrhythmia by atrial fibrillation, a cardiac origin to the respiratory
distress was suspected. Treatment of challenge with furosemide, maintenance of NIV,
slowing of complete arrhythmia by atrial fibrillation with amiodarone and
magnesium. There was no improvement after one hour, patient was intubated +
noradrenaline. Reduced atrial fibrillation on 27Feb2021 with amiodarone ESP.
Curative anticoagulation by Calciparin. Probable acute coronary syndrome (ACS) type
2. On 25Feb2021, heart rate was at 104bpm. On 01Mar2021, echocardiography showed
myocardial astonishment with global hypokinesia without recovery on the iterative
ultrasounds performed. On 02Mar2021, there was multiple organ failure with acute
respiratory distress syndrome (ARDS) severe, myocardial astonishment and renal
failure on dialysis which led to discontinuation of active therapies. Outcome of
event AFib was not recovered; and outcome of the rest of the events was unknown.
The patient died on 02Mar2021 due to PCR COVID19 positive. It was unknown if
autopsy was performed.; Reported Cause(s) of Death: PCR COVID19 positive; PCR
COVID19 positive" "No prior vaccinations for this event."
"1202899-1" "1202899-1" "Oxygen saturation decreased; COVID-19 antigen test
positive/positive COVID-19 test with symptoms; COVID-19 antigen test
positive/positive COVID-19 test with symptoms; High fever; This is a spontaneous
report from a contactable consumer downloaded from a regulatory authority-WEB,
Regulatory Authority report number is PL-URPL-DML-MLP.4401.2.156.2021. A 71-year-
old male patient of an unspecified age received the first dose of bnt162b2
(COMIRNATY), (Batch/Lot Number: EP9598) intramuscular on 19Feb2021 (at the age of
70 years-old) as single dose for covid-19 immunisation. The second dose was
scheduled for 12Mar2021. Medical history included ongoing diabetes treated with
oral hypoglycaemic drugs, ongoing hypertension. The patient's concomitant
medications were not reported. On 05Mar2021, SARS-COVID 2 test by ABBOTT was
performed with a positive result. The patient also had a high fever for several
days, the primary care physician did not start any treatment. On 05Mar2021,
patient's cardiovascular and respiratory were efficient, in full contact, sat.
Without oxygen 93%. Patient was prescribed with Levoxa 500 mg, Pyralgina, Berodual
N, Pabi-Dexamethason, Neoparin. Patient was then referred home. On 07Mar2021, in
the morning, the patient's condition worsened, and he was taken by ambulance to the
hospital at the Emergency Room, and then placed in the Department of Infectious
Disease. Oxygen was administered. On 09Mar2021, the patient's condition worsened,
and was connected to a ventilator. On 13Mar2021, at 18:20, patient was pronounced
dead. Oxygen saturation decreased, COVID-19 antigen test positive and High fever
all from 05Mar2021 were reported as the cause of death of the patient on 13Mar2021.
An autopsy was not performed. Sender's comment: Pyrexia is an expected adverse
reaction as described in the SmPC following the administration of Comirnaty.
Reduced saturation and a positive COVID-19 test result are unexpected symptoms. As
of 19Mar2021, 197 cases of SARS-Cov-2 test positive and 231 cases of oxygen
saturation decreased were reported in the database. The patient suffered from
hypertension and diabetes. Due to the lack of medical information on the cause of
death (no autopsy was also performed), the influence of other factors on the
patient's death cannot be ruled out. There is a time relationship between
vaccination and the occurrence of adverse reactions. A regulatory authority due to
the health result: death assessed the application as serious. No follow-up
attempts are possible. No further information is expected; Reported Cause(s) of
Death: high fever; COVID-19 antigen test positive/positive COVID-19 test with
symptoms; COVID-19 antigen test positive/positive COVID-19 test with symptoms;
Oxygen saturation decreased" "No prior vaccinations for this event."
"1203542-1" "1203542-1" "Unknown if pt had s/s at time of vaccination on
1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp
insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm
edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later,
readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette,
sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin,
rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT
w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA
r/t either a fib hx or hypercoagulability r/t covid. Pt died." "No prior
"1203575-1" "1203575-1" "Patient contracted COVID-19 after receiving 2 COVID-
19 vaccine doses (Pfizer) and was admitted to the hospital for treatment and is
still an inpatient currently. Patient admitted with hypoxic respiratory failure on
3/25/2021 for severe COVID-19. Patient is s/p convalescent plasma on 3/26, and s/p
remdesivir 3/26-3/30. Received tocilizumab x 1 dose prior to intubation. Patient
with persistent respiratory failure/ARDS requiring intubation. Course further
complicated by CMV viremia as well as shock with rising procalcitonin concerning
for superimposed bacteria pneumonia as respiratory culture is growing Enterobacter.
Goals of care conversations occurring with ICU team and family." "No prior
"1204069-1" "1204069-1" "Death Acute kidney injury COVID-19 virus infection
"1208840-1" "1208840-1" "contracts covid; contracts covid; This is a
spontaneous report from a contactable consumer (Pfizer colleague). A 104-year-old
female patient received first dose of bnt162b2 (COMIRNATY; Lot number was not
reported) in Jan2021 and second dose (Lot number was not reported) in the beginning
of Feb2021 both given via an unspecified route of administration, as single dose
for covid-19 immunisation. The patient medical history and concomitant medications
were not reported. The patient contracted covid in the mid of Mar2021 with fatal
outcome. The patient died on 26Mar2021 in the hospital. Cause of death was COVDI-
19. It was unknown if an autopsy was performed. Information on the lot/batch
number has been requested.; Reported Cause(s) of Death: covid; covid" "No prior
"1211717-1" "1211717-1" "fell again twice in a row; Fibrin D dimer is above
12000 ng/ml; Fibrin D dimer on 26Feb2021 was 12011 ng/ml.; collapsed (had syncope);
melaena diarrhea; gastrointestinal bleeding was suspected; developed anemia;
impaired renal function; erosive gastritis; pneumonia; COVID-19 was detected;
COVID-19 was detected; hypotonic, anuric; pulmonary circulation decompensation; low
GFR (glomerular filtration rate); dyspnoea; catarrhal cough; incipient bronchitis;
tension; he became confused; respiratory deterioration; cardiomegaly; Suspicion of
urinary incontinence; his condition started to gradually worsen/patient's condition
showed a gradual and unstoppable progression; melaena diarrhea; This is a
spontaneous report downloaded from the Regulatory authority-WEB. Regulatory
Authority report number is HU-OGYI-158121. A contactable physician reported that
an 83-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via
intramuscular route, administered in the left arm on 20Feb2021 (Batch/Lot Number:
EL0725) at 0.3 mL, as single dose for covid-19 immunization. Medical history
included hypertension, ischemic heart disease, atrial fibrillation and COPD.
Concomitant medications included tamsulosin, rivaroxaban (XARELTO), bisoprolol,
furosemide (FURON), allopurinol (MILURIT) potassium chloride (KALDYUM),
theophylline sodium aminoacetate (THEOSPIREX), salbutamol (VENTOLINE), budesonide,
formoterol fumarate (BUFOMIX EASYHALER) and amiloride hydrochloride,
hydrochlorothiazide (AMILOZID); all taken from unspecified dates (unknown if
ongoing) for unspecified indications. On 21Feb2021, the patient felt unwell while
standing in line before vaccination which resolved when he sat down. After the
observation period, the patient collapsed (had a syncope) after 10 m long walking.
The patient was taken home, where he fell again twice in a row, and had melaena
diarrhea twice. Ambulance was called because gastrointestinal bleeding was
suspected. In the emergency department, laboratory tests confirmed impaired renal
function and low GFR (glomerular filtration rate) which presumably caused the
development of erosive gastritis as a source of gastrointestinal bleeding. Due to
the developed anemia, a total of 6 units of blood were transfused without
complications, the patient's blood count improved. Anticoagulant therapy was
suspended and switched to low-dose LMWH corresponding to low (glomerular filtration
rate). During further observations, on day 5 of treatment, dyspnoea, catarrhal
cough occurred, and physical examination revealed pulmonary circulation
decompensation and incipient bronchitis. The patient became hypotonic, anuric, so
he received a pressor agent, his tension settled, and his diuresis started.
Parenteral broad-spectrum antibiotics were initiated with further careful infusion,
diureticization, and Berodual (ipratropium bromide; fenoterol)-ambroxol inhalation,
supplemented with oxygen therapy. However, his condition started to gradually
worsen, he became confused, so low-dose sedatives, steroids and intravenous
bronchodilator was also initiated. Due to significant respiratory deterioration,
the patient received mechanical ventilation for a short period of time. A chest X-
ray was taken, which showed significant cardiomegaly, a congestive pattern, and no
lesions suggestive to pneumonia. Suspicion of urinary incontinence also arose
during a urine test, based on the results of inoculation, antibiotic therapy was
switched to targeted treatment. Despite the treatment applied, the patient's
condition showed a gradual and unstoppable progression, the patient died on
06Mar2021 at 08:30 am. Autopsy was not done, COVID-19 was detected. The patient
underwent lab tests and procedures on 20Feb2021 which included ECG: HR: 90-130/min.
Tachyarrhythmia, left axis, right bundle branch block, disturbed repolarization and
gastroscopy showed gastric erosions. COVID-19 antigen test on 21Feb2021 was
negative. COVID-19 PCR test on 26Feb2021 was negative. Fibrin D dimer on 26Feb2021
was 12011 ng/ml. Senders Comment: The 83 year-old patient had syncope after
Comirnaty vaccination. TTO was around 30 minutes. The patient also felt unwell
right before vaccination. The patient had gastric erosions, anaemia, and impaired
renal function. Fibrin D dimer was 12011 ng/ml 6 days after vaccination. The
patients condition worsened, and died in hospital 14 after vaccination. Autopsy was
not done, COVID-19 was detected. The causal relationship between the events and
Comirnaty is considered unlikely. The case is serious due to hospitalization and
fatal outcome. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: collapsed (had syncope); Fibrin D dimer is
above 12000 ng/ml; Fibrin D dimer on 26Feb2021 was 12011 ng/ml." "No prior
"1212820-1" "1212820-1" "Unexpected death 3 days after vaccination" "No
"1213032-1" "1213032-1" "D69.6 - Thrombocytopenia (CMS/HCC) U07.1 - COVID-19
D72.819 - Leukopenia R77.8 - Elevated troponin I level J18.9 - Multifocal pneumonia
U07.1, J12.82 - Pneumonia due to COVID-19 virus" "No prior vaccinations for
this event."
"1213047-1" "1213047-1" "This is the patient's spouse reporting. The day
following the vaccination, wife began to suffer mild, common vaccination symptoms
such as fatigue, hills, and joint pain. In the days following, in addition to
those symptoms, she began to cough and had a sore throat. By March 8th, she had
lost her sense of taste and sense of smell. We realized we needed to have her
tested for COVID-19. We went to a testing area. She was seen and tested. She tested
positive for COVID-19 (as did I). The belief was that our illness was
uncomplicated and we were sent home with instructions to monitor our symptoms. On
03/14/2021, I took her to the hospital because her condition was worsening." "No
"1227511-1" "1227511-1" "Unknown cause of death; COVID-19 virus test: yes-
positive; This is a spontaneous report from a non-contactable physician downloaded
from the regulatory authority. The regulatory authority number is DE-PEI-
202100032177. A 90-year-old female patient received BNT162B2 (COMIRNATY, lot number
and expiration date were unknown) at the age of 90-years-old, via an unspecified
route of administration on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation.
The patient's medical history was not reported. There were no concomitant
medications. The patient died on 15Mar2021 due to an unknown cause. The patient
underwent lab test and procedure which included COVID-19 virus test: yes-positive
on 02Feb2021. The outcome of the event COVID-19 was unknown. The patient died on
15Mar2021. The cause of death was unknown. An autopsy was not performed.
Relatedness of the drug to unknown cause of death was reported as unclassifiable.
No follow-up attempts are possible; information on batch/lot number cannot be
obtained.; Reported Cause(s) of Death: Unknown cause of death" "No prior
"1227708-1" "1227708-1" "COVID-19/ COVID INFECTION; CONDITION DETERIORATED;
RTI; This is a spontaneous report from a contactable physician downloaded from the
regulatory authority, IE-HPRA-2021-066081. This is a report received from the
regulatory authority. A 90 -year- old male patient received first dose of bnt162b2
(COMIRNATY, Lot Number: EJ6134), via an unspecified route of administration on
21Jan2021 at single dose for covid-19 immunisation . Medical history included type
2 diabetes mellitus, atrial fibrillation and chronic obstructive pulmonary disease.
There were no concomitant medications. The patient did not have any COVID-19
symptoms prior to vaccination. On 21Jan2021, the patient was vaccinated and It was
reported that no adverse reactions were noted post vaccination. On 28Jan2021, the
patient tested positive for COVID-19 following a PCR nasal/pharyngeal swab. It was
reported that the patient's condition deteriorated in the days prior to death. The
patient was seen by a General Practitioner (GP). The patient was treated for a
respiratory tract infection (RTI) with antibiotics, intramuscular Rocephin and
oxygen (O2) therapy. However, there were no significant improvements. A palliative
care pathway was commenced. On 10Feb2021, at 12.10pm, the patient died. The
reported fatal events were Covid-19/COVID infection, condition deteriorated and
respiratory tract infection (RTI). On 11Feb2021 a Coroner reported that the patient
's death occurred as a result of COVID-19 following vaccination with COVID-19
vaccine. Follow-up information was received by the regulatory authority from a
healthcare professional on 16Mar2021: It was reported that the patient's death
certificate had been completed as ''COVID, vaccine related''. Follow-up attempts
are completed. No further information is expected; Sender's Comments: Linked
Report(s) : IE-HPRA-2021-066080 regulatory authority; Reported Cause(s) of Death:
"1230054-1" "1230054-1" "Pfizer COVID-19 Vaccine EUA Patient received vaccine
dose #1 on 1/14/2021 and Dose #2 on 1/31/2021. Patient presented to ED on 2/1/2021
with complaints of acute mental status change. He was recently diagnosed with
enterocoal/pseudomonas UTI four days prior to presenting to ED and was being
treated with Augmentin and Levaquin. Patient screened positive for COVID-19, with
the sample analyzed using PCR or equivalent. Patient suffered a cardiac arrest on
2/7/2021 x3, developed three pressor shock, and required maximum ventilator
settings. Patient subsequently expired." "No prior vaccinations for this event."
"1230246-1" "1230246-1" "My husband developed severe COVID symptoms, despite
testing negative for COVID via pcr tests on Sunday 3/21 /21 and Tuesday 3/23. He
was hospitalized on 3/28 due to low blood oxygen levels. Was diagnosed with COVID
and pneumonia. Treated with remdesivir and a steroid, then monoclonal antibodies.
Despite making progress to the extent doctors were cautiously optimistic on 4/9/21
he would be discharged on 4/16/21, he instead was transferred to ICU on 4/10/21,
placed on a ventilator on 4/11/21 and died on 4/15/21." "No prior vaccinations
for this event."
"1231929-1" "1231929-1" "COVID-19 PCR test positive; 06Mar21 died of virus
flu with proven Covid-19 infection; Influenza A virus infection from Mar2021; This
is a spontaneous report from a non-contactable consumer downloaded from the
regulatory authority, regulatory authority number is DE-PEI-CADR2021044761. Safety
report unique identifier DE-PEI-202100032456. A 71-year-old male patient received
the first dose of bnt162b2 (COMIRNATY), intramuscular on 24Feb2021 (Lot Number:
EP9598) as 0.3 mL, single for COVID-19 immunisation. Medical history included
schizophrenia; type 2 diabetes mellitus and all unknown if ongoing. The patient's
weight was 70 kg, and height was 167 cm. Concomitant medications were not reported.
The patient died of virus flu with proven covid-19 infection (unknown cause of
death) on 06Mar2021. He had Influenza A virus infection from Mar2021. And he had
cough on 04Mar2021 (2 days before death). Pulmonological clinically normal. The
patient underwent lab tests and procedures which included COVID-19 PCR test with
result of positive. The patient died on 06Mar2021. An autopsy was not performed.
No follow-up attempts possible. No further information expected.; Reported Cause(s)
of Death: Influenza A virus infection; Unknown cause of death; COVID-19 PCR test
"1231930-1" "1231930-1" ""Despite Covid-19 vaccination on 24Feb2021, the
patient died according to the death certificate on 21Mar2021 of viral pneumonia
with proven COVID-19 infection.; proven COVID-19 infection; vaccination on
24Feb2021, Covid-19 on 09Mar2021; This is a spontaneous report from a non-
contactable consumer downloaded from the Regulatory Agency-WEB DE-PEI-
CADR2021044771, Safety Report Unique Identifier DE-PEI-202100032478. An 88-year-
old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on
24Feb2021 (Lot Number: EP9598) as 0.3 mL, single for covid-19 immunisation. Medical
history included ongoing arterial hypertension, ongoing depression, ongoing
osteoporosis, ongoing apoplexy, ongoing dementia, ongoing hemiparesis. The
patient's concomitant medications were not reported. On 09Mar2021 the patient
experienced pneumonia viral NOS, COVID-19. Despite Covid-19 vaccination on
24Feb2021, the patient died according to the death certificate on 21Mar2021 of
viral pneumonia with proven COVID-19 infection. The patient's outcome was fatal for
Pneumonia viral NOS, not recovered for COVID-19. The patient died on 21Mar2021. An
autopsy was not performed. Sender's comments: ""Are you or the person concerned
known of any allergies? If yes, which? No. Information on risk factors or previous
illnesses: known dementia, depression, condition after apoplexy with hemiparesis,
arterial hypertension, osteoporosis / 09Mar21 cough, pulmonary increased vesicular
breathing, weakness"". The PEI assessed Pneumonia viral NOS and COVID-19 were D.
Unclassifiable. No follow-up attempts are possible. No further information is
expected. ; Reported Cause(s) of Death: Pneumonia viral NOS"" "No prior
"1231931-1" "1231931-1" "cardiovascular failure/Sudden cardiac death;
cardiovascular failure/Sudden cardiac death; COVID-19; COVID-19; Viral infection of
the respiratory tract; This is a spontaneous report from a non-contactable consumer
downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DE-
PEI-CADR2021044779, Safety Report Unique Identifier DE-PEI-202100032482. A 74-
year-old female patient received bnt162b2 (Pfizer vaccine, Solution for injection),
intramuscular on 24Feb2021 (Lot Number: EP9598) as single dose for covid-19
immunisation. Medical history included ongoing Chronic renal insufficiency, ongoing
Coronary heart disease, ongoing Arterial hypertension, ongoing Type 2 diabetes
mellitus. The patient's concomitant medications were not reported. The patient's
weight was 72 kg, and height was 156 cm. On 08Mar2021, the patient experienced
Viral infection of the respiratory tract, COVID-19. On 09Mar2021, the patient
experienced cardiovascular failure/Sudden cardiac death. The patient died on
09Mar2021. No autopsy was performed. It was reported that Information on risk
factors or previous illnesses arterial hypertension, coronary heart disease,
Diabetes mellitus type 2, chronic renal insufficiency / one day before death in
general. physical weakness, Pulmo exacerbated vesicular breathing. No concerned
have any allergies. Relatedness of drug to reactions was assessed as D.
Unclassifiable by PEI. The outcome of the events cardiovascular failure/Sudden
cardiac death was fatal, of the other events was not recovered. No follow-up
attempts are possible. No further information is expected. ; Reported Cause(s) of
Death: cardiovascular failure; Sudden cardiac death" "No prior vaccinations for
this event."
"1231936-1" "1231936-1" ""patient died approximately 1 week after first
vaccination; Covid-19 test positive; This is a spontaneous report based on
information received by Pfizer from a company [manufacturer control number: 38084],
license party for Comirnaty. A non-contactable physician reported that a female
patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via
an unspecified route of administration on an unspecified date in Apr2021 at SINGLE
DOSE for COVID-19 immunisation. The patient was not pregnant at the time of
vaccination. The patient's medical history and concomitant medications were not
reported. The patient has been vaccinated with bnt162b2 during Easter holidays. A
few days later the COVID-19 test was positive in Apr2021. The patient died
approximately 1 week after first vaccination according to the daughter in Apr2021.
It was not reported if an autopsy was performed. The outcome of the event COVID-19
test was positive was unknown. No follow-up attempts are possible, information
about lot/batch number cannot be obtained.; Sender's Comments: The limited
information provided in this report does not allow a full assessment of the case.
The event ""death"" with unknown cause is assessed as related to the suspect drug
per company guidance. This case will be reassessed when additional information,
particularly the clinical course before death, complete medical history and
concomitant medication and autopsy report, becomes available. COVID-19 is most
likely related to an intercurrent or underlying condition which is not related to
the suspected drug. Individuals may not be protected until at least 7 days after
their second dose of the vaccine. The case will be reassessed if additional
information becomes available. The impact of this report on the benefit/risk
profile of the Pfizer product is evaluated as part of Pfizer procedures for safety
evaluation, including the review and analysis of aggregate data for adverse events.
Any safety concern identified as part of this review, as well as any appropriate
action in response, will be promptly notified to Regulatory Authorities, Ethics
Committees and Investigators, as appropriate.; Reported Cause(s) of Death: patient
died approximately 1 week after first vaccination"" "No prior vaccinations for
this event."
"1231946-1" "1231946-1" "Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR
test was positive; Vaccination failure/ SARS-CoV-2 PCR test was positive; This is
as spontaneous report received from a contactable Physician downloaded from the
regulatory authority. The Regulatory Authority report number is EE-SAM-29862103261.
A 72-year-old male patient received BNT126B2 (COMIRNATY), first dose intramuscular
on 15Jan2021 (Batch/Lot number was not reported) as 0.3 mL, single and second dose
intramuscular on 05Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single
for COVID-19 immunisation. Medical history included Aneurysm aortic, Cardiac
insufficiency, Hypertension not adequately controlled, Permanent atrial
fibrillation, Terminal renal insufficiency (has been receiving hemodialysis for
many years), chronic obstructive pulmonary disease (COPD). The patient's
concomitant medications were not reported. The patient was vaccinated with the two
doses of Comirnaty vaccine (on January 15th and February 5th). SARS-CoV-2 PCR test
was positive on 21Mar2021. The patient is in the hospital since 21Mar2021, with
severe respiratory failure. Exitus letalis 25 March 2021. Serious side effects, as
a result of the ineffectiveness of the vaccine, the patient became ill with COVID-
19. The patient died on 25Mar2021. It was not reported if an autopsy was
performed. The causal link is considered possible. The outcome of the events was
fatal. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: Death; Respiratory failure; COVID-
19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was
"1233795-1" "1233795-1" "Information obtained from the Hospital. Began to not
feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on
4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21." "No prior
"1234378-1" "1234378-1" "drug ineffective; COVID-19 aggravated; unmeasurable
fever; cardiovascular decompensation; This is as spontaneous report received from a
contactable physician downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority report number is FR-AFSSAPS-MA20211228, Safety report unique
identifier FR-AFSSAPS-2021035332. A 93-year-old female patient received bnt162b2
(COMIRNATY), dose 1 intramuscular on 19Jan2021 (Lot Number: EM0477) as SINGLE DOSE
for covid-19 immunisation. Medical history included cognitive
disorder/neurocognitive disorders, renal failure, breast cancer, atrial
fibrillation, starvation, thyroid nodule. The patient's concomitant medications
were not reported. The patient experienced drug ineffective (death) on 02Feb2021,
covid-19 aggravated (death) on 02Feb2021, unmeasurable fever (death) on 02Feb2021,
cardiovascular decompensation(death) on 02Feb2021. On 02Feb2021, a unmeasurable
fever, a cardiovascular decompensation. PCR Covid 19 test performed and result was
positive on 02Feb2021. The patient died on 02Feb2021. It was not reported if an
autopsy was performed. Time Interval between Beginning of Drug Administration and
Start of Reaction / Event was 15 days. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: drug ineffective;
COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation" "No
COVID-19 test with symptoms; This is a spontaneous report received from a
contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The
regulatory authority report number is FR-AFSSAPS-RS20210728, Safety report unique
identifier FR-AFSSAPS-2021036243. A 98-year-old female patient received the first
dose of BNT162B2 (COMIRNATY), intramuscularly administered in Arm on 13Jan2021
(Batch/Lot Number: unknown) and the second dose of BNT162B2 intramuscularly
administered in Arm on 03Feb2021 (Batch/Lot Number: Unknown), both as single dose
for COVID-19 immunisation. Medical history included cardiac failure from Dec2016
and ongoing, bronchial infection from Dec2016 to an unknown date, decompensation
cardiac from Jan2018 to May2019 (Left ventricular decompensation in Jan2018, then
Feb2018, then May2019), Stroke in 2017 without sequelae, depression, Hypothyroidism
due to Hashimoto's thyroiditis, Extra pyramidal syndrome without proper Parkinson's
disease, Left eye blindness due to tumor enucleation, left eye prosthesis.
Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR);
paroxetine hydrochloride (DEROXAT); levothyroxine sodium (LEVOTHYROX);
acetylsalicylate lysine (KARDEGIC); ramipril; oxazepam (SERESTA); furosemide; and
tamsulosin. The patient has no history of COVID-19. On 19Feb2021, 16 days after the
second dose of BNT162B2 injection, symptoms appeared. The patient complained of
body aches. Pulmonary auscultation in which crackles were found mid-field of ICG.
Hyperthermia at 38.6 T. Oxygen requirement (saturation 97/3L). SARS-CoV2 PCR
positive the same day (PCR V1 profile- initial strain). On 22Feb2021, patient
apyretic, reports feeling tired. On 24Feb2021, hyperthermia at 39.1T, headache. On
25Feb2021, hyperthermia at 39 T and increased crackles. On 26Feb2021, intercostal
indrawing, cyanosis of the hands. On 27Feb2021, patient apyretic, severe crackles,
very mild Oedema of the Lower Extremities.On 03Mar2021, reduction of crackles.
Saturation 95/5L. On 05Mar2021, good clinical course with persistence of apyrexia,
no polypnea or cyanosis. Subsequently, on 20Mar2021, it was noted that the patient
was very anxious. On 22Mar2021, the patient was very thirsty and a wrong route was
observed during her hydration. On 23Mar2021, at 5.30 p.m., the patient was still
very anxious and dehydrated. Cyanosis, saturation 84/2L, polypnea, wet cough and
wrong routes, dry bi-basal, symmetrical crackles. Oxygen saturation increased to
93% under 10L. The patient's physician declares aspiration brings back milk-white
mucous fluid. On 23Mar2021, at 11 p.m., hemodynamic and respiratory failure with
desaturation to 79% under 15L. Patient in tachycardia. The patient's physician
declared Doubtful about pulmonary oedema in spite of dehydration and due to rapid
installation, auscultation and history. On 24Mar2021, hypotension at 70/60,
tachycardia with saturation at 89%, slight polypnea. The patient's physician
suggests cardiorespiratory failure due to hypovolemia. On 24Mar2021, collegial
decision to stop the treatment, death of the patient on 26Mar2021 Overall, vaccine
failure with a positive PCR 16 days after the second injection of the Comirnaty
vaccine, improvement in symptoms of COVID infection on 05Mar2021. Subsequently,
deterioration of the general condition with the onset of hemodynamic and
respiratory failure on 23Mar2021 in a context of dehydration and possible
aspiration. Death of the patient. Therapeutic measures were taken as a result of
positive COVID-19 test with symptoms. The patient died on 26Mar2021. An autopsy
expected. Information on lot and batch numbers cannot be obtained.; Reported
Cause(s) of Death: positive COVID-19 test with symptoms; Vaccination failure"
"1234958-1" "1234958-1" "drug ineffective; COVID-19 induced respiratory
insufficiency; respiratory insufficiency; thrombophlebitis; erysipelas; phlegmon;
regulatory authority HU-OGYI-196821. Case narrative: This spontaneous, serious
report received on 27Mar2021 from a physician describes the occurrence of adverse
events after vaccination with COMIRNATY (tozinameran). On 13Feb2021 at 8:20 a.m.,
the 77 years old male patient received COMIRNATY (concentrate for dispersion
injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms
of COVID-19 mRNA vaccine; batch number: PAA156571, expiry date: Mar2021, MAH:
BioNTech Manufacturing GmbH) applied intramuscularly to the left upper arm for
COVID-19 immunisation. Following vaccination, in Mar2021, the patient reported to
have erysipelas, thrombophlebitis and phlegmon. The patient was hospitalised, the
symptoms were resolving, but in the hospital, the patient had acquired COVID-19 and
developed respiratory insufficiency, and died. Discharge summary is not available.
The patient general condition, medical history and concomitant medicines were not
reported. Sender comment: Erysipelas, thrombophlebitis and phlegmon are not
expected adverse events of COMIRNATY. Alternatively, they might have been in
relation with the patient underlying diseases, but there is no detailed information
about them. Time to onset might have been several weeks, it is not correctly known
either. Causality between the adverse events and COMIRNATY is unlikely. The patient
acquired COVID-19 infection in hospital several weeks after the presumably first
dose of vaccine. Immunity might have not developed within this time frame. The case
is serious because the patient died. Further information is expected.; Reported
Cause(s) of Death: COVID-19 respiratory insufficiency; COVID-19 respiratory
insufficiency; drug ineffective" "No prior vaccinations for this event."
"1234964-1" "1234964-1" "Respiratory tract infection; REDUCED RESPIRATION
RATE, O2; REDUCED RESPIRATION RATE, O2; WEAK; PHYSICAL DETERIORATION; COVID-19;
This is a spontaneous report from a contactable other healthcare professional
downloaded from the Agency Regulatory Authority-WEB, regulatory authority number
IE-HPRA-2021-066080. An 88-year-old male patient received BNT162B2 (COMIRNATY), via
an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as Single
Dose for COVID-19 immunisation. Medical history included lower respiratory tract
infection secondary to aspirations, rectal cancer from 2013, oral cancer stage
unspecified from 2010. The patient's concomitant medications were not reported. The
reporter outlined that no adverse reactions were noted post vaccination. On
28Jan2021, the patient tested positive for COVID-19 via PCR nasal/pharyngeal swab.
It was reported that the patient's condition deteriorated in the days prior to his
death (onset date: Feb2021). On 03Feb2021, the patient was last seen by his General
Practitioner (GP). The patient's condition was comfortable but weak and the patent
experienced a reduced respiration rate and O2. The patient's GP was contacted.
Therapeutic measures were taken as a result of reduced respiration rate and O2. The
patient was treated for a respiratory tract infection (RTI) (onset date not
reported) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. The
patient also experienced physical deterioration on Feb2021. On 04Feb2021, at 11:40
am, the patient died. It was reported that the patient did not have any COVID-19
symptoms prior to vaccination, however, his death occurred as a result of COVID-19
seven days later. Other causes of death reported included weak, reduced respiration
rate and O2, and physical deterioration. It was unknown if an autopsy was
performed. Follow-up attempts are completed. No further information is expected.;
Sender's Comments: Linked Report(s) : IE-HPRA-2021-066081 HPRA; Reported Cause(s)
of Death: REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; PHYSICAL
DETERIORATION; WEAK; COVID-19" "No prior vaccinations for this event."
"1234966-1" "1234966-1" "DEVELOPED COVID 19; This is a spontaneous report
from a contactable consumer or other non healthcare profesional downloaded from the
Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070505. A
88-years-old female patient received BNT162B2 (COMIRNATY, BioNTech Covid-19 mRNA
vaccine), via an unspecified route of administration on 14Jan2021 (Batch/Lot
Number: Unknown) as single dose for COVID-19 immunisation. Medical history included
living in residential institution, renal disorder receiving treatment in clinic;
and hip arthroplasty from 2019 (18 months previously). Patient was recovering in
nursing home after treatment in Clinic for kidney issues. The patient was not
taking any concomitant medication. On 15Jan2021, the patient developed COVID-19. It
was reported that the patient had been doing well in residential care but then
crashed very quickly and it was decided not to send her to hospital as it was felt
the patient would not have wanted that. The patient received palliative care for
three days before she died. The patient died on 23Jan2021. It was unknown if an
autopsy was performed. No follow-up attempts are possible; information about
batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19" "No
"1235283-1" "1235283-1" "cough/choking cough; fever; very tiring; felt
unwell/ill; pneumonia caused by a virus; severe respiratory failure; Covid-19; This
is a spontaneous report from a contactable consumer. A 69-year-old male patient
received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on
12Feb2021 (Lot Number: EL8723) as a single dose for covid-19 immunisation. Medical
history included heart attack from 16Nov2020 to an unknown date. The patient's
concomitant medications were not reported. The reporter mentioned that her husband
was vaccinated with the Pfizer Comirnaty vaccine and after the vaccination, he felt
unwell sometime later, tests were done (unspecified results) on Feb2021, it turned
out that the patient was ill, he has Covid. On 20Mar2021 (also reported as
16Mar2021), he was taken to hospital but unfortunately the patient died. The
reporter confirmed that her husband had received the 1st dose of 12Feb21, lot
number EL8723. From the third day (15Feb2021) after vaccination, a fever developed,
and the patient was taking Teraflu. The temperature was maintained until 20Feb2021.
Meanwhile a cough appeared. 25Feb2021, the cough worsened and the patient was
referred for a COVID-19 test. The test came out positive on Feb2021. On 26Feb2021,
the patient was in an ambulance but did not take him to the hospital. On 29Feb2021,
the cough got worse and was very tiring. 01Mar2021 the patient was taken to
hospital because of a choking cough. On 03Mar2021, the patient was connected to a
respirator and on 16Mar2021, the patient died. The patient was not autopsied.
Doctors cited COVID-19 as the cause of death, viral pneumonia and severe
respiratory failure. The reporter mentioned that the patient on 16Nov2020 had a
heart attack. He has been taking heart medications since then, but she has not
stated what. The patient did not suffer from chronic diseases. The patient
underwent lab tests and procedures which included COVID-19 test was positive on
Feb2021, tests was done (unspecified results) on Feb2021 temperature was maintained
until 20Feb2021 (Feb2021). The outcome of the events malaise and fatigue were
unknown while the outcome of the other events was fatal. The patient died on
16Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: pneumonia
caused by a virus; severe respiratory failure; COVID-19" "No prior vaccinations
for this event."
"1235811-1" "1235811-1" ""COVID pneumonia; Hematological; bleeding; having
hemoxysis; slight troponin increase; GI bleed; headaches; COVID-19 test was
positive; COVID-19 test was positive; nauseous; abdominal discomfort; body aches;
This is a spontaneous report from a contactable physician. A 52-year-old female
patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE,
Batch/Lot number was not reported), via an unspecified route of administration at
the age 52-year-old on 12Mar2021 at single dose for COVID-19 immunisation. Medical
history included hemodialysis for many years, adherent to medical care, multiple
DVTs and Pes (On anticoagulants), morbid obesity, Patient was on dialysis for renal
failure and had lupus anticoagulant (positive), Afib, allergic to shellfish. Family
history included renal failure and had lupus anticoagulant. Concomitant medications
included warfarin sodium (COUMADIN); metoprolol; amitriptyline; calcitriol;
ergocalciferol (VIT D); calcium; calcium acetate (PHOSLO); amiodarone; albuterol.
The patient previously allergic to Cipro, clindamycin, doxycyclin, Lyrica,
tetracycline. The patient previously was non-responder to hepatitis B vaccine. The
patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19
VACCINE) on 17Feb2021 for COVID-19 immunisation. The patient hasn't been treated
with immunomodulating or immunosuppressing medications or received any other
vaccines around the time of COVID-19 vaccination. The patient wasn't smoker/ former
smoker. There was no any other vaccinations within four weeks prior to the first
administration date of the suspect vaccine. A nephrologist who reported patient in
her hemodialysis unit who were vaccinated with BNT162b2 but were recently diagnosed
with COVID-19. More detail is below on each patient. The patient COVID results were
sent to the local health department for genetic sequencing (pending) and SARS
titers were drawn (pending). Unfortunately, the HD unit does not have B/L
information (although the B/L # was put on the patient's COVID vaccine cards, a
record was not kept in the HD unit). Day she came in for dialysis she was already
short of breath she said she'd had body aches for 5 days, got short of breath on
05Apr2021. The day before, started getting cough, nauseous, chills, abdominal
discomfort on 04Apr2021. The patient was sent to the ER from dialysis and was
admitted for SOB on 05Apr2021 and passed away on 09Apr2021 due to a GI bleed.
Patient is over 500lbs so was unable to fit into hospital imaging equiment for CT
scans or weight measurements. COVID-19 test was positive on 05Apr2021; the patient
experienced COVID pneumonia on 05Apr2021. The patient admitted on 05Apr2021 to
regular floor. The patient was moved to an Intensive Care Unit on 06Apr2021. The
patient experienced short of breath on 05Apr2021 and required much more O2 than
normal. Sometimes required BP support while on Dialysis and BP was 113/61 in ER.
Pressure dropped to 100/70 and required mitrodrine after fluid was removed. The
patient needed 4 liters supplemental O2 vs. only needing 2 liters at home. The
patient experienced tachypnea and hypoxemia and no Respiratory failure. Respiration
was 22. After 5 litres of O2 improved. Pulse 93 in ER. Cardiovascular: There was no
heart failure, cardiogenic shock, Acute myocardial infarction, arrhythmia and
myocarditis. The patient Had chest pain which resolved when O2 was administered.
Gastrointestinal/Hepatic: There was no Vomiting, Diarrhea. The patient experienced
nausea but no vomiting or diarrhea and complained of abdominal pain. There was no
Jaundice and acute liver failure. Neurological: There was no altered consciousness,
altered consciousness, encephalopathy, meningitis and cerebrovascular accident. The
patient had headaches a couple days before admitting to ER. Hematological: There
was no Thrombocytopenia, Disseminated intravascular coagulation. INR was 3 due to
large dose of coumadin, and platelets were 180 and white count 6.8. Slight troponin
increased at 0.37 at admittance, BNP 39. The patient started coughing up blood,
having hemoxysis and bleeding on unspecified date. Laboratory test or diagnostic
studies was reported that test for SARS-CoV-2 by PCR, or other commercial or public
health assay. Xray showed vascular congestion with superimposed infiltrate which
could represent pneumonia. Blood count was 11 and 36.7% at ER. Clinical chemistry:
Sodium was 133; BUN was 68; Creatinine was 10. Evidence of hypoxemia: Pulse oO2 was
90 in ER. CT scans: unknown results. Urinalysis: On dialysis so does not make
urine. The patient had received Remdesivir, from 06Apr2021,
Hydroxychloroquine/chloroquine, Azithromycin from 06Apr2021 and Corticosteroids
from 06Apr2021 for COVID-19. The outcome of event ""GI bleed"" was fatal, the
event ""chest pain"" and ""body aches"" was recovered and other events was unknown.
The patient died on 09Apr2021. An autopsy was not performed. Information on the
lot/batch number has been requested.; Sender's Comments: Based on temporal
association, a contributory role of the suspect drug cannot be excluded for the
events vaccination failure, COVID-19, COVID-19 pneumonia, and sepsis. However, the
patient's multiple medical comborbidities including renal failure requiring
dialysis, lupus, and morbid obesity along with the risk of COVID-19 infection in
light of the current pandemic are the more likely explanations for the development
of these infections. The events gastrointestinal hemorrhage, hemorrhage, hemolysis
and troponin increased are attributed to intercurrent medical conditions, and are
considered unrelated to the suspect drug. The patient is currently on warfarin
which may increase the risk for bleeds. This case will be reassessed upon receipt
of additional information. The impact of this report on the benefit/risk profile of
the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
and Investigators, as appropriate.; Reported Cause(s) of Death: GI bleed"" "No
"1236493-1" "1236493-1" "A.R.D.S.; COVID-19; COVID-19; Dyspnoea; Shivering;
Coughing; Fever; peripheral circulatory failure; exhaustion; Groggy; This is a
spontaneous report from a non-contactable physician downloaded from the regulatory
authority-WEB, regulatory authority number DE-PEI-202100032679. A 61-year-old male
patient received bnt162b2 (COMIRNATY), via an unspecified route of administration
on 06Jan2021 (Batch/Lot Number: EJ6797) as 0.3 mL, single for COVID -19
immunization. Medical history included ongoing Arterial hypertension. The patient's
concomitant medications were not reported. The patient experienced shivering,
fever, exhaustion, groggy, coughing, peripheral circulatory failure on 07Jan2021,
Dyspnoea and COVID-19 on 11Jan2021 (both hospitalization), experienced ARDS on
02Feb2021 (hospitalization). The patient died on 02Feb2021 caused by ARDS. An
autopsy was not performed. The event outcome was not recovered for shivering,
fever, exhaustion, groggy, coughing, peripheral circulatory failure, dyspnoea,
COVID-19, fatal for ARDS. No follow-up attempts possible. No further information
expected. Information on lot# already obtained.; Reported Cause(s) of Death: ARDS"
"1237672-1" "1237672-1" "Presents with dyspnea for a few days. Pt was tested
positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm
numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to
have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and
dexamethasone (7 day course), completed 5 day course of remdesivir and received
tocilizumab due to increased oxygen requirements. Pt also has mildly elevated
troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin
bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on
4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in
setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon
return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family
contacted during code and in agreement to transition to comfort measures." "No
"1238478-1" "1238478-1" "He was healthy before vaccine. After vaccine a
small amount of chills for a couple days. He was sicker and was exposed to COVID
19, so went to hospital 4/14/2021 tested neg for influenza and + Coronavirus. Died
on 4/15/2021" "No prior vaccinations for this event."
"1238623-1" "1238623-1" "Patient was asymptomatic and was vaccinated on
1/22/2021. A facility caregiver tested positive for COVID, so patient was tested
and received results on 1/27/2021 indicating positive for COVID-19. Patient
expired early morning of 2/1/2021, still completely asymptomatic. Patient's
physical condition had been fairly stable for the previous few years." "No prior
"1240346-1" "1240346-1" "COVID-19 virus test positive; Weakness; Body
temperature increased/ 38 centigrade; This is a spontaneous report received from a
contactable consumer (patient's son) downloaded from the Regulatory Authority (RA).
The regulatory authority report number is PL-URPL-DML-MLP.4401.2.190.2021. A 73-
years-old female patient received BNT162B2 (COMIRNATY), intramuscular on 03Mar2021
(Batch/Lot Number: ER2659) as single dose for covid-19 immunisation. Medical
history included diabetes from 30 years ago. The patient's concomitant medications
were not reported. Patient was not pregnant during the period of taking the drug.
From 06Mar2021 there was a weakening, increased body temperature 38 centigrade. On
08Mar2021, a medical rescue team performed the COVID-19 virus test (positive), did
not take the patient to the hospital. On 12Mar2021 21:00 (9 days from the
administration) patient died. An autopsy was not performed. The reporting person
did not classified seriousness of the adverse reactions. The event outcome for
events was fatal. Sender comment: On 26Mar2021, additional information was
obtained during a telephone conversation (it was added to the notification) and the
statistical number of the death was sent by e-mail. Until 29Mar2021 no response was
received. Pyrexia is an expected adverse reaction listed in section 4.8 of
COMIRNATY Summary of Product Characteristics. Asthenia is an unexpected side effect
not included in the Summary of the Suspected Drug. There is a time relationship
between drug administration and the occurrence of side effects. Due to the lack of
detailed information (autopsy results, health history, medications taken, etc.), it
cannot be ruled out that a factor other than the administered vaccine may have
contributed to the death. The reporting person did not classify the seriousness of
the adverse reactions. Company classified the notification as serious (death). No
Death: Weakness; Body temperature increased; COVID-19 virus test positive" "No
"1241418-1" "1241418-1" "Acute pulmonary embolism resulting in death; COVID
positivity; This is a spontaneous report received from a contactable physician
downloaded from the regulatory authority. The regulatory authority report number is
BE-FAMHP-DHH-N2021-87195. An 81-years-old male patient received first dose of
bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Lot
Number: ER9480) as single dose for COVID-19 vaccination. Medical history included
COPD, hypertension and obesity. Concomitant medication(s) included metoprolol;
amlodipine besilate, perindopril arginine (COVERAM); fluticasone propionate,
salmeterol xinafoate (SERETIDE); tiotropium bromide (SPIRIVA HANDIHALER);
lormetazepam. The patient experienced acute pulmonary embolism resulting in death
on 02Apr2021. There was no treatment. After death COVID positivity determined
(Apr2021). The patient died on 02Apr2021. An autopsy was performed and results were
not provided. The outcome of COVID positivity was unknown. Reporter's comments:
Treatment - No Evolution of the ADR - Deceased Examinations - autopsy performed
After death COVID positivity determined No follow-up attempts possible. No further
information expected. Reported Cause(s) of Death: acute pulmonary embolism" "No
"1241494-1" "1241494-1" ""COVID-19 aggravated/ positive COVID-19 test with
symptoms; This is a spontaneous report from a contactable physician downloaded from
the Agency Regulatory Authority-WEB FR-AFSSAPS-2021035128. A 97-year-old male
patient received first dose of bnt162b2 (COMIRNATY, Lot ER9470) intramuscular on
23Mar2021 at single dose for COVID-19 immunisation (vaccination against covid-19).
Medical history included prostate neoplasia, arterial hypertension, vascular device
user from 2007 (stent in 2007), dyslipidaemia, cardiovascular disease and diabetes.
Concomitant medications were not provided. On 19Mar2021, the patient was in contact
with a non-symptomatic person carrying the variant who found out after, the patient
was vaccinated. On 24Mar2021 (also reported as two days after the beginning of drug
administration), the patient developed COVID-19 aggravated which led to death on
29Mar2021 (the event was reported that lasted for 7 days). On 24Mar2021, onset of
fever with dyspnea (cough) and fatigue. On 26Mar2021, patient hospitalized with an
OAP (Acute pulmonary edema). On admission, patient placed on high flow Optiflow
with 94% saturation under 100% FiO2, corticosteroid therapy, antibiotic therapy,
furosemide (ES) and hydration. No indication for heavy resuscitation. CT scan,
typical image of COVID-19 with severe involvement, dilated cardiomyopathy and
""small"" pleurisy. PCR Covid positive. Event was reported as life threatening.
Unfavorable evolution leading to the death of the patient on 29Mar2021. Conclusion:
Covid-19 associated with PDO in patient 2 days after a first vaccination. Patient
died on 29Mar2021. An autopsy was performed and the reported cause of death was
covid-19, autopsy result was covid-19 and acute pulmonary edema. No follow-up
COVID-19; Autopsy-determined Cause(s) of Death: covid-19 and Acute pulmonary edema;
covid-19 and Acute pulmonary edema"" "No prior vaccinations for this event."
"1241511-1" "1241511-1" "Vaccination failure; COVID-19 confirmed by positive
COVID-19 test; This is a spontaneous report received from a contactable consumer
downloaded from the Agency Regulatory Authority-WEB. The regulatory authority
report number is FR-AFSSAPS-MP20211103, Safety report unique identifier FR-AFSSAPS-
2021036865. An 84-year-old female patient received bnt162b2 (COMIRNATY)
intramuscular, first dose on 11Feb2021 at single dose, second dose on 04Mar2021 at
single dose as COVID-19 vaccination. Medical history was not provided. Concomitant
medications were not provided. The vaccination was desaturation supported by
attending physician. Patient was considered to be at risk of developing a severe
form of COVID-19 disease, COVID-19 confirmed by positive COVID-19 test. Search for
the viral variant not specified. The patient underwent lab tests and procedures,
which included on 01Apr2021, PCR COVID 19 by RT PCR positive. It was confirmed
vaccination failure. Patient was hospitalized in a COVID unit on 04Apr2021. Patient
died on 07Apr2021. An autopsy was not performed, the reported cause of death was
COVID-19 aggravated and vaccination failure. No follow-up attempts are possible;
Vaccination failure; COVID-19 aggravated" "No prior vaccinations for this event."
"1241517-1" "1241517-1" "COVID-19 aggravated; bacterial right lower lobe
superinfection; This is a spontaneous report from a contactable physician
downloaded from the Agency Regulatory Authority-WEB manufacturer report number FR-
AFSSAPS-NY20210690 . Sender's (Case) Safety Report Unique Identifier FR-AFSSAPS-
2021035236 An 85-years-old male patient received first dose of bnt162b2
(COMIRNATY), intramuscular, administered in Arm Right on 15Mar2021 (Lot Number:
EP9605) as single dose for COVID-19 immunisation. Medical history included ongoing
Type 2 diabetes mellitus (NIDDM), Ischemic cardiomyopathy, ongoing Arterial
hypertension, ongoing hypercholesterolemia, ischemic heart disease, right trans-
tibial amputation (following an accident at work). Concomitant medications included
molsidomine ; atorvastatin calcium (TAHOR); acetylsalicylate lysine (KARDEGIC);
atenolol (BETATOP); metformin hydrochloride, sitagliptin phosphate (VELMETIA);
amlodipine besilate (AMLOR); captopril, hydrochlorothiazide (ECAZIDE); gliclazide
(DIAMICRON); metformin (GLUCOPHAGE). The patient experienced covid-19 aggravated on
23Mar2021. The event was assessed serious as death, hospitalization. On 23Mar2021,
9 Day after the last drug administration, the patient developed COVID-19 infection
which required hospitalization or prolongation of hospitalization. The patient died
on 31Mar2021. It was not reported if an autopsy was performed. Imputability : I1
(dubious) for COMIRNATY Reporters comment: File from the 20210330154320877 85-
year-old patient. History: DNID, hypertension, hypercholesterolemia, ischemic heart
disease, right trans-tibial amputation (following an accident at work). 15Mar2021,
first injection of the COMIRNATY vaccine (batch EP9605) in the right arm. On
23MAr2021, occurrence of COVID-19 pneumonia. Patient hospitalized for treatment. No
indication for heavy resuscitation. 29Mar2021, patient transferred for further care
and implementation of palliative care in the event of clinical deterioration. On
the respiratory level, presence of dyspnea with indrawing. No cough. Limit ambient
air saturation under 15L of O2. On auscultation, bi-basal crackles without other
anomaly. Cardiovascularly, no chest pain. Regular heart sounds, without audible
murmur. No sign of right or left cardiac decompensation. No edema. Neurologically,
Glasgow 15/15. No disturbance of higher functions. No respiratory
encephalopathy.Note since the COVID-19 infection marked asthenia with reduced
autonomy. To biology, GB 7.3 G / L, Hb 13.7 g / dL, platelets 209 G / L. Urea
13.19, mmol / L, creatinine 92.3 �mol / L. CRP 167 mg / L. Normal troponin and BNP.
Gas without under 12L of O2: pH 7.42, pCO2 32 mmHg, pO2 53 mmHg for 85% saturation.
ECG: regular sinus rhythm, without other abnormality. Lung CT scan (not injected):
no pulmonary embolism. COVID-19 pneumonia occupying 40% of the lung volume
bilaterally associated with a focus of superadded bacterial right lower lobe
superinfection. Management with increased oxygen therapy, IV hydration, antibiotic
therapy with AUGMENTIN, corticosteroid therapy with dexamethasone. Unbalanced
diabetes treated with NOVORAPID. Evolution marked by a stability of the patient's
condition for 24 hours. Despite the absence of any sign of worsening of his
clinical condition, the patient died in his sleep on 31Mar2021. Conclusion: COVID-
19 lung disease in an 85-year-old patient, 8 days after a first injection of the
COMIRNATY vaccine (batch EP9605). Hospitalized patient. Unfavorable evolution
leading to the death of the patient. No follow-up attempts possible. No further
information expected.; Reporter's Comments: Conclusion: COVID-19 lung disease in an
85-year-old patient, 8 days after a first injection of the COMIRNATY vaccine (batch
EP9605). Hospitalized patient. Unfavorable evolution leading to the death of the
patient.; Sender's Comments: There is not a reasonable possibility that events
COVID-19 aggravated and pneumonia bacterial are related to BNT162B2. The events
are more likely intercurrent medial conditions. The impact of this report on the
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate.; Reported
Cause(s) of Death: COVID-19 aggravated" "No prior vaccinations for this event."
"1241519-1" "1241519-1" ""severe form of COVID; vaccination failure; This is
a spontaneous report from a contactable physician downloaded from the Agency
Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20210461. Safety
Report Unique Identifier FR-AFSSAPS-2021036800. A 93-years-old male patient
(Husband of a resident) received bnt162b2 (COMIRNATY), dose 2 intramuscular on
05Mar2021 (Batch/Lot Number: EP2166) as 0.3 ml, single, dose 1 via an unspecified
route of administration on 09Feb2021 (Batch/Lot Number: EJ6795) as single dose for
covid-19 immunisation. Medical history included Chronic obstructive pulmonary
disease, Cardiac insufficiency, Hypertension arterial. No previous history of
covid. Concomitant medication included fluindione (PREVISCAN [FLUINDIONE]);
rosuvastatin calcium (CRESTOR); atenolol (ATENOLOL), Izaar. The patient had good
tolerance for the first dose. The patient experienced severe form of covid and
vaccination failure on 23Mar2021, which required hospitalization in Mar2021 and
death on 26Mar2021. Clinical detail was reported as: the patient had respiratory
symptoms about 7/8 days after the second dose of vaccine which the patient
neglected. Then he presented with asthenia, fever and respiratory discomfort around
15 March 2021. He was hospitalised following his visit to the emergency room and
died on 26 March 2021 of a severe form of COVID (65% invasion on the thoracic
scan). The PCR done on 23Mar2021 showed an variant. IN TOTAL, severe SARS COV2
infection variant B117 resulting in the death of an elderly man with a risk factor
for developing a severe form of the disease. The patient underwent lab tests and
procedures which included thoracic scan: severe form of COVID (65% invasion on the
thoracic scan) on Mar2021, Covid-19 PCR test: positive on 23Mar2021 variant. The
patient died on 26Mar2021. An autopsy was not performed. NB: Imputation made
""without prejudice to the elements of investigation which could be carried out
within the framework of legal or amicable compensation procedures"". Reported
Cause(s) of Death: SEVERE FORM OF COVID"" "No prior vaccinations for this event."
"1243574-1" "1243574-1" "Cause of death is believed to be a fatal arrhythmia
resulting from advanced old age and aggravated by sepsis due to COVID-19 infection
along with gastroenteritis. The death was natural and not unexpected. Tobacco is
not believed to have contributed to t" "No prior vaccinations for this event."
"1244820-1" "1244820-1" "Positive corona test 1 day after completion of
vaccination and death on 09Apr2021 as a result of Covid; Positive corona test 1 day
after completion of vaccination and death on 09Apr2021 as a result of Covid; This
is a spontaneous report from a contactable physician downloaded from a regulatory
authority-WEB, received from Regulatory Authority. The regulatory authority report
number is NL-LRB-00505868. A 96-year-old female patient received second dose of
bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 (Lot
Number: ER7812) as single dose, first dose was administered via an unspecified
route of administration on 20Feb2021 (Lot number was not reported) as 0.3 mL,
single dose for covid-19 immunisation. Medical history and concomitant medications
were not reported. On 28Mar2021 patient experienced covid 19 following
administration of covid-19 vaccine pfizer Injectable solution. Patient was admitted
on unknown date in response to the event. Patient had positive corona test one day
after completion of vaccination (on 28Mar2021) and death on 09Apr2021 as a result
of Covid-19. The patient underwent laboratory tests and procedures which included
sars-cov-2 test: positive on 28Mar2021. The patient died on 09Apr2021 due to Covid-
19. It was not reported if an autopsy was performed. Reporter's Comments:
(Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after
completion of vaccination and death on 09Apr21 as a result of Covid.
Hospitalization information: Covid Additional information ADR: not applicable.
Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up
attempts possible. No further information expected.; Reporter's Comments:
(Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after
completion of vaccination and death on 09Apr21 as a result of Covid.
Hospitalization information: Covid Additional information ADR: not applicable.
Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up
covid; Drug ineffective" "No prior vaccinations for this event."
"1245691-1" "1245691-1" "inaugural seizure; Seizures (generalized); General
physical health deterioration; covid smear positive 26Jan; This is a spontaneous
report from a contactable pharmacist downloaded from the regulatory authority BE-
FAMHP-DHH-N2021-78170. A 79-years-old female patient received bnt162b2 (COMIRNATY),
dose 1 via an unspecified route of administration on 22Jan2021 (Batch/Lot Number:
EM04777) as single dose for covid-19 immunisation. The patient medical history and
concomitant medications were not reported. The patient experienced inaugural
seizure, convulsions 2 hours after vaccine and emergency room admission with
outcome of fatal, general physical health deterioration with outcome of fatal,
sars-cov-2 test: positive with outcome of unknown. The patient was hospitalized for
inaugural seizure (epilepsy) from 22Jan2021 to an unknown date. The patient
underwent lab tests and procedures which included sars-cov-2 test: negative on
22Jan2021, sars-cov-2 test: positive on 26Jan2021. The patient died on 10Feb2021.
It was not reported if an autopsy was performed. Reporter's comment: 2 hours
after vaccine seizure epilepsy admission emergency room covid smear negative 22Jan
-> transfer to neurology department, initiation of depakine with stabilization of
the state of consciousness but clear general deterioration, planned return to
nursing home -> covid smear positive 26Jan-> transfer to hospital covid unit -
performance deteriorated significantly on 03Feb - call from the rest home on 04Feb
for DEG -> readmission to hospital -> status epilepticus, 2nd then 3rd line of
unsuccessful treatment Passage to palliative care -> death on 10Feb. No follow-up
attempts possible. No further information expected.; Reporter's Comments: Summary
of Reporter Comment: 2 hours after vaccine, seizure epilepsy admission emergency
room covid smear negative 22Jan -> initiation of depakine with stabilization of the
state of consciousness but clear general deterioration, covid smear positive 26Jan,
transfer to hospital covid unit - performance deteriorated significantly on 03Feb -
call from the rest home on 04Feb for DEG, readmission to hospital, status
epilepticus, 2nd then 3rd line of unsuccessful treatment, death on 10Feb; Reported
Cause(s) of Death: inaugural seizure; Seizures (generalized); General physical
health deterioration" "No prior vaccinations for this event."
"1247832-1" "1247832-1" "patient was vaccinated with second covid vaccine on
2/12/21. Patient was admitted to the hospital on 03/04/2021 with fatigue and
diagnosed with COVID 19 (positive lab test on 2/26/21 and 3/4/21). Case expired on
"1250291-1" "1250291-1" "suspected aspiration pneumonia; Vaccination
failure/COVID-19 confirmed by positive COVID-19 test with symptoms; COVID-19
confirmed by positive COVID-19 test with symptoms; This is a spontaneous report
from a contactable pharmacist downloaded from a regulatory authority-WEB with
regulatory authority number FR-AFSSAPS-DJ20210885 and Safety Report Unique
Identifier is FR-AFSSAPS-2021037781. A 67-year-old male patient received bnt162b2
(COMIRNATY), dose 2 intramuscular on 05Feb2021 (Lot Number: EJ6788) as a single
dose; and dose 1 intramuscular on 15Jan2021 (Lot Number: EM0477) as a single dose
for covid-19 immunisation. Medical history included tobacco user, anxio-depressive
syndrome, hypertension arterial, chronic alcoholism (hepatic cirrhosis), alcoholic
cirrhosis, chronic obstructive pulmonary disease (COPD) under oxygen 2L / min day
and night and ischemic stroke from 2003 to an unknown date. Concomitant medications
included fluindione (PREVISCAN); budesonide; salbutamol; acetylsalicylate lysine
(KARDEGIC); ipratropium; tiotropium bromide (SPIRIVA); and tramadol hydrochloride
(TOPALGIC), indication, start and stop date were not reported. It was reported that
on 01Apr2021, the experienced covid-19 pcr test positive and vaccination failure.
It was further reported that the patient received the first dose of COMIRNATY on
15Jan2021 and the second dose on 05Feb2021. On 01Apr2021, the patient is vomiting
and was more tired. He didn't have fever. On 02Apr2021, the RT-PCR is positive with
the presence of mutations suggestive of the variant. Also on 02Apr2021, the death
of the patient was observed at 6 a.m. in his bed before the results of the PCR. The
reported cause of death was suspected aspiration pneumonia. The patient underwent
lab tests and procedures which included COVID-19 PCR test was positive on 02Apr2021
which showed positive with the presence of mutations suggestive of the variant. The
outcome of the events was fatal. The patient died on 02Apr2021. An autopsy was not
performed. No follow-up attempts are possible, no information is expected.;
Sender's Comments: Linked Report(s) : FR-AFSSAPS-DJ20210888 AFSSAPS;FR-AFSSAPS-
DJ20210896 AFSSAPS;FR-AFSSAPS-DJ20210890 AFSSAPS;FR-AFSSAPS-DJ20210892 AFSSAPS;FR-
AFSSAPS-DJ20210893 AFSSAPS;FR-AFSSAPS-DJ20210886 AFSSAPS; Reported Cause(s) of
Death: suspected aspiration pneumonia" "No prior vaccinations for this event."
"1250307-1" "1250307-1" "Patient's COVID-19 PCR test was positive on
08Apr2021; Patient's COVID-19 PCR test was positive on 08Apr2021; patient's first
dose given on 11Feb2021 and second dose on 25Mar2021; patient's first dose given on
11Feb2021 and second dose on 25Mar2021; This is a spontaneous report from a
contactable physician downloaded from the Agency Regulatory Authority-WEB,
regulatory authority number FR-AFSSAPS-MP20211192. A 99-year-old female patient
received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm on
25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19
immunization; bnt162b2 (COMIRNATY), dose 1 via unspecified route of administration
on 11Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19
immunization. Medical history included ongoing heart failure, dyspnea, and pleural
effusion. The patient's concomitant medications were not reported. The patient's
COVID-19 PCR test was positive on 08Apr2021. The patient underwent lab tests and
procedures which included Covid-19 PCR test: negative on 01Apr2021 and Covid-19 PCR
test: positive on 08Apr2021. The patient died on 10Apr2021 due to COVID-19. An
autopsy was not performed. No follow-up attempts are possible; information on
lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid" "No
"1250308-1" "1250308-1" "Vaccination failure/ On 23Mar2021, patient tested
PCR + for SARSCov2; Vaccination failure/ On 23Mar2021, patient tested PCR + for
SARSCov2; hypokalaemia 3.07 mmol/L; increased SRIS; tachycardia; Clinically fatty
cough without expectoration; neutrophil count 10 g/L; lymphopenia 0.5 g/L; Thoracic
CT: pneumopathy in the lower right lobe; This is a spontaneous report from a
contactable healthcare professional downloaded from the Regulatory Authority-WEB.
The regulatory authority number is FR-AFSSAPS-NC20211589 and the other case
identifier is FR-AFSSAPS-2021038008. An 88-year-old male patient received BNT162B2
(COMIRNATY) on 28Jan2021 (lot number: EJ6788) as first dose and on 16Feb2021 (lot
number: EJ6788) as second dose, both intramuscular at single dose for COVID-19
vaccination. Medical history included transient ischemic attack, anemia, beta
thalassemia minor, acute cholecystitis, mixed vascular dementia (cortical and
subcortical), partial epilepsy, hiatal hernia, arterial hypertension, pericarditis,
pneumonia with pleural effusion from Feb2020, alcoholic polyneuritis, and pyloric
stenosis. The patient is a GIR2 patient (as reported) residing in a nursing home.
Concomitant medications included tamsulosin, acetylsalicylate lysine (KARDEGIC),
lansoprazole, and folic acid. On 23Mar2021, the patient experienced vaccination
failure as he tested PCR positive (+) for SARS-Cov-2; the patient became
symptomatic: asthenia, hitchhiking and desaturation from 02Apr2021 prompting
hospitalization on 03Apr2021. Clinical examination on 03Apr2021: oxygen-retaining
at 6 L/min, bilateral crackles, polypneic without sign of struggle, no sign of
cardiac decompensation. Biology: D-dimer at 882, moderate anemia, CRP at 189.6
mg/L, BNP at 465 and troponins at 203. GDS: pH: 7.476, pCO2: 36.0, pO2: 71.1.
Thoracic CT: pneumopathy in the lower right lobe, presence of the VARIANT. Gradual
degradation. On 10Apr2021, afebrile, stable HD, hypertension and tachycardia, 92%
SAO2 under 7 L/ min with glasses. Clinically fatty cough without expectoration:
risk of major aspiration. No acute respiratory distress. Respiratory rate 22 cpm,
CRP 200 vs 100, and WBC 11 g/L including neutrophil count 10 g/L and persistence of
lymphopenia 0.5 g/L, hypokalaemia 3.07 mmol/L. D3 of tazocillin: extended
antibiotic therapy on increased SRIS, initiation of Dexamethasone on increase in O2
requirements above 6 L/ min, supplementation K + 1 g/24H in reaction + bio control
H48, introduction of SAP midazolam 0.2 mg/H for anxiolysis because it removes O2.
Summary of management: Hospitalized patient. Degradation in hospital with fatal
outcome on 12Apr2021 in the morning. Conclusion: Vaccine ineffectiveness with fatal
outcome. The pharmacovigilant notes: Accountability score (s) established without
prejudice to the elements of investigation which could be carried out within the
framework of legal or amicable compensation procedures.Official Bulletin of the
Minister in charge of Health no.84/50, January 24, 1985. Published in Therapy 1985;
40: 111-8. The patient died on 12Apr2021. The causes of death were vaccination
failure and COVID-19. It was unknown if autopsy was performed. The outcome of all
other events was unknown. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Vaccination failure/ On
23Mar2021, patient tested PCR + for SARSCov2; Vaccination failure/ On 23Mar2021,
patient tested PCR + for SARSCov2" "No prior vaccinations for this event."
"1250695-1" "1250695-1" ""He died on 22Feb; Apparently pneumonia; Oxygen
dropped; couldn't eat anymore; He had silent delirium and was absent; couldn't
drink anymore; Tested positive for corona on 17Feb2021; Drug ineffective; This is a
spontaneous report from a contactable consumer or other non hcp downloaded from the
Medicines Agency (MA) -WEB NL-LRB-00507869. A 72-years-old male patient received
BNT162B2 (Pfizer-vaccine), dose 1 via an unspecified route of administration on
29Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation.
Medical history included ongoing dementia, covid-19 from Mar2020 to an unknown date
(disease symptoms: hospitalization). The patient's concomitant medications were not
reported. The patient died on 22Feb2021; patient experienced oxygen dropped
(oxygen saturation decreased) (death) on 17Feb2021, couldn't eat anymore (feeding
disorder) (death) on 17Feb2021 , he had silent delirium and was absent (delirium)
(death) on 17Feb2021, couldn't drink anymore (fluid intake reduced) (death) on
17Feb2021, tested positive for corona on 17feb2021 (covid-19) (death) on 17Feb2021,
drug ineffective (drug ineffective) (death) on 17Feb2021. The patient underwent
lab tests and procedures which included sars-cov-2 test positive on 17Feb2021,
urine analysis unknown results on an unspecified date, ventilation/perfusion scan
unknown results on an unspecified date, pulmonary function test unknown results on
an unspecified date, oxygen saturation dropped on 17Feb2021. Therapeutic measures
were taken as a result of oxygen dropped (oxygen saturation decreased), couldn't
eat anymore (feeding disorder), he had silent delirium and was absent (delirium),
couldn't drink anymore (fluid intake reduced) , tested positive for corona on
17feb2021 (covid-19). The patient died on 22Feb2021, cause of death was also
reported as apparently pneumonia. It was not reported if an autopsy was performed.
The clinical course was reported as follows: ""This serious spontaneous report from
a consumer or other non-health professional concerns a male aged 72 years, with
death nos (death), Covid 19 (death), hypoactive delirium (death), unable to eat
(death), oxygen saturation decreased (death), fluid intake reduced (death)
following administration of covid-19 vaccine pfizer (Injection fluid) (action
taken: not applicable) for Covid 19 immunisation. Treatment: on 18Feb2021 Covid 19
is treated with mechanical ventilation, on 18Feb2021 fluid intake reduced is
treated with mechanical ventilation, on 18Feb2021 hypoactive delirium is treated
with mechanical ventilation, on 18Feb2021 oxygen saturation decreased is treated
with mechanical ventilation and on 18Feb2021 unable to eat is treated with
mechanical ventilation. The outcome of Covid 19 is fatal, the outcome of death nos
is fatal, the outcome of fluid intake reduced is fatal, the outcome of hypoactive
delirium is fatal, the outcome of oxygen saturation decreased is fatal and the
outcome of unable to eat is fatal. Drugs and latency: 1. Covid-19 vaccine pfizer
(Injection fluid), death nos: 22 days after start, Covid 19: 19 days after start,
hypoactive delirium: 19 days after start, unable to eat: 19 days after start,
oxygen saturation decreased: 19 days after start, fluid intake reduced: 19 days
after start. Concomitant medication: non specified drug. Medical history Covid 19,
dementia. Additional information ADR: After vaccination on 29Jan2021 he was feeling
well. He got fitter than before. Suddenly on 17Feb2021, he collapsed on. On
18Feb2021 - artificial respiration. He had silent delirium and was absent - could
no longer eat and drink. Oxygen dropped. He had already had Corona in March and was
quarantined for it. He never had a cold and had no complaints when he had corona
last year. BSN available: yes. Confounding factors: dementia. Previous COVID-19
infection: disease symptoms: hospitalization. Other: diagnostic procedures: They
examined lungs and a urine and did lung scan. Pfizer vaccine LOT number: UNKNOWN.
Reporter Comment: Past drug therapy BioNTech/Pfizer vaccin : no. 22Feb died.
Additional information ADR: After vaccination on 29Jan2021 he was feeling well. He
got fitter than before. Suddenly on 17Feb2021, he collapsed on. On 18Feb2021 -
artifical respiration. He had silent delirium and was absent - could no longer eat
and drink. Oxygen dropped. He had already had Corona in March and was quarantined
for it. He never had a cold and had no complaints when he had corona last year. BSN
available: yes. Confounding factors: dementia. Previous COVID-19 infection:
disease symptoms: hospitalization. Other: diagnostic procedures: They examined
lungs and a urine and did lung scan. No follow-up attempts are
of Death: Apparently pneumonia; Hypoactive delirium; Fluid intake reduced; COVID-
19; Drug ineffective; Death NOS; Oxygen saturation decreased; Unable to eat""
"1255836-1" "1255836-1" "Presented to ED on 1/12/21 slowly worsening constant
myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter
not acting herself and more confused. Clinical impressions included hypoxia, COVID-
19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care
steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at
1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC
success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became
pulseless and expired at 0451." "No prior vaccinations for this event."
"1257542-1" "1257542-1" "Pneumonia; COVID-19 confirmed by positive COVID-19
test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report
from a non-contactable consumer or other non hcp downloaded from a regulatory
authority-WEB [regulatory authority number: DE-PEI-CADR2021047458]. An 85-year-old
male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of
administration on 20Jan2021, dose 2 via an unspecified route of administration on
10Feb2021 (Batch/Lot Number: EK9877); both at vaccination age of 85 years old as
single dose for covid-19 immunisation. The patient medical history and concomitant
medications were not reported. On 10Mar2021 the patient experienced pneumonia,
COVID-19, vaccination failure. The patient underwent lab tests and procedures which
included PCR-Covid-Test: positive on 10Mar2021 and positive on 19Mar2021. The
patient's outcome was fatal for Pneumonia, fatal for COVID-19. The patient died on
31Mar2021. It was not reported if an autopsy was performed. Sender's comment: The
affected person received both vaccine doses from Comirnaty (20Jan21 and 10Feb21).
One month after the second vaccination (10Mar21) the person got sick with Covid-19.
The first symptoms were cough, runny nose and general symptoms of illness. On
19Mar2021 a PCR test was positive for Covid-19. On 25Mar2021, the affected person
developed pneumonia. The affected person was treated on an outpatient basis and
hospitalization was required. The person concerned died on 31Mar2021. Relatedness
of drug to reaction/events: It was D. Unclassifiable for all events per a
regulatory authority. No follow up attempts are possible, no further
information is expected. ; Reported Cause(s) of Death: Pneumonia; COVID-19
confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test"
"1257606-1" "1257606-1" "COVID-19; Drug ineffective; This is a spontaneous
report from Medical Agency, regulatory authority number FR-AFSSAPS-TO20212594. A
contactable physician reported that a 99 year old female patient received the
second dose of BNT162B2 (Pfizer vaccine, Lot number unknown) intramuscularly at
single dose for COVID-19 immunisation on 04Feb2021, the patient receive the first
dose of Pfizer vaccine intramuscularly at single dose for COVID-19 immunisation on
12Jan2021. Relevant history included FA (arterial fibrillation) and HTA (arterial
hypertension). Relevant concomitant drugs included folic ac, apixaban (ELIQUIS),
mirtazapine (NORSET), colecalciferol (UVEDOSE), oxazepam (SERESTA), all were long-
term used. The clinical course was reported as: 10Feb2021, the patient was
asthenic and listless since. 13Feb2021: resident found reactive in bedroom;
clinical signs: significant decrease in appetite, asthenia ++, desaturation,
diarrhea; call of 15: put under O2: 2l / min and no hospitalization. 16Feb2021:
Positive PCR test, English variant B.1.1.7. 17Feb2021: no longer takes anything
orally, asthenia ++, fever at 38.6 deg C , desaturation at 94% under 3l / min, goes
back to 92% after respiratory physiotherapy, not painful. Gradually deterioration
of the general condition: introduction of 5% Glucose, comfort care; clinically:
dyspnea on congestion: physiotherapist spends 2f / day to do respiratory
physiotherapy; not painful, asthenia ++, black tongue. Respiratory physiotherapy
continued on February 19, 20 and 21. Death was noted on 22Feb2021 at 6 am by the
nursing team; SOS doctor came to notice the death in the morning. No follow-up
attempts are possible. No further information is expected. Information on batch/lot
number cannot be obtained.; Reported Cause(s) of Death: Drug ineffective; COVID-19"
"1260554-1" "1260554-1" "THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER
DATED 23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April
12, she was admitted for septic shock and multi-organ failure (MOF) that resulted
in the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
23Mar2021. ON APRIL 08TH, SHE WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12,
she was admitted for septic shock and multi-organ failure (MOF) that resulted in
the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
the death of the patient; THE PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED
the death of the patient; This is a spontaneous report from a contactable physician
downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-
MINISAL02-716828. An 86-years-old female patient received 2nd dose of BNT162B2
(Pfizer vaccine, Formulation: Solution for injection) intramuscular on 24Mar2021
(Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. Medical
history included pulmonary embolism, depressive symptom, intestinal, atrial
fibrillation, hyperthyroidism, osteoarthritis, type 2 diabetes mellitus from an
unknown date and unknown if ongoing. The patient's concomitant medications were not
reported. On 08Apr2021, the patient experienced the vaccination failure,
coronavirus infection, septic shock and multiple organ dysfunction syndrome and was
positive to nasopharyngeal tampon. On 12 Apr 2021, she was admitted for septic
shock and multi-organ failure (mof) that resulted in the death of the patient.
Reporter comment: The death was related to multi-organ failure in the course of
septic shock in covid-19 positive post-vaccination (16 days interval between second
vaccination and positive swab and symptomatology). The action taken in response to
the events for bnt162b2 was not applicable. Actions taken (Non-invasive ventilation
with CPAP modality, empiric IV antibiotic therapy with ceftriaxone, meropenem and
vancomycin, high-flow oxygen therapy, administration of vasoactive amines, EBPM at
anticoagulant dosage, hydration and bicarbonate supplementation. Performance of
hemocultures with positive finding for Staphylococcus Capitis). The patient died on
12Apr2021. It was not reported weather an autopsy was performed or not.; Reporter's
Comments: The death was related to multi-organ failure in the course of septic
shock in covid-19 positive post-vaccination (16 days interval between second
vaccination and positive swab and symptomatology).; Reported Cause(s) of Death: THE
PATIENT RECEIVED SECOND VACCINE COVID PFIZER DATED 23Mar2021. ON APRIL 08TH, SHE
WAS POSITIVE TO Nasopharyngeal TAMPON. On April 12, she was admitted for septic
shock and multi-organ failure (MOF) that resulted in the death of the patient; THE
PA" "No prior vaccinations for this event."
"1265029-1" "1265029-1" "Vaccination failure/Patient PCR + (positive) COVID
on 16Mar2021, 39 days after the second dose; Patient PCR + (positive) COVID on
16Mar2021, 39 days after the second dose; This is a spontaneous report from a
authority number FR-AFSSAPS-BX20213213. An 84-year-old female patient received
bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 05Feb2021
(lot number: EJ6788) as single dose, and dose 1 intramuscular, administered in
right arm on 16Jan2021 (lot number: EJ6795) as single dose for COVID-19
immunisation. Medical history included dementia, meningioma surgery, arterial
hypertension; all from an unknown date and unknown if ongoing, and ongoing residing
in nursing homes. The patient's concomitant medications were not reported. The
patient experienced vaccination failure/patient PCR + (positive) COVID on
16Mar2021, 39 days after the second dose. Lung deterioration 3 days later,
implementation of comfort care in agreement with the family, death on 02Apr2021. No
information on the variant. The patient underwent COVID-19 PCR test: positive on
16Mar2021. The patient died on 02Apr2021 due to COVID-19 infection. An autopsy was
not performed. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: Infection COVID" "No prior vaccinations
for this event."
"1265037-1" "1265037-1" ""Vaccination failure/tested PCR + for
SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination
failure/tested PCR + for SARSCov2/Covid-19 type pneumonia with severe involvement
(50/70%); Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia
with severe involvement (50/70%); COVID-19 complicated by superinfection; severe
dehydration; disoriented; Na: 153 mmol/l; This is a spontaneous report from a
contactable healthcare professional downloaded from the regulatory authority-WEB,
regulatory authority number FR-AFSSAPS-NC20211590. This healthcare professional
reported similar events for two patients. This is the first of two reports. An 85-
year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on
28Jan2021 (Batch/Lot Number: EJ6788/EJ6788) as single dose; and dose 2 via an
unspecified route of administration on 16Feb2021 (Batch/Lot number was not
reported) as single dose for covid-19 immunisation. Medical history included
prostate adenoma, macular degeneration, renal failure, biliary lithiasis,
follicular B lymphoma in remission and post-chemotherapy pulmonary disease from
2014. The patient's concomitant medications were not reported. The GIR2 patient
residing in nursing house was vaccinated with COMIRNATY carried out on 28Jan2021
(D1) and 16Feb2021 (D2). On 15Mar2021, the patient tested PCR + for SARSCov2; the
patient also presented abnormal ""facies"". Stability at first then degradation
with desaturation which motivated his hospitalization on 29Mar2021. On admission
(29Mar2021), PAS/PAD: 152/75 mmHg, FC (heart rate): 65 bpm , SAT/O2: 92% /6 l/min,
T: 36.2 degrees C, GC: 1.06 g/l, ScGw: 15 = Y4/V5/M6, BU: Leuco/Nitrites/Blood:
-/-/traces, details: pro +. Clinically, patient was conscious but disoriented,
under O2 mask 6 l/min, cough, crackling of the 2 fields, supple calves, no other
sign of HF. Biology showed D dimer 1300, BNP 34 pg/ml, CKD 40ml, gb 15000 without
lymphopenia, tropo 73, hyperleukocytosis at 15 G/l at PNN (83.7 G/l), platelet 191
G/l, CRP 237 mg/l, Na: 153 mmol/l, urea: 14.7 mmol/l, serum creatinine 137 umol/l
and osmolality 338 mosm/l. Imaging showed Covid-19 type pneumonia with severe
involvement (50/70%). Diagnosis of COVID-19 complicated by superinfection and
context of severe dehydration. No variant analysis performed at the time of his
hospitalization. However, for all positive patients who were tested for a variant,
the variant was found. Patient was placed on corticosteroids, Lovenox and augmentin
before hospitalization. Other treatments inlcuded tamsulosin and Seresta. Rapid
deterioration in hospital with fatal outcome on 04Apr2021 in the evening.
Conclusion: Vaccine ineffectiveness with fatal outcome. The outcome of the events
was unknown. The patient died on 04Apr2021 due to vaccination failure, COVID-19 and
COVID-19 pneumonia. It was unknown if an autopsy was performed. The
pharmacovigilant notes: Accountability score (s) established without prejudice to
the elements of investigation which could be carried out within the framework of
legal or amicable compensation procedures "" No follow-up attempts possible. No
further information expected.; Sender's Comments: Linked Report(s) : FR-PFIZER INC-
2021431443 same reporter/drug, similar events, diferent patients; Reported Cause(s)
of Death: Vaccination failure/tested PCR + for SARSCov2/Covid-19 type pneumonia
with severe involvement (50/70%); Vaccination failure/tested PCR + for
SARSCov2/Covid-19 type pneumonia with severe involvement (50/70%); Vaccination
failure/tested PCR + for SARSC"" "No prior vaccinations for this event."
"1265519-1" "1265519-1" "Cardiorespiratory insufficiency due to COVID-19;
Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency
due to COVID-19; This is a spontaneous report downloaded from the Regulatory
Authority-WEB (Regulatory Authority report number: HU-OGYI-201721). A contactable
healthcare professional (contactable through Regulatory Authority only) reported
that an 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY,
Lot Number: EL0725; Expiration date was not reported), intramuscularly on the right
arm on 17Feb2021 as a single dose for COVID-19 immunization. Medical history
included hypertension, cholecystectomy, carotid artery stenosis, diabetic
nephropathy, vertebrobasilar insufficiency, ischemic heart disease, hypertensive
encephalopathy and diabetes; all were not ongoing. Concomitant medications included
alprazolam (FRONTIN), allopurinol (MILURIT), urapidil (EBRANTIL), fenofibrate
(FENOSWISS), amlodipine besilate (NORMODIPINE), rosuvastatin, amlodipine besilate,
indapamide, perindopril arginine (COVERCARD PLUS), acetylsalicylic acid and
piracetam (NOOTROPIL). On 07Mar2021, the patient had tested positive to COVID-19
antigen test (symptoms described as dizzy, weak, and had headache and cough). The
patient's chest X-ray showed bilateral multifocal infiltration, congestion and
cardiomegaly and C-reactive protein was 94.8 mg/l; both on 10Mar2021. On 22Mar2021,
the patient had cardiorespiratory insufficiency. The patient had died on 22Mar2021,
and the cause of death was cardiorespiratory insufficiency due to COVID-19. It was
unknown if an autopsy was performed. The causal relationship between the reported
death and Comirnaty was considered unlikely. Follow-up activities have been
closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of
Death: cardiorespiratory insufficiency due to COVID-19; cardiorespiratory
insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19"
"1267468-1" "1267468-1" "patient received her covid vaccine per her record:
1/3 and 1/24/21. Patient presented to Facility 4/20/21 diagnosed with COVID,
patient died 4/23/21 due to hypoxic respiratory failure/ bilateral pneumonia due to
covid." "No prior vaccinations for this event."
"1269848-1" "1269848-1" "Death Narrative: Patient was admitted to facility
from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and
poor oral intake. Admission was uneventful and follow-up notes post discharge from
both Cardiology APRN and Primary Care Physician that the Patient was recovering
well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and
second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15
minutes after administration of each dose. No reaction was noted during the post
vaccination observation period of either dose. Notice of death was received 5 days
after second dose of Covid Vaccine from funeral home. There were no reports of an
ADR occurring between observation period and death. There were no progress notes in
patients chart between second Covid 19 Vaccine note 4/22/201 and death notice
4/27/2021. Cause of death is unknown at this time." "No prior vaccinations for
this event."
"1269851-1" "1269851-1" "Death Narrative: Patient was previously tested
COVID-19 positive on 3/2/2021, but did not have any other predisposing factors(PMH,
allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at
the time of the administration of the vaccine nor was there an ADR that occurred
between the observation period and the date of death. Patient was admitted with
afib with RVR on 2/17/21 and was having a HFrEF exacerbation. HR was controlled
during admission and he was discharged on 2/19/21. Patient was hospitalized 4 more
times over the next two months for cardiac symptoms with last hospitalization
occurring 4/12/21 for hypotension/tachycardia and decompensated heart failure.
Patient never recovered and transitioned to hospice before passing on 4/16/21.
Patient had a PMH significant for afib s/p DCCV on eliquis, CKD, HFpEF on home O2
2L, PMR on prednisone, known R pleural effusion, Covid PNA in 11/2020 and chronic
foley" "No prior vaccinations for this event."
"1271190-1" "1271190-1" "Contracted COVID-19 on 4/4/2021, Pt. demise
"1274892-1" "1274892-1" "Vaccination failure; PCR carried out on 24Mar2021 is
positive for SarsCov-2; This is a spontaneous report from a contactable pharmacist
downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-
AN20211330. Safety Report Unique Identifier is FR-AFSSAPS-2021039336. A 86-years-
old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2
via an unspecified route of administration on 12Feb2021 (Lot Number: EJ6789), dose
1 via intramuscular route, in Arm Left on 19Jan2021 (Lot Number: EJ6795), both as
single dose for covid-19 immunization. Medical history included arterial
hypertension, permanent atrial fibrillation, mixed anxiety and depressive disorder
(chronic anxiety-depressive syndrome), hypercholesterolemia, hypertensive and
rhythmic heart disease, thyroid insufficiency and cardiac pacemaker insertion. The
patient had no history of anaphylactic shock. Concomitant medications included:
bisoprolol (2.5 mg) tablet, 1 DF in the morning, paracetamol (DOLIPRANE) 1 gram
morning, noon and evening, econazole (ECONAZOLE) 1% powder, 1 application morning
and evening, apixaban (ELIQUIS) (2.5 mg) 1 morning and evening, furosemide (40 mg)
1 in the morning, furosemide (500 g) 1/2 in the morning and at noon, levothyroxine
sodium (LEVOTHYROX) 125 �g in the morning, levothyroxine sodium (LEVOTHYROX) (25
�g) 1/2 in the morning, oxazepam (SERESTA) 10 mg as needed, macrogol 3350,
potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous
(TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM
CHLORIDE;SODIUM SULFATE ANHYDROUS]) as needed and salbutamol (VENTOLIN
[SALBUTAMOL]) (100 �g / dose) 2 doses morning, noon and evening. The patient
considered to be at risk of developing a serious form of COVID based on her age.
Previously the patient was not infected with Covid-19. On 23Mar2021, the patient
worsened clinically with the onset of a fatty cough, clear sputum, oxygen
regression (90% Sat under oxygen), crackles in the left base, afebrile. The patient
had already felt very asthenic the previous days and was lying more and more in her
bed. From 23Mar2021, she is initially put on Augmentin 1gram / 125 mg three times a
day for 7 days, and oxygen therapy. The hypotheses put forward are a new cardiac
decompensation, a lung infection or a COVID infection. The PCR carried out on
24Mar2021 is positive for SarsCov-2, an English variant found and had vaccination
failure. She was then transferred to a hospital unit for further care. She had
received the second dose of the vaccine by Comirnaty 6 weeks before. On 24Mar2021,
the patient's hypokalaemia at 3.3 mmol / l was demonstrated on the blood test but
there was no inflammatory syndrome. Augmentin is stopped and Diffu K is introduced.
On 25Mar2021, the patient was increasingly asthenic, became confused, saturation
was 90% under 3L of O2, had some nausea during meals, fever at 38 C. The PCR came
back positive that day and she was transferred for further treatment. The patient
was conscious, not oriented, respiratory distress with slight pulling and invasion
of the 2 lungs with crackles with spasticity. On 26Mar2021, pulmonary auscultation
improved, the patient remained very asthenic, was febrile, presented serious risk
factors (with lymphopenia at 644 / mm3, thrombocytopenia at 121 G / L). She
probably has an associated cardio-renal syndrome. On 26Mar2021, the patient
underwent lab tests and procedures which included: ALAT: 19 iu/l, AST: 65 iu/l,
serum albumin: 32 g/l, LDH: 705 iu/l, potassium: 3.6 mmol/l, sodium: 143 mmol/l,
TSH: 0.69 uiu/ml, CRP: 20.6 mg/l, GGT: 69 iu/l, haemoglobin: 14.6 g/dl, lymphocyte
count: 644 /mm3 and oxygen saturation: 90 %. On 29Mar2021, there was a
deterioration in his respiratory state with desaturation requiring a high
concentration mask. The cracklings are present in a diffuse way. She is very
asthenic, and every word spoken is extremely short of breath, she is dehydrated and
there is a sudden increase in ferritin at 1700, witnessing the inflammatory passage
of COVID. The IV hydration, corticosteroid therapy and PES furosemide are set up.
On 01Apr2021, she was still feverish at 39.4 C sweating with 82% saturation under
9L of O2, there was cyanosis of the extremities. On 05Apr2021, she deteriorates
more and more at the respiratory level, then enters a state of coma, is reactive.
She died during the day at 12:45 p.m. An autopsy was not performed. The outcome of
events was fatal. No follow-up attempts possible. No further information expected.
Amendment: This follow-up report is being submitted to amend previously reported
Information: Amended Listedness of vaccination failure from listed to unlisted and
added new event Covid-19.; Reported Cause(s) of Death: Respiratory distress
following vaccine failure" "No prior vaccinations for this event."
"1274939-1" "1274939-1" "death of the patient; Vaccination failure/ positive
COVID PCR test (screening: variant); Vaccination failure/ positive COVID PCR test
(screening: variant); This is a spontaneous report from contactable pharmacist
downloaded from a regulatory authority-WEB, regulatory authority report number: FR-
AFSSAPS-NT20211117, Safety Report Unique Identifier: FR-AFSSAPS-2021039449. An 88-
year-old female patient received bnt162b2 (COMIRNATY), second dose on 11Feb2021
(lot number: EJ6789) and first dose on 21Jan2021 (lot number: EJ6795), both via
intramuscular as single dose for COVID-19 immunisation. Medical history included
dementia alzheimer's type, starvation, myocardial infarction, falling down,
bradycardia, hypothyroidism, fracture of the 2 lower limbs, road accident, Arterial
hypertension, and COVID-19. Concomitant medications included bisoprolol fumarate
(CARDENSIEL); acetylsalicylate lysine (KARDEGIC); levothyroxine sodium
(LEVOTHYROX); oxazepam (SERESTA); colecalciferol (ZYMAD); paracetamol (DAFALGAN);
chlorphenamine maleate, dextromethorphan hydrobromide, guaifenesin, phenylephrine
hydrochloride (DEXERYL); macrogol 3350, potassium chloride, sodium bicarbonate,
sodium chloride (MOVICOL); and dietary supplement. The patient experienced death of
the patient on 12Apr2021, and vaccination failure/ positive covid pcr test
(screening: variant) on 01Apr2021 with outcome of unknown. The event 'vaccination
failure/ positive covid pcr test' was assessed as medically significant. The
clinical course was reported as follows: Resident of nursing home GIR1 - ambulation
- Person prone to swallowing disorder. On 21Jan2021: 1st dose of COMIRNATY and on
11Feb2021: 2nd dose of COMIRNATY. On 01Apr2021, patient was positive COVID PCR test
(screening: English variant). The patient did not develop a severe form of the
disease: no cough, no fever, no desaturation, no polypnea, but severe fatigue. On
11Apr2021: fatigue, eats very little. Body temperature at 36.6 C and minimum 96% O2
saturation. On 12Apr2021: resident crowded at breakfast, eats little. At lunch,
also eat very little. The patient left for a walk after lunch, fell suddenly and
died quickly. She was found with phlegm in her mouth. Doctor was called then
patient was put into immediate burial (no autopsy). NB: mouth treatments had been
carried out to see if there was any foreign body but nothing had been found. On
12Apr2021: death of the patient. NB: Accountability without prejudice to the
elements of investigation which could be carried out within the framework of legal
procedures. The patient died on 12Apr2021. An autopsy was not performed. No
Cause(s) of Death: death of the patient" "No prior vaccinations for this event."
"1274975-1" "1274975-1" "Reduced general condition; incoherent remarks;
hallucinations; anorexia; 2 falls; malaise; ARDS; Vaccination failure; Vaccination
failure/ ARDS linked to covid-19 infection; degradation of his chronic renal
failure (Cl at 25 mL/min); dehydrated; malnourished; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB. The
regulatory authority number is FR-AFSSAPS-PA20210562. An 83-year-old male patient
received BNT162B2 (COMIRNATY, lot number and expiration date were unknown),
intramuscular on 19Feb2021 as first dose and on 19Mar2021 as second dose at 0.3 mL,
single for COVID-19 immunisation. Medical history included adult T-cell leukemia-
lymphoma which was not ongoing (in remission with CT), radiotherapy (RT) and
gastrectomy in 1996, ongoing cardiac arrhythmia (NOS), ongoing hypertension
arterial, ongoing chronic renal insufficiency, and concept of benign liver tumor
but normal liver markers. Concomitant medications included bisoprolol fumarate
(CARDENSIEL); furosemide (LASILIX); perindopril arginine (COVERSY);
acetylsalicylate lysine (KARDEGIC); and alfuzosin hydrochloride (XATRAL), calcium
and PPI. The patient experienced reduced general condition on 19Mar2021 and
vaccination failure on 14Apr2021. The course of events was as follows: Notion of
incoherent remarks/hallucinations reported by the family in the aftermath of this
second dose associated with an alteration of the general condition (anorexia, 2
falls on malaise) on an unspecified date in 2021 leading to hospitalization in
geriatrics from 05Apr2021 to 15Apr2021. The patient was dehydrated and malnourished
on an unspecified date in 2021 with degradation of his chronic renal failure (Cl at
25 mL/min) on arrival (05Apr2021). 3 PCR tests were carried out during
hospitalization: negative on 06Apr2021, undetermined on 13Apr2021 and positive
(weakly) on 14Apr2021 (search for mutation not done because too little virus). On
14Apr2021, appearance of respiratory distress requiring high flow oxygen (OPTIFLOW)
but not sufficient. On 15Apr2021, the patient died from ARDS linked to COVID-19
infection. Note that the service hosts a COVID-19 unit. In total, death of an 83-
year-old man, hypertensive and chronic renal failure, as a result of a severe form
of COVID-19 in a context of SAE since second dose and confirmed vaccine failure.
The patient underwent lab tests and procedures which included SARS-COV-2 PCR test:
negative on 06Apr2021, undetermined on 13Apr2021, and positive (weakly) on
14Apr2021; creatinine clearance: 25 mL/min on 05Apr2021; and liver markers: normal
on an unspecified date. The patient died on 15Apr2021. The causes of death were
ARDS linked to COVID-19 infection and vaccination failure. An autopsy was not
performed. The outcome of the event reduced general condition was not recovered and
unknown for all other events. No follow-up attempts are possible; information on
lot/batch number cannot be obtained. No further information is expected.; Reported
Cause(s) of Death: ARDS; Vaccination failure; Vaccination failure/ ARDS linked to
covid-19 infection" "No prior vaccinations for this event."
"1275079-1" "1275079-1" "COVID antigen test positive/sars-cov-2 test PCR:
positive stain; COVID antigen test positive/sars-cov-2 test PCR: positive stain;
Regulatory Authority (RA)-WEB, regulatory authority number FR-AFSSAPS-RN20211105.
An 82-year-old female patient received BNT162B2 (COMIRNATY) dose 1 via unspecified
route of administration (Batch/Lot Number: Unknown) in Jan2021; and dose 2
intramuscular (Batch/Lot Number: EJ6788) in Feb2021 for COVID-19 immunization.
Medical history included in situ follicular lymphoma, shoulder arthroplasty,
hypothyroidism and COVID-19. Concomitant medications included sulfamethoxazole,
trimethoprim (BACTRIM FORTE); valaciclovir hydrochloride (ZELITREX); calcium
folinate (LEDERFOLINE); paracetamol; esomeprazole; mianserin (MIANSERIN);
phloroglucinol (SPASFON); bilastine; zopiclone; levothyroxine sodium (LEVOTHYROX);
all taken for an unspecified indication, start and stop date were not reported; and
3 courses of the association zanubrutinib (BRUKINSA) and obinutuzumab (GAZYVARO)
taken for lymphoma from an unspecified start date to Mar2021. The patient
experienced degradation of general health status in the middle of Mar2021: antigen
test positive on 23Mar2021. On 25Mar2021, patient hospitalized for general health
status degradation with fever at 38.5 degrees, saturation at 87% in ambient air
requiring oxygen supplementation, sars-cov-2 test PCR: positive stain.
Dexamethasone was introduced. On 01Apr2021, no improvement, patient was still
hospitalized and treated with dexamethasone, increase of oxygen supplementation as
saturation was 85%, strong asthenia, respiratory frequency at 30, sweating, dry
cough, diffuse crackling. The patient died on 01Apr2021. It was not reported if an
autopsy was performed. The events were reported as serious-fatal. Reporter's
comment: degradation of general health status in the middle of Mar2021 : antigen
test positive on 23Mar2021. On 25Mar2021, patient hospitalized for general health
status degradation with fever at 38.5 degrees, saturation at 87% in ambient air
requiring oxygen supplementation. Dexamethasone introduced. On 01Apr2021, no
improvement, patient still hospitalized and treated with dexamethasone, increase of
oxygen supplementation as saturation was 85%, strong asthenia, respiratory
frequency at 30, sweating, dry cough, diffuse crackling. death of patient on
01Apr2021; Reported Cause(s) of Death: antigen test positive/sars-cov-2 test PCR:
positive stain; antigen test positive/sars-cov-2 test PCR: positive stain" "No
"1275092-1" "1275092-1" "hospitalized following a fall; increase in the
weight loss; Vaccination failure; COVID-19; wound on the bridge of the nose; open
nose fracture; o the emergency room and there was a fracture of the left humerus;
persistence of pain; This is a spontaneous report from a contactable physician
downloaded from the Regulatory Authority (RA)-WEB FR-AFSSAPS-ST20211495, Safety
Report Unique Identifier FR-AFSSAPS-2021038673 A 93-year-old male patient
received bnt162b2 (COMIRNATY), then second dose intramuscular on 15Mar2021
(Batch/Lot Number: ET3620) as (reported as 0.3 mL, single) and first dose
intramuscular on 23Feb2021 (Batch/Lot Number: EK9788) as Single Dose (reported as
0.3 mL, single); both for covid-19 immunisation. It was added that there was no
adverse event between the doses on 15Mar2021 and 31Mar2021. Medical history
included extrapyramidal syndrome, vascular dementia, prostate adenoma, Choked on
food, gastritis, Deglutition disorder, Collapsed vertebra, osteoporosis, Chronic
renal insufficiency (reported as chronic renal failure), Starvation, anemia,
Falling down (reported as history of fall), Vascular atheroma, undernutrition and
Bedridden patient; all from an unknown date and unknown if ongoing. Concomitant
medication included macrogol 4000 (FORLAX) taken for an unspecified indication,
start and stop date were not reported. It was reported that on 31Mar2021, the
patient was hospitalized following a fall. On 01Apr2021, faced with the persistence
of pain, the patient was referred to the emergency room and there was a fracture of
the left humerus: Zimmer splint and lesion of the nose treated with Steristrip. On
02Apr2021, new fall, wound on the bridge of the nose with open nose fracture. A
Covid-19 PCR is performed and is negative. 04Apr2021, deterioration of the general
condition. Positive Covid-19 antigen test. On 05Apr2021, the general condition
continued to deteriorate in this patient with an increase in the weight loss due to
the fractures. On 07Apr2021, a PCR test is positive. No variant. Beginning of O2
desaturation. 90-92% saturation under 2 L of O2; does not exceed 84% even by
increasing the flow of O2. On 08Apr2021, gradual desaturation under 6L of O2.
09Apr2021: Death. It was concluded that: confirmed vaccine failure. Time Interval
between Beginning of Drug Administration was 41 days (as reported) and Time
Interval between Last Dose of Drug: 21 days (as reported). The patient died on
09Apr2021. An autopsy was not performed. The outcome of other events was unknown.
Based on the information currently available, the company assessed the relationship
of COMIRNATY, concentrate for injection. COVID-19 mRNA vaccine(modified nucleoside)
to the events, vaccination failure. Reporters' comments: COVID-19 HISTORY: NO,
Bedridden patient. (goes from bed to chair). No more information expected/was
available.; Reported Cause(s) of Death: Covid-19; vaccine failure" "No prior
"1275103-1" "1275103-1" ""positive COVID-19 test with symptoms; Death
unexplained/Sudden death; cyanotic appearance of the upper body (seen a few hours
before); asthenia; fall; respiratory alkalosis; CRP at 29; D Dimers at 2680;
Troponin at 37; This is a spontaneous report from a contactable physician
downloaded from the regulatory Agency-WEB. The regulatory authority number is FR-
AFSSAPS-TS20211312. A 92-year-old male patient received the first dose of BNT162B2
(COMIRNATY, lot number: EK9788), intramuscular, on 19Feb2021, as single dose, for
COVID-19 immunisation. The patient medical history included constipation.
Concomitant medication included an unspecified laxative for constipation. The
patient received the first dose on 19Feb2021. On 20Feb2021, next day, the patient
experienced asthenia and had a fall. A cluster of COVID cases in his residence was
reported. On 22Feb2021, day 4, the patient was coughing and tested positive for
SARS-CoV2 with respiratory symptomatology with desaturation (value not reported)
justifying his hospitalization from 23Feb2021 to 25Feb2021. In Feb2021, the patient
underwent examination which showed soft calves and no bleeding; D Dimers at 2680;
CRP at 29; Troponin at 37; proBNP at 311; and normal lung scan. In Feb2021,
respiratory improvement was noted after an episode of respiratory alkalosis. On
25Feb2021, day 7, the patient got better and was able to return on home with
hospitalization at home request. On 26Feb2021, day 8, the patient was found
deceased in his bed (death unexplained/sudden death), his phone in his hand with
cyanotic appearance of the upper body (seen a few hours before). It was reported
that ""Overall, unexplained death on D8 of the 1st dose of COMIRNATY in an elderly
patient but independent and without medical history, with recent symptomatic COVID,
but stabilized the day before death."" The outcome of the events positive COVID-19
test with symptoms and respiratory alkalosis was recovering, and the remaining
events was unknown. The patient died on 26Feb2021. Autopsy was not performed. No
Cause(s) of Death: Death unexplained/Sudden death"" "No prior vaccinations for
this event."
"1275910-1" "1275910-1" "Patient presented to ED on 3/28/21 with the
following information: patient reports home daughter was diagnosed with COVID-19
infection a few days ago. For about a week now the patient herself has had severe
fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She
denies fevers. She has however had a persistent cough and over the last few days
has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside
facility. Last night patient had multiple episodes of diarrhea making her fatigue
significantly worse today. Has been drinking a lot of free water. Additionally
noted increased cough and shortness of breath. Patient was admitted to the hospital
with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.""No prior vaccinations
for this event."
"1275922-1" "1275922-1" "On 3/8/21, patient presented to the ED with cough,
fever > 103, chills, SOB, all starting 9 days ago (2/27/21) about 3 days after 2nd
dose of Pfizer vaccine. Patient was admitted to the hospital with main diagnosis
COVID-19 pneumonia and patient expired on 4/8/21." "No prior vaccinations for
this event."
"1282520-1" "1282520-1" "62F with stage 2 mycoises fungoides, peripheral
neuropathy, HTN, HLD, admitted from hepatology clinic on 3/25/21 for worsening
liver injury and URI symptoms, found to be COVID positive. Liver biopsy with
evidence of severe hepatitis with bridging necrosis. Course complicated by increase
encephalopathy 3/31/21 concerning for acute liver failure, requiring stay in COVID
ICU, transferred to hepatology service on 4/2/21. DDx remains viral hepatitis,
autoimmune hepatitis, and drug-induced liver injury now on steroid therapy as of
3/31/21 and NAC. Pt. had worsening ALF and encephalopathy, transitioned to comfort
care. Pt died early morning of 4/4/21" "No prior vaccinations for this event."
"1282523-1" "1282523-1" "Pt received first COVID Pfizer vaccine on 3/2/21 and
second vaccine dose of Pfizer on 3/23/21 and tested positive for COVID 3/24/21 was
admitted through the ED on 3/24/21 with decreased oxygen levels (50%) and SOB.
Admitted to the floor on 3/25/21, Patient was never intubated but was put on
continuous BiPap. Patient treated with acetaminophine, albuterol, solumedrol, and
remdesivir. Patient expired on 4/15/21. Cause of death was secondary COVID
pneumonia and acute respiratory failure." "No prior vaccinations for this event."
"1283204-1" "1283204-1" "Per the nursing home facility patient received her
second dose of vaccine on 01/14/2021 but it was not listed on KYIR. Patient tested
positive on 04/14/2021 and died on 04/16/2021." "No prior vaccinations for this
event."
"1283618-1" "1283618-1" "Vaccination failure/COVID-19 PCR test was positive
for variant V1/of respiratory problems; Vaccination failure/COVID-19 PCR test was
positive for variant V1/of respiratory problems; This is a spontaneous report from
a contactable consumer, downloaded from the regulatory authority. Regulatory
Authority Report Number: FR-AFSSAPS-LL20212111, Safety Report Unique Identifier FR-
AFSSAPS-2021041026. A 92-years-old male patient received bnt162b2 (COMIRNATY),
(dose 2) intramuscular on 19Feb2021 (Batch/Lot Number: Unknown) as a single dose,
and (dose 1) intramuscular on 29Jan2021 (Batch/Lot Number: Unknown) as a single
dose for COVID-19 immunization. The patient's medical history and concomitant
medications were not reported. It was reported that the patient experienced
vaccination failure; a PCR test was done on 22Mar2021, and the COVID-19 PCR test
was positive for variant V1. On 26Mar2021, appearance of respiratory problems
occurred. The patient was hospitalized and died on 02Apr2021. It was not reported
if autopsy was performed. No follow-up attempts are possible; information about
batch/lot number cannot be obtained.; Reporter's Comments: COVID Vaccine
declaration 92 year old patient vaccinated with COMIRNATY IM Lot not specified 1st
injection on 29Jan2021 2nd injection on 19Feb2021 On 26Mar2021 appearance of
respiratory problems PCR test done on 22Mar2021 PCR test positive for variant V1
The patient is hospitalised and dies on 02Apr2021 NB: Imputability without
prejudice to the elements of investigation which could be carried out in the
context of legal or amicable compensation procedures.; Reported Cause(s) of Death:
Vaccination failure/COVID-19 PCR test was positive for variant V1; Vaccination
failure/COVID-19 PCR test was positive for variant V1" "No prior vaccinations
for this event."
"1283835-1" "1283835-1" "COVID-19/COVID-19 test was positive; patient died,
cause of death was not reported; febrile; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority, regulatory
authority number HU-OGYI-219821. An 86-year-old male patient received first
dose bnt162b2 (COMIRNATY; Lot Number: EL0725) intramuscularly administered into
left arm on 12Feb2021 14:20 as 0.3 mL, single for COVID-19 immunisation. The
patient's medical history and concomitant medications were not reported. The
patient started to have symptoms of COVID-19 two days after vaccination, patient
became febrile on 14Feb2021. The patient was diagnosed to have COVID-19 4 days
after vaccination on 16Feb2021 and was admitted to the hospital on an unspecified
date. The patient died on 20Feb2021, cause of death was not reported. The patient
underwent lab tests and procedures which included SARS-CoV-2 test: positive on
16Feb2021. It was not reported if an autopsy was performed. Outcome of events
COVID-19 and pyrexia was unknown. Sender Comment: The patient started to have
symptoms of COVID-19 two days after vaccination and diagnosed to have COVID-19 4
days after vaccination. Immunity may have not developed within 4 days after the
first dose of vaccine. The case is serious because the patient died. No further
information is expected. Follow-up attempts are completed. No further information
is expected.; Reported Cause(s) of Death: patient died, cause of death was not
reported" "No prior vaccinations for this event."
"1283836-1" "1283836-1" "died; COVID-19; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority, regulatory
authority number HU-OGYI-220021. An 85-year-old female patient received first
dose of bnt162b2 (COMIRNATY, solution for injection, lot: EL0725), intramuscular in
left arm on 12Feb2021 as 0.3 mL, single for covid-19 immunisation. Medical history
included ongoing diabetes, ongoing angina pectoris and ongoing myocardial
infarction. Before vaccination the patient's chronic diseases were in balance. The
patient's concomitant medications were not reported. The patient experienced
occurrence of covid-19 after vaccination with bnt162b2 (non-serious) in Feb2021.
The outcome of covid-19 was unknown. The patient died of an unknown cause on
22Feb2021. An autopsy was not performed. The physician considered the report as
serious. In the opinion of the patient's physician, the death was not related to
the vaccination. Sender Comment: The patient died ten days after vaccination.
Death is not expected adverse event of COMIRNATY. It might be related to the
patient's chronic cardiovascular diseases. Based on the above, and in lack of
detailed medical information, relationship between death and COMIRNATY is not
assessable. The case is serious because the patient died. No further information is
expected. Follow-up attempts are completed. No further information is expected.;
Sender's Comments: The information provided is very limited and does not allow for
a complete medical assessment. Based on current convention, the case of death is
assessed as related to bnt162b2 until sufficient information is available to
confirm an unrelated cause of death. The patient's angina pectoris, myocardial
infarction and diabetes may have contributed to the patient's death. The impact
of this report on the benefit/risk profile of the Pfizer product is evaluated as
part of Pfizer procedures for safety evaluation, including the review and analysis
of aggregate data for adverse events. Any safety concern identified as part of this
Reported Cause(s) of Death: died" "No prior vaccinations for this event."
"1283838-1" "1283838-1" "COVID-19; Drug Ineffective; This is a spontaneous
report from a contactable physician downloaded from a regulatory authority-WEB,
regulatory authority number: HU-OGYI-243821. An 83-year-old female patient received
first dose of bnt162b2 (COMIRNATY), intramuscular, administered on left arm on
04Mar2021 (lot number: EP2163) at 0.3 mL, single for COVID-19 immunisation. Medical
history included COVID-19 from an unknown date and unknown if ongoing. Concomitant
medications were not reported. On 30Mar2021, the patient experienced COVID-19 and
drug ineffective with fatal outcome. It was reported as occurrence of COVID-19
infection resulting in death after COMIRNATY injection for active immunization to
prevent COVID-19. The patient was hospitalized on an unknown date because of COVID-
19, and on 30Mar2021 at 21:15, the patient passed away. It was not reported if an
autopsy was performed. Sender's Comment: According to the SmPC of Comirnaty,
immunity usually develops 14 days after the second dose of the vaccine. The patient
received the first dose of Comirnaty on 04Mar2021 and passed away on 30Mar2021
after getting infected with the virus, therefore immunity may have not developed
yet. Based on the above, the causal relationship is unlikely between the suspected
drug and the adverse event. The case is considered serious because the outcome was
fatal. Further information is not expected. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: COVID-19; drug
ineffective" "No prior vaccinations for this event."
"1283839-1" "1283839-1" "COVID-19; This is a spontaneous report from a
authority number HU-OGYI-244621. An 83-year-old male patient received bnt162b2
(COMIRNATY), intramuscular in the left arm on 03Mar2021 (Lot Number: EP2163) as 0.3
mL, single, 1st dose for COVID-19 immunisation. Medical history included COVID-19
from an unknown date and unknown if ongoing. The patient's concomitant medications
were not reported. The patient experienced COVID-19 on 11Mar2021. Outcome of event
COVID-19 was fatal. The patient died on 11Mar2021. It was unknown if an autopsy was
performed. It was also reported as follows: occurrence of Covid-19 infection
resulting in death after COMIRNATY injection for active immunization to prevent
COVID-19. The patient was hospitalized on an unknown date because of Covid-19, and
on 11Mar2021 at 06:15 the patient passed away. Senders comment: According to the
HA of Comirnaty, immunity usually develops 14 days after the second dose of the
vaccine. The patient received the first dose of Comirnaty on 03Mar2021 and passed
away on 11Mar2021 after getting infected with the virus, therefore immunity may
have not developed yet. Based on the above, the causal relationship is unlikely
between the suspected drug and the adverse event. The case is considered serious
because the outcome was fatal. Further information is not expected. No follow-up
Death: COVID 19" "No prior vaccinations for this event."
"1283910-1" "1283910-1" "O2 saturation at 93%; COVID-19/positive SARS-CoV-2
PCR test; COVID-19/positive SARS-CoV-2 PCR test; Respiratory distress due to severe
hypoxemic SARS-Cov-2 infectious lung disease; onset of symptoms suggestive of
bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of
symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum,
fever 38-38.5C); onset of symptoms suggestive of bronchitis (pharyngitis,
congestion, coughing up sputum, fever 38-38.5C); onset of symptoms suggestive of
bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-38.5C); onset of
symptoms suggestive of bronchitis (pharyngitis, congestion, coughing up sputum,
fever 38-38.5C); This is a spontaneous report from a contactable pharmacist
downloaded from a regulatory authority-WEB FR-AFSSAPS-PS20210841. Safety Report
Unique Identifier FR-AFSSAPS-2021042007. An 80-year-old female patient received
second dose of bnt162b2 (COMIRNATY) intramuscularly on 15Feb2021 and first dose
intramuscular on 19Jan2021; both as single dose for COVID-19 immunisation. Medical
history included follicular lymphoma, deep vein thrombosis right leg from 2017,
extrinsic allergic alveolitis, diverticulosis of the sigmoid and a 4 mm left colon
polyp resected with forceps in 2013, hypertension and functional colopathy.
Concomitant medications included diltiazem hydrochloride (DILTIAZEM LP),
hydrochlorothiazide (ESIDREX), losartan (LOSARTAN), sertraline (SERTRALINE),
valaciclovir (VALACICLOVIR). On 28Feb2021 patient experienced onset of symptoms
suggestive of bronchitis (pharyngitis, congestion, coughing up sputum, fever 38-
38.5C). The patient was treated with antibiotic therapy with amoxicillin. On
12Mar2021, patient had COVID-19 confirmed by a positive SARS-CoV-2 PCR test. On
18Mar2021 patient's O2 saturation was at 93% leading to a visit to the emergency
room and was then hospitalized. The patient underwent lab tests and procedures
which included CT scan (18Mar2021): unknown results, thoracic angioscan
(24Mar2021): No pulmonary embolism on angioscan or signs of PAH. Increased
parenchymal abnormalities of Covid-19 compared to the CT scan of 18Mar2021.
Extensive involvement estimated to date at 50%, thoracic angioscan (02Apr2021): No
sign of pulmonary embolism or PAH. Appearance of diffuse mediastinal and cervical
emphysema (tracheal rupture?). Increase in ground-glass areas and thoracic
angioscan (09Apr2021): Subtotal resorption of the subcutaneous emphysema. Clear
regression of pneumomediastinum which persists in the pericardium and anterior
mediastinum. Complete resorption of the right pneumothorax. Persistence of a thin
blade of left apical pneumothorax. Increased parenchymal involvement at Covid-19
from 50% to 70%. Absence of adenopathy with a pejorative appearance. No
pleuropericardial effusion. Respiratory distress due to severe hypoxemic SARS-CoV-2
infectious lung disease leading to transfer to a continuing care unit. The patient
was treated with Oxygen therapy, Optiflow under 100% FiO2, G 5 500 ml + PV 1
ampoule B1-B6 500 mg, piperacillin/tazobactam (TAZOCILLIN) 4 g IV (intravenous)
every 8 hours, tocilizumab 600 mg IV, lansoprazole 15 mg/day,
trimethoprim/sulfamethoxazole (BACTRIM) 800/160 mg, valaciclovir 500 mg, Novorapid
subcutaneous protocol, tinzaparin (INNOHEP) 10,000 IU subcutaneous at night. The
patient died on 11Apr2021 due to respiratory distress due to severe hypoxemic SARS-
Cov-2 infectious lung disease. It was not reported if an autopsy was performed.
Outcome of all other events was unknown. No follow up attempts are possible;
information about lot/batch number cannot be obtained. No further information is
expected.; Reported Cause(s) of Death: Respiratory distress due to severe hypoxemic
SARS-Cov-2 infectious lung disease; COVID-19/positive SARS-CoV-2 PCR test; COVID-
19/positive SARS-CoV-2 PCR test" "No prior vaccinations for this event."
"1283962-1" "1283962-1" "Cardiorespiratory insufficiency; COVID-19; COVID-19;
This is a spontaneous report downloaded from the regulatory authority (Regulatory
Authority report number: HU-OGYI-219921). A contactable physician (contactable
through Regulatory Authority only) reported that an 84-year-old male patient
received the first dose of BNT162B2 (COMIRNATY) on 12Feb2021 (Lot Number: EL0725;
Expiration date was not reported) and the second dose on 05Mar2021 (14:20) (Lot
Number: EJ6790; Expiration date was not reported); both intramuscular as a single
dose, for COVID-19 immunization. Medical history included ongoing colonic neoplasm
(received chemotherapy); ongoing cardiac decompensation; and general condition was
wrong. The patient's concomitant medications were not reported. On an unspecified
date in 2021, after the first and second doses of vaccination, the patient had
COVID-19. On 15Mar2021, the patient had cardiorespiratory insufficiency. The
outcome of the event, COVID-19, was unknown. The patient had died on 15Mar2021, and
the reported cause of death was cardiorespiratory insufficiency. An autopsy was not
performed. As reported, death was not an expected adverse event of BNT162B2. It
might be related to the patient's chronic diseases and bad general condition. Based
on the above, and in the lack of detailed medical information, the relationship
between death and COMIRNATY was not assessable. Follow-up attempts are completed.
No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory
insufficiency" "No prior vaccinations for this event."
"1283963-1" "1283963-1" "Cardio-respiratory arrest; Drug Ineffective; COVID-
19 pcr test positive; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-
241121. An 88-year-old female patient received bnt162b2 (COMIRNATY),
intramuscular, administered in Arm Left on 02Mar2021 (Batch/Lot Number: EP2163) as
0.3 ml, single, left arm for covid-19 immunisation. Medical history included
ongoing cerebral infarction, ongoing arteriosclerosis, ongoing cardiac failure,
ongoing Vertebrobasilar artery syndrome, ongoing dementia , ongoing covid-19,
ongoing cerebral arteriosclerosis , ongoing hypertension , ongoing hypertensive
cardiomyopathy , ongoing anaemia, ongoing epilepsy, ongoing osteoporosis.
Concomitant medications included folic acid (FOLIC ACID) taken for anaemia;
potassium chloride (KALDYUM) taken for cardiac failure; ferrous sulfate (SORBIFER
DURULES [FERROUS SULFATE]) taken for anaemia; furosemide (FUROGAMMA) taken for
cardiac failure; alprazolam (FRONTIN) taken for dementia; carbamazepine (TEGRETOL)
taken for epilepsy; start and stop dates were not reported. On 21Mar2021,
occurrence of cardio-respiratory arrest after the use of Comirnaty was reported.
The patient experienced cardio-respiratory arrest and died. The patient was
hospitalized from an unknown date and received the vaccine in the hospital. On
19Mar2021, a COVID-19 PCR test was positive. Drug ineffective was reported. The
patient underwent lab tests and procedures which included sars-cov-2 test: positive
on 19Mar2021. The patient died on 21Mar2021. An autopsy was not performed.
Sender Comment: According to the SmPC of Comirnaty concentrate for dispersion for
injection, cardio-respiratory arrest is not listed and not expected. TTO is 19
days. Dechallenge and rechallenge were not applicable. The causal relationship
between the suspected drug and the event is considered not relatable. According to
the reporting physician, he does not consider a causal relationship between the
death of the patient and the vaccine. The case is considered serious due to fatal
outcome. Follow-up activities closed. No routine follow-up is possible for EV-WEB
ICSRs.; Sender's Comments: Reported cardio-respiratory arrest is considered
intercurrent and unrelated to suspect BNT162B2. Consider patient underlying
conditions and comorbidities as causative. ; Reported Cause(s) of Death: cardio-
respiratory arrest" "No prior vaccinations for this event."
"1285303-1" "1285303-1" "Patient admitted to Hospital on 4/16/2021 with 2
weeks of generalized weakness, chills, poor oral intake and nonproductive cough.
Chest x-ray shows consolidation. Patient tested for covid-19 which returned
positive on 4/18/21. Patient remained hospitalized and started on steroids and
vitamin c/e after covid testing returned positive. Patient respiratory status
worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not
want to be intubated and decided to go to comfort care. Patient passed away on
5/3/21 in the hospital." "No prior vaccinations for this event."
"1287149-1" "1287149-1" "consciousness disorder; hypernatremia due to
dehydration; hypernatremia due to dehydration; general state alteration;
Vaccination failure; Covid-19 test returned positive; respiratory failure due to
Covid-19 infection; the first signs of pneumonia; This is a spontaneous report from
a contactable consumer or other non hcp downloaded from the Medicines Agency (MA)
-WEB, regulatory authority number FR-AFSSAPS-GR20211364. A 98-year-old male
patient received first bnt162b2 (Pfizer vaccine, solution for injection) (Batch/Lot
Number: EJ6789) on 05Feb2021 via intramuscular route of administration as 30 ug, at
single dose and on 04Mar2021, second dose (Batch/Lot Number: EP2166) as 30 ug, at
single dose for covid-19 immunization. A 98-year-old male patient with a medical
history of optic nerve degeneration, benign prostatic hyperplasia treated with
surgery, right leg carcinoma, transient ischemic attack in Apr2014, carotid artery
atheroma, chronic glaucoma. Also prostatic adenoma from an unknown date and unknown
if ongoing , TIA from Apr2014 to an unknown date , carcinoma skin from an unknown
date and unknown if ongoing , optic nerve disorder from an unknown date and unknown
if ongoing , glaucoma from an unknown date and unknown if ongoing , carotid artery
atheroma from an unknown date and unknown if ongoing. The patient's concomitant
medications were not reported. The patient experienced vaccination failure (death)
on 29Mar2021. The patient died on 01Apr2021. An autopsy was not performed. Course
of the events : On 05Feb2021, first dose of COVID-19 mRNA Vaccine (nucleoside
modified) (COMIRNATY) was administered (lot number EJ 6789), followed by the second
dose on 04Mar2021 (lot number EP 2166). On 09Mar2021, the patient was hospitalized
for general state alteration, and discharged on 23Mar2021 with negative PCR Covid-
19 test. On 26Mar2021, the patient presented the first signs of pneumonia. On
29Mar2021, the patient was hospitalized for dyspnea with bronchial congestion and
breathing pauses. On the same day, nasopharyngeal real-time polymerase chain
reaction (RT-PCR) Covid-19 test returned positive, target 1 (protein envelope) at
13.2 and target 2 (nucleocapsid protein ) at 14.2. SARS-CoV2 variant screening
showed the UK variant VOC202012/01. Blood work up in an emergency unit showed no
anemia with hemoglobin at 147 g/L and platelets at 243 x 10^9/L, laboratory signs
of inflammation with leucocytes at 11.4 x 10^9/L and CRP at 134 mg/L probably
related to pulmonary superinfection in the context of Covid-19 infection. Stable
renal failure with creatinine at 119 uM (glomerular filtration rate (GFR) at
44ml/min), urea 13.9 mM. Blood electrolytes analysis showed hypernatremia at 154
mM, and normal potassium level at 4.4 mM..Blood glucose was at 7.01 mM, calcium at
2.33 and corrected calcium at 2.43 mM. proBNP was at 15255 and troponins at 112.
Overall, the patient was hospitalized for acute respiratory failure due to Covid-19
infection in the context of a general and especially cardiac vulnerability. The
patient presented hypernatremia due to dehydration, which contributed to a
consciousness disorder. Long-standing treatment included ramipril (unspecified
tradename), 5 mg in the morning, DL-lysine acetylsalicylate (KARDEGIC 75 mg, powder
for oral solution in sachet dose) 1 sachet at noon. Patient's family requested only
palliative care. On 01Apr2021, the patient presented alternation of long breathing
pauses followed by polypnea with agitation. Patient passed away. The outcome of the
event general state alteration was recovered on 23Mar2021 and other events was
fatal. No FU attempts possible. No further information expected.; Reported
Cause(s) of Death: COVID-19 infection" "No prior vaccinations for this event."
"1287787-1" "1287787-1" "Dizziness; Fatigability; Appetite lost; Breathing
difficult; diagnosed with SARS-CoV-2 virus infection confirmed by a test on March
16, 2021; This is a spontaneous report from a contactable consumer who is also the
patient's daughter downloaded from the regulatory authority-WEB, regulatory
authority number RO-NMA-2021-SPCOV6833-FU1. A 63-year-old female patient received
bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Mar2021 (Batch/Lot Number: EP2166)
as SINGLE DOSE (1 DF) for covid-19 immunisation. Medical history included Cancer of
head of pancreas (The patient had surgery for a pancreatic head cancer in December
2016). The patient's concomitant medications were not reported. On 12Mar2021 the
patient experienced fatigue/ Fatigability, dizziness, lack of appetite/ Appetite
lost, difficult breathing/ Breathing difficult. The events were assessed as serious
(hospitalization, fatal). The patient needed hospitalization where she was
diagnosed with SARS-CoV-2 virus infection confirmed by a test on March 16, 2021.
The patient underwent lab tests and procedures which included sars-cov-2 test:
diagnosed with sars-cov-2 virus infection on 16Mar2021 (diagnosed with SARS-CoV-2
virus infection confirmed by a test on March 16, 2021). The patient died on
20Mar2021. It was not reported if an autopsy was performed. Sender Comment:
Follow up information added on 26-Apr-2021: following investigation of the case, on
22-Apr-2021 it was concluded: it is denied that the death was caused by the post-
vaccination reaction; the person was confirmed with COVID-19 infection on 16-Mar-
2021 and died on 20-Mar-2021 at the Hospital. Routine follow-up is not conducted
for HA-web reports. No follow-up attempts are needed. No further information is
expected. The information about lot number was provided within the initial report.
The case was closed for follow-up activities.; Reported Cause(s) of Death:
Dizziness; Fatigability; Appetite lost; Breathing difficult" "No prior
"1289390-1" "1289390-1" "Patient hospitalized and died of pneumonia caused by
COVID-19 after being fully vaccinated." "No prior vaccinations for this event."
"1289414-1" "1289414-1" "Patient tested positive on 04/20/2021 via PCR. Upon
arriving to hospice care, patient tested positive via rapid on 04/29/2021. She died
in hospice care on 05/01/2021." "No prior vaccinations for this event."
"1289450-1" "1289450-1" "Hospitalized and died due to COVID-19 after being
fully vaccinated." "No prior vaccinations for this event."
"1292940-1" "1292940-1" "tested positive for covid" "No prior vaccinations
for this event."
"1295712-1" "1295712-1" "cough, body aches, fever--COVID +, afib,
tachycardia, acute coronary syndrome" "No prior vaccinations for this event."
"1295875-1" "1295875-1" "Presented to urgent care on 5/1/21 with dry cough
which started about 4 days prior. Symptoms worsened and presented to emergency
department on 5/5/21. Was found to be COVID-19 positive and was admitted for
further management. Patient had been exposed to COVID-19 positive person prior to
presentation. Patient is currently admitted at time of writing." "No prior
"1296067-1" "1296067-1" "Patient completed 2-dose Pfizer series on 1/31/21
and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness,
diffuse abdominal pain and diarrhea that started that day. Pt tested positive for
COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd
dose: 1/31/21" "No prior vaccinations for this event."
"1296831-1" "1296831-1" ""COVID-19; suspected vaccination failure; This is a
spontaneous report from a contactable other hcp downloaded from a regulatory
authority-WEB, regulatory authority number AT-BASGAGES-2021-24417. A 79-years-old
female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of
administration on 13Mar2021 (Batch/Lot number was not reported) as single dose,
dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number
was not reported) as single dose for COVID-19 immunization. The patient's weight
and height were not reported. No relevant medical history reported. The patient's
concomitant medications were not reported. On 25Mar2021 the patient experienced
COVID-19 death, Vaccination failure. It was reported that 1st dose was on
04Feb2021, 2nd dose was on 13Mar2021, date of illness on 25Mar2021, diagnosis date
was 29Mar2021. The patient had respiratory symptoms (e.g. cough with or without
fever), no hospital, Variant: (unlisted). Patient hospitalization was reported as
no but it was also reported that ""Stat. [PRIVACY, hospital] from 01Apr to
06Apr2021. Deceased on 06Apr2021 in the [PRIVACY, hospital]"". The patient's
outcome was fatal for COVID-19, unknown for Vaccination failure. It was not
reported if an autopsy was performed.; Reported Cause(s) of Death: patient
experienced COVID-19 death, Vaccination failure; patient experienced COVID-19
death, Vaccination failure"" "No prior vaccinations for this event."
"1296917-1" "1296917-1" "received both doses of bnt162b2 and on 15Mar2021,
the patient 's PCR test for COVID-19 was positive reported as vaccination failure;
received both doses of bnt162b2 and on 15Mar2021, the patient 's PCR test for
COVID-19 was positive reported as vaccination failure; This is a spontaneous report
from a contactable pharmacist downloaded from the Regulatory Authority (RA)-WEB,
regulatory authority number FR-AFSSAPS-BS20210631. An 86-year-old male patient
received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20Jan2021 (lot number:
EJ6788) as SINGLE DOSE and dose 2 intramuscular on 10Feb2021 (lot number: EJ6788)
as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing
auricular fibrillation. Concomitant medication included fluindione (PREVISCAN
[FLUINDIONE]). The patient received both doses of bnt162b2 and on 15Mar2021, the
patient 's PCR test for COVID-19 was positive reported as vaccination failure. The
patient was hospitalized for the events from 15Mar2021 to an unknown date. The
patient died on 30Mar2021 due to the events. An autopsy was not performed. No
Cause(s) of Death: received both doses of bnt162b2 and on 15Mar2021, the patient 's
PCR test for COVID-19 was positive reported as vaccination failure; received both
doses of bnt162b2 and on 15Mar2021, the patient 's PCR test for COVID-19 was
positive reported as vacci" "No prior vaccinations for this event."
"1297083-1" "1297083-1" "Acute respiratory decompensation; bronchitis without
fever; Vaccination failure/antigentic test positive/PCR test positive; antigentic
test positive/PCR test positive; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority-WEB, regulatory authority number
FR-AFSSAPS-PO20211949. A 90-year-old male patient received bnt162b2
(COMIRNATY), second dose on 16Feb2021 (Lot Number: EK9788) at 0.3 mL, single dose
in the left arm and first dose on 26Jan2021 (Lot Number: EJ6795) as single dose,
both intramuscular for COVID-19 immunization. Medical history included chronic
bronchitis, depression, rheumatoid arthritis (treated by tocilizumab (ROACTEMRA)
and methotrexate(NOVATREX)), lung nodule (2 pulmonary tissue nodules of 10mm),
heart failure, and arterial hypertension all from an unknown date. Inflammation
(Inflammatory syndrome) from Jul2019. The patient's concomitant medications were
not reported. On 25Mar2021, the patient tested positive for COVID-19 antigenic test
and on 26Mar2021, tested positive for COVID-19 PCR test (variant not communicated).
On 27Mar2021 had a negative antibody test result. On 02Apr2021, bronchitis without
fever was reported and start of treatment with amoxicillin. On 05Apr2021, the
patient had acute respiratory decompensation. Oxygen desaturation at 78%. Put under
9L of O2 in high concentration. Saturation raised to 85% in 1 hour. Death of the
patient occurred on 05Apr2021 around 6 pm and the cause was considered to be acute
respiratory decompensation and vaccination failure due to COVID-19. The outcome of
the event bronchitis without fever was unknown while for the acute respiratory
decompensation and vaccination failure due to COVID-19 was fatal. The patient died
on 05Apr2021. An autopsy was not performed. No follow up attempts possible. No
further information expected.; Reported Cause(s) of Death: Acute respiratory
decompensation; Vaccination failure/antigentic test positive/PCR test positive;
antigentic test positive/PCR test positive" "No prior vaccinations for this
event."
"1297230-1" "1297230-1" "Vaccination failure; cardiorespiratory
decompensation; oxygen desaturation; Covid-19 virus test positive; This is a
spontaneous report from a contactable other healthcare professional (HCP)
downloaded from the regulatory authority FR-AFSSAPS-LL20212270, Safety Report
Unique Identifier FR-AFSSAPS-2021043050. A 96-year-old male patient received
bnt162b2 (COMIRNATY), via intramuscular, first dose on 18Feb2021 and second dose on
12Mar2021, at single dose for COVID-19 immunisation. The relevant medical history
and concomitant medications were not reported. The patient experienced vaccination
failure on an unspecified date, Covid-19 virus test positive on 11Apr2021,
cardiorespiratory decompensation on an unspecified date, oxygen desaturation on an
unspecified date. The patient presented with cardiorespiratory decompensation with
89% desaturation under 3L of O2, PCR test carried out on 11Apr2021 Sending of the
test positive on 11Apr, variant not specified. The patient died on 11Apr2021. It
was unknown if autopsy was performed. The patient underwent lab test included O2
saturation showed 89% (under 3L of O2) on an unspecified date; Covid-19 PCR test
showed positive (variant not specified) on 11Apr2021. The outcome of the events was
fatal. No follow-up attempts are possible. Information on batch/lot number cannot
be obtained.; Reported Cause(s) of Death: Vaccination failure; Covid-19 virus test
positive; oxygen desaturation; cardiorespiratory decompensation" "No prior
"1298642-1" "1298642-1" "Respiratory failure; Pneumonia; Oxygen saturation
low; Dyspnoea; Psychomotor retardation; SARS-CoV-2 infection; This is a spontaneous
report from a contactable physician. This is a report received from the Regulatory
Authority. An 86-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at
the age of 86-year-old, intramuscular, administered in left arm on 15Mar2021 12:00
(Lot Number: ET3674; Expiration Date: 31Jul2021) as single dose for COVID-19
reported. The patient experienced respiratory failure, pneumonia, oxygen saturation
low, dyspnoea, and psychomotor retardation on 27Mar2021 at 10:00; and SARS-CoV-2
infection on 27Mar2021. The patient died on 04Apr2021. It was unknown if an autopsy
was performed. The events were reported as medically significant. The outcome of
the events was fatal. No follow-up attempts are possible. No further information
is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; pneumonia;
dyspnoea; psychomotor retardation; respiratory failure; low oxygen saturation"
"1299650-1" "1299650-1" "COVID-19 infection with pneumonia: Present on
admission. Patient was treated with remdesivir and convalescent plasma." "No
"1302209-1" "1302209-1" "death from covid 3 months after completing series"
"1302294-1" "1302294-1" "fever and generalized weakness bilateral pneumonia
secondary to COVID-19 infection Failure to Thrive, Severe Sepsis antibiotics:
Levaquin, ceftriaxone and Remdesivir, insulin: Humalog and respiratory therapy: O2"
"1304016-1" "1304016-1" "cough; fevers of 39.5; apathy; heart failure;
urosepsis; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by
positive COVID-19 test; bilateral pneumonia; This is a spontaneous report from a
contactable consumer and a physician downloaded from the Regulatory Authority-WEB,
regulatory authority number CZ-CZSUKL-21004736. A 73-year-old male patient received
bnt162b2 (COMIRNATY), dose 1 intramuscular on 31Mar2021 (Batch/Lot Number: Unknown)
as 1ST DOSE, SINGLE for Covid-19 immunization. Medical history included hip surgery
from 14Mar2021 to an unknown date, decubitus ulcer (heel) from Mar2021 to an
unknown date, ongoing non-smoker, ongoing hypertension arterial, and ongoing
diabetes. Concomitant medication included anti-diabetic (not specified). The
patient was recovering in a private medical center after hip surgery (14Mar2021),
where he was vaccinated on 31Mar2021. One day before the vaccination, the patient
already had elevated levels of CRP-120mg/l. It was reported that the patient died 8
days after the first dose of Comirnaty vaccine, which was administrated on
31Mar2021. On 02Apr2021, the patient was apathetic, he was thirsty, felt cold, was
moaning while urinating, and had decubitus on his heel. Since 04Apr2021, the
patient had fevers. On 06Apr2021, he had a cough. At night on 06Apr2021, the
patient was transported to another hospital. In the hospital, he was diagnosed with
severe urosepsis and on 07Apr2021 he had a positive PCR test for Covid-19, chest
imaging shown bilateral infiltrates on his lungs also reported as bilateral
pneumonia; his condition was getting worse then. The patient died on 08Apr2021
because of heart failure due to severe urosepsis. On 28Apr2021, his physician was
contacted and reported that the patient already had elevated levels of CRP-120mg/l
one day before the vaccination, since 04Apr2021, the patient had fevers of 39.5, on
the day of his admission to the hospital (06Apr2021) urea 16mmol/l, creatinine
166umol/l, the patient died because of heart failure due to severe urosepsis. The
patient died on 08Apr2021. It was not reported if an autopsy was performed. The
outcome of other events was unknown. Bilateral pneumonia assessed by Healthcare
professional: Result of Assessment: not related; Fever assessed by Healthcare
professional: Result of Assessment: not related; Urosepsis assessed by Healthcare
professional: Result of Assessment: not related; Apathy assessed by Healthcare
professional: Result of Assessment: not related; Cough assessed by Healthcare
professional: Result of Assessment: not related. No follow-up attempts are
of Death: The patient died on 08Apr2021 because of heart failure due to severe
urosepsis." "No prior vaccinations for this event."
"1304083-1" "1304083-1" "Status epilepticus; SARS-COV2 PCR: Positive; This is
a spontaneous report received from a contactable physician downloaded from the
regulatory authority. The regulatory authority report number is ES-AEMPS-846623. A
79-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot:
EW2246), intramuscularly on 10Apr2021 at 0.3 mL single for COVID-19 immunisation.
Medical history included arterial hypertension, pain loin, ventricular bigeminy,
facial droop (right hemiparesis from childhood due to infantile paralysis), and
mild cognitive impairment. She was admitted from 01Apr2021 to 09Apr2021 due to
dysarthria and disorientation, with a diagnosis of isovolemic hypotonic
hyponatremia, SIAD (syndrome of inappropriate antidiuretic hormone secretion)
(uncertain etiology), and UTI (urinary tract infection) due to multisensitive E.
Coli. Concomitant medications included omeprazole, calcium carbonate/colecalciferol
(CALCIUM CARBONATE AND VITAMIN D), acetylsalicylic acid 100 mg, amlodipine, sodium
valproate, denosumab (PROLIA), and trazodone. On 16Apr2021 she went to the
Emergency Service of a hospital due to paraphasia and disorientation, starting
treatment with valproic and was discharged. On 20Apr2021, she was admitted due to a
non-convulsive status, with progressive onset in recent weeks despite treatment
with valproic acid ((poor compliance). No evidence of epilepsy until Apr2021, but
there were episodes of similar characteristics on admission in 2020 Therefore, it
does not seem like status epilepticus in the context of any acute trigger, but
rather a serious epileptic decompensation within an infectious occurrence such as
covid19. Previous etiological study without significant alterations, although the
patient suffered from infantile cerebral palsy and had mild-moderate cognitive
impairment. Diagnostics: Complex focal epileptic status, in a patient with residual
brain injury that might be the etiology of the seizure, the injury was old and had
decompensated 10 days after vaccination. Severe bilateral pneumonia from COVID19.
Lab data on 20Apr2021 included: CT (computed tomography): No signs of acute
intracranial pathology. Residual areas of left frontoparietal encephalomalacia;
SARS-COV2 PCR: Positive; EEG (electroencephalogram) on admission: Focal status
epilepticus; The main novelty was a respiratory worsening, with work of breathing
and SatO2(Oxygen saturation) 87% with GN at 6lp. At the respiratory level:
Bilateral pneumonia due to severe covid19, requiring oxygen therapy with GN at 5
bpm. COURSE: No improvement despite pharmacological adjustment after 24h. The
patient died on 23Apr2021. No autopsy was done. Assessment of causality (SEFV): The
patient had severe bilateral Covid-19 pneumonia. Status epilepsy had been described
in positive CoVID-19 patients, so there was an alternative causal explanation to
the vaccine that could explain the condition. Outcome of event SARS-COV2 PCR:
Positive was unknown. No follow-up attempts are possible. No further information
expected.; Reported Cause(s) of Death: Status epilepticus" "No prior vaccinations
for this event."
"1304542-1" "1304542-1" "Drug Ineffective; COVID-19; This is a spontaneous
report from a contactable physician downloaded from the Agency Regulatory
Authority-WEB. The regulatory authority number is HU-OGYI-243321. A 60-year-old
male patient received BNT162B2 (COMIRNATY; Lot Number: ET3620), intramuscular on
21Mar2021 as 0.3 mL, single, first dose for covid-19 immunisation. Medical history
included covid-19 from an unknown date and unknown if ongoing. The patient's
15Apr2021, at 09:40, which was serious as it lead to death. The patient died on
15Apr2021. It was not reported if an autopsy was performed. Sender Comment:
According to the SmPC of Comirnaty, immunity usually develops 14 days after the
second dose of the vaccine. The patient received the first dose of Comirnaty on
21Mar2021 and passed away on 15Apr2021 after getting infected with the virus,
therefore immunity may have not developed yet. Based on the above, the causal
relationship is unlikely between the suspected drug and the adverse event. The case
is considered serious because the outcome was fatal. Further information is not
expected. No follow-up attempts are possible. No further information is expected.;
"1304623-1" "1304623-1" "ischemic and valvular heart disease; ischemic and
valvular heart disease; Positive molecular swab in subject vaccinated on 16Jan and
06Feb. Dead.; vaccination failure; This is as spontaneous report received from a
contactable Healthcare Professional (HCP) downloaded from the Agency-WEB. The
regulatory authority report number is IT-MINISAL02-722826. A 99-year-old female
patient received BNT162B2 (COMIRNATY) via intramuscular administered in Arm Left
(shoulder) on 06Feb2021 as 2nd dose, 0.3 ml single (Batch/Lot Number: EL0725;
Expiration Date: 31Mar2021), via intramuscular administered in Arm Left (shoulder)
on 16Jan2021 as 1st dose, 0.3 ml single (Batch/Lot Number: EJ6797; Expiration Date:
30Apr2021) for covid-19 immunisation. Medical history included left bundle branch
block (LBBB), femur fracture from 04Nov2020, hypokinesia, ischemic heart disease
(IHD), permanent atrial fibrillation, choledocholithiasis from 30Dec2020,
hypokalaemia, pneumonitis from 30Dec2020, interstitial lung disease from 01Jan2015,
decompensation cardiac. The patient's concomitant medications were not reported.
The patient experienced positive molecular swab on 19Apr2021 in subject vaccinated
on 16Jan2021 and 06Feb2021 and died. Reported evident signs of decompensation on
the day of death. Most relevant cause of death reported as ischemic and valvular
heart disease. The patient underwent SARS-CoV-2 molecular test and revealed
negative on 29Mar2021 and on 12Apr2021; revealed positive on 19Apr2021. The patient
died on 24Apr2021. It was not reported if an autopsy was performed. The reported
cause of death was ischemic and valvular heart disease, positive molecular swab.
Outcome of the events was fatal. Reporter comment: Death certificate attached.
Most relevant cause of death: ischemic and valvular heart disease.; Reported
Cause(s) of Death: Positive molecular swab; Positive molecular swab; ischemic and
valvular heart disease; ischemic and valvular heart disease" "No prior
"1304892-1" "1304892-1" "NAUSEA; died/Cause of death was unknown; covid19
detected/vaccination failure; covid19 detected/lack of drug effect; covid19
detected/asymptomatic covid-19; exposure to covid-19/Infection exposed; TIA; This
is a spontaneous report from a contactable physician downloaded from the Regulatory
Authority (RA)-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uqwd1x.
Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00026428]. An 88-year-old male
patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular
on 26Jan2021 14:15 (Lot Number: EJ6134) as single dose, dose 1 intramuscular on
05Jan2021 16:15 (Lot Number: EJ6795) as single dose, for covid-19 immunisation.
Medical history included Living in nursing home; Chronic ischemic heart disease,
unspecified; Hyperplasia of prostate; Uncomplicated hypertension. Concomitant
medications included oxazepam (SOBRIL); tamsulosin hydrochloride (OMNIC);
lercanidipine hydrochloride (ZANIDIP); metoprolol succinate (SELO-ZOK);
rivastigmine (EXELON [RIVASTIGMINE]); apixaban (ELIQUIS). The patient experienced
TIA (Transient ischaemic attack) on 15Mar2021, asymptomatic covid-19 on 05Apr2021;
exposure to covid-19 from 27Mar2021 - 28Mar2021) (B.1.351 lineage); Infection
exposed 27Mar2021-28Mar2021 - possibly also 01Apr2021-02Apr2021. On 05Apr2021, the
patient developed vaccination failure, lack of drug effect, COVID-19. Relevant
laboratory findings and investigations included in the report: SARS-COV-2 RT-PCR
TEST on 05Apr2021, Result: Positive. B.1.351 lineage. Low Ct value). COVID-19
detected as part of infection tracing 05Apr2021 - asymptomatic at the time. Little
affected in subsequent days. On 11Apr2021 at 14: 30, the patient developed a little
nausea but otherwise in good shape. Relevant laboratory findings and investigations
included in the report: C-reactive protein on 11Apr2021 14: 30: 6 mg/l; oxygen
saturation on 11Apr2021 14: 30: 96%; body temperature on 11Apr2021 14: 30: Normal
(value not specified). On the basis of findings stated above and after conversation
with the hospital, the patient started treatment with prednisolone 40 mg. The
patient was found dead in bed on 11Apr2021 just before midnight. An autopsy was not
performed. The reporter suspected that the patient died with and not because of
COVID-19. Cause of death was unknown to the reporter. The patient's outcome was
fatal. The case was considered to be Serious. The outcome of the event died/Cause
of death was unknown was fatal, of exposure to covid-19/Infection exposed was
recovered on 02Apr2021, of the other events was unknown. Health Authority Comment:
Since the vaccine is new, it will be subject to special monitoring to identify any
new safety information as soon as possible. It is especially important that serious
and/or unusual side effects be reported. Your message is therefore important to
expand knowledge about adverse reactions that were not discovered in the studies,
and it is an important contribution to international cooperation to maintain safe
vaccination worldwide. Causality assessment (Relatedness of drug to
reaction(s)/event(s)): Vaccination failure: Source of assessment: Center. Result
of Assessment: Possible; Drug ineffective: Source of assessment: Center. Result of
Assessment: Possible; COVID-19: Source of assessment: Center. Result of Assessment:
No relationship; Nausea: Source of assessment: Center. Result of Assessment:
Possible.; Reported Cause(s) of Death: died/Cause of death was unknown" "No
"1306940-1" "1306940-1" "Hospitalized and died due to COVID-19 after being
fully vaccinated." "No prior vaccinations for this event."
"1310308-1" "1310308-1" "Patient hospitalized on 4/15/2021 after being fully
vaccinated. Tested positive on 4/19/2021. Patient died on 4/27/2021." "No prior
"1311276-1" "1311276-1" "Pneumonia due to COVID-19 virus ED to Hosp-
Admission Discharged 4/14/2021 - 4/22/2021 (8 days) Last attending ? Treatment
team Maxillary fracture Principal problem Final Summary for Deceased Patient
Admission Date: 4/14/2021 Discharge Date: 4/22/2021 Final Diagnosis Principal
Problem: Maxillary fracture (CMS/HCC) Active Problems: Pneumonia due to COVID-
19 virus Demand ischemia (CMS/HCC) Dyslipidemia Essential hypertension
Acute kidney injury (CMS/HCC) Glomerulonephritis, IgA Lactic acidosis Septic
shock (CMS/HCC) Cytomegalovirus (CMV) viremia (CMS/HCC) Acute respiratory
failure with hypoxia (CMS/HCC) Left femoral vein DVT (CMS/HCC) Malnutrition
(CMS/HCC) Hypothermia DETAILS OF HOSPITAL STAY Presenting Problem/History
of Present Illness/Reason for Admission Hypoxia [R09.02] Acute respiratory failure
with hypoxia (CMS/HCC) [J96.01] Fall, initial encounter [W19.XXXA] COVID-19 [U07.1]
COVID-19 virus infection [U07.1] Hospital Course Patient is a 72-year-old
female with past medical history of hypertension, hyperlipidemia, recent
hospitalization due to CMV viremia and an AKI and myelosuppression. Who presented
to the emergency room after a fall in her house on 4/14. She had significant face
pain and was hypoxic with an O2 saturation of 68% on room air on presentation. She
was then found to be Covid positive. Initially admitted to the medical floor
however required increasing amounts of oxygen and was ultimately transferred to the
ICU on 4/16. She was maintained on nonrebreather oxygen until the evening of 4/21
when she was intubated and increasing vasopressor requirements. Given her
worsening condition, her husband elected to palliatively extubate and pursue
comfort care. Time of death was 10:02 AM on 4/22/2021. Disposition of the
body: morgue" "No prior vaccinations for this event."
"1311647-1" "1311647-1" "Vaccination failure; Symptomatic Covid sets in with
desaturation.; This is a spontaneous report from a contactable physician downloaded
from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20213133,
Safety Report Unique Identifier FR-AFSSAPS-2021047051. A 96-year-old female
patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Lot
Number: EK9788) as single dose, dose 1 intramuscular on 14Jan2021 (Lot Number:
EM0477) as single dose for COVID-19 immunisation. Medical history included disease
coronary artery, diabetes mellitus insulin-dependent, cardiac valvulopathy, cardiac
failure, peripheral obliterative arteriopathy, chronic renal failure, glaucoma,
atrial fibrillation paroxysmal, hypertension arterial, hernia hiatal, and carotid
artery stenosis; all from an unknown date and unknown if ongoing. Concomitant
medications included darbepoetin alfa (ARANESP); insulin aspart, insulin aspart
protamine (crystalline) (NOVOMIX); lansoprazole; clopidogrel; lercanidipine;
amiodarone; furosemide; and colecalciferol (ZYMAD); all taken for an unspecified
indication, start and stop date were not reported. The patient experienced
vaccination failure and symptomatic covid sets in with desaturation on 08Apr2021.
Support: monitoring and putting on oxygen. The patient underwent lab tests and
procedures which included PCR: positive (variant) and oxygen saturation:
desaturation on 08Apr2021. The patient died due to events on 22Apr2021. An autopsy
expected.; Reported Cause(s) of Death: Vaccination failure; Symptomatic Covid sets
in with desaturation." "No prior vaccinations for this event."
"1312091-1" "1312091-1" "Dyspnea; Coughing; Cardiac failure left; Drug
ineffective; COVID-19/COVID-19 PCR test positive; This is a spontaneous report from
a contactable physician downloaded from the Agency Regulatory Authority-WEB,
regulatory authority number HU-OGYI-254821 reported on 19Apr2021. An 81-year-old
male patient received bnt162b2 (COMIRNATY, tozinameran, concentrate for dispersion
for injection, COVID-19 mRNA Vaccine embedded in lipid nanoparticles), dose 1
intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EP2166) as
first dose, 0.3 mL single, for COVID-19 immunization/for active immunization to
prevent COVID-19. Relevant medical history includes myocardial infarction acute,
ischemic heart disease, COVID-19 and hypertension from unspecified dates and
unknown if ongoing. The patient's concomitant medications were not reported. On
08Apr2021, the patient's COVID PCR test was positive. On 15Apr2021 the patient was
admitted in the hospital because of coughing and dyspnea which started the day
before (14Apr2021). The patient received oxygen therapy as his oxygen saturation
was 85% and had severe dyspnea. On 17Apr2021 at 17:45 the patient died. The cause
of death were COVID-19 infection and cardiac failure left. The patient underwent
lab tests and procedures which included COVID-19 PCR test: positive on 08Apr2021,
and oxygen saturation: 85 % on an unspecified date. The patient died on 17Apr2021.
It was not reported if an autopsy was performed. Case was reported as serious,
medically confirmed. Sender Comment: According to the SmPC of Comirnaty, immunity
usually develops 14 days after the second dose of the vaccine. The patient received
the first dose of Comirnaty on 19Mar2021 and got infected with the virus 20 days
after, therefore immunity may not have developed yet without the second dose. Based
on the above, the causal relationship is unlikely between the suspected drug and
the adverse events. The case is considered serious because the outcome was fatal.
Further information is not expected.; Reported Cause(s) of Death: Drug ineffective;
Dyspnea; Coughing; COVID-19/COVID-19 PCR test positive; Cardiac failure left"
"1314801-1" "1314801-1" "Death: CHRONIC COMBINED SYSTOLIC -CONGESTIVE- AND
DIASTOLIC -CONGESTIVE- HEART FAILURE, COVID-19" "No prior vaccinations for this
event."
"1316428-1" "1316428-1" "COVID-19 pneumonia; Tachycardia; COVID-19; Fever;
Inanition/gaunt; Diarrhea caused by Clostridium difficile; Klebsiella pneumoniae
infection; induced coma; Headache, elevated temperature, fatigue; Ear pain; ear
inflammation; Rhinorrhea; Dacryorrhea; Pain in the left upper limb; This is a
spontaneous report from a contactable consumer downloaded from the regulatory
authority-WEB CZ-CZSUKL-21004773. An 81-year-old female patient received first
dose of bnt162b2 (COMIRNATY), intramuscular in left arm on 25Feb2021 (Lot Number:
Unknown, at age of 81 years old) as single dose for COVID-19 immunisation. The
patient's medical history and concomitant medications were not reported. In the
evening after the vaccination on 25Feb2021, the patient appeared pain of the
vaccinated arm (left). The next day on 26Feb2021, the patient had a headache, ear
pain, rhinorrhea, and dacryorrhea, Flu-like symptoms (Headache, elevated
temperature, fatigue). The headache escalated and fatigue appeared during the next
two days. On the fourth day after the vaccination on 01Mar2021, elevated body
temperature and dry cough appeared. On the fifth day on 02Mar2021, the cough
escalated and her physician prescribed Isoprinosine to her. On the seventh and
eighth day (04Mar2021 and 05Mar2021), a fever of 39�C appeared (also reported as
less or equal to 39) and she had prescribed Augmentin for ear inflammation. On the
tenth day (07Mar2021), an ambulance was called for the patient and she was admitted
to the hospital. On the eleventh day on 08Mar2021, a COVID-19 test was done with a
positive result, the level of her c-reactive protein was 100 mg/L and she still
complained about ear pain (ORL examination found no pathology). After 4 days, the
patient was put on an oxygen mask. She was then transferred to the Anesthesiology
department because of CRP elevation, where she was set to an induced coma and she
breathed using mechanical ventilation. She was administered Meropenem. After waking
up from the artificial sleep, a Klebsiella pneumoniae was isolated from the
patient's sputum and she was administered Vancomycin and Solumedrol in Mar2021.
After two more days in Mar2021, her O2 saturation decreased and she had diarrhea. A
Clostridium difficile was confirmed microbiologically, which resulted in a change
of antibiotics to Biseptol. Finding on chest CT was unspecified, the patient still
had a cough, was gaunt (Inanition) and her CRP kept elevating. She was administered
oxygen and after a week she was transferred to the pulmonary department (standard),
where she was put on an oxygen mask. On 10Apr2021, the patient developed
tachycardia and was therefore transferred to the Intensive care unit. According to
the reporter, the patient's lung was destroyed (about a 1/3 was working). Events
COVID-19 & COVID-19 pneumonia were reported with event stop dates DATA 14APR2021.
The outcome of events COVID-19 and COVID-19 pneumonia was fatal. The outcome of
event persistent dry cough was not recovered. The outcome of rest events was
unknown. On 14Apr2021, the patient died of pneumonia. The patient died on
14Apr2021. It was not reported if an autopsy was performed. No follow-up attempts
possible; batch/lot number cannot be obtained. No further information is expected.;
Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19" "No prior vaccinations
for this event."
"1316495-1" "1316495-1" "Vaccination failure; Covid-19; This is a spontaneous
Authority-WEB. The regulatory authority report number FR-AFSSAPS-DJ20211039 Safety
Report Unique Identifier FR-AFSSAPS-2021047437 A 96-year-old female patient
received bnt162b2 (COMIRNATY), intramuscular on 28Jan2021 (Batch/Lot Number:
EK9788) as 1st dose, single and intramuscular on 18Feb2021 (Batch/Lot Number:
EK9788) as 2nd dose, single for covid-19 immunization. The patient's medical
history included ongoing cardiac failure and ongoing dementia. The patient's
concomitant medications were not reported. The patient experienced vaccination
failure on 21Apr2021 as the patient had covid-19. First signs on 21Apr2021 includes
hoarse cough, wheezing. The patient's PCR return positive (variant identified) on
22Apr2021. Quickly appeared a desaturation (80%) and congestion.The patient
contracted COVID probably following a personal visit (no other patient in the sick
nursing home at this time nor any member of the staff). Patient was placed on
antibiotics, corticosteroids and O2. The outcome of the event vaccination failure
and Covid-19 was fatal. The patient died on 29Apr2021. An autopsy was not
performed. No follow-up attempts are possible; information about batch number
already obtained.; Reported Cause(s) of Death: vaccination failure; COVID-19"
"1316585-1" "1316585-1" "Desaturation and right focus; Vaccination
failure/COVID-19/Carrying out a PCR which turns out to be positive (so-called
variant).; COVID-19/Carrying out a PCR which turns out to be positive (so-called
variant).; fever; auscultatory bronchitis; This is a spontaneous report from a
contactable pharmacist downloaded from a regulatory authority-WEB regulatory
authority [FR-AFSSAPS-NT20211359], Sender's Safety Report Unique Identifier [FR-
AFSSAPS-2021047756]. An 88-year-old male patient received bnt162b2
(COMIRNATY), dose 2 on 12Feb2021 (Lot Number: EJ6789) and dose 1 on 22Jan2021 (Lot
Number: EJ6788); both via intramuscular at single dose for SARS-CoV-2 vaccination.
Medical history included stable COPD living in a nursing home. No respiratory
pathology since 2015. The patient's concomitant medications were not reported. On
13Apr2021, the patient experienced early auscultatory bronchitis. No cough (sore
throat isolated symptom). On 18Apr2021, he had fever. On 19Apr2021, carrying out a
PCR which turns out to be positive (so-called variant), Covid 19. On 21Apr2021:
Desaturation and right focus. Progressive worsening despite increased antibiotics,
dexamethasone and oxygen therapy and right pleural puncture. Therapeutic measures
were taken as a result of the events. The patient died on 25Apr2021 around 5 a.m.
Cause of death was Vaccination failure and Covid 19. It was unknown if an autopsy
was performed. The outcome of the events auscultatory bronchitis, fever and
desaturation was unknown. The outcome of the remaining events was fatal. No
Cause(s) of Death: Vaccination failure; COVID-19" "No prior vaccinations for
this event."
"1316645-1" "1316645-1" "Patient received dose 1 of the pfizer covid vaccine
on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at
outside clinic after presenting with about a week of cough, nausea and fatigue. On
5/2/21 she presented to our emergency department with persistence of the above
symptoms and hypoxia to the 70s on room air and again tested positive for COVID.
Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics
for 7 days and dexamethasone for 10 days. She was offered tocilizumab and
remdesivir but refused. She clinically improved and was weaned down to 2L NC
w/saturation of 93%. However on 5/13 she acutely desaturated and was found
pulseless. Patient was DNR/DNI so was pronounced dead." "No prior vaccinations
for this event."
"1318087-1" "1318087-1" ""his condition progressed; inflammatory markers
rose; Interstitial pneumonia due to COVID-19; Weakness; problems with
communication; Confusion; COVID-19; This is a spontaneous report from a contactable
consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB CZ-
CZSUKL-21004786. A 73-year-old male patient received bnt162b2 (COMIRNATY, Lot
number: ET7205) intramuscular on 26Mar2021 at single dose for covid-19
immunisation. The patient's medical history included special epileptic syndrome,
primary hypertension, LBBB - Left bundle branch block, prostatic hyperplasia, all
ongoing, ischaemic ictus from an unknown date and not ongoing. Concomitant
medications were none. On 01Apr2021, the patient was hospitalized on the COVID-19
department for confusion, weakness, and problems with communication. The patient
was found to have COVID-19. His condition slowly improved to the point when he was
07Apr2021 transferred to a standard department. Here his condition progressed, his
auscultatory readings worsened, and his inflammatory markers rose. On 11Apr2021 the
patient died. The patient experienced interstitial pneumonia due to COVID-19 on
07Apr2021. Time Interval between beginning of drug administration and start of
reaction Covid-19 pneumonia was 12 days. The cause of death was interstitial
pneumonia due to COVID-19. It was unknown if an autopsy was performed. The patient
underwent lab test included COVID-19 virus test: positive on 01Apr2021,
inflammatory markers: rose on an unknown date. The outcome of the event""
Interstitial pneumonia due to COVID-19"" was fatal, of the events ""weakness"",
""problems with communication"", ""confusion"" was recovered, of the other events
was unknown. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: Interstitial pneumonia due to COVID-19"" "No prior
"1318093-1" "1318093-1" "Vaccination failure; COVID-19 PCR test positive;
This is a spontaneous report from a contactable consumer downloaded from the
Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-DJ20211042, Safety
Report Unique Identifier FR-AFSSAPS-2021047636. An 83-year-old male patient
received BNT162B2 (COMIRNATY), intramuscular on 04Feb2021 (batch/lot number:
EK9788) as 2nd dose, single, and intramuscular on 14Jan2021 (batch/lot number:
EM0477) as 1st dose, single for COVID-19 vaccination. Medical history included
hyperthyroidism, hypertension arterial (high blood pressure), atrial fibrillation,
infarct myocardial, diabetes and cardiac failure (heart failure). Concomitant
medications included acidum folicum, atorvastatin, bisoprolol fumarate (BISOCE),
furosemide, metformin, carbimazole (NEO MERCAZOLE), olanzapine, ramipril,
picloxydine dihydrochloride (VITABACT) and rivaroxaban (XARELTO). The patient
experienced vaccination failure and COVID-19 PCR test positive on 26Apr2021 with
fatal outcome. It was further reported that PCR positive on 26Apr2021. He presented
flu-like symptoms on 01May2021 and died on 02May2021. On the day of death the
symptoms were fever of 39 degrees, asthenia and spasms. No variant identified.
Context of several cases in the same nursing home (cf DJ20211054 + other case under
documentation). In total: 83-year-old patient who presented with a vaccine failure
and died at the nursing home on 02May2021. A drug was substantially coded if the
name of the specialty was not known. The outcome of the rest of the events was
unknown. The patient died on 02May2021. An autopsy was not performed. No follow-up
Death: COVID-19 PCR test positive; Vaccination failure" "No prior vaccinations
for this event."
report from a contactable pharmacist downloaded from the Regulatory Authority-WEB
FR-AFSSAPS-LL20212462 with Safety Report Unique Identifier FR-AFSSAPS-2021047805.
An 85-year-old male patient received bnt162b2 (COMIRNATY lot/batch number and
expiration date not reported) intramuscular on Feb2021 as 1st dose, single and on
Mar2021 as 2nd dose, single for COVID-19 immunisation. Medical history included
gastrooesophageal junction cancer metastatic (chemotherapy with XELODA), prostatic
carcinoma and hypertension arterial. Concomitant medications included serenoa
repens extract (PERMIXON), nebivolol hydrochloride (TEMERIT), lercanidipine
hydrochloride (LERCAN), candesartan cilexetil (KENZEN [CANDESARTAN CILEXETIL]) and
pantoprazole sodium sesquihydrate (EUPANTOL). The patient experienced vaccination
failure and COVID-19 on 21Apr2021. On 21Apr2021: fall at home, inability to get up
then disturbance of consciousness. Supported by the Emergency and Resuscitation
Service then in the emergency room of the Hospital. On 22Apr2021: COVID diagnosis
with unfavorable prognosis, maximum care in room but rejected for resuscitation.
COVID disease management with oxygen therapy, roactemra 700 mg, levofloxacin 750 mg
/ 24h, dexamethaosone 6mg / 24h, cefotaxime 3g / 24h. On 22Apr2021: patient who
desaturated under O2 15 L / min. O2 increased to 30 L / min then to 40 L / min. On
23Apr2021: death of the patient due to the events. It was not reported if an
autopsy was performed. No follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination
failure; COVID-19" "No prior vaccinations for this event."
"1319090-1" "1319090-1" "Death; COVID-19 virus test positive; Covid 19 test
positive on 17th day after first dose (Drug Ineffective); This is a spontaneous
report from a contactable physician downloaded from the Regulatory Authority-WEB,
regulatory authority number HU-OGYI-257321. A 72-year-old male patient received
BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 05Apr2021
(Batch/Lot Number: WE2239) as 1st dose, 0.3 ml single for COVID-19 immunization.
Medical history included COVID-19. The patient's concomitant medications were not
reported. On 20Apr2021, the patient started having breathing difficulties and on
21Apr2021 early morning had to call an ambulance. The EMT confirmed the Covid-19
infection (positive), but the patient died at 05:30 on 21Apr2021 before arriving in
the hospital. It was not reported if an autopsy was performed. Sender Comment:
According to the product characteristics of Comirnaty, immunity usually develops
14 days after the second dose of the vaccine. The patient got infected with the
virus 16 days after the first dose, therefore immunity may have not developed yet.
Based on the above, the causal relationship is unlikely between the suspected drug
and the adverse event. The case is considered serious because the outcome was
fatal. Further information is not expected. Follow-up activities closed. No
routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of Death: COVID-
19; COVID-19" "No prior vaccinations for this event."
"1319463-1" "1319463-1" "COVID-19 pneumonia; Oxygen saturation of 30%;
Unconscious at arrival to Hospital; airway compromised by gastric content; Apneic;
central pulse not palpable; COVID-19; Dysopnea/Respiratory distress; Fever of 38
degrees Celsius; Diarrhea; Rhinorrhea; Cough; Dysopnea/Respiratory distress;
Myalgia; Arthralgia; This is a Spontaneous report from a non-contactable Other
Health Professional. This is a report received from Agency Regulatory Authority via
email. Regulatory authority report number is 12907-5 A 62-years-old male patient
received bnt162b2 (BNT162B2), via intramuscular, administered in Arm Left on
12Mar2021 (Batch/Lot Number: ER1742; Expiration Date: 30Jun2021) as 1st dose single
for covid-19 immunisation.Age at vaccination 62 years. The patient medical history
was not reported. The patient's concomitant medications were not reported. The
patient experienced fever of 38 degrees celsius on 22Mar2021 , diarrhea on
22Mar2021 , rhinorrhea on 22Mar2021 , cough on 22Mar2021 , dysopnea/respiratory
distress on 22Mar2021 , myalgia on 22Mar2021 , arthralgia on 22Mar2021 , covid-19
on 30Mar2021 , covid-19 pneumonia on 04Apr2021 , oxygen saturation of 30% on
04Apr2021 , unconscious at arrival to hospital on 04Apr2021 , airway compromised by
gastric content on 04Apr2021 , apneic on 04Apr2021 , central pulse not palpable (on
04Apr2021. The patient underwent lab tests and procedures which included blood
immunoglobulin g: 19.88 on 31Mar2021 , blood immunoglobulin m: 12.78 on
31Mar2021 , computerised tomogram: covid-19 on 30Mar2021 , oxygen saturation:
30 % on 04Apr2021. The patient died for the events n 04Apr2021. Clinical picture:
62-year-old male, unknown personal background, with a background of covid-19
vaccination in PRIVACY on 12Mar2021, begins with symptoms on 22Mar2021 of type of
flu mentioned by the patient's wife, letting go a week without presenting an
improvement, they go to a doctor on 30Mar2021 where they diagnosed covid-19 by
tomography and on 31Mar2021 they go to take quantitative antibodies at laboratory,
resulting in IgM 12.78 and IgG 19.88. Continues treatment at home with supplemental
oxygen without presenting an improvement, it is brought to this unit on 03Apr2021
in a private vehicle from their home, in treatment with supplemental oxygen for
pneumonia by sarscov2, relatives refer important desaturation as low as 30% prior
to his transfer to this unit. Unconscious patient is received on admission, airway
compromised by gastric content, apneic, non-palpable central pulse. Family members
refer at least 10 minutes of cessation of breathing until the arrival at this unit.
Declaring date of death 03Apr2021. It was not reported if an autopsy was
expected.; Reported Cause(s) of Death: unconscious at arrival to hospital; airway
compromised by gastric content; fever of 38 degrees celsius; diarrhea; rhinorrhea;
cough; dysopnea/respiratory distress; dysopnea/respiratory distress; myalgia;
arthralgia; Covid-19; covid-19 pneumonia; oxyg" "No prior vaccinations for this
event."
"1322956-1" "1322956-1" "Patient got second dose of the vaccine on 2/4/2021.
He was diagnosed with COVID 19 on 5/15/2021 (he was negative on 3/19/2021). He was
hypoxic, developed changed in mental status. Died on 5/16/2021" "No prior
"1323372-1" "1323372-1" "Patient received both doses of Pfizer vaccine (#1 on
2/9/21, #2 on 3/2/21) and was fully vaccinated when he presented to the ED on
5/9/21 w/ 3 week h/o cough, shortness of breath,. Tested positive for COVID19 by
PCR on 5/10/21. Patient treated w/ Remdesivir, Dexamethasone, and convalescent
plasma. Was on ventilator. Expired on 5/16/21 due to Acute Respiratory Failure with
Hypoxia, Pneumonia due to COVID-19." "No prior vaccinations for this event."
"1324154-1" "1324154-1" "5/2/2021 - productive persistent cough and poor
appetite. Received physician order to transfer to Hospital for evaluation." "No
"1324442-1" "1324442-1" "calm coma; acute respiratory distress; dyspnea;
diarrhea; hyperthermia; Vaccination failure; SARS-CoV-2 test positive; This is a
spontaneous report from a contactable pharmacist downloaded from the Regulatory
Authority-WEB regulatory authority FR-AFSSAPS-2021048283. A 65-years-old male
patient received bnt162b2 (COMIRNATY, solution for injection), on 24Feb2021 (lot
number and expiry date not reported) as first dose, single; and on 17Mar2021 (lot
number and expiry date not reported) as second dose, single; both via intramuscular
for covid-19 immunisation. Medical history included cirrhosis liver; severe anemia
with repeated transfusions every 15 days, auricular fibrillation, hypertension
arterial, COVID-19, end stage renal failure (end-stage chronic renal failure),
sleep apnoea syndromes (paired sleep apnea syndrome), heart valve replacement,
beginning of hemodialysis from Apr2020, beginning of peritoneal dialysis from
Jun2020, non-insulin-dependent diabetes mellitus, refractory ascites requiring
ascites punctures every 3 weeks, esopropic-duodenal fibroscopy (VO grade 1 on FOGD
(esopropic-duodenal fibroscopy)) in Feb2020, peptic ulcers from 2012,
angiodysplasia of the colon, essential hypertension (primary), effective
anticoagulation, tight aortic stenosis, transcatheter implantation of an aortic
valve (TAVI) in Dec2019, child C10 ethyl cirrhosis, IgA nephropathy secondary to
cirrhosis, atrial fibrillation and flutter, and heart disease valve. The patient's
concomitant medications were not reported. Patient who received 2 doses of Pfizer
vaccine (24Feb2021 and 17Mar2021), had a serology test (control serology) on an
unknown date with negative return. Patient had SARS-CoV-2 test PCR positive on
30Apr2021 (contact of his wife and son). Patient experienced appearance of
progressive dyspnea and diarrhea on 03Mar2021. On 03May2021, patient was reported
to have vaccination failure. Upon arrival on 03Mar2021, patient was in peritoneal
dialysis for consultation plus transfusion and patient was hyperthermia and with
acute respiratory distress with O2 saturation 77% in AA (03Mar2021), 87% under O2 5
L / min (03Mar2021), and 100% under O2 15L (03Mar2021), and patient was transferred
to COVID unit for treatment of severe infection. The patient was admitted in the
hospital on 03May2021. On 04May2021, patient was non-reactive and in calm coma, and
experienced death 05May2021. Treatments were received by the patient in response to
the events reported. The outcome of the events dyspnea, diarrhea, hyperthermia,
acute respiratory distress was unknown. The patient died on 05May2021. The causes
of death were reported as vaccination failure, SARS-CoV-2 test positive and coma.
It was unknown if an autopsy was performed. No follow-up attempts are possible;
SARS-CoV-2 test positive; Coma; vaccination failure" "No prior vaccinations for
this event."
"1324638-1" "1324638-1" "Multiorgan failure/heart failure/renal failure and
respiratory failure; Vaccination failure/positive for COVID-19; Vaccination
failure/positive for COVID-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority. Regulatory Authority Report
Number: FR-AFSSAPS-NT20211393. Safety Report Unique Identifier: FR-AFSSAPS-
2021048736. An 80-year-old male patient received BNT162B2 (COMIRNATY), dose 2
intramuscular, administered in arm left on 28Mar2021 (Batch/Lot Number: ET3620) as
2nd dose, single, dose 1 intramuscular, administered in arm left on 02Mar2021
(Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical
history included Coronary artery disease: last cardiological consultation in
Feb2021; type 2 diabetes being treated; high blood pressure; hypercholesterolaemia;
sleep apnoea syndrome not treated with a device; left frontotemporal stroke of
probable atheromatous origin; cognitive difficulties evolving since 2019. Last
assessment finding a mini-mental state at 19/30, with reported frontal behavioural
disorders (irritability); otorhinolaryngology cancer: Right tonsil treated with
surgery + radio-chemotherapy in 2019 considered to be in remission since then;
gout-like microcrystalline arthropathy; right inguinal hernia operated on; benign
prostate hypertrophy. Concomitant medications included aspirin [acetylsalicylic
acid] (ASPIRIN [ACETYLSALICYLIC ACID]) at 75 mg daily in the morning; pravastatin
at 20 mg daily in the evening; insulin glargine (ABASAGLAR) at 15 units in the
mornings; insulin lispro (HUMALOG) 4 units morning 4 units noon 4 units evening;
folic acid 5 mg; macrogol; serenoa repens extract (PERMIXON) 160 mg; vitamin D NOS;
enoxaparin sodium (LOVENOX HP) 6000 DF once a day; furosemide at 80 mg 4 times a
day; dexamethasone at 6 mg; ceftriaxone at 1 g; glucose, potassium chloride, sodium
chloride (GLUCIDION) at 1 L daily, all taken for an unspecified indication, start
and stop date were not reported. The patient experienced multiorgan failure on
21Apr2021 and vaccination failure/positive for covid-19 on 17Apr2021 with clinical
course was reported as patient referred by his attending physician to the Hospital
on 14Apr2021 for cognitive impairment with urinary disorders (sterile
cytobacteriogical urine test performed in the city). The assessment performed in
the city was the following: a cerebral CT scan finding sequelae of left temporal
stroke, a thoraco-abdomino-pelvic CT scan finding bilateral pleural effusions, an
enlarged prostate, a biological assessment performed finding deficiencies in
vitamin D and folate as well as sub-clinical hypothyroidism. Upon his admission,
the patient was diagnosed positive for COVID-19 on 17Apr2021 (the patient was
vaccinated with 2 doses, the last of which was performed on 28Mar2021). Respiratory
deterioration with appearance of a right base focus leading to the introduction of
antibiotic therapy with Augmentin on 19Apr2021. The next day, 20Apr2021, the
patient became oxygen-dependent (93% under 2 L/min) and also presented with a
deterioration of alertness with oral intake not being possible. Antibiotic therapy
with intravenous ceftriaxone associated with methylprednisolone 20 mg is then
introduced with regard to the COVID-19 infection. At the same time, the results of
20Apr2021 found ascending brain natriuretic peptide, as well as acute renal
failure. In the event of associated cardiac decompensation, intravenous furosemide
80 mg was introduced. On 21Apr2021, in view of a clear deterioration in alertness
with a Glasgow score of 10/15, the patient was referred to a Covid unit. The
patient presented with a comatose state with Cheyne-Stokes dyspnoea and loss of
alertness with a Glasgow score of 6/15 (Y1, V1, M4), also presence of signs of
Babinski in the lower left limb. Cerebral computerised tomography: Somewhat recent
superficial sylvian left ischemic stroke, also right and left occipital, without
haemorrhagic change. Permeable Willis polygon. Probable embolic aetiology.
Biological assessment: Moderate hypernatraemia at 147 mmol/L, acute renal failure
at 236 �mol/L. Gasometry under 6 L: Respiratory alkalosis associated with
hypoxaemia: pH 7.57, pCO2 at 20 mmHg, bicarbonates at 18 mmol/l, pO2 at 70 mmHg,
lactates at 2.6 mmol/l. Electrocardiogram: discovery of atrial fibrillation.
Medical care: Bolus of acetylsalicylic acid 300 mg administered on 21Apr2021.
Introduction of a curative anticoagulant on 22Apr2021. Summary: 80-year-old patient
admitted to the department with a COVID 19 infection. Picture of multi-visceral
failure upon arrival in the department with major alertness problems secondary to
recent multiple strokes probably of emboligenic origin, heart failure on probable
non-ST + acute coronary syndrome with left ventricular ejection fraction plummeting
to 25%, renal failure and respiratory failure on SARS CoV 2 infection with probable
bacterial superinfection. No improvement after 48 hours of active therapy
combining: Oxygen therapy with high-concentration mask. Corticosteroid therapy with
dexamethasone 20 mg. Bolus of ASPIRIN alternating with curative heparin calcium
(CALCIPARIN). Antibiotic therapy with tazocillin. Evolution: collective decision to
limit treatment with suspension of active therapy: comfort care with midazolam and
morphine. Suspension of oxygen therapy with high-concentration mask. Temperature
and respiratory rate monitoring only. The patient died on 27Apr2021. It was not
reported if an autopsy was performed. Outcome of the events was fatal. No follow-
up attempts are possible, information on batch number cannot be obtained.; Reported
Cause(s) of Death: Multiple organ failure; Vaccination failure/positive for COVID-
19; Vaccination failure/positive for COVID-19" "No prior vaccinations for this
event."
"1324706-1" "1324706-1" "comatose state / a state of hyper osmolarity linked
to a decompensation of her diabetes/hyperosmolar coma; decompensation of her
diabetes; respiratory decompensation; hypoxia/oxygen saturation 85%; Vaccination
failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021,
Injection 2; COVID-19 confirmed by positive COVID-19 test; Vaccination date:
19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; Vaccination
date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; This is
as spontaneous report received from a contactable pharmacist downloaded from the
regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-
TO20213292, Safety report unique identifier FR-AFSSAPS-2021049377. A 69-year-old
female patient received BNT162B2 (COMIRNATY), intramuscularly on 25Mar2021 as 2nd
dose, single (Batch/Lot Number: ER9470), intramuscularly on 19Jan2021 as 1st dose,
single (Batch/Lot Number: ES6788) for covid-19 immunisation. Medical history
included ketosis-prone diabetes mellitus, insulin-dependent diabetes, arterial
hypertension, complete arrhythmia due to atrial fibrillation (AFib), kidney
failure, sequelae cognitive disorders, stroke, sleep apnea, hypothyroidism,
obesity, hyperuricaemia, deglutition disorder, hyponatraemia, hyperkalemia,
swallowing disorders with currently rehydration by exclusive gastric tube.
Concomitant medications included phenobarbital (GARDENALE); oxazepam (SERESTA 10 mg
tablet); mirtazapine 15 mg tablet; levothyroxine sodium (L THYROX); erythromycin;
racecadotril (TIORFAN); hyoscine (SCOPODERM patch); oxycodone hydrochloride
(OXYNORMORO 5mg); insulin lispro (HUMALOG). On 25Mar2021, vaccination against COVID
19 Dose 2. On 02Apr2021, covid-19 tested positive, British variant. On 06Apr2021,
tested positive for COVID 19 with on 06Apr2021 respiratory decompensation, dextro
5.8g/l, oxygen saturation 85%, heart beat 65, blood pressure 100/60. Patient was
hospitalized on an unspecified date. Hospital care put under oxygen (O2) 6L/min.
the patient presented on arrival a comatose state with concomitant hypoxia linked
to COVID and especially a state of hyper osmolarity linked to a decompensation of
her diabetes. Treatment was performed with rehydration for hyperosmolar coma
insulin therapy antibiotic therapy. Palliative comfort management given the
patient's condition and the seriousness of the situation with the appearance of
signs of respiratory discomfort justifying the prescription of a low dose of
MIDAZOLAM. The patient eventually died on 08Apr2021 despite the treatment. An
autopsy was not performed. The reported cause of death was drug ineffective, COVID-
19, hyperosmolar (non-ketotic) coma and decompensation of diabetes. Outcome of drug
ineffective, COVID-19, hyperosmolar (non-ketotic) coma and decompensation of
diabetes was fatal, outcome of other events was unknown. No follow-up attempts
are possible. No further information is expected.; Reported Cause(s) of Death:
Vaccination failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination:
25Mar2021, Injection 2; COVID-19 confirmed by positive COVID-19 test;
decompensation of her diabetes; Hyperosmolar (non-ketotic) coma" "No prior
"1326331-1" "1326331-1" "Covid disease after 2 vaccinations; Covid disease
after 2 vaccinations; fever; general weakness/ General debility; This is a
spontaneous report from a contactable physician and consumer downloaded from the
Regulatory Authority-WEB, Safety Report Unique Identifier AT-BASGAGES-2021-24747.
A 96 years old female patient received 1st dose of BNT162B2 (COMIRNATY, lot#
EJ6796) on 12Jan2021 at single dose, 2nd dose (lot#EJ6134) at single dose on
02Feb2021 for COVID-19 immunization. Medical history was Dementia (continuing),
Bradycardia (persistent symptomatic bradycardia, pacemaker since 17Apr2018),
Cardiac pacemaker insertion (continuing), Decompensation cardiac (continuing),
General physical condition decreased (continuing). Concomitant medications included
glucose/potassium chloride/sodium citrate acid (ELECTROLIT), Candesartan 8 mg,
ginkgo biloba extract (CEREBOKAN, 80 mg), apixaban (ELIQUIS, 2.5 mg),
furosemide/spironolactone (FURO-SPIROBENE), furosemide (LASIX, 40 mg), macrogol
3350/potassium chloride/sodium bicarbonate/sodium chloride (MOLAXOLE),
Pantoprazolum 20 mg, quetiapine fumarate (QUETIALAN, 25 mg), Sertraline 50 mg,
trazodone hydrochloride (TRITTICO,150 mg). On 28Mar2021 the patient experienced
Vaccination failure, SARS-CoV-2 infection, COVID-19 PCR test positive. COVID
illness after 2 vaccinations. Other diseases/basic diseases not known, except poor
AZ (old age). At the end of Mar2021 she developed a fever, then general weakness/
General debility, otherwise she had no symptoms. At the time of the vaccination she
was so far healthy, had no infection. It was tested once a week and the quick test
on 28Mar2021. if it was positive, a PCR test was then carried out by the Agency,
also on 28Mar2021, which was also positive. We are not aware of any sequencing. The
antibody titers were never determined. Patient was passed away on 09Apr2021, not in
the hospital. No autopsy was made. Cause of death reported as covid-19 infection.
The patient's outcome was fatal. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID illness after 2
vaccinations; Covid disease after 2 vaccinations" "No prior vaccinations for
this event."
"1327666-1" "1327666-1" "Patient received second Pfizer vaccine on 2/8/2021.
Became symptomatic with COVID like S/S on 4/30/2021. Was admitted to Hospital on
5/4/2021 and tested positive for COVID 19 upon admission. Patient was intubated on
5/12/21 and expired while still admitted to the hospital on 5/17/21." "No prior
"1327755-1" "1327755-1" "Hospitalized for COVID-19 pneumonia on 4/23, ICU on
5/3, passed on 5/17 of 2021" "No prior vaccinations for this event."
COVID-19 test; This is as spontaneous report received from a contactable physician
downloaded from the regulatory authority. The regulatory authority report number is
FR-AFSSAPS-2021048847. A 89-years-old male patient received bnt162b2 (COMIRNATY),
dose 1 intramuscular on 23Jan2021 (Batch/Lot Number: EM0477) as 1st dose, single,
dose 2 intramuscular on 13Feb2021 (Batch/Lot Number: EK9788) as 2nd dose, single
for covid-19 immunisation. Medical history included arrhythmia NOS, cardiac failure
(rhythm disorders), type 2 diabetes mellitus. No COVID-19 disease history. The
patient's concomitant medications were not reported. On 14Apr2021, the patient
experienced vaccination failure and COVID-19 confirmed by positive COVID-19 test
with fatal outcome. Event description: 2 months after complete vaccination, the
patient experienced severe COVID SARS infection with respiratory distress. After a
call from the establishment, vaccine failure confirmed by a positive test a few
days before death. No information on variant search. Treatment in place /
correction included: urgent medical intervention, maintenance in the accommodation
establishment for dependent elderly people and comfort care. Relevant test included
SARS-CoV-2 test: positive on Apr2021. The patient died on Apr2021. An autopsy was
not performed. No follow-up attempts possible. No further information expected.
Information about batch number already obtained.; Reported Cause(s) of Death:
"1327946-1" "1327946-1" "Respiratory distress; Vaccination failure; COVID-19
positivity; This is a spontaneous report from a consumer or other non HCP
downloaded from the regulatory authority. Regulatory Authority Report Number: FR-
AFSSAPS-DJ20211054. Safety Report Unique Identifier: FR-AFSSAPS-2021048085.
Declaration from an EHPAD director via the reporting portal of the Agency and
registered under the number 2021.0503124559648. This consumer reported similar
events for two patients. This is the first of two reports. A 69-year-old female
patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 11Feb2021 (Lot
Number: EJ6789) as single dose, dose 2 via intramuscular on 04Mar2021 (Lot Number:
EP2166) as single dose for COVID-19 immunisation. Patient age at vaccination was
reported as 69 years old. The patient medical history included ongoing diabetes,
ongoing hypertension arterial, ongoing obesity, ongoing insufficiency renal,
coronary arteritis. The patient had no history of COVID-19 disease. The patient's
concomitant medication included potassium chloride (DIFFU K), etifoxine
hydrochloride (STRESAM), furosemide, insulin aspart (NOVORAPID), insulin glargine
(LANTUS), clopidogrel bisulfate (PLAVIX), allopurinol (ZYLORIC), esomeprazole,
nicorandil (IKOREL), bisoprolol. The patient experienced vaccine failure with a
fatal outcome. The registrant reported on 26Apr2021, or 53 days after the injection
of the second dose of vaccine, the occurrence of COVID-19 positivity. Before
26Apr2021 no variant has been identified. On 02May2021 the patient presented with
respiratory distress requiring hospitalization. The patient died on 06May2021. The
cause of death was reported as COVID infection following vaccination failure.
Autopsy was not done. Hospitalization report pending. Several cases in the same
AFDEP (Accommodation facility for dependent elderly people), in particular another
death (DJ20211042). No follow-up attempts possible. No further information
expected.; Sender's Comments: Linked Report(s) : FR-PFIZER INC-2021546915 Different
patient/ same AE and suspect product.; Reported Cause(s) of Death: COVID infection
following vaccination failure; respiratory distress; COVID infection following
vaccination failure" "No prior vaccinations for this event."
"1328793-1" "1328793-1" "covid-19 infection; covid-19 infection; Congestive
Heart Failure; Atrial Fibrillation; Arrhythmia; Acute kidney injury; Altered
consciousness; Thrombocytopenia; Increased lethargy; This is a spontaneous report
from a contactable physician. A 96-years-old female patient received BNT162B2
(COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Arm Left
on 11Feb2021 (Lot Number: EL8723) as 2nd dose, single; dose 1 intramuscular,
administered in Arm Left on 21Jan2021 (Lot Number: EM0477) as 1st dose, single for
covid-19 immunisation. Medical history included hypertension, atrial fibrillation,
chronic kidney disease since 2016, right eye cataract, spinal osteoarthritis. Non-
smoker. Concomitant medications included atenolol at 100 mg daily; bumetanide
(BURINEX) at 1 mg daily; amitriptyline hydrochloride (AMIROL) at 10 mg nocte;
omeprazole at 20 mg twice daily; paracetamol at 1 g, as needed (tds) and Diarolyte
sachet as needed (twice daily). The patient experienced covid-19 infection
03Apr2021. The patient was hospitalized for covid-19 infection on 03Apr2021. The
patient experienced Dyspnea (Hypoxia), Tachypnea (RR more than 25bpm), Respiratory
failure (Type 1 Respiratory Failure), Arrhythmia (atrial fibrillation known case),
Hypoxemia (SPO2 73% RA rising to 95% on 15L/min NRM), Acute kidney injury (CKD -
GFR about 38), Altered consciousness, Increased lethargy, Thrombocytopenia
(Platelets - 77). On 05Apr2021 she was administered treatment with Remdesivir
200mg iv stat, then 100mg iv daily, Dexamethasone 6mg iv daily and Augmentin 1.2g
8hrly IV. The patient underwent lab tests and procedures which included: Nasal swab
(RT-PCR) - positive on 05Apr2021 (new infection, Detected: CT=36 Abnormal). On
admission (03Apr2021: Rectal Temp 36.4; RR=28; Pulse=54; Heart 54 - Slow AF; SpO2
on room air - 73%. Oxygen saturations rose to 96% on 15L/min Oxygen. ABGs on
15L/min NRM: pH 7.498; pCO2 28.1; pO2 79.4; SO2 97.2; HCO3 22. Imaging for COVID-
Pneumonia (04Apr2021) No significant abnormality. On 04Apr2021 WBC, Neutrophils -
normal, Lymphocytes 0.82 (1.3-3.6 X 109 g/L) LOW, Hb - 10.5 (12-15.5g/dL) LOW,
Platelets - 77 (132-349 X109/L) LOW, PT 11.7 (9.96-11.24s) RAISED, INR 1.13 (0.94-
1.06 ratio) RAISED, Imaging for COVID-Pneumonia: No significant abnormality, Urine
microscopy E.coli ESBL positive cultivated. On 07Apr2021 D-DIMER 563 (0-500ng/ml)
ABNORMALLY HIGH, Creatinine 118 (45-84micromol/L) RAISED, Bilirubin 29.6 (0-
21micromol/L) RAISED, Alk phosphatase 143 (40-104 units/L) RAISED, GFR 39
ml/min/1.73m2, CRP 50.3 (0-5mg/L) RAISED, Procalcitonin 0.137 (0.02-0.046 ng/mL)
RAISED. The patient died on 09Apr2021. It was unknown if an autopsy was performed.
Cause of death: Hypoxia due to COVID-19 infection. Significant contributory causes:
Congestive Heart Failure; Atrial Fibrillation. Outcome of the events covid-19
infection, Congestive Heart Failure, Atrial Fibrillation was fatal; of the other
events was unknown. Follow-up attempts completed. No more information are
expected.; Sender's Comments: This patient experienced Fatal vaccination failure
since a COVID-19 Infection developed 1 month 23 days days after the administration
of the 2nd dose. The doses were properly spaced (42 days between the 1st and second
dose).The vaccine preventable illness, COVID-19 infection, showed unfavorable
course with Respiratory failure, Hypoxemia and Congestive Heart Failure, Atrial
Fibrillation as significant contributory factors to the fatal outcome. Other
serious events, like Arrhythmia, Acute kidney injury, Altered state of
consciousness, Thrombocytopenia further worsened the clinical course of current
infection. The impact of this report on the benefit/risk profile of the Pfizer
product is evaluated as part of Pfizer procedures for safety evaluation, including
the review and analysis of aggregate data for adverse events. Any safety concern
identified as part of this review, as well as any appropriate action in response,
will be promptly notified to Regulatory Authorities, Ethics Committees, and
Investigators, as appropriate; Reported Cause(s) of Death: Hypoxia due to COVID-19
infection; Congestive Heart Failure; Atrial Fibrillation; Hypoxia due to COVID-19
"1330021-1" "1330021-1" "Patient was vaccinated on 1/22/2021 and 2/12/2021
and had out of hospital cardiac arrest on 5/5/2021 where he was tested for COVID-19
and was positive. He had previously tested negative on 4/19/2021." "No prior
"1332849-1" "1332849-1" "passed away from COVID (positive test on 24Apr2021);
passed away from COVID (positive test on 24Apr2021); This is a spontaneous report
from a contactable physician. A 37-years-old female patient received second dose of
bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 37-years-old, via an
unspecified route of administration on 20Mar2021 (Lot Number: EP7534, also reported
as EPT534) as single dose for covid-19 immunisation. Medical history was none. The
patient's concomitant medications were not reported. Patient received first dose of
bnt162b2 at the age of 37-years-old on 27Feb2021 (Lot Number: EN6205) for covid-19
immunisation. Patient with no comorbidities passed away from COVID (positive test
on 24Apr2021) in the ICU on 09May2021. Autopsy is still pending. Patient's family
members provided vaccination card and she would like to verify if the lot numbers
are from Pfizer Covid-19 vaccine. Added that it is freighting as the patient
developed fatal Covid a month after being fully vaccinated. Additionally, she would
like to verify if it is possible to know where the vaccines were shipped or any
other distribution or facility information she could get from these lots. Stated
that the vaccination card has something written on a box from the right hand side.
Reporter seriousness for Tested Positive for Covid was Hospitalization, Death.
Cause of death: Autopsy Pending, they assume Covid. Autopsy performed, Autopsy
details not available. Events outcome was fatal. The patient died on 09May2021.;
Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported
events cannot be excluded in a context of LOE. The impact of this report on the
benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures
for safety evaluation, including the review and analysis of aggregate data for
adverse events. Any safety concern identified as part of this review, as well as
any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. ; Reported
Cause(s) of Death: passed away from COVID (positive test on 24Apr2021)" "No
"1333218-1" "1333218-1" "No event description for this event." "No prior
"1338191-1" "1338191-1" "dyspnoea; fever; Vaccination failure/tested positive
for the specific countries variant; COVID-19/tested positive for the specific
countries variant; This is a spontaneous report from a contactable other health
professional downloaded from a regulatory authority-WEB, regulatory authority
number FR-AFSSAPS-2021050910. A 95-year-old female patient received BNT162B2
(COMIRNATY), 1st dose intramuscularly, administered in arm left on 26Jan2021 (Lot
Number: EM0477) as a single dose, 2nd dose intramuscularly, administered in arm
left on 16Feb2021 (Lot Number: ER0641) as a single dose for COVID-19 immunisation.
Medical history included ongoing COVID-19 (as reported), ongoing fibrosis
pulmonary. The patient's concomitant medications were not reported. The patient
experienced vaccination failure/tested positive for the specific countries variant,
COVID-19/tested positive for the specific countries variant, both on 01Apr2021 and
the events were reported as death, dyspnoea and fever, both on 11Apr2021, and the
events were reported as being hospitalization and death. The patient was tested
positive for the specific countries variant on 01Apr2021, hospitalized on 11Apr2021
for fever and dyspnoea, death on 14Apr2021. The patient underwent lab tests and
procedures which included SARS-CoV-2 test: positive (tested positive for the
specific countries variant) on 01Apr2021. The patient died on 14Apr2021. An
autopsy was not performed. No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: Vaccination failure/tested positive for the
specific countries variant; dyspnoea; fever; COVID-19/tested positive for the
specific countries variant" "No prior vaccinations for this event."
"1338206-1" "1338206-1" "SARS-CoV-2 infection; Vaccination failure; death;
This is a spontaneous report from a contactable pharmacist reporting for a patient
downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-GR20211204, Safety
Report Unique Identifier FR-AFSSAPS-2021037815. An 83-year-old female patient
received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Feb2021 (Batch/Lot Number:
EJ6788) as 2ND DOSE, SINGLE; and dose 1 intramuscular on 20Jan2021 (Batch/Lot
Number: EJ6788) as 1ST DOSE, SINGLE for covid-19 immunisation, age at vaccination
unknown. The patient medical history and concomitant medications were not reported.
Patient was a symptomatic COVID-19-positive case (12Mar2021). She was a female
resident of a residential care home having had the complete vaccine round with
COMIRNATY (2 injections, one on 20Jan2021 and one on 10Feb2021, lot EJ6788). Onset
of symptoms was on 12Mar2021. Differential diagnosis was a non-identified strain.
Patient was admitted to hospital on 15Mar2021 with oxygen treatment. Outcome of the
event SARS-CoV-2 infection and Vaccination failure was not recovered. The resident
died, from a different primary cause, on 05Apr2021. It was not reported if an
autopsy was performed. No follow-up attempts possible. No further information
expected. Lot number has been received.; Reported Cause(s) of Death: died of
different primary cause" "No prior vaccinations for this event."
"1338262-1" "1338262-1" "drug ineffective; COVID-19 confirmed by positive
COVID-19 test; This is a spontaneous report from a contactable other hcp downloaded
from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RN20211289.
A 73-years-old male patient received first dose of bnt162b2 (COMIRNATY),
intramuscular on 13Feb2021 (Lot Number: EM0477) as 1st dose, single, second dose
intramuscular on 03Apr2021 (Lot Number: EJ6788) as 2nd dose, single, for covid-19
immunisation. Medical history included ongoing Bone metastases, ongoing type 2
diabetes mellitus , ongoing Hypertension arterial , covid-19. The patient's
concomitant medications were not reported. Symptoms included flu syndrome (asthenia
and febrile 38C) from 14Apr2021, as well as diarrhoea on 22Apr2021. Patient
positive for Covid-19. COVID-19 test on 18Apr2021 was positive. On 04May2021, the
patient was dead. It was not reported if an autopsy was performed. No follow-up
COVID-19 confirmed by positive COVID-19 test; drug ineffective" "No prior
"1339116-1" "1339116-1" "Death; drug ineffective; COVID-19; General body
pain; Dyspnoea; Acute respiratory insufficiency; Cardiac arrest; Acute renal
insufficiency; Somnolence; This is a spontaneous report from a contactable consumer
or other non hcp downloaded from a regulatory authority-WEB GR-GREOF-20213117 A
78-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified
route of administration on 31Mar2021 (Batch/Lot number was not reported) as single
dose, dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot
number was not reported) as single dose for covid-19 immunisation. The patient
medical history was not reported. The patient's concomitant medications were not
reported. The patient experienced drug ineffective on 05Apr2021, covid-19 on
05Apr2021, death on 25Apr2021, acute respiratory insufficiency on an unspecified
date, cardiac arrest on an unspecified date, acute renal insufficiency on an
unspecified date, general body pain on 05Apr2021, dyspnoea on 05Apr2021, somnolence
on 05Apr2021. The patient was hospitalized on 14Apr2021. On 20Apr2021 he was
intubated. The patient died on 25Apr2021. Causes of death were: acute renal
insufficiency, acute respiratory insufficiency and cadiac arrest. No cases of
COVID-19 in the working environment of 5 persons of the deceased , neither on the
friend cycle on the reported dates. It was not reported if an autopsy was
performed. Time Interval between Beginning of Drug Administration and Start of
Reaction / Events: Covid-19, Somnolence, General body pain, Dyspnoea / 5 days Time
Interval between Beginning of Drug Administration and Start of Reaction / Event:
death / 25 days Information about lot/batch number cannot be obtained. No further
information expected.; Reported Cause(s) of Death: Acute respiratory insufficiency;
Cardiac arrest; Acute renal insufficiency" "No prior vaccinations for this
event."
"1339140-1" "1339140-1" "Covid-19 positive/chest pain; cough; dyspnoea; acute
respiratory distress syndrome; This is a spontaneous report from a contactable
physician downloaded from a regulatory authority-WEB, regulatory authority number
HU-OGYI-285221. This is a report received from another regulatory authority.
Regulatory authority report number HU-OGYI-285221. This serious, spontaneous case
was reported by a physician on 26Apr2021, concerning the occurrence of positive
Covid-19 rapid POC test after the use of Comirnaty concentrate for dispersion for
injection (BioNTech Manufacturing). On 09Mar2021, the 65-year-old female patient
received the first dose of 0.3 ml Comirnaty concentrate for dispersion for
injection (tozinameran; batch number: I035926710000I3, expiry date: not reported,
intramuscularly in the left arm) for COVID-19 immunisation. Medical history
included ongoing hyperlipidemia, hypertension, and vertebrobasilar insufficiency.
The patient's concomitant medicinal products were not reported. On 14Mar2021, the
patient experienced fever, cough, chest pain, and dyspnoea. The Covid-19 POC test
was positive, therefore the patient was admitted to the hospital. On 17Mar2021, the
patient died. According to the patient's death certificate, the direct cause of
death was acute respiratory distress syndrome, the indirect cause was Covid-19
infection. Events stop date is provided -17APR2021- with outcome fatal. The autopsy
was not performed. No further information is expected. Sender's comment: According
to the publication for Comirnaty, immunity usually develops 14 days after the
second dose of the vaccine. The patient received the first dose of Comirnaty on
09Mar2021 and got infected with the virus 5 days after, therefore immunity may not
have developed yet without the second dose. Based on the above, the causal
relationship is unlikely between the suspected drug and the adverse events. The
case is considered serious because the outcome was fatal. No follow-up attempts
are needed. No further information is expected.; Reported Cause(s) of Death:
respiratory distress syndrome; Covid-19 infection; cough; dyspnoea" "No prior
"1339144-1" "1339144-1" "Covid-19 infection; This is as spontaneous report
received from a contactable physician downloaded from the Regulatory Authority.
This is a spontaneous report from a contactable physician. This is a report
received from Regulatory Authority. A 77-years-old male patient received bnt162b2
(COMIRNATY), dose 1 intramuscular, administered in Arm Right on 12Feb2021
(Batch/Lot Number: 10359267100013) as 0.3mL single for covid-19 immunisation .
Medical history included ongoing gastrooesophageal reflux disease , ongoing
hypertension. The patient's concomitant medications were not reported. The
patient experienced covid-19 infection on 18Feb2021 leading to patient death on
12Mar2021. The patient underwent lab tests and procedures which included
computerised tomogram thorax: covid-19 pneumonia, Sars-cov-2 test: positive on
18Feb2021. Course of the event. On 18Feb2021, the patient's Covid-19 PCR test was
positive. On 22Feb2021, the patient was admitted to the hospital because of
coughing, fever, and loss of consciousness. According to CT, Covid-19 pneumonia was
detected. Mechanical ventilation was necessary. On 12Mar2021, the patient died.
Medical history included hypertension and gastroesophageal reflux disease. The
patient's concomitant medicinal products were not reported. According to the
patient's death certificate, the direct cause of death was respiratory
insufficiency, the indirect cause was pneumonia and Covid-19 infection. The
autopsy was not performed. Sender Comment: According to the Summary of Product
Characteristics of Comirnaty, immunity usually develops 14 days after the second
dose of the vaccine. The patient received the first dose of Comirnaty on 12Feb2021
and got infected with the virus 6 days after, therefore immunity may not have
developed yet without the second dose. Based on the above, the causal relationship
is unlikely between the suspected drug and the adverse events. The case is
considered serious because the outcome was fatal. No further information is
expected.; Reported Cause(s) of Death: Covid-19 infection; respiratory
insufficiency; pneumonia" "No prior vaccinations for this event."
"1339150-1" "1339150-1" "respiratory failure; shock; multiple organ failure;
heart failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a
authority number HU-OGYI-288321. A 72-year-old female patient received first
dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 04Mar2021
(Batch/Lot Number: ET1831) as 0.3 mL single dose for COVID-19 immunisation.
Medical history included ongoing type 2 diabetes mellitus (NIDDM), pulmonary
embolism in 2016, ongoing gastrooesophageal reflux disease, ongoing fatty liver,
choroid neoplasm from an unknown date and unknown if ongoing and ongoing obesity.
Concomitant medications included trimetazidine hydrochloride (ADEXOR, strength: 80
mg ) at 80 mg once a day and apixaban (ELIQUIS, strength: 2.5 mg) at 2.5 mg twice a
day, both taken for an unspecified indication, start and stop date were not
reported. On an unspecified date the patient experienced fever and dyspnoea. On
11Mar2021, the patient was hospitalized. On 16Mar2021, the patient's COVID-19 test
was positive. On the same day, chest X-ray showed COVID-19 pneumonia. The patient's
condition worsened with time in the hospital. In the hospital, the patient received
medicinal therapy as antibiotics, antiviral therapy, steroids, mucolytic medicines,
mucus protective medicines, LMWH and oxygen therapy. The course of the disease was
critical, the patient had respiratory failure, shock and multiple organ failure. On
02Apr2021, the patient died. According to the patient's death certificate, the
direct cause of death was heart failure. The primary disease that caused the
patient's death was COVID-19, which escalated to COVID-19 pneumonia and respiratory
failure. It was not reported if an autopsy was performed. No follow-up attempts
are needed. No further information is expected.; Reported Cause(s) of Death: heart
failure; COVID-19 pneumonia; covid-19; respiratory failure; shock; multiple organ
failure" "No prior vaccinations for this event."
"1339152-1" "1339152-1" "COVID-19 infection; drug ineffective/COVID-19; Acute
renal insufficiency; Urosepsis; chills without fever; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-
288921. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY,
concentrate for dispersion for injection tozinameran (COVID-19 mRNA Vaccine
embedded in lipid nanoparticles), lot number: ET1831, expiry date: unknown:
BioNTech Manufacturing Pfizer) intramuscularly on 05Mar2021 at 0.3 ml single dose
for COVID-19 immunization. Medical history included appendectomy, anal fistula,
diabetes mellitus, hypertension, hyperuricemia, obesity, pneumonia, polyarthritis,
renal insufficiency, spondylosis, vertebrobasilar insufficiency and generalized
atherosclerosis. Concomitant drugs were hydrochloride/vildagliptin (EUCREAS),
famotidine (APO-FAMOTIDIN), acetylsalicylic acid (ASA PROTECT PHARMAVIT),
bisoprolol fumarate (BISOBLOCK), amlodipine besilate, indapamide/ perindopril
arginine (COVERCARD PLUS), allopurinol (MILURIT), tiotropium bromide (SPIRIVA) and
amlodipine besilate/atorvastatin calcium/ perindopril arginine (VALONGIX). On
19Mar2021 the patient was admitted in the hospital because of urosepsis, acute
renal insufficiency and needed mechanical ventilation. Before hospitalization, the
patient was experiencing chills for 2 days without fever. A covid antigen test was
done in the ambulance which came back negative on 19Mar2021, but on 20Mar2021 a PCR
test confirmed the Covid-19 infection. On 03Apr2021 the patient passed away. It was
unknown if autopsy was done. The direct cause of death was COVID-19. The outcome of
events urosepsis, acute renal insufficiency, COVID-19 was reported as fatal
( urosepsis, acute renal insufficiency were not reported as cause of death),
outcome of chills was unknown. Sender Comment: The causal relationship is unlikely
between the suspected drug and the adverse events as the cause of death was
determined to be Covid-19. The case is considered serious because the outcome was
fatal. Further information is not expected. No follow-up attempts are needed. No
further information is expected.; Reported Cause(s) of Death: COVID-19" "No
"1339154-1" "1339154-1" "SARS-CoV-2 infection/COVID-19 pneumonia/COVID-19
rapid antigen test became positive; dyspnoea; coughing; fever; acute respiratory
distress syndrome; Cardiac arrest; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority also received from the agency,
The regulatory authority report number is HU-OGYI-289721. A 70-year-old male
patient received BNT162B2 (COMIRNATY, strength: 0.3 ml), dose 1 intramuscular,
administered in Arm Left on 31Mar2021 (Batch/Lot Number: ET3620) as 1st dose, 0.3
ml single for COVID-19 immunisation. Medical history included diabetic angiopathy,
Type II diabetes mellitus, cerebral vascular lesion from 26Nov2013, vertebrobasilar
insufficiency from Nov2013, dyslipidaemia and hypertension, all were not ongoing.
Concomitant medications included hydrochlorothiazide, irbesartan hydrochloride (CO
IRABEL, strength: 150 mg/12,5 mg); ciprofibrate (LIPANOR); rosuvastatin calcium
(XETER); insulin human (ACTRAPID HM); amlodipine besilate, perindopril arginine
(COVERCARD, strength: 5 mg/5 mg). Clinical course: On 01Apr2021, COVID-19 rapid
antigen test became positive (SARS-CoV-2 infection). The patient was transferred to
the emergency department due to fever, dyspnoea, and coughing. On 06Apr2021, chest
X-ray confirmed COVID-19 pneumonia. Despite the applied therapy (clarithromycin 500
mg (KLACID); Dexamethasone 4 mg; vitamin D 3000 IU; Vitamin C 1000 mg; acetyl
salicylic acid 100 mg; Pantoprazol 40 mg; Frontin (alprazolam) 0,25 mg; O2-
supplementation, enoxaparin sodium 0,6 ml (CLEXANE), amoxicillin; clavulanic acid
1,2 g (AKTIL INJECTION); methylprednisolone 40 mg (SOLU MEDROL), acute respiratory
distress syndrome developed, the patient died on 16Apr2021. Cause of death was
cardiac arrest according to the death certificate. Autopsy was not done. All events
reported as serious with seriousness criteria of fatal. All events reported
requiring hospitalization except event 'cardiac arrest'. Please note that it was
unknow whether the reporter was also the patient, thus VAERS Primary Reporter Addl
Qualification could not be completed. No follow-up attempts are needed. No further
information is expected.; Reported Cause(s) of Death: Cardiac arrest; SARS-CoV-2
infection; Dyspnoea; coughing; fever; acute respiratory distress syndrome" "No
"1339159-1" "1339159-1" ""COVID-19; This is a spontaneous report from a
contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-291121
received via regulatory authority. This spontaneous, serious, medically confirmed
case was reported on 28Apr2021 by a physician and concerns the occurrence of Covid-
19 infection resulting in death after COMIRNATY injection for active immunization
to prevent COVID-19. A 70-year-old female patient received the first dose of
bnt162b2 (COMIRNATY, Lot Number: ET1831), intramuscular in right arm on 17Mar2021
at 0.3 ml single for covid-19 immunisation. The patient was hospitalized on
27Mar2021 because of weakness which has been ongoing for 1 week and difficulty in
breathing which occurred the day before. Previously a covid antigen was done on
23Mar2021 because the patient's daughter got infected with covid, who she lives
together with. The test result was positive. Bilateral pneumonia was confirmed in
the hospital. The patient received antiviral, steroid, anticoagulant, anti-
decompensation therapy and ulcus prophylaxis. Despite the therapy, the patients
oxygenation continued to worsen and passed away on 30Mar2021 at 18:02. Medical
history included atherosclerosis of arteries of the extremities, cardiac
insufficiency, cardiomyophathy, COPD, non-insulin-dependent diabetes mellitus,
hypertension, measles, myocardial infarct, obesity, respiratory insufficiency,
triple vessel disease and ventricular tachycardia. Drug history included Xigduo
(metformin; dapagliflozin), clopidogrel and canakinumab. Concomitant drugs were ASA
Protect Pharmavit 100 mg (acetylsalicylic acid), Concor 2.5 mg (bisoprolol
fumarate), Cordarone 100 mg (amiodarone), Furon 40 mg (furosemide), Kalim-R 1 g
(potassium chloride), Nolpaza 40 mg (pantoprazole), Renitec 2.5 mg (enalapril) and
Synjardy (empagliflozin; metformin). Further information is not expected. Sender
Comment: According to the information of Comirnaty, immunity usually develops 14
days after the second dose of the vaccine. The patient got infected with Covid-19 6
days after the first dose, therefore immunity may have not developed yet. Based on
the above, the causal relationship is unlikely between the suspected drug and the
adverse event as the patient died due to Covid-19. The case is considered serious
because the outcome was fatal. Further information is not expected. No follow-up
attempts are needed. No further information is expected.; Sender's Comments: Based
on the available information the event ""infected with Covid-19"" is attributed to
an intercurrent medical condition that was not related to BNT162B2 (COMIRNATY0
vaccine.; Reported Cause(s) of Death: covid-19"" "No prior vaccinations for
this event."
"1339164-1" "1339164-1" "Lack of drug effect; COVID-19; This is a spontaneous
report from a contactable physician downloaded from the Regulatory Authority (RA)-
WEB HU-OGYI-292121, received from Regulatory Authority. A 70-year-old female
patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in
Arm Left on 26Mar2021 (Lot Number: ET7205) as 0.3 ml single for Covid-19
immunisation. Medical history included ongoing chronic obstructive pulmonary
disease (Her COPD was very severe with regular exacerbation requiring antibiotic
treatment), ongoing allergic asthma, ongoing thyroid disorder, ongoing
arteriosclerosis, ongoing smoker, ongoing breast cancer, ongoing hypertension.
Concomitant medications included aclidinium bromide (BRETARIS GENUAIR); alprazolam
(FRONTIN); clopidogrel; glyceryl trinitrate (NITROMINT); montelukast; theophylline
(THEOSPIREX); vinpocetine (CAVINTON); pantoprazole; beclometasone dipropionate,
formoterol fumarate (FOSTER); levothyroxine sodium (LETROX); metoprolol succinate
(BETALOC); paroxetine hydrochloride (PAROGEN). On 12Apr2021, the patient died at
home. Post-mortem COVID-19 test was positive. The patient died on 12Apr2021. An
autopsy performed (also reported as autopsy had not been done) and COVID-19 test
was positive. Sender's comments: The patient was detected to have COVID-19 17 days
after receiving the first dose of COMIRNATY. Immunity may have not developed within
less than 3 weeks before the first dose of vaccine. The case is serious because the
patient died. No further information is expected. No follow-up attempts possible.
No further information expected.; Reported Cause(s) of Death: COVID-19; COVID-19;
Autopsy-determined Cause(s) of Death: COVID-19 test was positive" "No prior
"1339168-1" "1339168-1" "pulmonary oedema; high fever; cardiovascular
insufficiency; COVID-19 PCR positive; COVID-19 PCR positive; This is a spontaneous
report received from a contactable physician downloaded from the regulatory
authority-WEB. The regulatory authority report number is HU-OGYI-316021. A 82-
years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on
30Jan2021 (Batch/Lot Number: EJ6134) as 0.3ML SINGLE for covid-19 immunisation.
Medical history included diabetes mellitus, hyperlipidemia and Brain infarction.
The patient's concomitant medications were not reported. On 16Feb2021 the patient
was tested positive with COVID-19 polymerase chain reaction (PCR) test. On
21Feb2021 he experienced high fever and pulmonary oedema and he died due to
cardiovascular insufficiency. The outcome of the events was fatal. The patient died
on 21Feb2021. An autopsy was not performed. Sender Comment: COVID-19 was detected
16 days after vaccination with COMIRNATY. The patient died due to pulmonary eodema
caused by COVID-19 infection. Immunity does not develop within 16 days after the
first dose of the vaccine. The causality between the vaccine and the event is
unlikely. The case is considered serious due to fatal outcome. No follow-up
Death: pulmonary oedema; COVID-19 PCR positive; COVID-19 PCR positive; high fever;
cardiovascular insufficiency" "No prior vaccinations for this event."
"1339171-1" "1339171-1" "a covid PCR test showed a positive result; Covid
positive; fever; This is a spontaneous report from a contactable physician
downloaded from the Regulatory Authority. An 85-year-old female patient received
BNT162B2 (COMIRNATY), via intramuscular, administered in Arm Left on 30Jan2021 (Lot
Number: EJ6134, expiration date unknown) as 0.3ML, single dose for prevent Covid-
19. Medical history included dementia, hypertension, covid-19 and covid-19
pneumonia, all from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. The physician concerned the occurrence
of Covid-19 infection resulting in death after COMIRNATY injection for active
immunization to prevent COVID-19. On 4-5 days (in Feb2021) after vaccination the
patient experienced fever. On 16Feb2021 a covid PCR test showed a positive result
and on 25Feb2021 the patient passed away. According to the reporter, the patient's
physical and mental health was heavily deteriorated already and rapidly progressed
in the last few months. The patient underwent lab tests and procedures which
included COVID-19 PCR test: positive on 16Feb2021. The outcome of the event fever
was unknown. The patient died on 15Feb2021 due to Covid-19 infection. It was
unknown if autopsy was done. Sender Comment: The causal relationship is unlikely
between the suspected drug and the adverse event as the patient had Covid-19 and
her state was already heavily deteriorated. The case is considered serious because
the outcome was fatal. Further information is not expected. No follow-up attempts
possible. No further information expected. ; Reported Cause(s) of Death: COVID-19;
"1339174-1" "1339174-1" "Vaccination failure; COVID-19; COVID-19 pneumonia;
Regulatory Authority. An 89-year-old male patient received bnt162b2 (COMIRNATY),
first dose via an unspecified route of administration on 27Feb2021 at single dose,
second dose intramuscularly administered in left arm on 20Mar2021 (Batch/Lot
Number: EP2166) at 0.3 ml single, for COVID-19 immunisation. Medical history
included atrial fibrillation, hypertension, congestive heart failure, COVID-19
pneumonia, COVID-19, all unknown if ongoing. Concomitant drugs included amoxicillin
trihydrate, clavulanate potassium (AUGMENTIN DUO); alprazolam (FRONTIN); lacidipine
(LACIPIL); furosemide; allopurinol (MILURIT); solifenacin succinate (VESICARE);
troxerutin (VENORUTON); perindopril erbumine (PRENESSA); spironolactone
(VEROSPIRON); potassium chloride (KALIUM-R); apixaban (ELIQUIS); tamsulosin
hydrochloride (PROSOLIN); dexamethasone; pantoprazole. The patient experienced
vaccination failure (death, hospitalization) on 28Mar2021, covid-19 (death,
hospitalization) on 28Mar2021, covid-19 pneumonia (death, hospitalization) on
28Mar2021. The patient was hospitalized from 01Apr2021. The patient died on
09Apr2021. Clinical course: On 01Apr2021 the patient was hospitalized with a
positive Covid-19 antigen test result and dyspnea. His oxygen saturation was 70%
and laboratory tests also implied abnormalities in association with Covid-19. Chest
X-ray confirmed bilateral Covid-19 pneumonia. The patient received covid treatment
but his respiratory insufficiency intensified and passed away on 09Apr2021 at 8:20.
An autopsy was not performed. The outcome of the events was fatal. Health
Authority Comment: According to the SmPC of Comirnaty, immunity usually develops 14
days after the second dose of the vaccine. Vaccination failure can be considered
possible as the patient died of Covid-19, 19 days after the second dose. The case
expected. No follow-up attempts are needed. No further information is expected.;
Reported Cause(s) of Death: Vaccination failure; COVID-19; COVID-19 pneumonia"
"1339292-1" "1339292-1" "Initial fever, test positive on 19Apr, treated with
azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy
at 3-4 L / min. From 22Apr significant dyspnea and subsequent; Initial fever, test
positive on 19Apr, treated with azithromycin 500, amoxi + clav 3 times / day and
Medrol 32mg day and oxygen therapy at 3-4 L / min. From 22Apr significant dyspnea
and subsequent; Initial fever, test positive on 19Apr, treated with azithromycin
500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen therapy at 3-4 L /
min. From 22Apr significant dyspnea and subsequent; This is a Non-Interventional
Study from a contactable physician downloaded from the regulatory authority,
regulatory authority number IT-MINISAL02-727345. A 54-year-old male subject
received BNT162B2 (COMIRNATY), via an unspecified route of administration on
17Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and via
intramuscular, administered in arm left on 07Apr2021 11:53 (Batch/Lot Number:
ET7205) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history and
concomitant medications were not reported. The subject experienced initial fever,
test positive on 19apr, treated with azithromycin 500, amoxi + clav 3 times / day
and medrol 32mg day and oxygen therapy at 3-4 l / min. from 22apr significant
dyspnea and subsequent hospitalization on 16Apr2021. Clinical course reported as
follows: DOSE NUMBER (2); Time of administration (11:53) site of administration
(left shoulder) Attached is a clinical report from the GP and an extract from the
clinical record of the positive patient. The patient underwent lab tests and
procedures which included SARS-CoV-2 PCR test: positive on 19Apr2021. Therapeutic
measures were taken as a result of the events. The subject died on 26Apr2021. It
was not reported if an autopsy was performed. Causes of death was reported initial
fever, test positive on 19apr, treated with azithromycin 500, amoxi + clav 3
times / day and medrol 32mg day and oxygen therapy at 3-4 l / min. from 22apr
significant dyspnea and subsequent hospitalization on 16Apr2021. The reporter's
assessment of the casual relationship of the events was not provided at the time of
this report. Since no determination has been received, the case is managed based on
the company causality assessment. No follow-up attempts are possible; information
about lot/batch number cannot be obtained. Senders comment: The compromised
response to the vaccine was reported among the ADRs - based on what is reported in
the regulatory authority document dated 27APR21, although close to the week after
the second dose. The immunization, on the basis of the reported knowledge, was
performed correctly and appropriately as reported in the SmPC of Comirnaty and
respecting the three weeks between the two administrations.; Sender's Comments:
Based on the information currently available, lack of efficacy of the suspected
vaccine BNT162B2 (COMIRNATY) cannot be completely excluded. Covid-19 infection /
Covid-19 PCR test positive were possibly due to LOE of BNT162B2 (COMIRNATY). The
impact of this report on the benefit/risk profile of the Pfizer product is
promptly notified to Regulatory Authorities, Ethics Committees and Investigators,
as appropriate.,Linked Report(s) : IT-PFIZER INC-2021560472 same patient /different
drugs; Reported Cause(s) of Death: Initial fever, test positive on 19Apr, treated
with azithromycin 500, amoxi + clav 3 times / day and Medrol 32mg day and oxygen
therapy at 3-4 L / min. From 22Apr significant dyspnea and subsequent
hospitalization; Initial fever, test positive on 19A" "No prior vaccinations for
this event."
"1339293-1" "1339293-1" "death from covid-related infection in a patient
vaccinated with PFIZER BIONTECH 1st and 2nd dose; death from covid-related
infection in a patient vaccinated with PFIZER BIONTECH 1st and 2nd dose; oxygen
saturation decreased; hyperpyrexia; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority-WEB, regulatory authority number
IT-MINISAL02-727439. A 92-years-old female patient received second dose of
bnt162b2 (COMIRNATY), Formulation: Solution for injection, Batch/Lot number was not
reported), dose 2 via an unspecified route of administration on 21Apr2021 as 2nd
dose, single and patient received first dose of bnt162b2 (COMIRNATY), Formulation:
Solution for injection, (Batch/Lot Number: ET3620; Expiration Date: 30Jun2021),
dose 1 intramuscular on 31Mar2021 14:58 as 1st dose, single for covid-19
immunization. The patient medical history and concomitant medications were not
reported. On 05May2021 he carried out a molecular swab (swab code 74380966) with a
positive result due to close contact of confirmed case (cohabitants). Since
01May2021 he has been experiencing the following symptoms: hyperpyrexia, nausea and
vomiting, headache, low saturation, lack of appetite. On 06May2021 reduced oxygen
saturation, 118 alerted, patient. On 06May2021, the patient experienced death from
covid-related infection in a patient vaccinated with pfizer biontech 1st and 2nd
dose. On 05May2021, the patient underwent lab tests and procedures which included
oxygen saturation was reduced, On 05May2021, sars-cov-2 test was positive. The
patient died on 06May2021. It was not reported if an autopsy was performed.
Batch/Lot# and expiry date not provided and not possible to obtain No follow-up
attempts possible. No further information expected." "No prior vaccinations for
this event."
"1339911-1" "1339911-1" "patient was the second resident in nursing home who
died of covid19, despite being vaccinated/ Diagnostic procedures were regarded the
specific variant of Covid-19; patient was the second resident in nursing home who
died of covid19, despite being vaccinated/ Diagnostic procedures were regarded the
specific variant of Covid-19; This is a spontaneous report from a contactable
physician downloaded from the regulatory authority, regulatory authority number NL-
LRB-00537347. A 76-year-old female patient received BNT162B2 (COMIRNATY, Solution
for injection), first dose via an unspecified route of administration on 28Jan2021
(batch/lot number unknown) as 0.3ml single dose, second dose via an unspecified
route of administration on 25Feb2021 (lot number: EJ6790) as 0.3ml single dose for
covid-19 immunization. Medical history included ongoing recurring pneumonia, no
previous COVID-19 infection. The patient's concomitant medications were not
reported. The patient died on 10May2021 due to Covid-19 and vaccination failure
since 30Apr2021 following administration of covid-19 vaccine Pfizer injection 2
months after start (as reported). Confounding factor was recurring pneumonia.
Diagnostic procedures were regarded the British variant of Covid-19 on 30Apr2021.
The events were treated with dexamethasone and oxygen therapy. The patient was the
second resident in nursing home who died of covid19, despite being vaccinated. The
outcome of the events was fatal. It was unknown if an autopsy was performed, cause
of death was reported as Covid-19 in known lung disease. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death: patient
was the second resident in nursing home who died of covid19, despite being
vaccinated/ Diagnostic procedures were regarded the British variant of Covid-19;
patient was the second resident in nursing home who died of covid19, despite being
vac" "No prior vaccinations for this event."
"1346723-1" "1346723-1" "Patient contracted covid 2 months after receiving
the full vaccine series. He was admitted the hospital and subsequently passed away.
Variant testing was conducted (results are pending) and antibody testing was done.
Antibody testing showed no antibodies were produced in response to the vaccine."
"1347843-1" "1347843-1" "4/21/21 Pt was reportedly admitted to the Hospital
for generalized weakness. Her nephrologist noted worsening renal function and had
her admitted for hemodialysis. Of note, she had not been able to keep her
appointment for mAB due to weakness. At the outlying hospital she had a palliative
consult and started dialysis. First day of RRT was 4/24/21. Approximately one hour
after dialysis she developed 10/10 CP and her EKG changed from a partial LBBB to a
complete LBBB. She was transferred to a different Hospital for further evaluation.
Her BP was fairly labile and troponins were positive. Approx 7 hours after arrival,
she became unresponsive. Heart rate was very irregular in what appeared to be a
fib. Transcutaneous pacing was initiated. She was given several amps of bicarb and
started on a dopamine infusion. Her daughter arrived shortly thereafter and the pt
became apneic. She was transitioned to comfort care and death was pronounced at
04:13 on 4/25/21." "No prior vaccinations for this event."
"1347948-1" "1347948-1" ""received the first dose of the BNT162b2 mRNA COVID-
19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; received the first
dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-
2 positive; the patient died from acute renal and respiratory failure on the
following day; the patient died from acute renal and respiratory failure on the
following day; hypernatremia; Anemia; worsening diarrhea; This is a literature
report from a publication. We report on an 86-year-old male resident of a
retirement home who received vaccine against SARS-CoV-2. Past medical history
included systemic arterial hypertension, chronic venous insufficiency, dementia and
prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-
formulated, nucleosidemodified RNA vaccine BNT162b2 in a 30 mg dose. On that day
and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On
day 18 (26Jan2021), he was admitted to hospital for worsening diarrhea. Since he
did not present with any clinical signs of COVID- 19, isolation in a specific
setting did not occur. Laboratory testing revealed hypochromic anemia and increased
creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for
SARSCoV-2 were negative. Gastroscopy and colonoscopy were performed to investigate
the cause of diarrhea further. Colonoscopy, in particular, demonstrated an
ulcerative lesion of the left colonic flexure, which was histologically diagnosed
as ischemic colitis. PCR-analysis on biopsy specimens, following a previously
reported method, was negative for SARS-CoV-2. Treatment was supportive with
mesalazine and intravenous iron substitution. Subsequently, the patient's condition
deteriorated under the development of renal insufficiency. On day 24 (01Feb2021), a
patient in the same hospital room as our case tested positive for SARS-CoV-2. On
day 25 (02Feb2021), our patient tested SARS-CoV-2 positive by real-time PCR (RT-
PCR), with a low cycle threshold (Ct) value indicating high virus load. On further
analysis of the swab sample, there was no evidence for mutant SARS-CoV-2 variants
B.1.1.7, B.1.351 or B.1.1.28.1. Taken together, it appears the patient became
infected from the patient in his hospital room. Our patient now presented with
fever and respiratory discomfort, and lung auscultation displayed crackles. Despite
starting supplemental oxygen (2L per minute) and antibiotic therapy by ceftriaxone,
the patient died from acute renal and respiratory failure on the following day.
Immunogenicity assessment by measuring spike protein (S1) antigen-binding
immunoglobulin (Ig) G in the serum samples obtained at day 25 (02Feb2021) showed
antibody response (8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM), while
(nucleocapsid) NCP- IgG/IgM was not elicited (<0.1 U/ml, reference value >1.0 U/ml;
Roche ECLIATM). These results indicate that the patient had already developed
relevant immunogenicity through vaccination. Postmortem study revealed acute
bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial
cocci (Figure 1). There were no findings of commonly described manifestations of
COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy
(weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We
detected amyloidosis of the transthyretin type in the heart and to a lesser extent
in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and
interstitial fibrosis, and acute renal failure with hydropic tubular degeneration.
The examination of the brain revealed a left parietal pseudocystic tissue necrosis,
which was diagnosed as an old infarction area. Figure 1 showed that synopsis of
the relevant histological findings and the results of molecular mapping is
presented. The histomorphology is obtained by standard hematoxylin and eosin
reaction, except for the myocardium on the right side (Congo red staining). The
magnification is shown by bars. Note that in the lungs, we also observed colonies
of cocci (arrow) in granulocytic areas. In addition, the results of molecular
mapping are given as evaluated cycle threshold values of the real-time polymerase
chain reaction for SARSCoV- 2. Note that only in the olfactory bulb and the liver
SARS-CoV-2 could not be detected. Table 1 showed Summary of major features of the
patient's history, clinical symptoms and laboratory findings, including SARS-CoV-2
testing (reference values given in brackets). On day1 (09Jan2021), the patient
vaccination, No relevant symptoms recorded. On day 15 (23Jan2021), the patient
collapse during breakfast and no further relevant symptoms recorded, blood pressure
(mmHg) 130/70. On day 18 (26Jan2021), the patient admission to hospital;
gastroscopy (mild gastritis) and diarrhea. The temperature (C) was 36.4, blood
pressure (mmHg) 187/83, Oxygen saturation (SpO2) 97%, SARS-CoV-2 test: Antigen-
test: negative PCR-test: negative. White-cell count (4-9/nl): 6.6. Platelet count
(140-400/nl): 267. Hemoglobin (14.0-8.0 g/dl): 7.4. Lactate dehydrogenase (135-250
U/L): 179. Creatinine (0.7-1.2 mg/dl): 1.91. C-reactive protein (<0.5 mg/dl): 1.0.
Sodium (135-145 mmol/l): 138. On day 19 (27Jan2021), the patient had abdominal
ultrasound, initiating intravenous iron application. The patient had anemia. White-
cell count (4-9/nl): 7.1. Platelet count (140-400/nl): 263. Hemoglobin (14.0-8.0
g/dl): 7.1. Lactate dehydrogenase (135-250 U/L): 165. Creatinine (0.7-1.2 mg/dl):
1.78. C-reactive protein (<0.5 mg/dl): 0.8. Sodium (135-145 mmol/l): 138. On day 20
(28Jan2021): the patient had colonoscopy (ischemic colitis), initiating mesalazine.
Still had anemia. SARS-CoV-2 test: PCR-test: negative. White-cell count (4-9/nl):
12.1. Platelet count (140-400/nl): 262. Hemoglobin (14.0-8.0 g/dl): 7.2. On day 23
(31Jan2021): the patient had acute renal insufficiency, initiating intravenous
glucose application. Lung uscultation with any pathological signs, hypernatremia.
The temperature (C) was 36.8. Blood pressure (mmHg) 180/80. White-cell count (4-
9/nl): 13.5. Platelet count (140-400/nl): 254. Hemoglobin (14.0-8.0 g/dl): 8.0.
Creatinine (0.7-1.2 mg/dl): 2.04. C-reactive protein (<0.5 mg/dl): 2.0. Sodium
(135-145 mmol/l): 154. On day 24 (01Feb2021): Patient in same hospital room has
positive SARS-CoV-2 RT-PCR test (Ct,15) and hypernatremia. The temperature (C) was
36.2. Blood pressure (mmHg) 166/73. Sodium (135-145 mmol/l): 155. On day 25
(02Feb2021): Patient somnolent, initiating antibiotic therapy, chest radiograph
with minimal infiltrates. Dehydration, lung auscultation with crackles. The
temperature (C) was 38.8, blood pressure (mmHg) 160/80, Oxygen saturation (SpO2)
97% + 2l O2, SARS-CoV-2 test: RT-PCR-test: positive (Ct, 20). White-cell count (4-
Creatinine (0.7-1.2 mg/dl): 2.17. On day 26 (03Feb2021): the patient death at 14:30
due to acute renal and respiratory failure. White-cell count (4-9/nl): 15.2.
Platelet count (140-400/nl): 196. Hemoglobin (14.0-8.0 g/dl): 9.3. Lactate
dehydrogenase (135-250 U/L): 439. Creatinine (0.7-1.2 mg/dl): 3.23. C-reactive
protein (<0.5 mg/dl): 8.8. Sodium (135-145 mmol/l): 156. We conducted molecular
mapping of 9 different anatomical parts of formalin-fixed paraffin-embedded tissue
as previously described. RNA was extracted from paraffin sections using the
specific method. Multiplex RT-PCR analysis targeted 2 independent genes of the
SARS-CoV-2-genome (Fluorotype SARS-CoV-2 plus Kit): RNA-dependent RNA polymerase
(Target 1) and nucleopeptide (Target 2). The negative cut-off value was Ct >45. We
examined 9 different tissue samples for known and relevant pathways of virus
spreading in the human body (Figure 1). To prevent cross-contamination, each
specimen was directly embedded in separate tissue cassettes and separately fixed in
4% phosphate-buffered saline-buffered formalin. We demonstrated viral RNA in nearly
all organs examined except for the liver and the olfactory bulb (Figure 1). A
detailed autopsy study including molecular virus mapping of a patient vaccinated
against SARS-CoV-2 with a positive SARS-CoV-2 test post-vaccination has not
previously been reported, to the authors' knowledge. We suggest that a single
treatment with BNT162b2 RNA vaccine elicited significant immunogenicity, as
reflected in the reported spike proteinbased neutralizing IgG serum values. From
the weeks before vaccination, through vaccination (day 1), to shortly before death
(day 24), the patient was free of any clinical symptoms typically ascribed to
COVID-19. Furthermore, blood work did not show an IgM titer that is generally
observed 7-14 days after symptom onset (Kim et al., 2020). However, the patient
tested SARS-CoV-2 positive. Both the Ct value measured in nasopharyngeal swab and
values measured in formalin-fixed paraffinembedded autopsy specimens indicate viral
load and suggest transmissibility. Because our patient died approximately 2 days
after his first positive SARS-CoV-2 test result, we suppose that the molecular
mapping data reflects an early stage of viral infection. An early stage of
infection might also explain why different regions such as the olfactory bulb and
liver were not (yet) affected by systemic viral spread. We did not observe any
characteristic morphological features of COVID-19 reported in comprehensive
morphological autopsy studies so far. We did not find any typical signs of diffuse
alveolar damage in the lungs, but we identified extensive acute bronchopneumonia,
possibly of bacterial origin. We concluded that the In summary, the results of our
autopsy case study in a patient with mRNA vaccine confirm the view that by first
dose of vaccination against SARS-CoV-2
immunogenicity can already be induced, while sterile immunity is not adequately
developed.; Sender's Comments: The efficacy of a drug varies from patient to
patient and can be affected by different factors; however, a contributory role of
BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out. There
is a reasonable possibility that the event diarrhea is related to BNT162b2 based on
known drug safety profile. Based on the temporal relationship, the association
between the events ""renal failure, respiratory failure, hypernatremia, and
anemia"" with BNT162b2 cannot be completely excluded. Possible contribution from
patient's advanced age and underlying medical conditions are assessed as possible.
The impact of this report on the benefit/risk profile of the Pfizer product is
part of this review as well as any appropriate action in response, will be promptly
notified to regulatory authorities, Ethics Committees, and Investigators, as
appropriate.; Reported Cause(s) of Death: the patient died from acute renal and
respiratory failure on the following day; the patient died from acute renal and
respiratory failure on the following day; COVID-19; received the first dose of the
BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks l"" "No prior vaccinations for
this event."
"1348004-1" "1348004-1" "Vaccination failure; covid-19/respiratory distress;
Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021053331.
A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on
31Mar2021 (Batch/Lot Number: ER9470) as single dose; dose 1 via an unspecified
route of administration on Mar2021 (Batch/Lot number was not reported) as single
dose for covid-19 immunization. Medical history included ongoing stented ischemic
heart disease, ongoing atrial fibrillation, Syncope due to severe hypotension and
hospitalized in 2014 with malaise, complete arrhythmia by atrial fibrillation
anticoagulated and treated with amiodarone (defibrillation on 10Sep2014), pacemaker
in 2015, benign prostatic hypertrophy (2 transurethral resections of the prostate),
glaucoma, cataract left eye, cholecystectomy, appendicectomy, Right inguinal hernia
cure, Meniscectomy right knee and Parkinson's (as reported). The patient had no
allergy. The patient's concomitant medications were not reported. Patient who
completed his complete vaccination schedule with Comirnaty with administration of
the 2nd dose on 31Mar2021. The patient had COVID on 26Apr2021 (26 days after the
2nd dose). Computerized tomography chest scan in favour. Negative blood culture.
The patient was however placed on antibiotics. Death of the patient from
respiratory distress on 06May2021. Overall, vaccine failure with COVID-19 infection
26 days after the 2nd dose of Comirnaty. The patient was hospitalized due to the
event. The patient underwent lab tests and procedures which included COVID-19 virus
test positive on 26Apr2021. The patient died on 06May2021. It was not reported if
an autopsy was performed. No follow-up attempts possible. No further information
expected. Information on batch/lot number already obtained.; Reported Cause(s) of
Death: COVID-19; Distress respiratory/COVID-19" "No prior vaccinations for this
event."
"1348453-1" "1348453-1" "Vaccination failure; COVID-19 infection; Multiorgan
failure; Sepsis syndrome; This is a spontaneous report from a contactable physician
downloaded from the regulatory authority, regulatory authority number HR-HALMED-
300047493. An 81-years-old female patient received second dose of bnt162b2
(COMIRNATY), intramuscular on 10Feb2021 (Lot Number: EL0725) as single dose, first
dose intramuscular on 19Jan2021 (Lot Number: EJ6134) as single dose both for covid-
19 immunisation. The patient medical history and concomitant medications were not
reported. The patient experienced vaccination failure, COVID-19 infection,
multiorgan failure, sepsis syndrome on 24Apr2021. On 24Apr2021, she was admitted to
the Hospital, a rapid antigen test was found positive. On 01May2021 she passed away
- the conclusion of the discharge letter stated that the cause of death of the
patient with comorbidities was COVID-19 infection, consequent sepsis syndrome, and
multiorgan failure. Epidemiologically she came from a foster care where the owner
and her son were positive for the SARS CoV-2 virus. The outcome of the events was
fatal. The report was considered as serious with the criteria of medically
significant and death. It was not reported if an autopsy was performed.; Reported
Cause(s) of Death: multiorgan failure; COVID-19 infection; consequent sepsis
syndrome; Vaccination failure" "No prior vaccinations for this event."
"1348459-1" "1348459-1" "COVID-19 pneumonia; COVID-19; COVID-19/COVID-19
pneumonia; heart failure; septicaemia; respiratory failure; fever; cough; This is a
spontaneous report from a contactable physician downloaded from a regulatory
authority-WEB, the Regulatory Authority number is HU-OGYI-288621. A 66-year-old
female patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on
27Mar2021 (lot number: ET7205) in the right arm at 0.3 ml single dose for COVID-19
immunization. Ongoing medical history included hypertension, Type II diabetes
mellitus, paroxysmal atrial fibrillation, deep vein thrombosis prophylaxis, brain
stem stoke and obesity. Concomitant medications included glyceryl trinitrate
(NITRODERM), digoxin, diosmin, hesperidin (DETRALEX), acetylsalicylic acid (ASA
PROTECT PHARMAVIT), bisoprolol fumarate (CONCOR), metformin hydrochloride (ADIMET),
rosuvastatin, apixaban (ELIQUIS), potassium chloride (KALIUM-R), furosemide,
pantoprazole sodium sesquihydrate (PANTACID FLUX), allopurinol (MILURIT),
amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS), amlodipine
besilate, perindopril arginine (COVERCARD). After the vaccination in Mar2021, the
patient experienced fever and cough. One week later, the patient's condition
worsened. On 04Apr2021, the patient was hospitalized. The COVID-19 rapid POC test
was positive. The patient was diagnosed with COVID-19 and COVID-19 pneumonia on
04Apr2021. COVID-19 treatment was initiated, the patient's condition worsened with
time. On 13Apr2021, the patient died. According to the death certificate, direct
cause of death was heart failure. The patient's primary disease was COVID-19, which
escalated to COVID-19 pneumonia, septicaemia and respiratory failure. It was
unknown if autopsy was done. The outcome of events fever and cough were unknown
while outcome of other events were fatal. Sender Comment: COVID-19 and COVID-19
pneumonia is not expected after Comirnaty vaccination. TTO is 8 days until COVID-19
diagnosis. Dechallenge and rechallenge were not applicable. According to the SmPC,
individuals may not be fully protected until 7 days after their second dose of
vaccine. The causal relationship between the suspected drug and the event is
considered unlikely. The case is considered serious due to hospitalization and
fatal outcome.; Reported Cause(s) of Death: heart failure; COVID-19; COVID-19
pneumonia; septicaemia; respiratory failure" "No prior vaccinations for this
event."
"1350521-1" "1350521-1" "Patient was hospitalized 5/7/2021 after testing
positive for COVID-19 on 4/30/2021. Patient was fully vaccinated. He died
"1350978-1" "1350978-1" "78y.o. male with a past medical history of COPD, DM
II, and HTN who presented to the hospital's emergency department from an extended
care facility. Patient was recently hospitalized and treated with IV antibiotics
for HCAP. Patient tested positive for COVID on 3/24/2021. EKG was negative for
ischemic signs but patient had an elevated troponin. CXR showed right pleural
effusion. Patient was admitted with COVID-19 pneumonia and severe respiratory
failure. Patient's oxygenation continued to deteriorate despite Remdesivir,
decadron and lovenox. Patient went into respiratory failure and expired from
progressive respiratory failure." "No prior vaccinations for this event."
"1351466-1" "1351466-1" "88-year-old male with lymphoma that received a
transfusion of 2 units of packed red blood cells prior to admission. The patient
has a history of pleural effusions and he states after the blood transfusion, he
became increasingly more short of breath and could not catch his air. He was
dyspneic at rest and exertion. There is no cough. No fevers. He also has a
history of cardiomyopathy and chest x-ray is suggestive of increasing sizes of his
pleural effusions. Tested positive for COVID on 4/20/2021. Moved to hospice and
Authority-WEB. The regulatory authority report number is [EE-SAM-36762105059]. An
83-years-old female patient received BNT162B2 (COMIRNATY), first dose intramuscular
on 21Jan2021 (Batch/Lot Number: EL1491) as 0.3 ml single, second dose intramuscular
on 11Feb2021 (Batch/Lot Number: EJ6789) as 0.3 ml single for covid-19 immunisation.
Medical history included ongoing hypertension, ongoing atherosclerosis of arteries
of the extremities. The patient's concomitant medications were not reported.
Patient experienced vaccination failure after vaccination with COVID-19 mRNA
vaccine. The patient became ill on 22Mar2021. SARS-Cov-2 PCR test was positive on
23Mar2021. The patient was in hospital between 23 and 26Mar2021. She died on
26Mar2021, the cause of death: acute respiratory failure, Covid-19 pneumonia.
Possible causes of ineffectiveness: co-morbidities - hypertension, atherosclerosis
of arteries of the lower extremities. It was not reported if an autopsy was
performed. Outcome for events was fatal. Sender Comment: Serious, fatal vaccine
ineffectiveness report. The causal link is considered possible. No follow-up
COVID-19 pneumonia; Acute respiratory failure" "No prior vaccinations for this
event."
"1351781-1" "1351781-1" "COVID-19 confirmed by positive COVID-19 test; COVID-
19 confirmed by positive COVID-19 test; This is a spontaneous report received from
a contactable physician downloaded from the Regulatory Authority-WEB. The
regulatory authority report number is EE-SAM-36882105068. An 87-year-old female
patient received BNT162B2 (COMIRNATY) 1st dose (lot number EM0477) on 12Jan2021,
2nd dose (lot number EL1491) on 02Feb2021, both at 0.3 ml single dose intramuscular
for COVID-19 immunisation. Medical history included hypertension with cardiac
damage without (congestive) heart failure; non-insulin dependent diabetes mellitus
with unspecified complications; dementia from other diseases, and age-related
immunodeficiency. Concomitant drug was not provided. Patient experienced
vaccination failure after vaccination with COVID-19 mRNA vaccine. The clinical
course was reported as follows: The patient was in hospital due to another medical
condition and on 17Feb2021 became ill with COVID-19. On 20Feb2021, SARS-CoV-2 PCR
test was positive. The patient died on 28Feb2021 due to another illness. The course
of COVID-19 was not severe; according to the physician, age-related
immunodeficiency may have been the reason for the low efficacy. Outcome of the
event was fatal. Sender Comment: Serious vaccine ineffectiveness report. The
causal link is considered possible. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive
COVID-19 test; COVID-19 confirmed by positive COVID-19 test" "No prior
"1354193-1" "1354193-1" "Patient received second COVID 19 vaccine on 4/13/21
at Site. Patient tested positive for COVID on 5/16/2021. Patient had worsened short
of breath on 5/25/2021 and was admitted to Medical and placed on a vent. Patient
"1354959-1" "1354959-1" "Muscle ache, loss of smell and taste The PUI started
feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a
loss of appetite due to his loss of taste/smell. The patient is currently
undergoing chemo therapy and is most likely the reason why he still got sick with
COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC
RESPIRATORY FAILURE, COVID 19 PNEUMONIA" "No prior vaccinations for this event."
"1355174-1" "1355174-1" ""On 5/20/21 the patient was at home with his mother
when he had acute nausea, light-headedness, and abdominal pain. He presented to the
ED by ambulance. Excerpt from ED notes od MD follows: ""Initial ED interventions:
iv fluids, low dose iv ativan, iv toradol, iv zofran. ED course: patient arrives
very anxious, writhing on bed, difficult to redirect. With chronic tonicity, not
seizing. Mother arrives, and he recognizes her, seems to be consoled somewhat by
her presence, but she is unable to direct him, and describes his behavior as
irregular, and events acute this evening at her home. Patient rests, and then HR
decrease to 50s on monitior and patient found to be pulseless - I immediately start
chest compressions, and achieve ROSC after PEA arrest with administration of
EPI/compressions. Patient intubated per procedure note without complication. L
femoral central attained per procedure note without complication. CPR performed
over ED course intermittently (always PEA arrest) with ROSC achieved with
administration of EPI, EPI drip started in addition to sedation meds, and iv
fluids. No obvious STEMI on ECG to administer lytics, with suspicion of dissection
and AAA prominent. I am able to stabilze and accompany patient to CT suite, where I
recognize B/L massive PE immediately. I discuss with Dr. of Cardiology, who agrees
with admininstration of alteplase. I disucss risks with mother who consents
verbally. Patient without response to alteplase, and with continued pattern of PEA
arrest following bradycardia. I discuss etiology of presentation with mother,and
that patient is with very poor prognosis of survival, and likely poorer prognosis
of neurological status, and patient is made comfort care, and fentanyl drip
increased, patient is taken off of ventilation and drips. Pronounced deceased at
22:00. MDM: Initial concern for but not limited to appendicitis, AAA,
diverticulitis, renal stones, pyelonephritis, musculoskeletal pain, pancreatitis,
toxic ingestion, ACS, obstruction, perforation, sepsis (2/2 PNA, UTI, meningitis,
intra-abdominal infection), AAA, dissection, PE - as ED course progresses,
differential narrows and consider more likely PEA arrest secondary to ACS, PE,
dissection, AAA, necrotic pancreatitis, tension PNX (less likely). Considered but
do not suspect seizures, stroke. Imaging studies reviewed - CXR with ETT in place,
no acute pathology. CTA chest/A/P remarkable for massive proximal B/L PE. Labs
reviewed. ECGs without STEMI, with sinus tach initially, LBBB after initial ROSC,
and then AFib in RVR on subsequent ECG. Per above, patient suffered massive B/L PE,
with subsequent cardiac arrest, despite heoric efforts including thrombolysis.
Death called art 22:00. Diagnosis: massive B/L PEs, PEA arrest. Disposition:
deceased."""" "No prior vaccinations for this event."
downloaded from the Regulatory Authority- WEB (Regulatory Authority report number:
-OGYI-333921). A contactable physician (contactable through Regulatory Authority
only) reported that a 79-year-old male patient received the second dose of BNT162B2
(COMIRNATY, Lot number and expiration date were not reported), intramuscularly on
the right arm on 07Apr2021 as a 2nd dose, single dose, for COVID-19 immunization.
Medical history included ongoing diabetes mellitus; ongoing hypertension; ongoing
cardiomyopathy; and myocardial infarction (unknown if ongoing). Concomitant
medications included clopidogrel bisulfate (ZYLLT), bisoprolol fumarate (COVIOGAL),
rosuvastatin, famotidine (QUAMATEL), perindopril erbumine (RANBAPRIL), piracetam
(MEMORIL) and acetylsalicylic acid (ASPIRIN PROTECT). The patient had previously
received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were
not reported) on an unspecified date, for COVID-19 immunization. On 10Apr2021, the
patient had started to have fever, cough and dyspnea. The patient's COVID-19
antigen test was positive on 10Apr2021. The patient was hospitalized on 16Apr2021
with pneumonia affecting the 70% of his lung. The patient had died on 01May2021 due
to the severe symptoms of COVID-19. It was unknown if an autopsy was performed.
Sender Comment: The patient was diagnosed to have COVID-19 three days after the
second dose of COMIRNATY. Immunity may have not developed within 3 days after the
second dose of vaccine. The case is serious because the patient died. Information
on the batch/lot number has been requested.; Reported Cause(s) of Death: COVID-19;
"1356560-1" "1356560-1" "COVID-19 antigen test positive; COVID-19 pneumonia;
COVID-19; This is a spontaneous report from a contactable physician downloaded from
the regulatory authority- WEB, the Regulatory Authority number is HU-OGYI-334721.
An 85-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EL0725),
via an unspecified route of administration, administered in left arm on 27Feb2021
as 1st dose, 0.3ml single to prevent Covid-19. Medical history included atrial
fibrillation, hypertension, ischemic heart disease, hernia surgery, pacemaker
insertion, hysterectomy, tonsillectomy and adnexectomy. Concomitant medications
included perindopril arginine (COVEREX AS); acenocoumarol (SYNCUMAR). The patient
was hospitalized on 02Mar2021 with symptoms of fever and confusion. On 02Mar2021,
Covid-19 antigen test was positive and chest X-ray confirmed pneumonia (COVID-19
pneumonia). The patient received COVID therapy but her general condition
continuously deteriorated and passed away on 09Mar2021 at 20:00. Cause of death
were COVID-19 antigen test positive, COVID-19 pneumonia and COVID-19. An autopsy
was not performed. Sender Comment: According to the HA of Comirnaty, immunity
usually develops 14 days after the second dose of the vaccine. The patient got
infected with the virus 3 days after the first dose, therefore immunity may have
not developed yet. Based on the above, the causal relationship is unlikely between
the suspected drug and the adverse events. The case is considered serious because
the outcome was fatal. Further information is not expected.; Reported Cause(s) of
Death: COVID-19 pneumonia; COVID-19 antigen test positive; COVID-19" "No prior
"1357990-1" "1357990-1" "Patient hospitalized. Patient died after testing
positive for COVID-19. Admitted to hospital 4/2/2021 for right flank pain. Tested
positive on 4/1/2021. Died 4/29/2021" "No prior vaccinations for this event."
"1363337-1" "1363337-1" "hypostatic pneumonia; COVID-19 confirmed by positive
PCR COVID-19 test; COVID-19 confirmed by positive PCR COVID-19 test; Fever; This
is a spontaneous report from a contactable healthcare professional downloaded from
the regulatory authority [HU-OGYI-322221], received from the agency. An 87-year-old
female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in
arm left on 30Jan2021 (Batch/Lot Number: EJ6134) as 0.3 ml single for covid-19
immunisation. Medical history included musculoskeletal disorder and hypertension,
dates unknown. The patient's concomitant medications were not reported. The
patient had covid-19 confirmed by positive PCR covid-19 test on 16Feb2021 (fatal
outcome), hypostatic pneumonia on 25Feb2021 (fatal outcome), and high fever on
15Feb2021 with outcome of unknown. The patient experienced physical weakness and
subfebrility, and died on 25Feb2021 due to COVID-19. The patient underwent lab
tests and procedures which included COVID-19 PCR test positive on 16Feb2021. The
patient died on 25Feb2021. An autopsy was not performed. Sender Comment: COVID-19
PCR test was positive 17 days after, and the patient died 26 days after Comirnaty
vaccination due to COVID-19. Autopsy was not done. The event is not related to
Comirnaty vaccination. The case is serious due to fatal outcome. No follow-up
Pneumonia hypostatic; COVID-19; Drug ineffective" "No prior vaccinations for
this event."
"1363339-1" "1363339-1" "Cardiac failure; Drug Ineffective; COVID-19
pneumonia; COVID-19 virus test positive; COVID-19; This is as spontaneous report
received from a contactable physician downloaded from the regulatory authority-WEB.
The regulatory authority report number is HU-OGYI-335221. A 80-years-old female
patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm
Left on 10Mar2021 (Batch/Lot Number: ET1831) as 0.3mL single for covid-19
immunisation . Medical history included ongoing type 2 diabetes mellitus ,
ongoing hypertension , ongoing myocardial ischaemia , uterine prolapse , suicidal
ideation ongoing atrial fibrillation. Concomitant medications included metformin
hydrochloride, vildagliptin (EUCREAS) taken for an unspecified indication, start
and stop date were not reported; ramipril (AMPRILAN) taken for an unspecified
indication, start and stop date were not reported; furosemide (FUROSEMIDE) taken
for an unspecified indication, start and stop date were not reported; allopurinol
(MILURIT) taken for an unspecified indication, start and stop date were not
reported; potassium chloride (KALDYUM) taken for an unspecified indication, start
and stop date were not reported; apixaban (ELIQUIS) taken for an unspecified
indication, start and stop date were not reported; eplerenone (EPLERENONE) taken
for an unspecified indication, start and stop date were not reported; trimetazidine
hydrochloride (ADEXOR) taken for an unspecified indication, start and stop date
were not reported; bisoprolol fumarate (CONCOR) taken for an unspecified
indication, start and stop date were not reported. On an unknown date the patient
received the first dose of BNT162B2 vaccine. The patient experienced drug
ineffective on Mar2021 , covid-19 pneumonia on Mar2021 , Covid-19 virus test
positive on Mar2021 , Covid-19 on Mar2021 , cardiac failure . All the reported
events led to patient's death on 16Mar2021. The patient underwent lab tests and
procedures which included blood gases on 16Mar2021: metabolic acidosis, increased
lactate levels, hypoxia, hyperkalaemia , blood test: on 16Mar2021 increased DDI,
increased inflammatory parameters, increased necroenzyme levels , chest x-ray:
diagnose of covid-19 pneumonia, hydrothorax on 16Mar2021 , sars-cov-2 test:
positive. The patient died on 16Mar2021. It was not reported if an autopsy was
performed. Course of the events: On 10Mar2021, the 80-year-old female patient
received the second dose of 0.3 ml Comirnaty concentrate for dispersion for
injection (tozinameran; batch number: ET1831, expiry date: unknown,
intramuscularly, in the left arm) for COVID-19 immunisation. On 16Mar2021, the
patient was sent to the hospital, due to dyspnoea, fatigue and weakness. The
patient's COVID-19 test was positive, COVID-19 was diagnosed. Several tests were
initiated. Chest x-ray showed COVID-19 pneumonia, hydrothorax. Blood gas analysis
showed metabolic acidosis, increased lactate levels, hypoxia and hyperkalaemia.
Blood test showed impaired renal function, increased DDI, increased inflammatory
parameters and increased necroenzyme levels. The patient received diuretic therapy
and oxygen supplementation, but died on the same day, on 16Mar2021. According to
the death certificate, the direct cause of death was cardiac failure and acute
respiratory failure. The patient's primary disease was COVID-19, which escalated to
hyperkalaemia and COVID-19 pneumonia. No further information is expected. Sender
Comment: COVID-19 and COVID-19 pneumonia are not expected after vaccination with
Comirnaty. TTO (Time Trade -Off) is 6 days until the patient's death but COVID-19
symptoms occurred earlier. Dechallenge and rechallenge were not applicable. The
causal relationship between the suspected drug and the event is considered
unlikely. The case is considered serious due to fatal outcome.; Reported Cause(s)
of Death: cardiac failure; acute respiratory failure" "No prior vaccinations for
this event."
"1363343-1" "1363343-1" "Vaccination failure; COVID-19 pneumonia; COVID-19;
COVID-19 antigen test positive; This is a spontaneous report from a contactable
other healthcare professional downloaded from the regulatory authority-WEB [HU-
OGYI-343221]. This is a spontaneous report from a contactable other hcp. This is a
report received from the agency. Regulatory authority report number HU-OGYI-
343221]. A 84-years-old male patient received bnt162b2 (COMIRNATY), dose 2
intramuscular, administered in Arm Left on 10Mar2021 (Batch/Lot Number: EP2163) as
0.3 mL, single, and dose 1 intramuscular on 17Feb2021 (Batch/Lot Number: EL0725)
as 0.3 mL, single for covid-19 immunisation . Medical history included covid-19
from an unknown , hypertension, covid-19 pneumonia , appendicectomy ,
hypersensitivity , tonsillectomy , cholecystectomy , atrial fibrillation ,
varicose vein (Varicectomy) , eye operation. The patient's concomitant
medications were not reported. The patient experienced vaccination failure on
19Mar2021 , covid-19 pneumonia on 19Mar2021 , covid-19 on 19Mar2021 , covid-19
antigen test positive on 19Mar2021. All the reported events caused patient
hospitalization and led to patient's death on 22Mar2021. The patient underwent lab
tests and procedures which included chest x-ray: confirmed pneumonia on 19Mar2021
, sars-cov-2 test: positive on 19Mar2021 . The patient died on 22Mar2021. An
autopsy was not performed. Course of the event: The patient was admitted to the
hospital because of breathing difficulty, diarrhea, and general weakness. Covid-19
antigen test was positive, and chest X-ray confirmed pneumonia. The patient
received covid therapy, but his condition worsened, and passed away on 22Mar2021 at
04:30 due to cardiorespiratory insufficiency. Sender Comment: The patient got
infected with Covid-19 nine days after the second dose, therefore vaccination
failure is considered possible. The case is serious because the outcome was fatal.
Further information is not expected. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19 pneumonia" "No prior
"1366096-1" "1366096-1" "COVID-19 pneumonia; COVID positive; COVID-19
infection; This is a spontaneous report from a contactable physician downloaded
from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-
345321. A 68-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot
Number: EP2166), intramuscular, administered in arm left on 24Feb2021 as 1st dose,
0.3 ml single for COVID-19 immunisation. Medical history included COVID-19
pneumonia, varicosity, tonsillectomy, COVID-19, lymphoma (non-Hodgkin's) from 2020
(low-grade B cell lymphoma progressed) and hypertension. The patient's concomitant
medications were not reported. On 08Mar2021 thee patient experienced COVID-19
pneumonia , COVID positive and COVID-19 infection. It was reported that on
08Mar2021 COVID-19 infection was confirmed and the patient was hospitalized. Chest
X-ray also showed bilateral pneumonia. The patient received COVID therapy but his
condition did not get better and passed away on 24Mar2021 at 07:00. The patient was
diagnosed with incurable low-grade B cell lymphoma in 2020 which progressed,
therefore the patient's general condition was not adequate enough to recover from
the COVID-19 infection. The patient underwent lab tests and procedures which
included chest x-ray: bilateral pneumonia on 08Mar2021, chest x-ray: positive
(confirmed pneumonia) on 16Mar2021, COVID-19 antigen test: positive on 08Mar2021.
The patient died on 24Mar2021 due to COVID-19. An autopsy was not performed.
Sender comments: As the patient got infected with COVID-19 after the first dose,
the causal relationship is unlikely between the suspected drug and the adverse
events. The case is considered serious because the outcome was fatal. Further
information is not expected. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: COVID-19" "No prior
"1366666-1" "1366666-1" "Embolism; Saturation low; COVID-19; COVID-19; This
is a spontaneous report from contactable consumer. This consumer reported for two
patients (parents). This is the first of two reports. A male patient of an
unspecified age received BNT162B2 (COMIRNATY) at single dose, on 10Mar2021, for
COVID-19 immunisation. Relevant medical history and concomitant medications were
unknown. On 26Mar2021 (Friday), the patient began to feel bad, the temperature was
38.3 degrees Celsius. On 27Mar2021 (Saturday) and on 28Mar2021 (Sunday) his health
did not improve, he still had a temperature, dry cough and malaise. Patient called
the clinic and reported his symptoms. The physician ordered to perform test in
towards COVID-19. The test was positive on an unspecified date, in Mar2021. The
patient received drugs and stayed in home isolation. On 31Mar2021, an ambulance was
called, which concluded that the vital parameters were normal, including
saturation. On 02Apr2021, the patient felt very bad. He didn't have the strength to
get out of bed. Saturation was measured twice, it was very low 80. General
physician called an ambulance. In the hospital, it turned out that the patient was
occupied with the disease 80% spit. Doctors gave him large amounts of oxygen.
Unfortunately, the disease progressed as well. On 04Apr2021, 90% of the lungs were
affected and there was an embolism. In the evening, patient was put into a
pharmacological coma and put on a respirator. Patient died on 13Apr2021. The
information on the lot number has been requested.; Reported Cause(s) of Death: Drug
ineffective; COVID-19; Arterial oxygen saturation decreased; Embolism" "No prior
"1366669-1" "1366669-1" "Pneumonia; Anaemia; COVID-19 PCR test positive;
Parkinson's syndrome; Gastritis; Fever 40-40.4 degree Celsius up to 24 hours;
Vaccination failure; COVID-19; This is a spontaneous report from a contactable
physician downloaded from a regulatory authority-WEB PL-URPL-3-633-2021t An 88-
year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular,
administered in Arm Left on 18Feb2021 15:18 (Batch/Lot Number: EP9598; Expiration
Date: 30Jun2021) as 0.3ml single at the age of 88-year-old for COVID-19
reported. The patient received bnt162b2 (COMIRNATY), dose 1 on an unknown date for
COVID-19 immunisation. On 03Mar2021 the patient experienced pneumonia, anaemia,
COVID-19 PCR test positive, Parkinson's syndrome, gastritis, fever 40-40.4 degree
celsius up to 24 hours, vaccination failure, COVID-19. The patient underwent lab
tests and procedures which included: body temperature increased: 40-40.4 centigrade
on 03Mar2021, Sars-cov-2 antibody test: negative on 03Mar2021, Sars-cov-2 test:
positive on 03Mar2021. The patient died on 04Mar2021. It was not reported if an
autopsy was performed. The course of events was as follows: Description of the
reaction: on 03Mar2021 a patient was admitted to Hospital in a serious condition
with diagnosed pneumonia. On admission, an antigen test for COVID-19 (-) and a PCR
test for Covid-19 (+) were performed. On 04Mar2021, at approximately 14 hour, the
patient died. Additional information: Emergency department diagnosis: COVID 19
virus identified, pneumonia, anemia, gastritis, parkinsonian syndrome, cause of
death has not been clearly defined. Sender Comments: Pyrexia is an expected
adverse drug reaction as described in a publication, after Comirnaty
administration. Pneumonia and a positive covid-19 PCR test result are unexpected
symptoms, but reported in a database (pneumonia, SARS-Cov-19 test positive). There
is a time relationship between the second dose of the vaccine and the occurrence of
side effects. Parkinson's syndrome (so-called parkinsonism) is an unexpected
adverse drug reaction for Comirnaty vaccine. Parkinsonism is most often caused by
other virals or it occurs in inflammatory and neurodegenerative diseases. Anemia is
most likely a symptom of inflammation in the lining of the stomach. A regulatory
authority considers that these adverse drug reactions (parkinsonian syndrome,
anemia, gastritis) coincided with vaccination. The reporting person qualified NOP
as heavy. A regulatory authority assessed the NOP as heavy. The notification
concerns the medicinal product Comirnaty, with regard to the lack of protective
efficacy of the vaccine and the severe course of COVID-19 after vaccination (VAED -
vaccine associated enhanced disease), therefore the reporting person was provided
with a form on 13May2021 in order to obtain additional data, in accordance with
Corminaty RMP. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: unknown cause of death" "No prior vaccinations for
this event."
"1368008-1" "1368008-1" "4/28/21 Pt presented to the ED with complaints of a
cough that started 2 weeks ago and was getting worse and weakness with several
falls. She also admitted to intermittent diarrhea. She was found to be febrile with
a temp to 101.1, tachypneic w/RR of 20. Sats were in the low 90's. NP was was
positive for SARS-CoV-2. CXR showed bilateral opacities and she was admitted for
PNA and sepsi. She was given Rocephin and Z-max in ED and both were discontinued
upon admission. She was started on Decadron in ED 4/30 she had increasing
hypoxemia and was placed on a non rebreather. She was transferred to critical care
and given tocilizumab. Her respiratory status continued to worsen and she was
intubated. She subsequently developed a pneumothorax that persisted despite 2 chest
tubes. She developed a large air leak and she was not a surgical candidate. Family
ultimately decided to w/draw care on 5/15/21" "No prior vaccinations for this
event."
"1368670-1" "1368670-1" "Admitted to hospital on 5/2/2021 due to hypoxia and
ultimately intubated. Family moved to comfort care and he died on 5/2/2021 at
10am." "No prior vaccinations for this event."
report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB
[Regulatory Authority number EE-SAM-377521051426]. A 97-year-old female patient
received bnt162b2 (COMIRNATY), dose 1 intramuscular on 16Jan2021 (Lot Number:
EL1491) as 0.3 ml single, dose 2 intramuscular on 06Feb2021 (Lot Number: EL8725) as
0.3 ml single for COVID-19 immunisation. The patient's medical history and
concomitant medications were not reported. The patient experienced COVID-19
(medically significant, death) on 27Apr2021. The patient underwent lab tests and
procedures which included COVID-19 PCR test: positive on 27Apr2021. On 28April 2021
morning the patient was in coma. On 29April2021 there was fever. The patient died
on 02May2021. It was unknown if an autopsy was performed. Per doctors assessment,
death was not due to COVID-19. Sender Comment: Serious vaccine ineffectiveness
report but death is not related to COVID-19 infection, fever might have accelerated
it. No follow-up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: Vaccination failure; COVID-19" "No prior vaccinations
for this event."
"1370971-1" "1370971-1" "shortness of breath; COVID-19; Vaccination failure;
fever 38,9 degree; This is a spontaneous report from a contactable other health
professional downloaded from the Agency Regulatory Authority-WEB, regulatory
authority number EE-SAM-377721051428. A 90-year-old male patient received
BNT162B2 (COMIRNATY), dose 2 on 06Feb2021 (Batch/Lot Number: EL8723) and dose 1 on
16Jan2021 (Batch/Lot Number: EL1491), both intramuscular as 0.3 mL single dose for
COVID-19 immunisation. Medical history included ongoing heart failure, ongoing
atrial fibrillation, atrial flutter from an unknown date and unknown if ongoing,
ongoing hypertensive heart disease, ongoing diabetes mellitus non-insulin
dependent. Concomitant medications included amlodipine
besilate/hydrochlorothiazide/olmesartan medoxomil (SANORAL HCT, formulation: coated
tablet, strength: 5mg/12.5 mg, 40 mg) oral and flurbiprofen (FLOSIN, formulation:
capsule hard, strength: 0.4 mg) oral, both concomitants were taken for an
unspecified indication, start and stop date were not reported. The patient
experienced SARS-CoV-2 (PCR) test positive on 27 April 2021. On 27Apr2021, fever of
38.9 degree occurred. On 10May2021, the patient died on the background of fever and
shortness of breath. It was not reported if an autopsy was performed. Doctor's
assessment: death is not due to COVID, but due to comorbidities. Sender Comment:
Serious vaccine ineffectiveness report but death is not related to COVID-infection.
Fever and shortness of breath might have accelerated it but death due to
comorbidities. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: covid-19; fever; shortness of breath" "No prior
"1371438-1" "1371438-1" "Clinet was vaccinated on 2/16/21 and on 3/9/21"
"1375231-1" "1375231-1" "COVID-19; COVID-19 pneumonia; COVID-19 PCR test
positive; This is a spontaneous report received from a contactable physician via
Regulatory Authority, downloaded from the regulatory authority-WEB (regulatory
authority report number HU-OGYI-347021). A 77-year-old female patient received the
first dose of BNT162B2 (COMIRNATY) intramuscular in the left arm on 22Mar2021
(Batch/Lot Number: ET3620) at 0.3 mL single dose for COVID-19 immunisation.
Relevant medical history included angina pectoris, type 2 diabetes, hypertension,
COVID-19, diabetic retinopathy, COVID-19 pneumonia, cardiomyopathy, myocardial
ischaemia, hyperlipidaemia and arteriosclerosis, all from unknown dates and unknown
if ongoing. The patient's concomitant medications were not reported. On 29Mar2021,
the patient experienced COVID-19, COVID-19 pneumonia and COVID-19 PCR test
positive. On 29Mar2021, the patient was hospitalized because of breathing
difficulties. PCR test was positive and chest X-ray confirmed COVID-19 pneumonia on
29Mar2021. The patient received COVID therapy and oxygen, but her general condition
gradually deteriorated and passed away on 31Mar2021 at 7:20. The cause of death was
reported as COVID-19. An autopsy was not performed. Sender Comment: The patient
got infected with COVID-19 nine days after the first dose, therefore immunity may
not have developed yet. Based on the above, the causal relationship is unlikely
between the suspected drug and the adverse events. The case is considered serious
because the outcome was fatal. Further information is not expected.; Reported
Cause(s) of Death: COVID-19" "No prior vaccinations for this event."
"1375972-1" "1375972-1" "Symptom onset began on 4/29/2021. Tested (+) on
4/29/2021. Symptoms included fatigue, congestion, cough. Case was interviewed by
public health department on 5/3/2021 and family reported he was in hospital and was
admitted on 4/30/2021. Deceased as of 5/14/2021. Unknown if in ICU or mechanically
ventilated." "No prior vaccinations for this event."
"1377497-1" "1377497-1" "COVID-19 pneumonia; Critical condition; Fever;
COVID-19 positive; Cough; General physical condition decreased; COVID-19
pneumonia/Vaccination failure; Retching; pronounced Gait instability; This is a
spontaneous report from a contactable other Healthcare Professional downloaded from
the regulatory authority-WEB local regulatory authority number AT-BASGAGES-2021-
29654. A 81-year-old male patient received second dose of BNT162B2 (COMIRNATY,
Solution for injection, Lot Number: EJ6797; Expiration Date: 30Apr2021) via an
unspecified route of administration, administered at an unspecified anatomical
location 02Feb2021 (age at vaccination was unknown) as 2ND DOSE, SINGLE DOSE for
COVID-19 immunization. The patient's medical history and concurrent conditions
included hard of hearing, myopia, astigmatism, presbyopia, glaucoma, degeneration
macular, senile cataract, amblyopia, mitral valve insufficiency, extrasystoles,
diabetes mellitus, dyspnoea exertional, arterial hypertension, fibromatosis, cyst,
atherosclerotic plaque, prostatic hypertrophy (benign), dementia vascular,
behaviour disorder, impaired self-care, vision decreased, swallowing difficult.
Concomitant medications included diclofenac diethylamine (VOLTAREN EMULGEL) from
31Aug2020 to 13Mar2021, trospium chloride (INKONTAN)dose of 15mg from 17Nov2020 to
13Mar2021, dimeticone (CEOLAT) dose of 1mg/ml from 16Dec2020 to 13Mar2021,
prothipendyl hydrochloride (DOMINAL) dose of 80mg from 07Dec2020 to 13Mar2021,
citalopram hydrobromide dose of 40mg from 12Oct2020 to 13Mar2021, glyceryl
trinitrate (NITROLINGUAL) dose of 0.4mg from 14Sep2020 to 13Mar2021, quetiapine
fumarate (QUETIALAN) dose of 50 mg from 30Nov2020 to 13Mar2021; tamsulosin
hydrochloride (TAMSULOSIN HEXAL) dose of 0.4 mg from 17Nov2020 to 13Mar2021,
quetiapine fumarate (QUETIAPIN GENERICON) dose of 25 mg from 29Oct2020 to
13Mar2021, paracetamol (MEXALEN) dose of 500 mg from 23Oct2020 to 13Mar2021,
carvedilol (CARVEDILOL HEXAL) dose of 25mg from 11May2020 to 13Mar2021, macrogol
3350, potassium chloride, sodium bicarbonate, sodium chloride (MOLAXOLE) from
04Mar2021 to 13Mar2021, latanoprost (LATANOPROST AGEPHA) dose of 50 ug/ml from
11May2020 to 13Mar2021. The patient previously took first dose of BNT162B2
(COMIRNATY, Solution for injection, Lot Number: EJ6796; Expiration Date: unknown)
via an unspecified route of administration, administered at an unspecified
anatomical location 12Jan2021 (age at vaccination was unknown) as 1ST DOSE, SINGLE
DOSE for COVID-19 immunization. On 01Mar2021, the patient experienced gait
instability. On 04Mar2021, the patient experienced retching, cough, general
physical condition decreased. On 04Mar2021 at 20:30 pm, the patient was
hospitalized. On 04Mar2021, the patient underwent lab tests and procedures which
included blood pressure measurement: 220/110 and 200/100 and sars-cov-2 test:
negative on 09Feb2021, 12Feb2021 and 04Mar2021. On 05Mar2021, the patient
experienced COVID-19. On 06Mar2021, the patient experienced fever, critical illness
and COVID-19 pneumonia. On 13Mar2021, the patient died. It was unknown if an
autopsy was performed. The reporter's causality assessment was reported as related.
The outcome of the event COVID-19 pneumonia was fatal. The outcome of the event
retching was unknown. The outcome of the event gait instability was resolved on
03Mar2021. The outcome of the events cough, general physical condition decreased,
fever, critical illness and COVID-19 was not resolved. No follow-up attempts
needed. No further information is expected, batch/lot.no. has already been
reported. ; Reported Cause(s) of Death: COVID-19 pneumonia""No prior vaccinations
for this event."
"1378907-1" "1378907-1" "COVID-19 confirmed by positive COVID-19 test; COVID-
19 confirmed by positive COVID-19 test; oxygen saturation decreased; swallowing
disorder; loss of appetite; This is a spontaneous report from a contactable
physician downloaded from a regulatory authority-WEB, regulatory authority number
FR-AFSSAPS-2021059585. An 81-year-old male patient received BNT162B2
(COMIRNATY), dose 2 intramuscular, administered in arm left on 10Feb2021 (Batch/Lot
Number: EJ6795) as 0.3 mL single dose and dose 1 via an unspecified route of
administration on 20Jan2021 (Batch/Lot number was not reported) as single dose,
both for COVID-19 immunisation. Medical history included myocardial infarction,
hypertension arterial, bronchogenic cyst, anxiety, adenocarcinoma of prostate
treated with radiotherapy and hormone therapy, dementia and depression, all from an
unknown date and unknown if ongoing. The patient's concomitant medications were
not reported. The patient experienced on 07May2021 appearance of symptoms of
pulmonary decompensation with 78% saturation and neurological with absence, loss of
appetite and swallowing disorder. Patient put on O2. On 10May2021 the patient
tested positive to SARS-COV-2 PCR test (specific country variant). The patient died
on 12May2021. An autopsy was not performed. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: Covid-19 respiratory
"1380070-1" "1380070-1" "COVID-19 pneumonia; COVID-19 rapid POC test
positive; drug ineffective; This is a spontaneous report from a contactable
physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority
number HU-OGYI-344221. A 66-years-old male patient received BNT162B2 (COMIRNATY),
dose 1 intramuscular, administered in Arm Left on 10Apr2021 (Batch/Lot number was
not reported) as 1st dose, 0.3 mL, single for covid-19 immunisation. Medical
history included peripheral artery bypass from an unknown date and unknown if
ongoing, lung adenocarcinoma stage iv from an unknown date and unknown if ongoing
(patient was under oncological treatment), lung neoplasm surgery from 2016 to an
unknown date, hypertension from an unknown date and unknown if ongoing. On
27Apr2021 the patient was hospitalized due to fever, dyspnoea and positive COVID-19
rapid test. Chest CT was not typical for COVID-19 pneumonia. Antiviral and
antibiotic therapy was started. His condition initially stabilized, then his
inflammatory parameters increased, and his oxygenation deteriorated. Due to
deteriorating respiratory mechanics and deteriorating state of consciousness,
mechanical ventilation was considered, but they could not properly connect a
mechanical ventilator to the patients tracheostoma. His respiratory insufficiency
progressed. The tracheostoma was replaced with endotracheal tube. The patient had
circulatory disturbances, he became bradycardic, advanced level resuscitation
failed, the patient died on 07May2021 at 20:56. The patient underwent lab tests and
procedures which included computerised tomogram thorax not typicial for pneumonia
on 27Apr2021, sars-cov-2 test: positive on 27Apr2021. The patient died on
07May2021. It was not reported if an autopsy was performed. COVID-19 rapid test
became positive 17 days after, and the patient died 27 days after the first dose of
COMIRNATY due to COVID-19 pneumonia. Immunity has not developed after the first
dose. The case is serious due to hospitalization and fatal outcome. No follow-up
attempts are possible; information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19; Drug ineffective" "No
"1380077-1" "1380077-1" "COVID-19 PCR test positive; death; This is a
Authority-WEB: HU-OGYI-348021. A 77-year-old female patient received the first
dose of BNT162B2 (Comirnaty, batch/lot number: EJ6790) intramuscularly in the left
arm on 03Mar2021 at 8:34 a.m at 0.3 mL single for COVID-19 immunization. Medical
history included hyperthyroidism, struma nodosa, insulin dependent diabetes
mellitus, hypertension, atrial fibrillation and dementia. The patient was treated
in Cardiology until 31Jan2021 due to progressive effort intolerance, dyspnoea, and
swelling of feet. The patient was admitted to the Psychiatric Department on
08Feb2021 for examination and medication adjustment, she had not had any
psychiatric treatment or examination before. Internal medicine examinations have
also found the patient often extremely restless and desoriented. As a result of the
drug adjustment, her condition improved. On 03Mar2021 the patient received
BNT162B2, no events occurred after vaccination. But on 09Mar2021, before emittion,
the patient's PCR test became positive and her infection was confirmed. COVID-19
symptoms has not occurred during observations. Anxiolytic medication was stopped,
but her condition was characterized by negativism, and antihypertensive drugs were
also discontinued due to low tension. Laboratory abnormalities have been attempted
to be normalized by parenteral medication. Despite the treatment according to the
protocol, her condition progressed further, and the patient died among the symptoms
of cardiorespiratory insufficiency on 22Mar2021 at 21:40 . Autopsy was not done,
the patient's death was considered to be related to her underlying diseases.
Sender's comment: COVID-19 PCR test became positive after 6 days, and the patient
died 19 days after Comirnaty vaccination. Immunity has not developed after the
first dose. Autopsy was not done, the patient's death was considered to be related
to her underlying diseases. The case is serious due to hospitalization and fatal
outcome. No further information is expected.; Reported Cause(s) of Death: Death;
"1380079-1" "1380079-1" "COVID-19 pneumonia; COVID-19; drug ineffective; This
is a spontaneous report from a contactable physician downloaded from the Regulatory
Authority-WEB HU-OGYI-349921. This spontaneous, serious case was reported on
13May2021 by a physician via the national competent authority for vaccines and
concerns the occurrence of Covid-19 infection and pneumonia resulting in death
after COMIRNATY injection for active immunization to prevent COVID-19. An 84-year
old female patient received her first dose of BNT162B2 (COMIRNATY) intramuscularly
on 20Mar2021 (batch/Lot number ET1831) at 0.3 mL single for Covid-19 immunization.
Relevant medical history included hypertension, NIDDM, chronic kidney failure,
osteoporosis, glaucoma, Covid-19 and Covid-19 pneumonia. Concomitant medications
were not reported. The patient was admitted in the hospital on 13Apr2021 because
she has been experiencing coughing and breathing difficulty for the last 3-4 days.
Chest X-ray confirmed Covid-19 pneumonia. The patient had to be intubated because
her oxygen saturation worsened and had tachypnea. Despite the therapy, the patient
passed away on 15Apr2021 at 22:18 due to ARDS, multiple organ failure and tissue
hypoxia caused by the Covid-19 infection. The case was investigated by the national
competent authority for vaccines, the investigator did not find any irregularities
regarding the transportation and storage of the vaccine. Sender Comment: As the
patient got infected with Covid-19 after the first dose, immunity may have not
developed yet, therefore the causal relationship is unlikely between the suspected
drug and the adverse event. The investigator via the national competent authority
for vaccines also assessed the events as not related to the vaccine. The case is
considered serious because the outcome was fatal. Further information is not
expected. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19; Covid-19 pneumonia" "No prior vaccinations
for this event."
"1380212-1" "1380212-1" "Asthenia, bed rest and fever, gradual worsening,
25May ER for marked dyspnoea, diagnosis of pneumonia with septic shock and renal
insufficiency; Asthenia, bed rest and fever, gradual worsening, 25May ER for marked
dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency;
Asthenia, bed rest and fever, gradual worsening, 25May ER for marked dyspnoea,
diagnosis of pneumonia with septic shock and renal insufficiency; Asthenia, bed
rest and fever, gradual worsening, 25May ER for marked dyspnoea, diagnosis of
pneumonia with septic shock and renal insufficiency; Asthenia, bed rest and fever,
gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic
shock and renal insufficiency; This is a spontaneous report from a contactable
Physician downloaded from the regulatory authority-WEB, regulatory authority number
IT-MINISAL02-736640. An 83-years-old female patient received bnt162b2
(COMIRNATY), intramuscular on 17May2021 (Batch/Lot Number: FA4597) as UNKNOWN,
SINGLE DOSE for covid-19 immunisation. Medical history included hemicolectomy on
Apr2021 for adenocarcinoma surgery and adenocarcinoma from an unknown date and
unknown if it was ongoing. Concomitant medications were not reported. The patient
experienced asthenia, bed rest and fever, gradual worsening, 25May ER for marked
dyspnoea, diagnosis of pneumonia with septic shock and renal insufficiency. The
patient visited emergency room for the events dyspnoea, diagnosis of pneumonia with
septic shock and renal insufficiency. The events were reported as serious (fatal).
The patient underwent lab tests and procedures which included covid-19: positive on
Dec2020. The patient died on 28May2021. The cause of death was reported as
diagnosis of pneumonia with septic shock and renal insufficiency. It was not
reported if an autopsy was performed. Case narrative including clinical course,
therapeutic measures, outcome and additional relevant information: On Dec 2020
infez. from SARS COV2 treated at home, in April 2021 hemicolectomy for
adenocarcinoma surgery. ; Reported Cause(s) of Death: Asthenia, bed rest and fever,
gradual worsening, 25May ER for marked dyspnoea, diagnosis of pneumonia with septic
shock and renal insufficiency; Asthenia, bed rest and fever, gradual worsening,
25May ER for marked dyspnoea, diagnosis of pneumonia wit" "No prior vaccinations
for this event."
"1381212-1" "1381212-1" "Hypoxic respiratory failure; pneumonia; Stomach
cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is
a spontaneous report from a contactable consumer (patient's husband). A 65-year-old
female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an
unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot
Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation.
Medical history included back disorder from an unknown date and unknown if ongoing.
The patient's concomitant medications were not reported. Previously the patient
received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot
number: ENG201, injection in arm, possibly in left arm: patient had no problems
with the first shot. The patient experienced covid-19 (death, medically
significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on
08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-
serious) on an unspecified date with outcome of unknown, could not breathe well
(non-serious) on an unspecified date with outcome of unknown, she had back problems
(non-serious) on an unspecified date with outcome of unknown. Patient went to
Emergency Room (ER) 8 hours later administration of the second dose and on
08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she
died. Patient was positive for covid 19 on unknown date. She was diagnosed with
covid when she went to ER. Patient was on a ventilator. The patient underwent lab
tests and procedures which included endoscopy: gerd or abdomen problem on
unspecified date, COVID test: positive on unknown date. Therapeutic measures were
taken as a result of hypoxic respiratory failure and pneumonia (on ventilator).
The patient died on 16Apr2021. An autopsy was not performed. It was stated that
cause of death on death certificate listed as Covid 19, pneumonia, hypoxic
respiratory failure. Follow attempts are needed. Further information is expected;
Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory
"1382347-1" "1382347-1" "COVID Infection post immunization" "No prior
"1382468-1" "1382468-1" "Per discharge summary, patient presented to BHL with
his wife with increased shortness of breath, diarrhea and hematuria. Found to be
COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer
vaccinations. Patient was admitted and started on treatment for Covid with
remdesivir and steroids. He was continued on his home dialysis schedule. He
continued to have intermittent confusion and then for the last 3 to 5 days was very
confused and more unresponsive. Reviewed goals of care with wife at length and
palliative care was consulted. Decision was made not to pursue feeding tube due to
patient having clearly outlined his wishes and his advanced directive. Upon
further discussion with family hospice was consulted and patient was transitioned
to inpatient hospice" "No prior vaccinations for this event."
"1383878-1" "1383878-1" "Positive during a screening in nursing home PRIVACY,
worsened in the following days for respiratory failure, hospitalized on 02Apr, died
on 06Apr; Positive during a screening in nursing home PRIVACY, worsened in the
following days for respiratory failure, hospitalized on 02Apr, died on 06Apr;
Positive during a screening in nursing home PRIVACY, worsened in the following days
for respiratory failure, hospitalized on 02Apr, died on 06Apr; This is a
spontaneous report from a contactable physician downloaded from the European
Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number IT-
MINISAL02-737047. A 89-year-old female patient received second dose of BNT162B2
(COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6790-14-006;
Expiration Date: 31May2021) via intramuscular route, administered in Right Arm on
11Feb2021 10:00 as a 2nd dose, single dose for COVID-19 immunization. The patient's
medical history included mixed dementia, difficulty in walking and bronchitis. The
patient's concomitant medications were not reported. The patient previously
received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection,
Batch/Lot Number: Not reported; Expiration Date: Not reported) via unspecified
route on 18Jan2021 as 1st dose, single dose for COVID-19 immunization. On
22Mar2021, the reporter stated that, the patient underwent lab test and procedure
which included SARS-CoV-2 PCR test: Positive to Covid infection, in a patient
vaccinated with two doses of Comirnaty (18Jan2021 and 11Feb2021). On 02Apr2021, the
reporter stated that, COVID19 outbreak in a nursing home in the province of privacy
involving health workers and residents vaccinated with two doses of Comirnaty.
Therapeutic measures were taken as a result of Covid-19 positive during a screening
in nursing home privacy and worsened in the following days for respiratory failure
included: Supportive therapy with hydration, antibiotic, EBPM, oxygen. On
06Apr2021, the reporter stated that the patient was deceased, positive genotyping
for variant. It was unknown if an autopsy was performed or not. Outcome of the
events reported as fatal. Health Authority Comment: COVID19 outbreak in a nursing
home in the province of PRIVACY involving health workers and residents vaccinated
with two doses of Comirnaty.; Reported Cause(s) of Death: unknown cause of death"
"1385401-1" "1385401-1" "Patient received Pfizer COVID-19 vaccine on 1/24/21
(first dose) and 2/5/21 (second dose). Patient tested positive for COVID on
5/22/21, hospitalized on 5/22/21 for acute respiratory failure with hypoxia and
passed away on 5/29/21: Preliminary cause of death: Respiratory failure with
hypoxia Diagnoses contributing to death: SARS-CoV-2 respiratory infection COVID-19
vaccination breakthrough infection (Pfizer vaccine) Rheumatoid arthritis on
methotrexate Anemia Hypertension Obesity" "No prior vaccinations for this
event."
COVID-19 test; This is as spontaneous report received from a contactable pharmacist
downloaded from the Agency Regulatory Authority-WEB. The regulatory authority
report number is FR-AFSSAPS-NY20210874, Safety report unique identifier FR-AFSSAPS-
2021046807. A 82-year-old male patient received the second dose of BNT162B2
(COMIRNATY), intramuscular on 09Feb2021 (Batch/Lot Number: Unknown) as a single
dose, and received the first dose of BNT162B2 intramuscular on 19Jan2021 (Batch/Lot
Number: Unknown) as a single dose for COVID-19 immunisation. Medical history
included osteoarthritis from an unknown date and unknown if ongoing, knee
arthroplasty from an unknown date and unknown if ongoing, hypercholesterolaemia
from an unknown date and unknown if ongoing, cataract from an unknown date and
unknown if ongoing, atrial fibrillation from an unknown date and unknown if
ongoing, complete arrhythmia by atrial fibrillation from an unknown date; arterial
hypertension from an unknown date and unknown if ongoing, obesity from an unknown
date and unknown if ongoing. Concomitant medications included paracetamol/tramadol
hydrochloride (IXPRIM) for an unspecified indication, start and stop date were not
reported; bisoprolol fumarate/hydrochlorothiazide (LODOZ) for an unspecified
indication, start and stop date were not reported; apixaban (ELIQUIS) for an
unspecified indication, start and stop date were not reported; solifenacin
succinate (VESICARE) for an unspecified indication, start and stop date were not
reported; candesartan for an unspecified indication, start and stop date were not
reported. On 26Apr2021, the patient experienced vaccination failure and COVID-19
confirmed by positive covid-19 test, both fatal events for which she was
hospitalized from 28Apr2021 to an unknown date. The patient underwent lab tests and
procedures which included oxygen saturation: 95 % on 28Apr2021, SARS-COV-2 test:
positive on 26Apr2021. Clinical course: 19Jan2021, first injection of the
COMIRNATY vaccine. 09Feb2021, second injection of the COMIRNATY vaccine. On
26Apr2021, patient tested positive for COVID-19 South African variant. On
28Apr2021, patient hospitalized for respiratory distress. Bilateral multifocal
frosted glass surfaces, alveolar condensation with air bronchogram of the two basal
pyramids, more marked on the right. Absence of proximal pulmonary embolism. No
pleural reaction. No dilation of the right heart chambers. Severe COVID lung
disease greater than 40% progressing to a known interstitial syndrome. Oxygen
dependent patient with 4L oxygen for 95% saturation. Patient presenting with
confusional syndrome. Start of treatment with SALBUTAMOL 5 mg / 2.5 mg,
dexamethasone 4 mg, paracetamol, ROCEPHINE 1 gram, ROVAMYCIN, MEDIATENSYL. On the
evening of 28Apr2021, rapid deterioration of the patient leading to cardio-
respiratory arrest progressing to death. Conclusion: Severe COVID-19 infection
resulting in the death of an 82-year-old patient, more than 2 months after the
second injections of the COMIRNATY vaccine (batches not specified). PCR Covid-19
positive. The patient died on 28Apr2021. It was not reported if an autopsy was
Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test;
Vaccination failure" "No prior vaccinations for this event."
"1386921-1" "1386921-1" "fever; cough; SARS-CoV-2 PCR test positive; SARS-
CoV-2 PCR test positive; respiratory distress; Dyspnea; This is a spontaneous
report received from a contactable physician downloaded from the Agency Regulatory
Authority-WEB. The regulatory authority report number is IT-MINISAL02-730845. A 92-
years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular,
administered in Arm Left (reported as left shoulder) on 15Mar2021 (Batch/Lot
Number: ET1831) (age at vaccination: unknown) as 0.3 ML SINGLE, dose 1
intramuscular, administered in Arm Left (reported as left shoulder) on 21Feb2021
(Batch/Lot Number: EJ6790) (age at vaccination: unknown) as 0.3 ML SINGLE for
covid-19 immunisation. Medical history included Venous insufficiency (Venous
insufficiency of lower limbs), Arthrosis multiple, Varicose veins of lower
extremities, Chronic atrial fibrillation from 01Jan2017 to an unknown date, Hip
prosthesis user from 01Jan2011 to an unknown date (In 2011 surgery for total right
hip prosthesis). Concomitant medications included furosemide (LASIX [FUROSEMIDE])
taken for an unspecified indication, start and stop date were not reported;
diltiazem hydrochloride (DILZENE) taken for an unspecified indication, start and
stop date were not reported; lansoprazole (PEPTAZOL [LANSOPRAZOLE]) taken for an
unspecified indication, start and stop date were not reported; edoxaban tosilate
(LIXIANA) taken for an unspecified indication, start and stop date were not
reported. On 19Apr2021, the patient had fever with cough, respiratory
distress/Dyspnea; on 23Apr2021, hospitalization for respiratory distress/Dyspnea,
on admission emergency room swab positive, death in hospital setting on 03May2021,
family member reported 30% lung involvement. COVID-19 PCR test on 30Apr2021 was
positive. The events were reported as serious due to death and hospitalization. It
was unknown if an autopsy was performed. Reporter's comments: performed 1st covid
vaccination inoculation 21Feb2021 Pfitzer mRNA COMIRNATY EJ6790; 2nd on 15Mar2021
Pfitzer mRNA COMIRNATY ET1831. 192Apr20021 fever with cough; 23Apr2021
hospitalization for respiratory distress on admission emergency room swab positive
death in hospital setting, family member reported 30% lung involvement; Reporter's
Comments: performed 1st covid vaccination inoculation 21Feb2021 Pfitzer mRNA
COMIRNATY EJ6790; 2nd on 15Mar2021 Pfitzer mRNA COMIRNATY ET1831. 192Apr20021 fever
with cough; 23Apr2021 hospitalization for respiratory distress on admission
emergency room swab positive death in hospital setting, family member reported 30%
lung involvement; Reported Cause(s) of Death: cough; SARS-CoV-2 PCR test positive;
Vaccination failure; respiratory distress; Dyspnea; Fever" "No prior vaccinations
for this event."
"1387001-1" "1387001-1" "Positive RT-PCR for SARSCoV2 on 22Mar2021 in a
subject vaccinated with two doses of COMIRNATY (18Jan2021 and 11Feb2021). Deceased
on 01Apr2021. Positive genotyping for variant; Positive RT-PCR for SARSCoV2 on
22Mar2021 in a subject vaccinated with two doses of COMIRNATY (18Jan2021 and
11Feb2021). Deceased on 01Apr2021. Positive genotyping for variant; This is a
spontaneous report received from a contactable physician downloaded from a
regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-
736211. A 94-year-old male patient received BNT162b2 (COMIRNATY, Solution for
injection) of 2nd dose, single dose (Lot number- EJ6790-14-006, Expiration date:
31May2021) via intramuscularly in right arm on 11Feb2021 at 09:00 and 1st dose,
single dose (Lot number: unknown) via unspecified route of administration on
18Jan2021 for COVID-19 immunization. Medical history included diabetes mellitus,
COPD, IHD, chronic renal failure. Concomitant medication (before hospitalization)
included acarbose (GLUCOBAY), insulin, furosemide, nadroparin calcium (SELEPARINA),
bisoprolol, thiamazole (TAPAZOLE), paroxetine, paracetamol, omeprazole, lorazepam
(LORAZEPAM), macrogol. It was reported that covid 19 comirnaty vaccine (pfizer)
195FL 0.45ML. On 22Mar2021, Positive RT-PCR and subsequent detection of the
specific country variant of SARSCoV2 at the genotyping performed and resulted
positive at the Local Healthcare Area. It was reported that addition of antibiotic
therapy, enoxaparin 6000UI qd (daily) and Oxygen Therapy Reservoir - Actions taken
(Hospitalization, Repeated Testing of Healthcare Workers and other guests of the
Nursing Home, genotyping, cohortization of guests). On 01Apr2021, patient was died
due to COVID-19 respiratory infection. It was not reported if an autopsy was
performed. The outcome of the events was fatal. Reporter's comments: Outbreak of
COVID19 in the Nursing Home involving health workers and residents vaccinated with
two doses of Comirnaty Sender's comments: 28May2021: adverse reaction updated;
Reporter's Comments: Outbreak of COVID19 in the Nursing Home involving health
workers and residents vaccinated with two doses of Comirnaty; Sender's Comments:
Linked Report(s) : IT-PFIZER INC-2021650363 Original Case : 2021638906; Reported
Cause(s) of Death: COVID-19 respiratory infection" "No prior vaccinations for
this event."
"1388057-1" "1388057-1" "Admitted 5/26 from outside facility for GI bleed,
cardiac arrest and severe sepsis. COVID+. Treated with tocilizumab, vit C, vit D,
alinia, zinc. Family opted for comfort care and W/D life support. Expired 6/5."
"1388749-1" "1388749-1" "Respiratory insufficiency; General physical
condition decreased; COVID-19 PCR test positive; This is a spontaneous report from
a non-contactable physician downloaded from the Agency Regulatory Authority-WEB,
regulatory authority number DE-PEI-202100085098. A 85-year-old female patient
received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN, lot number: EW8904) via an
unspecified route of administration on 10Apr2021 at unknown 0.3 mL single dose for
prophylactic vaccination. Medical history and concomitant medications were not
reported. On 20Apr2021 the patient experienced COVID-19 PCR test positive. On
22Apr2021 the patient experienced General physical condition decreased, Respiratory
insufficiency. The patient underwent lab tests and procedures which included sars-
cov-2 test: positive on 20Apr2021. The events resulted in death. The patient died
on 25Apr2021. It was unknown if an autopsy was performed. The cause of death was
respiratory insufficiency, General physical condition decreased, and COVID-19 PCR
test positive. The outcome of events was fatal. No follow-up attempts needed, no
further information is expected.; Reported Cause(s) of Death: COVID-19 PCR test
positive; General physical condition decreased; Respiratory insufficiency" "No
"1388763-1" "1388763-1" "Pulmonary congestion, ARDS, cardiac decompensation;
Pulmonary congestion, ARDS, cardiac decompensation; Pulmonary congestion, ARDS,
cardiac decompensation; COVID-19; COVID-19 pneumonia; Vaccination failure; This is
a spontaneous report from a non-contactable consumer downloaded from the Regulatory
Authority-WEB, regulatory authority number DE-PEI-CADR2021079508, Sender's (Case)
Safety Report Unique Identifier DE-PEI-202100072522. An 84-year-old female patient
received bnt162b2 (COMIRNATY, 0.3 ml), dose 2 via an unspecified route of
administration on 19Feb2021 (Batch/Lot Number: EP9598) as single dose, dose 1 via
an unspecified route of administration on 28Jan2021 (Batch/Lot number was not
reported) as single dose for covid-19 immunisation. Medical history included type
II diabetes mellitus, CHD (coronary artery disease). Concomitant medications
included furosemide; meropenem trihydrate (MERONEM); enoxaparin sodium (CLEXANE);
insulin glulisine (APIDRA). On 27Feb2021 the patient experienced pulmonary
congestion (fatal, hospitalization), ARDS (acute respiratory distress syndrome)
(death, hospitalization), Vaccination failure, COVID-19, COVID-19 pneumonia,
Decompensated heart failure. The patient underwent lab tests and procedures which
included sars-cov-2 test: positive on 27Feb2021, x-ray: covid-19 pneumonia on
27Feb2021. The affected person was hospitalized and died. She received both
vaccinations with Comirnaty. One week after the second vaccination, a Covid-19
infection was detected by means of PCR (27Feb2021). Sequencing was not performed.
Symptoms (from 27Feb2021): Covid pneumonia (confirmed by X-rays), pulmonary
congestion, Acute Respiratory Distress Syndrome, cardiac decompensation. The person
concerned died on 11Mar2021. An autopsy was not performed. The patient's outcome
reported as fatal for Acute Respiratory Distress Syndrome, fatal for Decompensated
heart failure, not recovered for other events. This report is serious - death.
Sender Comment: Information on risk factors or previous illnesses. Comirnaty/ all
events/ Regulatory Authority/ Unclassifiable. No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: Vaccination failure;
Decompensated heart failure; Pulmonary congestion; COVID-19; COVID-19 pneumonia;
ARDS" "No prior vaccinations for this event."
"1389353-1" "1389353-1" "5L 02 not sufficient at hospital; COVID-19 antigen
test positive; Fall, risk; limited mobility; social interaction is impaired; Fluid
balance impaired; Development of resources impaired; 5L O2 not sufficient at
Hospital; Akinesia deterioration, General condiction further reduced; 92%
saturation O2 5L; 83% saturation O2 4L; Cough and fever; Cough and fever; Body
temperature abnormal; Vaccination failure; This is a spontaneous report from a
contactable other healthcare professional downloaded from the Agency Regulatory
Authority-WEB AT-BASGAGES-2021-29987. A 83-year-old male patient received BNT162b2
(COMIRNATY; solution for injection, Lot Number: EJ6796, Expiration date: Unknown),
via an unspecified route of administration on 12Jan2021 as 1st dose, single dose
for COVID-19 immunisation; received BNT162b2 (COMIRNATY; solution for injection,
Lot Number: EJ6797, Expiration date: Unknown), via an unspecified route of
administration on 02Feb2021 as 2nd dose, single dose for COVID-19 immunisation.
Medical history included Phacoemulsification (phacoemulsification and Posterior
chamber lens oculus dexter) from an unknown date in Nov2019 and unknown if ongoing,
Angiodysplasia in the rectum from an unknown date in Jun2015 and taken therapy,
Femoral neck fracture from an unknown date in Oct2018 and unknown if ongoing,
Stroke from an unknown date in Apr2015 and unknown if ongoing, Below knee
amputation from 1971 and unknown if ongoing, Cholecystectomy from an unknown date
in Nov2018 and unknown if ongoing and Scheuermann's disease, Retroperitoneal mass,
Sigmoid diverticulitis, Coxarthrosis bilateral, Right ventricle lymphoma, Hydrocele
bilateral, ACE inhibitor intolerance, Enthesopathy (Right ventricle insertion on
tendinopathy of the hamstring muscle right), inguinal both sides herniotomy,
Prostatic cancer, Severe penicillin allergy from an unknown date and unknown if
ongoing. Concomitant medications included hydrochlorothiazide, valsartan
(VALSARCOMP) from 11Dec2020 to 10Mar2021; diclofenac diethylamine (VOLTAREN
EMULGEL) from 01Mar2021 to 10Mar2021; valsartan (VALSARTAN SANDOZ) from 11Dec2020
to 10Mar2021; acetylsalicylic acid (THROMBO ASPIRIN) from 14Dec2018 to 10Mar2021;
caffeine, paracetamol, propyphenazone (NOVALGIN
[CAFFEINE;PARACETAMOL;PROPYPHENAZONE]) from 15Feb2021 to 10Mar2021; doxazosin
mesilate (HIBADREN) from 14Dec2018 to 10Mar2021; ectoine, hyaluronate sodium (HYLO
DUAL) from 02Dec2019 to 10Mar2021; colecalciferol (OLEOVIT D3) from 09Dec2019 to
10Mar2021; xylometazoline hydrochloride (HYSAN SCHNUPFENSPRAY) from 01Mar2021 to
10Mar2021; nystatin (MYCOSTATIN) from 18May2020 to 10Mar2021; clonazepam (RIVOTRIL)
from 14Sep2020 to 10Mar2021; furosemide (LASIX [FUROSEMIDE]) from 04Jan2021 to
10Mar2021; bisoprolol fumarate (CONCOR) from 07Jan2019 to 10Mar2021; beclometasone
dipropionate, formoterol fumarate (FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL
FUMARATE]) from 08Mar2021 to 10Mar2021; cimicifuga racemosa, cyclamen purpurascens,
gelsemium sempervirens, iris versicolor, spigelia anthelmia (RESTAXIL) from
11Oct2019 to 10Mar2021; ascorbic acid, biotin, calcium carbonate, calcium
pantothenate, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl
acetate, ferrous oxalate, folic acid, magnesium oxide, manganese sulfate,
nicotinamide, olea europaea oil, panax ginseng, potassium iodide, pyridoxine
hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenite, thiamine
mononitrate, zinc oxide (SUPRADYN VITAL 50+ [ASCORBIC ACID;BIOTIN;CALCIUM
CARBONATE;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;DL-
ALPHA TOCOPHERYL ACETATE;FERROUS OXALATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE
SULFATE;NICOTINAMIDE;OLEA EUROPAEA OIL;PANAX) from 04Mar2019 to 10Mar2021;
mometasone furoate (MOMETASON RATIOPHARM) from 28Apr2020 to 01Mar2021; all for
unknown indications. The patient experienced COVID-19 antigen test positive (death,
hospitalization) and body temperature abnormal on 05Mar2021, cough and fever on
06Mar2021, 83% saturation o2 4l on 07Mar2021, akinesia deterioration, general
condition further reduced and 92% saturation o2 5l on 08Mar2021, 5l 02 not
sufficient at hospital on 09Mar2021, vaccination failure on an unknown date in
Mar2021 and fall, risk; limited mobility; fluid balance, development of resources,
social interaction was impaired on an unknown date. The patient underwent lab tests
and procedures which included sars-cov-2 test: positive on 05Mar2021, COVID-19 PCR
test: positive on 08Mar2021, sars-cov-2 test: negative on 09Feb2021, sars-cov-2
test: negative on 12Feb2021. Diagnoses together: After Adverse Event, After test,
Special nursing diagnosis: Fall, risk; limited mobility; fluid balance, development
of resources, social interaction, impaired. The patient died on 10Mar2021. It was
not reported if an autopsy was performed. Diagnoses together: After Adverse Event,
After test. The outcome of Fall, risk; limited mobility; fluid balance, development
of resources, social interaction was impaired was unknown and rest of the all
events was reported as fatal. Sender Comment: Regulatory Authority comment:
Follow-up information has been requested 2nd dose Comirnaty: Batch/lot number:
EJ6796 1st dose Comirnaty: Batch/lot number: EJ6796 The Reporter assessed the
causal relationship between bnt162b2 (COMIRNATY) and all events as Related. No
Death: Unknown cause of death" "No prior vaccinations for this event."
"1389385-1" "1389385-1" "Fever, Covid pneumonia, congestive bronchitis and
ARDS; COVID-19; Fever, Covid pneumonia, congestive bronchitis and ARDS; Fever,
Covid pneumonia, congestive bronchitis and ARDS; Fever, Covid pneumonia, congestive
bronchitis and ARDS; Vaccination failure; This is a spontaneous report from a non-
contactable consumer or other non hcp downloaded from the Agency Regulatory
Authority-WEB DE-PEI-CADR2021078045, Safety Report Unique Identifier DE-PEI-
202100071274. An 85-year-old female patient received bnt162b2 (COMIRNATY,
strength: 0.3 ml), dose 2, via an unspecified route of administration on 19Feb2021
at single dose(Lot number: EP9598), dose 1, via an unspecified route of
administration on 28Jan2021 at single dose(Lot number unknown), all at the age of
85 years old for covid-19 immunisation. The patient's medical history included
chronic renal insufficiency, COPD, atrial fibrillation, chronic kidney failure, all
ongoing. Concomitant medications were not reported. The patient experienced fever,
Covid pneumonia, congestive bronchitis, ARDS, COVID-19 on 17Mar2021. The patient
was hospitalized due to Covid pneumonia, COVID-19, congestive bronchitis and ARDS.
The patient died on 23Mar2021 at the sanatorium. The cause of death was Covid
pneumonia. It was not reported if an autopsy was performed. The patient underwent
lab test included Covid-19 PCR test: positive on 17Mar2021(Sequencing showed the
mutant B.1.1.7.). The outcome of the event Covid pneumonia was fatal, of the other
events was not recovered. Senders comment: Information on risk factors or previous
illnesses: COPD, chronic kidney failure, atrial fibrillation / *Privacy. The
affected person received both vaccinations with Comirnaty, about one month after
the second vaccination, a Covid-19 infection was detected by means of PCR on
17Mar2021. Sequencing showed the mutant B.1.1.7. Symptoms were fever, Covid
pneumonia, congestive bronchitis and acute respiratory distress syndrome. The
person concerned died on 23Mar2021 at the sanatorium.Relatedness of drug to events
for all events was unclassifiable. No follow-up attempts are possible; information
about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Covid
"1389479-1" "1389479-1" "ischemic stroke; Vaccination failure; COVID-19; This
is a spontaneous report from a contactable physician downloaded from the regulatory
authority-WEB, regulatory authority number FR-AFSSAPS-2021059716. A 94-year-old
male patient received bnt162b2 (COMIRNATY), the first dose via intramuscular in the
right arm on 21Jan2021 (Batch/Lot Number: unknown) at 0.3 mL, single and the second
dose via intramuscular in the right arm on 11Feb2021 (Batch/Lot Number: EJ6789) at
0.3 mL single for covid-19 immunisation. Medical history included ongoing
hypercholesterolaemia, ongoing arterial hypertension, ongoing type 2 diabetes
mellitus, ongoing vascular dementia (Iso-Resource Groups score (dependence level):
2), pacemaker user (Unspecified indication) from unspecified date. Concomitant
medications included tamsulosin hydrochloride (unspecified trade name) and ramipril
(unspecified trade name). On 06May2021, positive SARS COV 2 test (N50Y1 mutation)
detected in the context of a cluster at the establishment for dependent elderly
people. The patient developed a form of covid-19 that was not very symptomatic
(onset of symptoms estimated on 28Apr2021). On 19May2021, occurrence of an ischemic
stroke with hemiplegia and swallowing disorders, according to the referring
physician, related to the ongoing covid19 infection. Outcome: Death of the patient
on 22May2021 following the stroke. in Total, confirmed vaccine failure associated
with the onset of a stroke (attributed to low-symptomatic SARS-CoV-2 infection)
leading to death in a 94-year-old patient. The patient died on 22May2021. Reported
cause of death was ischemic stroke. An autopsy was not performed. The outcome of
the event ischemic stroke was fatal, while the other events were unknown. No
Follow-up attempts are possible. No further information is expected.; Reported
Cause(s) of Death: Ischaemic stroke" "No prior vaccinations for this event."
"1390067-1" "1390067-1" "COVID-19/COVID-19 pneumonia/ COVID-19 antigen test
positive; COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive;
thrombocytopenia; leucopenia; hyponatremia; elevated urea, CRP, CK, bilirubin and D
dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; elevated urea,
CRP, CK, bilirubin and D dimer values; elevated urea, CRP, CK, bilirubin and D
dimer values; elevated urea, CRP, CK, bilirubin and D dimer values; This is a
Authority-WEB [HU-OGYI-349721] This spontaneous, serious, medically confirmed case
was reported on 13May2021 by a physician and concerns the occurrence of Covid-19
infection and pneumonia resulting in death after COMIRNATY injection for active
immunization to prevent COVID-19. On 15Apr2021 the 77-year-old male patient
received the first dose of 0.3 ml BNT162B2 (COMIRNATY, Solution for injection, lot
number: EW4815, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer)
intramuscularly in the left arm as 1st dose, 0.3 ml, single dose for COVID-19
immunisation. Medical history hypertension, myasthenia gravis and NIDDM, all from
an unspecified and unknown if ongoing, decompensation cardiac, urinary infection.
Concomitant medications included furosemide sodium (FURON) from 06May2021 to
08May2021 for decompensation cardiac, ceftriaxone sodium, lidocaine hydrochloride
(ROCEPHIN IM.) from 03May2021 to 08May2021 for urinary infection. On 03May2021 the
patient was examined in the Outpatient Department because of weakness, fever and
decreased appetite ongoing for 3 weeks. Covid-19 antigen test was positive.
Laboratory tests showed thrombocytopenia, leucopenia, hyponatremia, elevated urea,
CRP, CK, bilirubin and D dimer values. Chest CT did not confirm pulmonary embolism
despite the elevated D dimer level but showed signs of Covid pneumonia. The patient
received covid therapy and his inflammatory parameters started to get better at
first, but later the patient passed away on 08May2021 at 04:45. No autopsy was
performed. While hospitalized, the patient received dexamethasone and Clexane
(enoxaparin sodium) injection for Covid pneumonia from 03May2021 to 08May2021. The
outcome of events COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive was
fatal. Outcome of the other events was unknown. Further information is not
expected. Senders Comment: As the patient got infected with Covid-19 after the
first dose of Comirnaty, immunity may have not developed yet, therefore the causal
relationship is unlikely between the suspected drug and the adverse event. The case
expected. No follow-up attempts are possible. No further information is expected.;
Reported Cause(s) of Death: COVID-19/COVID-19 pneumonia/ COVID-19 antigen test
positive; COVID-19/COVID-19 pneumonia/ COVID-19 antigen test positive" "No prior
"1390068-1" "1390068-1" "COVID-19 antigen test positive; COVID-19 pneumonia;
COVID-19; This is a Spontaneous report received from the Regulatory Authority
downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB HU-OGYI-
358021 from a contactable physician. A 71-years-old female patient received the
first dose of 0.3 ml BNT162B2 (COMIRNATY) concentrate for dispersion for injection
(tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), batch number:
ET7205, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer)
intramuscularly On 30Mar2021 in the left arm for Covid-19 immunization. Medical
history included hypertension, NIDDM (Type 2 diabetes mellitus), chronic kidney
failure, cholecystectomy, varicectomy and brain infarction. Concomitant drugs were
losartan (ARBARTAN, 100 mg), vinpocetin (CAVINTON FORTE), calcium citrate
(CITROKALCIUM), pinaverium (DICETEL, 50 mg), levocetirizine (LERTAZIN, 5 mg),
piracetam (MEMORIL), famotidine (MOTIDIN, 40 mg), mometason furoate (NASOTSONE),
Nebivolol-Teva 5 mg, metamizole sodium monohydrate (OPTALGIN, 500 mg), rosuvastatin
calcium (ROXERA, 15 mg), antazoline/tetryzoline (SPERSALLERG) and clopidogrel
bisulfate (ZYLLT, 75 mg). The patient was hospitalized on 07Apr2021 where her
antigen test was positive and chest X-ray confirmed Covid-19 pneumonia. As the
patients condition worsened, she was transferred to the ICU on 13Apr2021 and had to
be intubated. Despite the treatment, the patient did not get better and after an
unsuccessful reanimation, she passed away on 29Apr2021 at 12:10. Autopsy was not
performed. This is a serious, medically confirmed case. Sender Comment: As the
patient got infected with Covid-19 after the first dose, immunity may have not
developed yet, therefore the causal relationship is unlikely between the suspected
drug and the adverse event. The case is considered serious because the outcome was
fatal. Further information is not expected. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: COVID-19; COVID-19
pneumonia; COVID-19 antigen test positive" "No prior vaccinations for this
event."
"1390069-1" "1390069-1" "COVID-19 rapid test positive; COVID-19 pneumonia;
This is a spontaneous report received from the RA via a contactable physician
downloaded from the Regulatory Authority-WEB HU-OGYI-358621. This is a report
received from the Regulatory Authority. An 82-year-old male patient received the
second dose of BNT162B2 (COMIRNATY, lot number: EW2239), intramuscularly in arm
left on 07Apr2021 at single dose (0.3 ML SINGLE), and the first dose (lot number:
EJ6790) via an unspecified route of administration on 01Mar2021 at single dose for
COVID-19 immunisation. Medical history included STEMI in 2018, cerebral infarction,
adenocarcinoma of colon in 2015, insulin dependent diabetes mellitus and chronic
renal failure. The patient's concomitant medications were not reported. The patient
experienced COVID-19 rapid test positive, and COVID-19 pneumonia on 08Apr2021. On
08Apr2021 the patient was admitted to the hospital due to dyspnoea and positive
COVID-19 rapid test. Chest X-ray showed bilateral, multi-focal, extensive pneumonia
on unknown date. The patient received oxygen supplementation, dexamethasone,
favipiravir, ceftriaxone, and LMWH. Despite the applied therapy, the patient died
on 11Apr2021 at 15:40. Autopsy was not requested. Sender Comment: COVID-19
pneumonia occurred after 1 day, and the patient died 4 days after the second dose
of BNT162B2. Autopsy was not done. Immunity may has not developed after the first
dose of vaccine. The case was serious due to hospitalization and fatal outcome. No
Cause(s) of Death: COVID-19 pneumonia; COVID-19 rapid test positive" "No prior
"1390071-1" "1390071-1" "COVID-19 pneumonia; COVID-19 rapid POC test
positive/COVID-19 and COVID-19 pneumonia; COVID-19; This is a spontaneous report
received from a contactable physician from the Local RA downloaded from the
regulatory authority HU-OGYI-363321. This is a report received from the regulatory
authority. Regulatory authority report number HU-OGYI-363321. A 77 years old
female patient received the first dose of BNT162B2 (COMIRNATY concentrate for
dispersion for injection, tozinameran; batch number: EW2239, expiry date: unknown)
intramuscularly in the left arm on 01Apr2021 at 0.3 ml single dose for COVID-19
immunisation. In the patient's medical history, there is ongoing hypertension,
hypertensive cardiomyopathy, hyperlipidaemia, Type II diabetes mellitus (since
2000), hyperuricemia, hypothyreosis, depression, cataract operation (in 2013), knee
prosthesis (since 2018) and bladder carcinoma from 2015 to 2017. The patient's
concomitant medicinal products were febuxostat (ADENURIC), metformin hydrochloride
(ADIMET), atorvastatin calcium (ATORIS), diosmin, hesperidin (DETRALEX), doxazosin
mesilate (DOXICARD), furosemide, zopiclone (IMOVANE), lercanidipine hydrochloride
(LERCATON), levothyroxine sodium (LETROX), mirtazapine, Folic acid, ferrous
sulphate, dried (NEO-FERRO-FOLGAMMA), B vitamins (Neuromultivit-EP), sodium
polystyrene sulphonate (RESONIUM), paroxetine hydrochloride (REXETIN) and
telmisartan (TANYDON). This serious, spontaneous case was reported by a physician
on 19May2021, concerning the occurrence of COVID-19 and COVID-19 pneumonia after
the use of Comirnaty concentrate for dispersion for injection (MAH: BioNTech
Manufacturing GmbH). It was reported after the vaccination, the patient experienced
fever and fatigue. On 14Apr2021, the patient was hospitalized. The patient's rapid
POC test was positive on 14Apr2021 (onset from last dose 13days). Chest x-ray
showed COVID-19 pneumonia with small circulatory stagnation on 15Apr2021 (onset
from last dose 14days). On 14Apr2021 the blood tests showed impaired renal
function, increased inflammatory parameters and increased fibrin D-dimer levels. In
the hospital, the patient general condition has steadily deteriorated. On
17Apr2021, the patient died. According to the death certificate, cause of death was
COVID-19 pneumonia. The patient's primary diseases that contributed to the death
were TYPE 2 DIABETES MELLITUS (NIDDM) and hypertension. Sender Comment: COVID-19
and COVID-19 pneumonia after vaccination with Comirnaty is not expected. TTO is 13
days calculated from the first dose. Dechallenge and rechallenge were not
applicable. The causal relationship between the suspected drug and the events is
considered unlikely. The case is considered serious due to hospitalization and
fatal outcome. The patient's outcome was fatal for COVID-19 and COVID-19 pneumonia.
It is unknown if autopsy was done. No follow-up attempts are possible. No
further information is expected.; Sender's Comments: Based on available
information, a possible contributory role of the subject product, BNT162B2
vaccine, cannot be excluded for the reported events of COVID-19, COVID-19 pneumonia
and suspected LOE. There is limited information provided in this report. This
case will be reassessed once additional information is available. The impact of
Reported Cause(s) of Death: COVID-19; COVID-19 pneumonia" "No prior vaccinations
for this event."
"1390462-1" "1390462-1" "Delirious; Disorientation; Temperature elevation;
Pneumonia; Vomiting; Appetite lost; Drug ineffective; COVID-19 test positive; This
is a spontaneous report from a contactable consumer downloaded from the Regulatory
Authority. An 87-year-old male patient received bnt162b2 (COMIRNATY) via an
unspecified route of administration on Apr2021 (Batch/Lot Number: asked but
unknown) as 1ST DOSE, single for covid-19 immunisation. The patient medical history
and concomitant medications were not reported. The patient experienced covid-19
test positive and drug ineffective in 2021, and experienced delirious,
disorientation, temperature elevation, pneumonia, vomiting and appetite lost in
Apr2021. The case considered serious due to death, hospitalization. During 24 hours
after vaccination patient started vomiting, had no appetite, his body temperature
elevated. Ambulance was called out for a few times, unspecified medicines were
injected. As condition of the patient didn't get better, he was hospitalized in
Covid-19 department for more than 3 weeks. Patient was diagnosed with pneumonia,
treatment with oxygen applied, he was delirious, disorientated, didn't recognize
people. Covid-19 test was done at the hospital - positive. Patient died at the
hospital on 20May2021. It is unknown if autopsy was done. No follow-up attempts
are possible, information on batch number cannot be obtained. ; Reported Cause(s)
of Death: pneumonia; covid-19 test positive; drug ineffective; delirious;
disorientation; temperature elevation; vomiting; appetite lost" "No prior
"1390517-1" "1390517-1" "covid-19 infection/vaccination failure and lack of
drug effect; covid-19 infection; FEVER; COUGH; Hypoxia, oxygen deficient; This is a
spontaneous report from a contactable physician downloaded from the Agency
Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-U9pgj7. An 87-year-old-male patient
received 1st dose of bnt162b2 (COMIRNATY) on 04Feb2021 (lot number: EJ6789) and 2nd
dose (lot number: EP9605) administered in left arm on 05Mar2021 both via
intramuscular at single dose for vaccination. The medical history included living
in residential institution, alzheimers disease, cardiovascular disorder NOS,
osteoporosis, hypothyreosis, myocardial infarction. Concomitant medication the
patient was given included alendronate sodium (ALENDRONAT SANDOZ) for osteoporosis,
atorvastatin calcium (ATORVASTATIN XIROMED) for hypercholesterolaemia, calcium
carbonate/colecalciferol (CALCIGRAN FORTE) for thrombosis prophylaxis, melatonin
(CIRCADIN) for sleep disorder, clopidogrel bisulfate (CLOPIDOGREL ARISTO),
levothyroxine sodium (LEVAXIN) for hypothyroidism, metoprolol for hypertension. On
11May2021, the patient developed fever and cough. On 12May2021, the patient took a
COVID-test with positive result, thereby confirming COVID-19, vaccination failure
and lack of drug effect. The patient developed hypoxia, which demanded oxygen
therapy. The patient received palliative care and died peacefully but related to
worsening on 16May2021. Cause of death was reported COVID-19. No autopsy was done.
Relevant laboratory findings and investigations included in the report SARS-COV-2
PCR TEST on 12May2021 with result positive, B.1.1.7 lineage (VOC 202012/01). The
outcome of events was fatal. The Regional Pharmacist assessed the causal
relationship between bnt162b2 (COMIRNATY) and Pyrexia, Oxygen therapy, Cough,
Hypoxia, COVID-19 events as No relationship. The Regional Pharmacist assessed the
causal relationship between bnt162b2 (COMIRNATY) and Vaccination failure, Drug
ineffective events as Possible. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: covid-19; COVID-19" "No prior
"1392259-1" "1392259-1" ""1st vaccination on 20FEB2021,2nd vaccination on
13MAR2021 and PCR positive on 29MAR2021; Symptom onset with fever; 1st vaccination
on 20FEB2021,2nd vaccination on 13MAR2021 and PCR positive on 29MAR2021;
Respiratory insufficiency in covid-19 pneumonia; This is a spontaneous report
received from a contactable physician downloaded from the Regulatory Authority-WEB.
The regulatory authority report number is AT-BASGAGES-2021-29101. A 90-year-old
male patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular on 13Mar2021
(Batch/Lot Number: unknown) as single dose, dose 1 via an unspecified route of
administration on 20Feb2021 (Batch/Lot number unknown) as single dose for covid-19
immunisation. Medical history included ongoing polyneuropathy, hairy cell leukaemia
from 2011 and ongoing there was a hair cell - leukemia for 10 years, he was
controlled semi-annually at the hematology, no related medication in this regard
necessary, last control stable, ongoing vertebral foraminal stenosis (lumbar
vertebrostenosis), B-Lymphocytic, CLL (Kiel Classification), B-cell small
lymphocytic lymphoma from 2008 and not ongoing, ongoing multifocal seizure,
basalioma condition after basal cell removal at ear shortly before corona infection
from Mar2021 and not ongoing, Aneurysm atrial, atrial septal aneurysm from 2015 and
not ongoing, squamous cell carcinoma from 2020 and unknow if it was ongoing. It was
not known that the patient had an immune deficiency. Concomitant medications
included gabapentin (NEURONTIN) taken for an unspecified indication, start and stop
date were not reported; donepezil taken for an unspecified indication, start and
stop date were not reported; minerals nos, vitamins nos (CENTRUM A TO ZINC) taken
for an unspecified indication, start and stop date were not reported; levothyroxine
sodium (THYREX) taken for an unspecified indication, start and stop date were not
reported; lamotrigin taken for multifocal seizures, start and stop date were not
reported. On 28Mar2021: symptom onset with fever, PCR positive on 29Mar2021 (Ct
21.06), ""clinical manifestation: respiratory symptoms with/without cough"",
variant: -> vaccination failure, death on 06Apr2021 from COVID-19 in the hospital.
The final exact cause of death was reported as Respiratory insufficiency associated
with Covid-19 pneumonia. The patient's wife did not have the vaccination
certificate anymore - but she herself was vaccinated at the same time as her
deceased husband - her batch was COMIRNATY EJ 6136 and ET 1831, it could be assumed
that the husband was vaccinated with the same batch, but this could no longer be
traced with certainty. The husband was free of infections during both vaccinations
and had no side effect after the vaccination. A good 2 weeks after the 2nd
vaccination, the onset of symptoms of the Corona infection occurred, source
unknown, PCR positive on 29Mar2021, death from COVID-19 in hospital on 06Apr2021.
Probably a reduced immune response due to the existing leukemia and therefore
infection despite vaccination and finally unfortunately death from COVID-19. An
autopsy was not performed. On 28Mar2021 the patient experienced Fever, other,
Vaccination failure. On 29Mar2021 the patient experienced COVID-19 PCR test
positive, other, other. On 28Mar2021 the patient experienced COVID-19 pneumonia
death. The patient's outcome was unknown for Fever, unknown for Vaccination
failure, unknown for COVID-19 PCR test positive, fatal for COVID-19 pneumonia. The
positive (Ct 21.06, variant (as reported)) on 29Mar2021. The patient died on
06Apr2021. An autopsy was not performed. The outcome of the event fever was
unknown, of the other events was fatal outcome. No follow-up attempts needed,
batch/lot. no. will be followed-up by Regulatory Authority and automatically
provided as soon as available. No further information is expected.; Reported
Cause(s) of Death: PCR positive on 29Mar2021; Respiratory insufficiency associated
with Covid-19 pneumonia; Respiratory insufficiency associated with Covid-19
pneumonia; vaccination failure"" "No prior vaccinations for this event."
"1393609-1" "1393609-1" "Lumbal puncture showed abnormalities suggestive of
Guillain-Barre syndrome; Severe hypoxia; High ventricular rate atrial fibrillation;
Circulatory failure; COVID-19 pneumonia; COVID-19 antigen test positive; COVID-19
antigen test positive; Lower limb weakness/ muscle strength of her upper limbs also
decreased; Inappropriate schedule of vaccine administered; This is a spontaneous
report received from a contactable physician downloaded from a regulatory
authority-WEB; the Regulatory Authority report number is HU-OGYI-360521. A 75-
year-old female patient received BNT162B2 (COMIRNATY) [reported as 30 ug/ 0.3mL
COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran Concentrate for dispersion
for injection] intramuscularly, administered in the left arm on 24Mar2021
(batch/lot number: ET3620) as 1ST DOSE, 0.3mL SINGLE for COVID-19 immunization. The
patient's medical history included hypertension, diabetes mellitus, chronic renal
failure, steatosis hepatic, myocardial infarct, ischemic heart disease,
hypothyreosis, deep vein thrombosis of leg, and ulcus cruris, all from an unknown
date. Concomitant medications were not reported. On 30Apr2021, the patient called
an ambulance due to lower limb weakness, which has started 3 weeks earlier
(09Apr2021). On 30Apr2021, COVID-19 antigen rapid test showed positive and urgent
chest CT showed bilateral COVID-19 pneumonia and the patient was hospitalized.
Antiviral, antithrombotic, and steroid treatment was started. The patient's
condition deteriorated; muscle strength of her upper limbs also decreased. On
07May2021, lumbar puncture showed abnormalities suggestive of Guillain-Barre
syndrome. Mechanical ventilation was started on 07May2021 due to severe hypoxia.
Cordarone (amiodarone) was given due to high ventricular rate atrial fibrillation,
which was later supplemented with digoxin saturation. Severe hypoxia and
circulatory failure (unknown date in May2021) were irreversible, and resuscitation
was unsuccessful. The patient died on 13May2021 at 10:20 a.m; the cause of death
was considered clarified. An autopsy was not performed. Senders comments: COVID-
19 antigen test became positive, and COVID-19 pneumonia occurred after 5 weeks, and
the patient died 7 weeks after the first dose of Comirnaty. Autopsy was not done.
Immunity may have not developed after the first dose of vaccine. The case is
serious due to hospitalization and fatal outcome. No follow-up attempts are
pneumonia; COVID-19 antigen rapid test; COVID-19 antigen rapid test; Guillain-Barre
syndrome; Severe hypoxia; High ventricular rate atrial fibrillation; Circulatory
"1394137-1" "1394137-1" "Her husband passed away; Sepsis; Shock due to
bilateral pulmonary acute disease syndrome; Shock due to bilateral pulmonary acute
disease syndrome due to diffuse alveolar damage; misery and feeling horrible;
Severe chills; Headache; Shortness of breath; Fever; Fatigue; Diarrhea; Muscle
aches; Skin sensitivity and rash; Skin sensitivity and rash; Sore throat; This is a
spontaneous report from a contactable consumer. A 57-year-old male patient received
second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified
route of administration, administered in arm on 22Feb2021 at 10:00 (Lot Number:
EN6202) (at the age of 57-year-old) as single dose for COVID-19 immunisation.
Medical history included high cholesterol from 2017 to an unknown date, seasonal
allergy from an unknown date and unknown if ongoing and arteriosclerosis from 2017
to an unknown date. The patient's concomitant medications were not reported. The
patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration on 01Feb2021 (Lot Number:
EL9264) (at the age of 57-year-old) as single dose for COVID-19 immunisation; the
patient previously received ZYRTEC (10mg almost daily) for seasonal allergy,
ibuprofen (ADVIL, 200 mg) and TYLENOL both for pain. Caller stated that the patient
passed away on 02Mar2021 which was 8 days after the 2nd dose of the Pfizer COVID
Vaccine. On 26Feb2021 the patient went to urgent care and then on 01Mar2021 he went
to the hospital emergency room (ER). It was reported that an autopsy was performed
on 06Mar2021 and the cause of death listed sepsis and complications from sepsis and
shock due to bilateral pulmonary acute disease syndrome due to diffuse alveolar
damage. The manner of death was natural and the lung presentation is highly
suggestive of diffuse alveolar damage due to COVID-19 although the patient had
several negative tests for COVID. The patient tested negative for influenza AB,
negative for valley fever, negative for Legionnaire's disease and was in the
hospital for less than 24 hours. The patient went back to urgent care on 28Feb2021
and was feeling miserable and asking for blood tests and urine tests, stated at
that time his platelets were low at 122, glucose was high at 105, sodium was low at
134, calcium was low at 8.3, urine was negative and the patient did not get these
labs til Monday when he was on the way to the emergency room and it was all
different when he got to the hospital. The test for strep was negative, the oxygen
was low at 86 percent when he got to the hospital on Monday and they just had to
keep increasing his oxygen, stated a culture, no further details provided about the
culture. A CTA done on the chest on Monday which was bad and stated the patient was
symptomatic and they did not treat him for COVID but had a clinical suspicion for
COVID. Adenovirus was not detected, metapneumonia virus was not detected,
respiratory syncytial virus was not detected, parainfluenza was not detected, his
platelets kept dropping and he had two tests for valley fever which is Cocci IGG
and IGM and those were negative, the sodium level on 02Mar2021 was 126, all of
these things were low: chloride 92, CO2 18, calcium 7.8, glucose was high at 222,
bun was high at 21, creatinine was high at 1.4, EGFR was low at 52, WBC was high at
18.6, RBC was high at 7.39, HGB was 22.6, HCT was 66.4, RDW was high at 15, RDWFD
was 45.5, and platelets were low at 61. The patient came into the emergency room
those labs were when he was failing completely and on 01Mar2021 was when he arrived
in the ER; at that time his WBC were normal, RBC was high at 6.16, HGB was high at
18.5, HCT was high at 54.9, platelets were low at 73, monocytes absolute were high
at 0.96, sodium was low at 129, chloride was low at 95, calcium was low at 8.3,
glucose was high at 150 and this was 7 days past the Pfizer COVID Vaccine. The
patient was negative for strep pneumonia antigen and negative for Legionnaires
Urinary antigen. The chest X-ray was done on 26Feb2021 and the patient was in
misery and feeling horrible and they sent him home with albuterol and possible
antibiotic to start that Monday and he had severe chills, headache, shortness of
breath, fever, fatigue, diarrhea, muscle aches, skin sensitivity and rash, sore
throat. Chest X-ray says normal; states the albuterol was PROAIR HFA 90mcg and he
tested negative for influenza AB and he never got to the antibiotic because they
said to wait til Monday and by that time this was an emergency. The patient outcome
of sepsis and shock due to bilateral pulmonary acute disease syndrome due to
diffuse alveolar damage was fatal and unknown for the other events. The patient
died on 02Mar2021. An autopsy was performed that revealed the cause of death was
sepsis and complications from sepsis and shock due to bilateral pulmonary acute
disease syndrome due to diffuse alveolar damage.; Reported Cause(s) of Death:
Sepsis; Autopsy-determined Cause(s) of Death: Shock due to bilateral pulmonary
acute disease syndrome; Diffuse alveolar damage" "No prior vaccinations for
this event."
"1395873-1" "1395873-1" "Pt went to the hospital with covid 05/30. She was on
bipap at 100%. Pt ended up passing away 06/11 at 5:32 pm.""No prior vaccinations
for this event."
"1397970-1" "1397970-1" "COVID-19 pneumonia; COVID-19; COVID-19
pneumonia,Antigen test result was posiand chest X-ray confirmed covid pneumonia.,;
Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-365421. A 81-
years-old male patient received bnt162b2 (COMIRNATY, Solution for injection,
Lot/Batch number: ET1831, expiry date: unknown), intramuscular in left arm on
08Mar2021 as 1st dose, 0.3 ml, single dose for covid-19 immunisation. Comirnaty was
concentrate for dispersion for injection, tozinameran (COVID-19 mRNA Vaccine
embedded in lipid nanoparticles). Medical history included ongoing hypertension,
atrial fibrillation, Barret's oesophagus, bulbar palsy, coronary sclerosis, gas-
tritis, hiatus hernia, hyperlipidemia, pericarditis and chronic renal
insufficiency, all from an unknown date and unknown if ongoing. Concomitant drugs
were not reported. The patient was hospitalized on 21Mar2021 because of Covid-19
symptoms. Antigen test result was positive on 21Mar2021 and chest X-ray confirmed
covid pneumonia on 22Mar2021. The patient received therapy but his general
condition rapidly progressed and passed away on 26Mar2021 at 02:30 due to
cardiorespiratory insufficiency. Therapeutic measures were taken as a result of the
events. The patient died on 26Mar2021. It was not reported if an autopsy was
performed. Health authority comment: The patient got infected with Covid-19 after
the first dose, therefore immunity may have not developed yet. Based on the above,
the causal relationship is unlikely between the suspected drug and the adverse
events. The case was considered serious because the outcome was fatal. Further
information expected.; Sender's Comments: Based on temporal association, the causal
relationship between BNT162B2 and the events cannot be excluded. The information
available in this report is limited and does not allow a medically meaningful
assessment. This case will be reassessed once additional information becomes
available.; Reported Cause(s) of Death: COVID-19" "No prior vaccinations for
this event."
"1397973-1" "1397973-1" "COVID-19 pneumonia; COVID-19; This is a spontaneous
report from a contactable physician downloaded from the Regulatory Ambulatory-WEB,
regulatory authority number HU-OGYI-365721. An 83-year-old male patient
received first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm
right on 17Feb2021 (Lot Number: EL0725) as 0.3 mL single dose for COVID-19
immunisation. Medical history included benign prostatic hyperplasia (BPH),
polyarthritis, hypertension, arteriosclerosis all from an unknown date and unknown
if ongoing; Bell's Palsy from 2010 to an unknown date. The patient's concomitant
medications were not reported. The patient was hospitalized because of COVID-19
symptoms. On 01Mar2021 an antigen test was done with a positive result. Chest X-ray
on 06Mar2021 confirmed COVID-19 pneumonia. The patient received therapy, but his
respiratory insufficiency progressed and passed away on 16Mar2021 at 02:00. An
autopsy was not performed. Sender Comment: the patient got infected with COVID-19
after the first dose, therefore immunity may have not developed yet. Based on the
above, the causal relationship is unlikely between the suspected drug and the
adverse events. The case is considered serious because the outcome was fatal.;
Reported Cause(s) of Death: COVID-19; COVID-19 pneumonia" "No prior vaccinations
for this event."
"1397975-1" "1397975-1" "Vaccination failure; COVID-19; Pneumonia; This is a
spontaneous report downloaded from the Agency Regulatory Authority-WEB, regulatory
authority number HU-OGYI-383421. A contactable physician 83-years-old female
patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot
number: EP2163 and Expiry date: Unknown), intramuscular on 26Feb2021 as 2nd dose,
0.3 ml single dose for covid-19 immunization. Medical history included
hypertension, diabetic nephropathy, renal failure, angiopathy, glaucoma,
hyperlipidemia, diabetes mellitus, obesity from an unknown date and unknown if
ongoing. . The patient's concomitant medications were not reported. The patient
previously took first dose of bnt162b2 (COMIRNATY, Lot Number: EJ6136), on
05Feb2021 for covid-19 immunization. On 04Mar2021, the patient experienced
pneumonia, covid-19, vaccination failure. The patient was hospitalized on
04Feb2021, where covid-19 antigen test was positive and chest X-ray showed
pneumonia. The patient was hospitalized for pneumonia from 04Mar2021 to an unknown
date. The patient was hospitalized for covid-19 from 04Mar2021 to an unknown date.
The patient was hospitalized for vaccination failure from 04Mar2021 to an unknown
date. On 04Mar2021, the patient underwent lab tests and procedures which included
chest x-ray: pneumonia, sars-cov-2 test: positive. Therapeutic measures were taken
as a result of pneumonia, covid-19, vaccination failure and treatment included. The
patient died on 06Mar2021. An autopsy was not performed. Sender Comment included
second dose. The patient had a positive Covid-19 antigen test 6 days after the
second dose, therefore vaccination failure is considered possible. The case is
considered serious because the outcome was fatal. Further information is not
expected. No follow-up attempts possible. No further information expected.;
"1400742-1" "1400742-1" "Vaccination failure; COVID-19 respiratory infection;
Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021062307.
A 90-year-old male patient received the first dose of BNT162B2 (COMIRNATY),
intramuscularly on 22Jan2021 at single dose (0.3 mL, single), and the second dose
intramuscularly on 11Feb2021 (lot number: EJ6789) at single dose (0.3 mL, single)
for COVID-19 immunisation. Medical history included ongoing arteriopathic disease,
ongoing korsakoff's syndrome, myocardial infarction, ongoing dyslipidaemia, ongoing
diabetes mellitus, phlebitis lower limb, pulmonary embolism, and ongoing arterial
hypertension. The patient's concomitant medications were not reported. In May2021,
SARS COV 2 cluster in the patient's residence was reported. On 06May2021, SARS COV
2 polymerase chain reaction (PCR) was positive (N501Y mutation). The patient
presented clinical symptoms with progressive cardiorespiratory deterioration.
Patient experienced vaccination failure and COVID-19 respiratory infection. On
16May2021, the patient was hospitalized for respiratory tract infection with oxygen
saturation at 85% under 15 L of oxygen and laboratory signs of inflammation (C-
reactive protein at 106 mg/L, procalcitonin (PCT) 0.26), and probable aspiration
pneumonia evolving for several days. The patient received piperacillin
sodium/tazobactam sodium (TAZOCILLINE) and metronidazole (FLAGYL). The patient was
agitated and refused care (removed the mask at high concentration), requiring
clonazepam (RIVOTRIL) administration. Respiratory rate was 28, systolic blood
pressure was 120/10 mmHg and heart rate 108. The patient was bedridden with
consciousness disorder. The decision to limit active care was made.
Electrocardiogram showed sinus tachycardia and left axis deviation, a right
ventricular hypertrophy and sequelae of myocardial infarction. No chest
computerized tomography (CT) scan was reported. On 19May2021, the patient died due
to cardio-respiratory decompensation aggravated by a COVID-19 infection.
Conclusion: Vaccine failure with SARS Cov 2 infection N501Y mutation in a 90-year-
old patient living in a community having been vaccinated by BNT162B2 with a
complete vaccination schedule. Death was due to aggravation of cardio-respiratory
decompensation by a COVID-19 infection in the context of a serious cardiac co-
morbidities. An autopsy was not performed.; Reported Cause(s) of Death: COVID-19
respiratory infection; Vaccination failure" "No prior vaccinations for this
event."
"1400979-1" "1400979-1" "implied a massive pulmonary embolism; COVID-19
pneumonia/symptoms of decreased appetite, throat dryness, fever and feeling unwell;
regulatory authority-WEB HU-OGYI-361921. A contactable physician reported that a 66
years old male patient received first dose BNT162B2 (COMIRNATY, lot number EW9127),
intramuscular at Arm Left on 16Apr2021 at 0.3 ml single dose for COVID-19
immunisation. Medical history included colon cancer for which the patient received
radio-chemotherapy. He also had a stoma. Concomitant drugs were not reported. On
16Apr2021 the 66-years-old male patient received the first dose of 0.3 ml COMIRNATY
concentrate for dispersion for injection (tozinameran (COVID-19 mRNA Vaccine
embedded in lipid nanoparticles), batch number: EW9127, expiry date: unknown, MAH:
BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm to prevent
Covid-19. The patient was hospitalized on 26Apr2021 with symptoms of decreased
appetite, throat dryness, fever and feeling unwell, Covid-19 antigen test was
positive on 26Apr2021. The chest CT on 26-APR-2021 showed Covid-19 pneumonia and
Echocardiography 09-MAY-2021 implied a massive pulmonary embolism. The patient
received covid therapy, but his respiratory parameters worsened and after an
unsuccessful reanimation, passed away on 10May2021 at 00:15. The patient underwent
lab tests and procedures, which included Chest CT : covid pneumonia on 26-APR-
2021; Echocardiography on 09-MAY-2021: pumonary embolism; COVID-19 antigen test:
Positive on 26-APR-2021.The patient died on 10-MAY-2021. The autopsy was performed,
and the autopsy result was not available. The cause of death was COVID-19
pneumonia, COVID-19 antigen test positive and Pulmonary embolism. The outcome of
events was fatal. Sender Comment: According to the SmPC of Comirnaty, immunity
usually develops 14 days after the second dose of the vaccine. The patient got
infected with the virus after the first dose, therefore immunity may have not
developed yet. Based on the above, the causal relationship is unlikely between the
suspected drug and the adverse event. The case is considered serious because the
outcome was fatal. No follow-up attempts possible. No further information
expected.; Sender's Comments: Based on available information and temporal
relationship, a possible contributory role of BNT162B2 vaccine cannot be excluded
for the reported events of COVID-19 and Pulmonary embolism. The impact of this
report on the benefit/risk profile of the Pfizer product is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of
regulatory authorities, Ethics Committees, and Investigators, as appropriate.;
Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 antigen test positive;
massive pulmonary embolism" "No prior vaccinations for this event."
"1403441-1" "1403441-1" "dyspnea, pneumonia, difficulty breathing. positive
for COVID-19 3/25/2021, hospitalized and later died of COVID-19" "No prior
"1407048-1" "1407048-1" "Pt. did not die from COVID vaccine. He was
diagnosed with COVID19 on 06/04/2021. He had an extensive past medical history
with several preexisting conditions which COVID exacerbated." "No prior
"1407151-1" "1407151-1" "DIARRHEA, COUGH , PNEUMONIA STARTING 4/27/2021"
"1407166-1" "1407166-1" "84 y/o M PMHx of non-hodgkin's lymphoma,
adenocarcinoma of the colon (1996) and type 2 DM, presented ED 4/17 with complaints
of weakness x 1 week. He reported some Memory loss but denied fever/chills,
coughing, dyspnea or fever. Admitted for UTI. On 4/19 patient developed fever,
tested positive COVID, started on decadron and remdesivir, pulmonology consulted.
5/1 increasing O2 requirements, prompting transfer to ICU. Mental status improved.
5/3: Fluctuant FiO2 requirements. Transferred to the floor and back to the ICU for
hypoxemia. Intubated 5/7. Pt with worsening AKI, metabolic acidosis and shock in
the evening of 5/8. Daughter on 5/9 and pt made a DNR. Worsening shock, metabolic
acidosis and MODS. Decision to dc to hospice" "No prior vaccinations for this
event."
"1407184-1" "1407184-1" "DYSPNEA 3/7/2021, CONFIRMED BREAKTHROUGH WITHA
POSITIVE COVID-19 RESULTING IN DEATH" "No prior vaccinations for this event."
"1408205-1" "1408205-1" "2/22/2021 - Tested positive for Covid 3/9/2021 -
found down at her SNF, taken to ER. complains of lower back pain, left hip pain,
bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC),
*Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff
negative. 3/22: placed on palliative care after speaking with family 3/23:
Expired" "No prior vaccinations for this event."
"1408206-1" "1408206-1" "Patient received both COVID vaccines. On 5/21/21
she presented to the ED with COVID symptoms. She was tested on 5/21/2021 and was
positive for COVID-19. She died on 6/7/2021 in hospital from complications of
"1408892-1" "1408892-1" "COVID-19/COVID-19 virus test positive; COVID-19
pneumonia; This is a spontaneous report from a contactable physician downloaded
from the Regulatory Authority WEB HU-OGYI-365821. An 80-years-old female patient
received bnt162b2 (COMIRNATY), dose 1 intramuscular in the right arm on 17Feb2021
(Batch/Lot Number: EL0725) as 0.3mL, single dose for COVID-19 immunisation. Medical
history included COVID-19, COVID-19 pneumonia, chronic renal insufficiency,
hypertension, atrial fibrillation, hyperlipidaemia, hyperthyroidism from an unknown
date and unknown if ongoing. The patient's concomitant medications were not
reported. The patient experienced COVID-19 on 25Feb2021, COVID-19 virus test
positive on 25Feb2021, COVID-19 pneumonia on 25Feb2021, reported as death,
hospitalization. Clinical course reported as follow: The occurrence of COVID-19
infection and pneumonia resulting in death after COMIRNATY injection for active
immunization to prevent COVID-19. The patient was hospitalized because of COVID-19
symptoms. On 25Feb2021 a COVID-19 virus test was done with a positive result. Chest
X-ray confirmed COVID-19 pneumonia. The patient received therapy, but after a
temporary improvement in her condition, the patient passed away on 09Mar2021 at
14:30. An autopsy was not performed. Case was assessed as serious, medically
confirmed. Sender Comment: The patient got infected with COVID-19 after the first
dose, therefore immunity may have not developed yet. Based on the above, the causal
case is considered serious because the outcome was fatal. Further information is
not expected. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19/COVID-19 virus test
"1408893-1" "1408893-1" "the patient was diagnosed with COVID-19; the patient
was diagnosed with COVID-19; This is a spontaneous report from a contactable
physician downloaded from the Regulatory Authority WEB, regulatory authority number
HU-OGYI-385521. This report is regarding the 1st dose and death due to vaccine. A
48-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection,
Lot Number: ET6956 and expiration dates were not reported), via intramuscular route
of administration in the left upper arm administered on 21Apr2021 as 1ST dose, 0.3
ML single dose for COVID-19 immunisation. Medical history included ongoing crohn's
disease from an unknown date and she was a smoker. Concomitant medications included
budesonide (BUDENOFALK) taken for an unspecified indication, start and stop date
were not reported and mesalazine (SALOFALK) taken for an unspecified indication,
start and stop date were not reported. On about 05May2021, the patient started to
have unspecified symptoms and fever. On 14May2021, the patient was diagnosed with
COVID-19. Her condition was worsening, she was submitted to hospital on 19May2021.
She had severe symptoms requiring invasive ventilation. The patient died on
25May2021. It was not reported whether an autopsy was performed. Sender Comment:
The patient started to have symptoms of COVID-19, 14 days after vaccination and was
diagnosed to have COVID-19, 23 days after vaccination. Immunity may have not
developed within 2 weeks after the first dose of COMIRNATY. The case is serious
because the patient died. No further information was expected. Stop date for event
Covid-19: 25May2021 No follow-up attempts possible. No further information
expected.; Reported Cause(s) of Death: the patient was diagnosed with COVID-19; the
patient was diagnosed with COVID-19" "No prior vaccinations for this event."
"1408894-1" "1408894-1" "bradycardia; cardiorespiratory failure; heart
attack; COVID-19 pneumonia; COVID-19 confirmed by positive COVID-19 test; This is a
spontaneous report from a contactable physician. This is a report received from the
Regulatory Authority HU-OGYI-394221. This spontaneous, serious, medically confirmed
case was reported on 27May2021 by a physician and concerns the occurrence of Covid-
19 infection and pneumonia resulting in death after COMIRNATY injection for active
immunization to prevent COVID-19. A 67-years-old male patient received bnt162b2
(COMIRNATY, concentrate for dispersion for injection tozinameran [COVID-19 mRNA
Vaccine embedded in lipid nanoparticles]), dose 1 intramuscular on 12Apr2021 (at
the age of 67-year-old) (Batch/Lot number and expiry date was reported as unknown)
as 1st dose, 0.3ml single dose for covid-19 immunisation. Medical history of the
patient included COVID-19, COVID-pneumonia, chronic bronchitis, COPD, diabetes
mellitus, gastric ulcer, hypertension, obesity, prostatitis, BPH and ischemic heart
disease. Concomitant drugs were acetylsalicylic acid (ASACTAL 100 mg), niflumic
acid (DONALGIN 250 mg), diclofenac (FLECTOR), furosemide (FURON 40 mg), potassium
chloride (KALIUM-R), fentanyl (MATRIFEN 25 microgram), metformin hydrochloride
(METFOGAMMA 1000 mg), beclometasone; formoterol; glycopyrronium bromide (TRIMBOW)
and salbutamol (VENTOLIN EVOHALER l) all taken for an unspecified indication, start
and stop date were not reported. On 20Apr2021, patient started experiencing COVID
symptoms. On 25Apr2021, patient underwent a lab test of COVID-19 antigen and
resulted positive for COVID-19, and his wife also died because of COVID-19 on
25Apr2021. On 28Apr2021, the patient was hospitalized because of dyspnea which was
ongoing for 3 days. On 28Apr2021, patient had a chest X-ray and was diagnosed with
COVID-19 pneumonia. Patient received therapy, but on 29Apr2021 suddenly bradycardia
and cardiorespiratory failure occurred. After an unsuccessful reanimation, the
patient passed away at 05:25. Cause of death was reported as COVID-19. According to
the autopsy report, the direct cause of death was a heart attack. Health
authority comment: The patient got infected with Covid-19 after the first dose,
therefore immunity may not have developed yet. Based on the above, the causal
case is considered serious because the outcome was fatal. Further information is
not expected. Case Comment: Based on the current available information and the
plausible drug-event temporal association, a possible contributory role of the
suspect product BNT162B2 to the development of serious events COVID-19, COVID19-
Pneumonia,Myocardial infarction,cardiopulmonary failure and bradycardia cannot be
totally excluded. The impact of this report on the benefit/risk profile of the
Pfizer product is evaluated as part of Pfizer procedures for safety evaluation,
and Investigators, as appropriate. No follow-up attempts possible. No further
information expected. Information about lot/batch number cannot be obtained.;
Reported Cause(s) of Death: COVID-19; Autopsy-determined Cause(s) of Death: heart
attack" "No prior vaccinations for this event."
"1410464-1" "1410464-1" "Patient was diagnosed with COVID-19 on 6/13/2021 and
subsequently died on 6/17/2021. Patient was considered to be fully vaccinated as of
3/24/2021 having received both doses of Pfizer." "No prior vaccinations for
this event."
"1410894-1" "1410894-1" "Patient was hospitalized due to COVID-19 from May
19, 2021 to May 22, 2021. Patient was then placed on hospice on 6/5/2021 and
"1411020-1" "1411020-1" "Shaking, almost spasm type shaking. Weakness in her
legs. progressing to abd. pain, cough, headache, nausea" "No prior vaccinations
for this event."
"1411815-1" "1411815-1" "Respiratory failure in subject with positive
antigenic swab; COVID-type interstitial pneumonia with >75% involvement; pulmonary
embolic thrombosis in CPAP (Continuous Positive Airway Pressure); pulmonary embolic
thrombosis; respiratory failure; vaccination failure; sars-cov-2 test: positive on
21May2021; This is a spontaneous report received from a contactable pharmacist
IT-MINISAL02-739120. An 85-year-old female patient received first dose of
BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EW2246-
37-030, expiration date: 31Jul2021) via an unspecified route of administration on
10Apr2021 as single dose for COVID-19 immunisation. The patient received second
dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number:
EX0893-01-117, expiration date: 31Jul2021) via an intramuscular route of
administration on 01May2021 at a dose of 0.3 ml as single dose for COVID-19
immunisation. The patient's medical history included ongoing chronic kidney
disease, ongoing hypertension and atrial fibrillation. Concomitant medications
included amlodipine besilate, olmesartan medoxomil (GIANT) taken for hypertension,
bisoprolol fumarate taken for hypertension, torasemide sodium (DIURESIX [TORASEMIDE
SODIUM]) taken for chronic kidney disease and olmesartan medoxomil taken for
hypertension. On 21May2021, the patient experienced respiratory failure in subject
with positive antigenic swab, COVID-type interstitial pneumonia with >75%
involvement, pulmonary embolic thrombosis in CPAP (continuous positive airway
pressure) and vaccination failure. The patient underwent lab tests and procedures
which included SARS-COV-2 antibody test: positive on 24May2021, SARS-COV-2 antibody
test: positive on 24May2021, SARS-COV-2 test: positive on 21May2021. Therapeutic
measures were taken as a result of adverse event. The patient died on 03Jun2021.
The death was due to respiratory failure in subject with positive antigenic swab;
COVID-type interstitial pneumonia with >75% involvement; pulmonary embolic
thrombosis in CPAP (Continuous Positive Airway Pressure), pulmonary embolic
thrombosis, respiratory failure, vaccination failure and SARS-COV-2 test: positive
on 21May2021. It was not reported if an autopsy was performed. The outcome of
events was fatal.; Sender's Comments: Linked Report(s) : IT-PFIZER INC-2021668395
patient spouse case; Reported Cause(s) of Death: Respiratory failure in subject
with positive antigenic swab; COVID-type interstitial pneumonia with >75%
involvement; pulmonary embolic thrombosis in CPAP (Continuous Positive Airway
Pressure); Pulmonary embolic thrombosis; Respiratory failure; Covid" "No prior
"1413141-1" "1413141-1" "Patient had bad headache within the hour, difficulty
breathing soon after, became delirious, couldn't make sense, couldn't walk and had
to call EMS." "No prior vaccinations for this event."
"1413354-1" "1413354-1" "Active COVID infection diagnosed 06/14/21" "No
"1414207-1" "1414207-1" "Pt w/hx significant for COPD (on 1L O2 a baseline)
p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test
positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted
for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. During
admission received dexamethasone, convalescent plasma, remdesivir. Culture
indicated pseudomonas PNA, but likely colonization given hx, however, due to
illness and underlying bronchiectasis, was given cefepime. Hospital stay
complicated by significant resistant hypercarbia and respiratory failure, pt placed
on comfort measures given that death is imminent. Unfortunately, pt passed on
"1414492-1" "1414492-1" "Nursing Home Visit 6/2/2021 Geriatric Medicine
COVID-19 virus infection +4 more Dx Progress Notes SUBJECTIVE: Patient with history
of multiple myeloma, osteonecrosis of jaw on IV antibiotic, CAD with history of
stent, seizure disorder and hypertension was seen today. She has been complaining
of sinus congestion for past 3 to 4 days. Apparently there has been other resident
who tested positive for COVID-19 so rapid antigen test was performed on her.
Unfortunately she also tested positive for COVID-19. She has received full dose of
COVID-19 vaccine earlier in February. She denies any fever or chills. She denies
any shortness of breath. She does complain of cough and sinus congestion going on
for a week or so. Chief complaint: Acute hypoxic respiratory failure due to
COVID-19 SUBJECTIVE: Patient with history of multiple myeloma, osteonecrosis of
jaw on IV antibiotic, hypertension, CAD and seizure disorder was tested positive
for COVID-19 yesterday. She has been complaining of sinus congestion for the past
for 5 days. However this has been at her baseline. She has multiple allergies and
taking antihistamine chronically. There has been Covid outbreak in the facility
and multiple other residents are positive for COVID-19. She also tested positive
for COVID-19 yesterday. Unfortunately this morning she declined and needed oxygen
support. Her oxygen saturation dropped to mid 70s to upper 80s on 5 L O2. She was
not using any accessory muscle. She did complain of mild cough but denied any
chest pain. Her appetite is poor. She does not look toxic. Date: 6/3/2021
Admission Date: 6/3/2021 Assessments Patient is a 74 y.o. female on hospital
day number 0 Medical Problems Hospital Problems POA * (Principal)
Pneumonia due to COVID-19 virus Yes Plan Chief Complaint
Patient presents with ? Shortness of Breath #. COVID-19 pneumonia with
hypoxia. -Patient was offered plasma and she wants to get plasma therapy. Patient
has signed a consent form for blood product transfusion. -Patient states she cannot
take steroids due to her medical history. She is refusing steroid therapy. -IV
remdesivir ordered for the patient. -Patient is consulted with the ID due to her
complicated history. -Patient is on oxygen support via nasal cannula. #.
Mandible osteomyelitis diagnosed recently. -Patient has been seen by infectious
disease during the prior admission and has PICC line for long-term IV antibiotic.
-Patient is reordered IV antibiotic in the form of imipenem and oral doxycycline as
well as azithromycin. #. Essential hypertension -Patient continues on various
antihypertensive medication. #. Diabetes mellitus type 2 -Patient is on insulin
therapy while in the hospital. Patient is on polypharmacy and was advised to
discuss with her family doctor to cut down on her unnecessary or unimportant
medications if possible. History of Present Illness Patient is an 74 y.o.
female. Patient is 74-year-old Caucasian female, who presented from a facility
chief complaint of acute hypoxic respiratory failure due to COVID-19 pneumonia.
Patient has been at this facility since 5/12/2021 after being diagnosed with
bisphosphonate related out for necrosis of the jaw with cellulitis and possible
osteomyelitis. Patient had been transferred from a Hospital on 5/12/2021. Patient
had been getting IV antibiotics for the osteomyelitis of the mandible and was
apparently doing well until today when she was noted to be hypoxic. Patient has
been complaining of sinus congestion over the past 5 to 7 days. According to the
medical director, there has been Covid outbreak in the facility and multiple other
residents are noted to be positive for COVID-19. Patient had a Covid test done
yesterday and she was COVID-19 positive. Patient respiratory status declined.
Patient required oxygen support. Her oxygen saturation had dropped into the mid
70s to upper 80s and patient was on 5 L/min of oxygen via nasal cannula. Patient
had not been using accessory muscles. Patient also reports occasional cough and
has yellowish phlegm production. Patient was referred to Hospital emergency
department for further evaluation and treatment. ED to Hosp-Admission Discharged
6/3/2021 - 6/14/2021 (11 days) Last attending ? Treatment team Sepsis due to
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Principal problem
DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for
Admission Hypoxia COVID-19 virus infection Pneumonia due to COVID-19 virus Acute
respiratory failure Hospital Course Patient is a 74 y.o. female with a history
of multiple myeloma on fifth line treatment. Patient with recent diagnosis of
osteomyelitis and on antibiotics per ID. She was admitted to the hospital 6/3 with
acute shortness of breath and following 2 days on the general medical floor she
required increasing oxygen supplementation and was transferred to the ICU. In the
ICU patient had a seizure and required acute intubation for protection of her
airway. Patient had further decline of her respiratory status. She did pass SBT's
and was extubated. Shortly after she experienced likely an episode of aspiration.
She continued to have increased work of breathing following this event. Patient
transitioned to comfort care per family request. She received morphine and Ativan
as needed and experienced asystole at 0834 this morning." "No prior vaccinations
for this event."
"1414839-1" "1414839-1" "to do the test, and the patient's and the patient's
wife results were positive; heart attack; in the tomography the patient presented
75% of compromise; shortness of breath; light flu symptoms; coryza; This is a
spontaneous report from a contactable consumer (patient's brother). A 42-years-old
male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of
administration on 28May2021 (Batch/Lot number was not reported) as single dose for
covid-19 immunisation. Medical history included ongoing obese and did not have
other pre-existing condition. The patient's concomitant medications were not
reported. On the day of 28May2021, the patient took the first dose of the Pfizer
vaccine. Until the present moment he did not have any flu symptoms or anything of
the like. On the following of 29May2021 and 30May2021, the patient had light flu
symptoms, with a bit of coryza. The patient thought that it could be a reaction to
the vaccine. On the day of 31May2021, the patient woke up with a lot of shortness
of breath. Before going to the hospital the patient went to the drugstore to do the
test, and the patient's and the patient's wife results were positive. Immediately
the patient went to a certain hospital from a certain neighborhood in a certain
city. When the patient got there, his saturation was between 83-84%. Immediately
they introduced the oxygen, the patient's oxygenation went up to 90-94%, they
collected blood exams, and lots of indicators were altered and in the tomography
the patient presented 75% of compromise. And 13 hours after the first symptoms the
patient was already doing treatment with the medications of the COVID protocol. The
clinical condition during the following days of 31May to 06Jun2021 was rapidly
evolving. On the day of 06Jun2021 in the afternoon, the patient's saturation
dropped to 90% and on the day of 07Jun2021 the patient was sent to the ICU
(Intensive Care Unit) and his clinical condition evolves rapidly. In approximately
24 hours of ICU, they did the intubation process. And after this, in approximately
4 hours the patient suffered a heart attack (Jun2021). The reporter was reporting a
family experience to help in the process of enhancement of the vaccine use.
Probably, the patient was with a COVID in the asymptomatic and when the patient
took the vaccine, all the process was intensified. The outcome of heart attack was
fatal, of other events was unknown. The patient died in Jun2021. It was not
reported if an autopsy was performed. Information on the lot/batch number has been
requested.; Reported Cause(s) of Death: heart attack" "No prior vaccinations for
this event."
"1415561-1" "1415561-1" "Death NOS/Death which occurred suddenly; COVID test
positive/COVID-19; This is a spontaneous report from a contactable physician
downloaded from the Regulatory Authority-WEB FR-AFSSAPS-2021069085. A 78-year-old
male patient received first dose of bnt162b2 (COMIRNATY), intramuscular in left arm
on 20Jan2021 (Lot Number: EJ6788) as single dose for COVID-19 immunisation. Medical
history included diabetes, dementia and epilepsy. Concomitant medications included
insulin glargine (LANTUS); metformin; valproic acid (DEPAKINE). The patient
experienced death nos on 30May2021. Death which occurred suddenly on 30May2021:
resident found dead on the ground in the morning. The patient underwent lab tests
and procedures which included Covid-19 virus test: positive on 21Jan2021. The
patient died on 30May2021. It was unknown if an autopsy was performed with unknown
cause of death. No follow-up attempts are possible. No further information is
expected.; Reported Cause(s) of Death: Unknown cause of death" "No prior
"1417119-1" "1417119-1" "lightheadedness, weakness, Pain Narrative: A 63yo
male with history of tobacco use, Cocaine dependence in remission, PTSD,
Depression, Cirrhosis of Liver due to Chronic Hepatitis, Alcohol Dependence, Spinal
Stenosis of Lumbar Region, Obesity, HTN, OA, COPD and OSA. It's documented he
received Covid-19 vaccine on January 11, 2021, per protocol, without complications
and was advised to stay on site for 15 minutes. Instructions about side effects and
ADR reporting were also provided. He called hospital advice line on January 12,
2021 to report ADR symptoms of having LT arm pain that radiates to his back and
chest which started on his way home after he received the vaccine. Also reported he
felt weak, had diarrhea, nausea, chills and lightheadedness. He was advised by the
call documenting nurse, to go the hospital ED, for evaluation. Per telephone note -
Physician A/P documentation included that symptoms were discussed with the patient
on January 12, 2021 @13:01 PM, patient was assured what he experienced was an
expected reaction from the vaccine and it'd be safe to get his second scheduled
shot On January 14 the patient called back to report feeling a little light headed,
having muscle/ body ache and feeling weaker after the Covid-19 vaccine.
Recommendation was made to go to the ER by the call taker Patient called on January
15, 2021 with a fever of 101.5 and asking if it maybe due to the vaccine March 17,
2021 the patient presented to the ED with chief complaint of Chest pain, was
hypoxic and with a temp of 101.8, was started on O2 nasal cannula, saturation
improved from 83% to 87% and with 5L to 90% He was diagnosed with Covid-19 and
admitted to Critical Care. Psox remained above 92% on 6L HFNC The patient remained
in MICU and passed away on February 4, 2021" "No prior vaccinations for this
event."
"1417182-1" "1417182-1" "I am the epidemiologist reporting on behalf of
patient who tested positive for COVID-19 via PCR on 5/15/21 after the completion of
a full Pfizer vaccine series (Dose 1 on 2/8 and Dose 2 on 3/1). The patient later
died on 5/28/21. Cause of Death is listed as ?Acute hypoxemic respiratory failure
Pneumonia COVID-19?. Pre-existing conditions listed as: CARDIOVASCULAR DISEASE,
DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)" "No prior
"1417184-1" "1417184-1" "The patient died of COVID-19" "No prior
"1417262-1" "1417262-1" "Died of COVID-19" "No prior vaccinations for
this event."
died on 5/04/21. Pre-existing conditions listed as: OTHER CHRONIC DISEASES,
IMMUNOCOMPROMISED CONDITION. Comments:05/04/21:Patient was admitted to the
hospital on 4/28/2021 for COVID-19 infection, pneumonia, and acute on chronic renal
failure. He was transferred to the ICU on 4/29/2021 due to acute hypoxic
respiratory failure requiring intubation. Despite maximum therapies, the patient's
respiratory status did not improve. He remained mechanically ventilated from 4/29
through 5/4. On 5/4, the patient became hypotensive and bradycardic. The patient
died at 10:45." "No prior vaccinations for this event."
"1417294-1" "1417294-1" "I am the epidemiologist for reporting on behalf of
died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic
encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing
conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE,
IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing
chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14
was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she
could be admitted to hospital for cardiac catheterization. Case reports having a
mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX
was mild case of COVID with elevated enzymes that indicated a cardiac event. Case
is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has
history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-
3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to
follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines.
Case lives alone but has 2 adult sons who live nearby that will provide food drop-
offs at door. Emailing vaccination breakthrough info to Epidemiologist &
supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM."
a full Pfizer vaccine series (Dose 1 on 12/28/20 and Dose 2 on 1/18/21). The
patient later died on 4/9/21. Cause of Death is listed as ?Metastatic Rectal
cancer?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR
DISEASE, IMMUNOCOMPROMISED CONDITION, DIABETES MELLITUS Comments: Spoke to the
case adult daughter. She informed that the case resides at a rehabilitation center.
The case's daughter stated that her mother is not having any symptoms and was fully
vaccinated. The daughter did not have all the information on dates of vaccine.
called center spoke to the administrator who provided the information. The case was
at the hospital from 3/27-4/1. Rehab requires a (-) test result to return and a (-)
test four days after returning. The case test (+) on her 4th day 4/5.nnn" "No
"1417680-1" "1417680-1" "presented with a cough, difficulty breathing, sinus
congestions and headache on 2/7. tested positive for COVID-19. admitted to the
hosp. completed 5 days of remdesivir 2/16 and 10 days of dexamethasone 2/21" "No
"1420492-1" "1420492-1" "Patient hospitalized after testing positive for
COVID-19. Patient died. Patient was fully vaccinated." "No prior vaccinations
for this event."
"1421500-1" "1421500-1" "Covid 19, Blood Clot in Lung, Myocardia" "No
"1421711-1" "1421711-1" "Patient died in a context of symptomatic COVID
infection despite a complete vaccination with COMIRNATY; Patient died in a context
of symptomatic COVID infection despite a complete vaccination with COMIRNATY;
fever; deterioration of general condition; congestion; This is a spontaneous report
received from a contactable other health care professional downloaded from the
Agency Regulatory Authority-WEB. The regulatory authority report number is FR-
AFSSAPS-2021056925. A 100-year-old female patient received the second dose of
bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: EJ6789), via an
intramuscular route of administration on 10Feb2021 and first dose of bnt162b2
(COMIRNATY, solution for injection, Batch/Lot number: EM0477) on 20Jan2021 as a
single dose for COVID-19 immunisation. The patient medical history included macular
degeneration, anxiety depression and vascular dementia. Concomitant medications
were not reported. Patient was very bedridden before Covid infection and no
evidence of a problem during the prior vaccination. On 10May2021, the patient
experienced fever, deterioration of general condition and congestion. On the same
day PCR test was performed which was positive, Screening: variant V1. Patient died
in a context of symptomatic COVID infection despite a complete vaccination with
Comirnaty on 12May2021 (no hospitalization, palliative care from the outset given
the already altered condition of the patient). Patient did not receive any
treatment for the events. The time interval between beginning of drug
administration and start of event was 111 days and time interval between last dose
of drug and start of event was 90 days. It was not reported whether if an autopsy
was performed or not. Cluster in RA (10 cases including 2 asymptomatic; including
2 in 2 unvaccinated patients, 2 in patients having had 1 single dose (including 1
asymptomatic); 5 symptomatic cases reported to Regulatory Authority (DJ20211289;
DJ20211290; DJ20211291; DJ20211292 and DJ20211293). 1 death (DJ20211289, the
others are progressing favorably), all have a V1 screening, and all the patients
having had 2 doses were vaccinated on the same dates, same batches.; Reported
Cause(s) of Death: symptomatic COVID infection; fever; deterioration of general
condition; congestion" "No prior vaccinations for this event."
"1421782-1" "1421782-1" "Vaccination failure; hyperthermia; dyspnoea;
positive COVID-19 test; This is a spontaneous report from a contactable other
health care professional downloaded from the WEB, regulatory authority number FR-
AFSSAPS-2021067716. Case Summary and Reporter's Comments Text: COVID-19
VACCINATION, Dose 1+Dose 2 , Confirmed vaccination failure. A 80-year-old male
patient received second dose of BNT162B2 (COMIRNATY: Solution for injection, Lot
Number: EJ6788, Expiration date: unknown), via intramuscularly, in right arm on
05Feb2021 as 2nd dose, single for COVID-19 immunization. Patient took his first
dose of BNT162B2 (COMIRNATY: Solution for injection, Lot Number: EM0477, Expiration
date: unknown), via intramuscularly, in right arm on 14Jan2021 as 1st dose, single
for COVID-19 immunization. The patient medical history includes Cerebrovascular
accident and concomitant medications were not reported. On 21May2021, the patient
had PCR Covid-19 test positive (English variant) and on 27May2021 patient
experienced, hyperthermia to 39 degree C and dyspnoea of sudden onset requiring 24-
hour oxygen therapy. Later, the same day patient died with unknown cause of death.
The patient underwent lab tests and procedures which included sars-cov-2 test
resulted as positive on 21May2021 and body temperature 39 degree centigrade on
27May2021. The outcome of the events was fatal. No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: unknown cause of death"
"1421860-1" "1421860-1" "Vaccination failure; COVID-19; COVID-19 antigen test
positive; Cough; Liquid stools; Dyspnea; Psychomotor slowing; This is a spontaneous
report from a contactable other healthcare professional downloaded from the
Regulatory Authority-WEB FR-AFSSAPS-2021060880. Additional identifier: FR-AFSSAPS-
AM20211422. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE; Solution for injection; Lot number: EM0477), via intramuscular route of
administration on 19Jan2021 as 1st dose, single for COVID-19 immunization and
second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection;
Lot number: EK9788) via intramuscular route of administration on 09Feb2021 on
deltoid Left, as 2nd dose, single for COVID-19 immunization. Medical history of the
patient included hypertension arterial, respiratory failure, sleep apnoea syndrome,
cardiac insufficiency, obesity. It was unknown if patient had any history of COVID-
19 infection. Concomitant medications included acetylsalicylate lysine (KARDEGIC);
fluticasone propionate, salmeterol xinafoate (SERETIDE DISKUS); perindopril;
omeprazole; furosemide cyanocobalamin (VITAMINE B12); paracetamol (DOLIPRANE);
diltiazem hcl; colecalciferol (UVEDOSE); tiotropium bromide (SPIRIVA); unknown
start, stop date and indication for all. On 13May2021, the patient had appearance
of liquid stools, dyspnoea, cough, psychomotor slowing. The COVID 19 antigenic test
was positive for variant and vaccine failure was confirmed. The patient was put on
O2. On the next day, 14May2021, patient was found dead. It was reported as to be
noted that the storage of the vaccine was in accordance with the recommendations
with injection on the day of receipt by the city pharmacy preparation and injection
of the vaccine in accordance with the recommendations. The patient underwent lab
test that included: COVID 19 antigenic test: Positive (for variant as reported) on
an unspecified date. The outcome of cough, liquid stools, dysponea and psychomotor
slowing was unknown. The outcome of vaccination failure, COVID-19 and COVID-19
antigen test positive was reported as fatal. It was unknown if an autopsy was
performed. NB: Imputability score(s) established without prejudice to the
elements of investigation that could be carried out in the context of legal or
amicable compensation procedures. No follow-up attempts were possible. No further
information was expected.; Reported Cause(s) of Death: COVID-19 antigen test
positive; COVID-19; Vaccination failure" "No prior vaccinations for this event."
"1421893-1" "1421893-1" "Vaccination failure; acute respiratory distress
syndrome with comatose state; 20May2021, positive Covid-19 PCR test, presence of a
variant.; This is a spontaneous report from a contactable physician downloaded from
the Regulatory Authority-WEB regulatory authority number FR-AFSSAPS-NY20211436,
Safety Report Unique Identifier FR-AFSSAPS-2021064802. A 95-year-old female
patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for
injection, batch/lot number: EJ6789) via intramuscular route of administration on
16Feb2021 as single dose for COVID-19 immunisation. The patient received first dose
of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number:
EJ6788) via intramuscular route of administration on 26Jan2021 as single for COVID-
19 immunisation. The patient's medical history included ongoing hypertension,
atrioventricular block (with pace-maker), ongoing hypertrophic heart disease, fall
with a fracture on a prosthesis, and on 22FEb2021 fracture surgery (favorable
operative consequences). Concomitant medication included candesartan cilexetil
(CANDESARTAN CILEXETIL) taken for an unspecified indication, start and stop date
were not reported, tramadol hydrochloride (TRAMADOL HYDROCHLORIDE) taken for pain
from 20May2021 to an unspecified stop date, mianserin hydrochloride (MIANSERIN
HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not
reported, pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start
and stop date were not reported; potassium chloride (DIFFU K) taken for an
unspecified indication, start and stop date were not reported; acetylsalicylate
lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not
reported; heparin calcium (HEPARIN CALCIUM) taken for an unspecified indication
from 20May2021 to an unspecified stop date, paracetamol (DOLIPRANE) taken for an
unspecified indication, start and stop date were not reported, risperidone
(RISPERDAL) taken for an unspecified indication, start and stop date were not
reported; furosemide (FUROSEMIDE) taken for an unspecified indication, start and
stop date were not reported. It was reported as, vaccination failure with acute
respiratory distress syndrome in a 95 years old patient, 3 months after vaccination
with 2 doses of COMIRNATY (26Jan2021 lot EJ6788, 16Feb2021 lot EJ6789) during
hospitalization after a fall with a fracture on a prosthesis (which had a
favourable outcome) leading to the patient's death. The patient's clinical
condition was satisfactory for her age (still walking). On 20May2021, the patient
presented with hoarseness of the voice. 1 hour later, she fell. Transported to the
emergency room, diagnosis of fracture on prosthesis and evidence of a COVID-19
infection, asymptomatic. 20May2021, positive COVID-19 PCR test, presence of the
British variant. On 25May2021, in the afternoon, sudden onset of a severe 70%
desaturation requiring the establishment of oxygen therapy. Diagnosis of acute
respiratory distress syndrome with comatose state leading to death around midnight.
The patient underwent lab tests and procedures which included oxygen saturation: 70
% on 25May2021 requiring the establishment of oxygen therapy, SARS-COV-2 test:
positive on 20May2021 with presence of a variant. Treatment added during
hospitalization: heparin calcium, tramadol 50 mg (1.0.1). Reduction of the dosage
of furosemide to 40 mg/day. The patient died on 25May2021. The death was due to
acute respiratory distress syndrome with comatose state. It was not reported if an
autopsy was performed. Event vaccination failure was reported with outcome event
stop date as 25May2021. No follow-up attempts are needed. No further information
was expected.; Reported Cause(s) of Death: acute respiratory distress syndrome with
comatose state" "No prior vaccinations for this event."
"1421895-1" "1421895-1" "Vaccination failure; COVID-19 respiratory infection;
Acute respiratory decompensation; Fever; This is a spontaneous report from a
contactable physician downloaded from the regulatory authority. A 87-years-old
female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection,
Lot number: EP2166) via intramuscular route of administration on 03Mar2021 as
single dose and second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot
number: EW2239) via intramuscular route of administration on 09Apr2021 as 0.3 ML
single dose both for covid-19 immunization (both at the age of 87 years). The
patient medical history and concomitant medications were not reported. On
24Apr2021, the patient had respiratory decompensation accompanied by fever. In this
context, patient was transferred to the hospital. An anti SARS-COV2 PCR test was
carried out and came back positive. In total, vaccination failure demonstrated by a
respiratory infection with COVID-19 characterized by respiratory decompensation,
which occurred on Day + 16 of a second vaccination with COMIRNATY and evolution to
death. The clinical outcome of all the events was fatal and the patient died on
07May2021. All the events were considered as the cause of death. It was not
reported if an autopsy was performed. Reporter's Comments: Reaction(s) Events
Assessed All AEs Comitnaty. Time Interval between Beginning of Drug Administration
and Start of Reaction Event 16 Days. Time Interval between Last Dose of Drug and
Start of Reaction Event 16Days. Did reaction recur on re-administration YES - UNK
rechallenge was done, outcome unknown. No follow-up attempts are possible. No
further information expected.; Reported Cause(s) of Death: Vaccination failure;
COVID-19 respiratory infection; Acute respiratory decompensation; Fever" "No
"1421897-1" "1421897-1" "Fall with a head trauma (finding of bleeding in the
head); Fall with a head trauma (finding of bleeding in the head); Fall with a head
trauma (finding of bleeding in the head); positive for COVID-19; positive for
COVID-19; Bronchitis; This is a spontaneous report from a contactable physician
downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PO20212141, Safety
Report Unique Identifier FR-AFSSAPS-2021051240. A 99-years-old female patient
received second dose of BNT162B2 (COMIRNATY, formulation solution for injection,
Batch/Lot Number: EM6950, expiration date unknown) 0.3 mL, via an intramuscular
route of administration, administered in Arm Left on 18Feb2021 as single dose for
covid-19 immunization. The patient medical history and concomitant medications were
not reported. The patient previously received first dose of bnt162b2 (COMIRNATY,
formulation solution for injection, Lot Number, and expiration date unknown) via an
unspecified route of administration on an unspecified date as single dose for
COVID-19 immunization. No information on the patient's COVID-19 history or her
medical history. Oa an unspecified date in Apr2021, the patient presented symptoms
of COVID-19 (bronchitis) and on 27Apr2021 a test was done, and it was positive for
COVID-19. On 29Apr2021, it exhibits 86 percent desaturation and was placed under
oxygen and on the same day she fell with a head trauma (finding of bleeding in the
head) and she consulted the emergency department. On return, her general condition
deteriorated rapidly. First, she gets up from her bed from time to time with the
help of a caregiver. Then gradually she no longer gets up and no longer feeds and
on 18May2021 death was declared. and reported cause of death was head trauma. An
autopsy was not performed and no death letter available. No follow-up attempts
possible. No further information expected.; Reported Cause(s) of Death: Head
trauma" "No prior vaccinations for this event."
"1423092-1" "1423092-1" "ischemic stroke; infection; progressive weakness;
poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes
and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung
infection; some lesions on her liver; a small mass in her lung,which they said were
suspicious for cancer; a small mass in her lung,which they said were suspicious for
cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-
year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose
1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-
19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia
(HLD), type II diabetes mellitus (DM2). Concomitant medications included regular
prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines
prior to four weeks. Known allergies were unknown. No COVID prior to vaccination.
Covid test post vaccination in May2021 was negative. The patient had no acute
issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing
progressive weakness and poor appetite to the point of hardly being able to walk.
The patient saw her primary doctor who ran some blood work and noticed she was
dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted
to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The
patient started having some SOB and scans done indicated possible lung infection.
The patient was switched to IV meropenem which did not help. The doctors also noted
some lesions on her liver and a small mass in her lung (no biopsy was done cause
she declined) which they said were suspicious for cancer. The patient then suffered
a large ischemic stroke and she passed about a week later. The patient was feeling
well before her vaccine and everything started to go downhill after her vaccine.
AEs result in Doctor or other healthcare professional office/clinic visit and
Emergency room/department or urgent care. The patient underwent covid test:
negative in May2021. The outcome of events weakness, decreased appetite, unable to
walk, dehydration, elevated liver enzymes, white blood cell count increased, short
of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown.
The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was
not performed. No follow-up attempts are possible; information about lot/batch
number cannot be obtained.; Sender's Comments: Based on the available information
and known product profile, the causal relationship between the reported suspicion
on malignancy and BNT162B2 use is unrelated while the causal relationship between
the remaining events and the use of BNT162B2 cannot be fully excluded. There is
limited information available which precludes a more meaningful assessment.
However, the underlying conditions and the age of the patient maybe risk factors.
The impact of this report on the benefit/risk profile of the Pfizer drug is
promptly notified to Regulatory Authorities, Ethics Committees and Investigators,
as appropriate; Reported Cause(s) of Death: ischemic stroke; infection" "No
"1423438-1" "1423438-1" ""PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism,
hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma,
Parkinsons brought to ED after her caregiver found her in bed in AM w/a ""dark
substance in her bed"" and minimally responsive. On admission vomiting x1, no
cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM
asked to take over due to rapid decline.Pt w/ shallow breathing, guarded
prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to
be without any pulse or breathing. DNR DNI with pupils fixed and dilated without
any spontaneous breathing. No pulse palpated.pronounced dead at 8:30 a.m."" "No
"1423845-1" "1423845-1" "Death 3/25/2021 Causes of death listed on patient's
death certificate: 1) COVID-19 Infection, 2) Acute Hypoxic Respiratory Failure, 3)
Acute on Chronic Deconditioning" "No prior vaccinations for this event."
"1423882-1" "1423882-1" "Death 4/1/2021 Causes of death listed on patient's
death certificate: 1) Acute on chronic respiratory failure 2) Metastatic spindle
cell malignancy Other: COVID-19, pneumonia" "No prior vaccinations for this
event."
"1424049-1" "1424049-1" "Death 3/30/2021 Causes of death listed on death
certificate: 1) Respiratory distress 2) ITP 3) COVID 19 4) Dementia Other:
acute cardiopulmonary failure" "No prior vaccinations for this event."
certificate: 1) ADULT RESPIRATORY DISTRESS SYNDROME WITH HYPOXIA 2) RAPID ATRIAL
FIBRILLATION WITH DIASTOLIC HEART FAILURE 3) COVID-19 Other: COVID-10
ENCEPHALOPATHY, COVID-19 PNEUMONITIS, MULTIPLE MYELOMA, STAGE 3 CHRONIC KIDNEY
DISEASE, TYPE 2 DIABETES MELLITUS" "No prior vaccinations for this event."
"1424514-1" "1424514-1" "COVID-19 infection; COVID-19 infection; This is a
spontaneous report from a contactable other healthcare professional downloaded from
the Regulatory Authority, regulatory authority number FR-AFSSAPS-2021072456. A 99-
year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot
number: EJ6795 and expiry date was not reported), dose 2 intramuscular on 18Feb2021
as dose 2, single for COVID-19 immunisation. Medical history included diabetes
mellitus non-insulin-dependent, ischaemic leukoencephalopathy, hypertension
arterial, chronic lymphocytic leukaemia and stroke. Reportedly, patient was
bedridden and living in nursing home. The patient concomitant medications were not
reported. The patient previously received first dose of BNT162B2 (COMIRNATY,
solution for injection, lot number and expiry date was not reported), administered
on an unknown date in Jan2021 as single dose for COVID-19 immunisation. On
20May2021, the patient had COVID-19 infection and died on an unspecified date in
May2021. The patient underwent lab tests and procedures which included PCR sars-
cov-2 test: positive on 20May2021. The patient died on an unspecified date in
May2021 due to COVID-19. It was not reported if an autopsy was performed.
Investigation summary from PQC conclusion includes that reference ID (see File
attachment in this investigation record). The complaint for fatal outcome of
PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included
reviewing the involved batch records, deviation investigation, evaluation of
reference sample, an analysis of the complaint history for the reported lot and
product type. The final scope was determined to be the associated lot(s) of the
reported lot EJ6795. A complaint sample was not returned. No related quality issues
were identified during the investigation. There is no impact on product quality,
regulatory, validation and stability. PGS concludes that the reported defect is not
representative of the quality of the batch and the batch remains acceptable. The
process determined that a regulatory notification was required. The reported defect
could not be confirmed on the evaluation of reference samples. No root cause or
CAPA were identified as the complaint was not confirmed. The outcome of the events
was fatal. No follow-up attempts possible. No further information expected. ;
Reported Cause(s) of Death: Covid-19" "No prior vaccinations for this event."
"1424517-1" "1424517-1" "COVID-19 respiratory infection; COVID-19 respiratory
infection; This is a spontaneous report from a contactable physician downloaded
from the Agency Regulatory Authority-WEB FR-AFSSAPS-LL20211639. A 97-year-old
female patient received BNT162B2 (COMIRNATY) Solution for injection, intramuscular
on 28Jan2021 (Lot Number: Unknown, at unknown age) as dose 1, single, intramuscular
on 18Feb2021 (Lot Number: Unknown, at unknown age) as dose 2, single for COVID-19
reported. It was reported that 13Mar2021 was D23, after the last injection,
appearance of dyspnea and respiratory infection COVID. The patient died on
17Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are
of Death: COVID-19 respiratory infection; COVID-19 respiratory infection" "No
"1424643-1" "1424643-1" "pulmonary embolism; tested positive for covid; pain
in her leg; Stroke; bleed on the brain; she received treatment for a clot;
collapsed with what we now know was a bleed on the brain; DVT (Deep vein
thrombosis); Influenza like illness; fatigue and feeling generally fluish; This is
a spontaneous report received from a contactable consumer by Pfizer from the
Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-
202106060242168970-PMNPP, Safety Report Unique Identifier GB-MHRA-ADR 25426673.
A 78 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid
19 vaccine), via an unspecified route of administration in Feb2021 at single dose
for COVID-19 immunisation. The medical history was Suspected COVID-19 from
03FEB2021 and ongoing. The concomitant medications were lansoprazol and losartan.
The reporter's grandmother was an outgoing healthy very alert woman who was doing
everything asked of her by isolating and taking every precaution asked of her as
was we, she received her first injection and literally within a couple of days fell
ill, she then tested positive for covid on 16FEB2021, the reporter's mother and
uncle both living with her tested negative, she was bed ridden with fatigue and
feeling generally fluish for around 10 days and Influenza like illness in Feb2021,
as she started to feel better she came downstairs insisting to make her own
breakfast and Stroke, collapsed with what we now know was a bleed on the brain in
Feb2021, she received treatment for a clot but was also diagnosed as having a
pulmonary embolism on 20FEB2021, we later found out a couple of days after the
injection she had complained of a pain in her leg in FEB2021, we think was a DVT
(Deep vein thrombosis), the patient did have underlying health issues but the
reporter has no doubt in the mind that she became ill after her vaccination. Also
considering she had a positive covid result covid was not added to her death
certificate. The patient underwent lab tests and procedures, which included COVID-
19 virus test Positive on 16FEB2021. The patient died on 20FEB2021. It's not
reported if an autopsy was performed. The cause of death was Pulmonary embolism.
The outcome of the event Pulmonary embolism was fatal, the others was unknown. No
follow-up attempts are possible; information about batch number cannot be
obtained.; Reported Cause(s) of Death: Pulmonary embolism" "No prior vaccinations
for this event."
"1425840-1" "1425840-1" "Died 5/11/2021 Causes of death listed on death
certificate: 1) covid 2) chronic lymphocytic leukemia" "No prior vaccinations
for this event."
certificate: 1. COVID 19 pneumonia 2. acute respiratory distress syndrome due to
COVID 19 3. Acute heart failure with reduced ejection fraction 4. aspergillus
pneumonia 5. history of prostate cancer, history hypertension" "No prior
"1427004-1" "1427004-1" "Died of COVID-19" "No prior vaccinations for
this event."
"1427073-1" "1427073-1" "Death on 3/12/2021. Primary cause of death was COPD,
with COVID-19 listed as an underlying cause." "No prior vaccinations for this
event."
"1427664-1" "1427664-1" "Died 3/6/2021" "No prior vaccinations for this
event."
"1427697-1" "1427697-1" "Tested positive for COVID-19 on 3/7, likely an
incidental finding. Died of liver cancer 3/17." "No prior vaccinations for this
event."
"1427848-1" "1427848-1" "Symptom onset 4/12, hospital admission date 4/19,
died 4/25. Primary cause of death COVID-19, underlying causes sepsis secondary to
COVID-19, hepatic encephalopathy, liver cirrhosis" "No prior vaccinations for
this event."
"1428052-1" "1428052-1" "cough, difficulty breathing, productive cough, 02
requirement, weakness resulting in hospitalization and death. received treatment :
Azithromycin and Decadron 02/09/2021-02/19/2020" "No prior vaccinations for
this event."
"1428156-1" "1428156-1" "This is a spontaneous report from a contactable
consumer. A 74-year-old female patient received the second dose of BNT162B2
(COMIRNATY), intramuscularly on 10May2021 (lot number: EX8679) at single dose, and
the first dose intramuscularly on 16Apr2021 (lot number: EW4815) at single dose for
COVID-19 immunisation, acetylsalicylic acid (ADIRO), via an unspecified route of
administration from 2016 and ongoing at 100 mg once a day (0-1-0) for an
unspecified indication, and ticagrelor (BRILIQUE), orally from 14May2021 and
ongoing at 90 mg twice a day for angioplasty. Medical history included hypertension
arterial, dyslipidaemia, angioplasty (elective angioplasty with vasoactive stent 2
weeks ago in the LAD (80% closure). Currently double antiaggregated), ischemic
heart disease, and exertional dyspnea. Concomitant medications included
atorvastatin for dyslipidaemia, omeprazole, amitriptyline hydrochloride/medazepam
(NOBRITOL), sertraline, paracetamol, valsartan, lorazepam (ORFIDAL), calcifediol
(HIDROFEROL), calcium carbonate/colecalciferol (NATECAL D), and chondroitin sulfate
sodium (CONDROSULF). The patient previously took metoprolol tartrate (BELOKEN) 100
mg orally and 10 mg IV, and sublingual nitroglycerin. The patient experienced
cerebral haemorrhage on 21May2021, vaccination failure on 25May2021, and sars-cov-2
test positive on 25May2021. The patient was hospitalized for cerebral haemorrhage
from 21May2021. Coronary CT scan of 15Apr2021: Coronary angiography was performed
with 64-slice CT and a low-dose technique. Patient with hypertension, DL and FA of
ischemic heart disease. Exertional dyspnea. The total radiological dose received
was DLP 309.7 mGy/cm. The coronary calcium assessment had a score of 640, which
corresponded to a 90 percentile. Coronary angiography: Coronary dominance: right.
Angioplasty is performed with an active drug stent implantation in the anterior
descending region. Distally it reaches the cardiac cross and gives the posterior
descending and posterolateral branches of good development. Other findings:
Dilation of the ascending aorta with a maximum transverse diameter of 43 mm.
Conclusion: Diffuse calcified atheroma plaques in the LAD, second diagonal and
circumflex that at some point in the LAD could lead to significant stenosis. Reason
of Admission: Low level of consciousness secondary to left lobar frontal
intraparenchymal hematoma open to ventricles with displacement of the midline and
surgically drained transtentorial herniation 24 hours ago. Patient beg TAC control.
Current illness: Patient brought as a stroke code for presenting right hemiparesis
and sudden onset language alteration around 10:00 on 21May2021. She is seen by the
Neurology Service at around 11:30, and in the initial examination, spontaneous
ocular opening, aphasia without obeying orders, gaze deviation and facial ismetry
that she does not correct are observed. As for the motor, she presents Right Lower
Limb plegia, moving the Left Lower Limb on plan. She scores on the NIHSS 23 (1
consciousness, 2 questions, 2 commands, 1 Horizontal extraocular movements, 2
visual fields, 2 facial, 4 Motor Arm, 3 Motor Leg, 1 sensitive, 3 language, 2
dysarthria, 0 ataxia, 0 neglect). They performed a cranial CT with a finding of a
left frontal lobar hematoma, for which Neurosurgery was notified, who indicated
urgent surgery. Pending intervention, she remains under observation in the
emergency room, with progressive deterioration of the level of consciousness, for
which we are notified. Upon arrival, patient at 0 degrees, with signs of
aspiration, and GCS 8 (E1, V1, M4), middle pupils with gaze deviation to the left.
She was admitted urgently to the ICU and underwent orotracheal intubation and
osmotherapy. Examination on admission: BP 140/70 mmHg, HR 80 bpm, SpO2 95%
conventional. Examination on admission: Spontaneous eye opening, lazy mydriatic
pupils. Mutist. No motor response to verbal or painful stimuli. CA: rhythmic, muted
tones. Mitral murmur II / VI. PA: generalized hypophonesis. Abdomen: soft,
depressible, without signs of peritoneal irritation. Lower Limbs: No edema. Apache
score: 25. Apache Category II: Brain Hemorrhage (SAH, ICH, SDH). Physical
exploration: Temperature (C): 37.3; Heart rate: 66 bpm; Respiratory rate: 27 RPM;
O2 saturation: 96%; Non-invasive BP: 88/56 (67). Supplementary tests: 21May2021:
Cranial CT: Large acute left frontal intraparenchymal hematoma that generates a
large mass effect with signs of subfacial and slight descending transtentorial
herniation, and with intraventricular hemorrhage. In the postcontrast study:
Filiform right vertebral artery with distal repermeabilization. Possible fetal
origin of the left PCA. Chest X-Ray (supine position), no parenchymal infiltrates,
no signs of fluid overload, no cardiomegaly, TOT, normalized CVC. 22May2021:
Control baseline cranial CT 24h after decompressive craniectomy. Summary evolution:
She returned from the operating room connected to MV and under the effects of
sedation and analgesia. Surgical incidents: Patient in supine position with head
lateralized to the right. Incision. Extended frontal parietal temporal craniectomy.
A very edematous brain is observed that begins to herniate. An acute frontoparietal
subdural hematoma is evacuated. Evacuation of a very extensive intraparenchymal
hematoma. Comprehensive and compressive hemostasis is performed with surgicel.
Dural not hermetic closure. Bone is sent in biobank. Subgaleal drainage without
vacuum. A right frontal PIC is placed. Anesthetic incidents: She arrived in the
operating room intubated under the effects of sedation and analgesia. Cefazolin
prophylaxis. Maintenance with sevorane. Dexamethasone and levetiracetam are
administered. Potassium and HCO3 are replenished. 2 PRBC and 2 platelets are
transfused. Accurate start of NA. Refers to anesthesia in a verbal report of
tension lability. The family was informed of a bad prognosis. They request extreme
anointing. Presents an episode of desaturation and hypotension in relation to
progression of TOT with left atelectasis that is resolved by mobilizing the TOT,
leaving a mark in the commissure of 21-22. She left with PEEP of 8. Coinciding with
the episode, she presented self-limited generalized tremor. Levetiracetam is
increased to 1.5 g / 12h ivA follow-up CT scan was requested at 24h showing an
increase in the size of the acute left supratentorial intraparenchymal hemorrhage,
of the acute subdural hematoma, as well as the volume and hemorrhage of the
ventricular system. New onset foci of subarachnoid hemorrhage and intra-axial
pneumocephalus. We request consultation to Neurosurgery who reject surgical
treatment. Given the situation, the foreseeable consequences and, in agreement with
the family, we made the adequacy of the treatment effort. Transplant Coordination
is notified for its evaluation. In the afternoon, on call, due to abundant
bronchorrhea and low-grade fever, we extracted selective bronchial aspiration for
multiarray film, being positive for S. aureus, covering with linezolid and
ceftriaxone. Later they warn us that it is meticillin-sensitive. The transplant
unit was informed that it will reevaluate the case next day. In the morning of
25May2021, the former pharynx is positive for SARS-CoV-2 PCR. Left lobar frontal
intraparenchymal hematoma open to ventricles with midline displacement and
transtentorial herniation. Decompressive craniectomy with evacuation of hematoma.
22May2021: Increase in the size of acute left supratentorial intraparenchymal
hemorrhage, acute subdural hematoma, as well as volume and ventricular system
hemorrhage. New onset foci of subarachnoid hemorrhage and intra-axial
pneumocephalus. Adequacy of the Treatment Effort. Exitus lethalis. The action taken
in response to the events for acetylsalicylic acid and ticagrelor was dose not
changed. The patient died on 25May2021. It was not reported if an autopsy was
Reported Cause(s) of Death: Cerebral haemorrhage; vaccination failure; SARS-CoV-2
test positive" "No prior vaccinations for this event."
"1428295-1" "1428295-1" "congested lung but saturation ok; Vaccination
failure; COVID with PCR with identification of the variant; This is a spontaneous
report from a contactable pharmacist from the Regulatory Authority (RA), regulatory
authority number FR-AFSSAPS-TO20213797. A 92-years-old male patient received
bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6789)
via intramuscular on 09Feb2021 as 2nd dose, single and first dose (COMIRNATY,
Formulation: Solution for injection, Batch/Lot Number: ES6788) via intramuscular on
19Jan2021 as 1st dose, single both for covid-19 immunisation. Medical history
included covid-19 from an unknown date and unknown if ongoing. The patient's
concomitant medications were not reported. On 07Apr2021 COVID with PCR with
identification of the variant. On 12Apr2021 congested lung but saturation ok. On
19Apr2021 still very crowded despite aerosol no cyanosis. On 21Apr2021 transferred
to hospitalization unit in the face of worsening clinical condition. On 15May2021
death of the patient in hospital. Evolution: patient died of the consequences on
15May2021 as a result of his infection with COVID 19. An autopsy was not performed.
Outcome of events were fatal. Follow-up (21Jun2021): This is a follow-up report
from Product Complaint Team. New information provided from division includes: The
complaint for LOE/adverse event of PFIZER-BIONTECH COVID-19 VACCINE was
investigated. The investigation included reviewing the involved batch records,
deviation investigation and an analysis of the complaint history for the reported
lot and product type. The final scope was determined to be the associated lot(s) of
the reported lot EJ6789. A complaint sample was not returned. No related quality
issues were identified during the investigation. There is no impact on product
quality, regulatory, validation and stability. PGS concludes that the reported
defect is not representative of the quality of the batch and the batch remains
acceptable. The process determined that no regulatory notification was required.
The reported defect could not be confirmed. No root cause or CAPA were identified
as the complaint was not confirmed. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: INFECTION COVID 19" "No prior
"1428704-1" "1428704-1" "COVID-19; Vaccination failure; COVID-19 pneumonia;
Regulatory Authority-WEB. Regulatory authority number HU-OGYI-415121. A 79-years-
old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot
Number: ET6956), via intramuscular route in the left arm on 26Apr2021 as DOSE 2,
0.3 ML, single dose for covid-19 immunization and first dose of bnt162b2
(COMIRNATY, solution for injection, Lot Number: EZ3620), via on an unspecified
route of administration on 22Mar2021 as DOSE 1, single for covid-19 immunization.
The patient's medical history included hypertension, covid-19 pneumonia, chronic
lymphocytic leukaemia in Feb2003 and received cytostatic treatments, covid-19 and
gastrooesophageal reflux disease. The patient's concomitant medications were not
reported. The patient was hospitalized on 04May2021 after experiencing Covid-19
symptoms. Antigen test was positive. The patient received covid therapy, but her
respiratory insufficiency progressed and was transferred to the Intensive Care Unit
on 09May2021. Despite therapy, permanent improvement of the patients condition
could not be reached. The patient passed away on 16May2021 at 18:49 due to Covid-19
pneumonia and ARDS. Sender Comment: The patient got infected with Covid-19
approximately 1 week after the second dose, therefore vaccination failure is
considered possible. The case is serious because the outcome was fatal. Further
information expected.; Reported Cause(s) of Death: ARDS; COVID-19" "No prior
"1429136-1" "1429136-1" "detected COVID-19 and died; detected COVID-19 and
died; Sepsis; This is a spontaneous report from a contactable other Health Care
Professional downloaded from the Regulatory Authority-WEB, regulatory authority
number NO-NOMAADVRE-FHI-2021-00297-U8e7rq. A 102-year-old male patient received
bnt162b2 (COMIRNATY), intramuscular in Jan2021 (Batch/Lot Number: Unknown) as dose
1, single and intramuscular on 27Jan2021 (Batch/Lot Number: Unknown) as dose 2,
single for COVID-19 immunisation. Medical history included living in residential
institution (DNR code minus; Evaluated as preterminal before positive corona test).
The patient's concomitant medications were not reported. The patient was living in
a nursing home (DNR code minus) was vaccinated with both doses of Comirnaty in
Jan2021 and had no adverse effects from the vaccinations. About three months later,
on 25Apr2021, he became ill and felt weak. He was diagnosed with sepsis and
treatment with antibiotics was started due to strongly increasing CRP values on
26Apr2021. He was evaluated as preterminal. An outbreak of COVID-19 disease was
discovered in his ward on the following day and all patients and staff were tested.
The disease started in an unvaccinated employee. The patient tested positive for
COVID-19 on 27Apr2021 (Variants of Concern unknown). On 27Apr2021, patient
experienced drug ineffective and COVID-19. He was isolated and was ill for about a
week before he died. Antibiotics were stopped two days before he died and
palliative care was started on the day before his death. The institution had been
followed all COVID-19 routines closely. On 27Apr2021, the patient was detected with
COVID-19 and died. The patient underwent lab tests and procedures which included c-
reactive protein: increasing on 26Apr2021 (Strongly increasing values (not
specified)) and SARS-CoV-2 PCR test: positive on 27Apr2021. The patient died on
30Apr2021. It was not reported if an autopsy was performed. The Agency assessed the
causal relationship between bnt162b2 (COMIRNATY) and all the reported events as
Possible. Reporter's comments: Reporter's qualification: Physiotherapist.
07Jun2021 Agency: information about Variants of Concern requested. No follow-up
attempts are possible; Information on batch/lot number cannot be obtained. No
further information expected.; Reporter's Comments: Physiotherapist. Reporter's
qualification: Physiotherapist 07Jun2021 Agency: information about Variants of
Concern requested; Reported Cause(s) of Death: Sepsis; COVID-19; Drug ineffective"
"1431289-1" "1431289-1" ""Date of Admission: 6/19/2021 Date of Death:
6/20/2021 Primary Care Physician: No primary care provider on file. REASON FOR
ADMISSION: Patient is a 13-year-old previously healthy male who was admitted after
out-of-hospital cardiac arrest with ROSC after CPR for 15 minutes in the field,
found to be in the context of large cerebellar hemorrhage secondary to brain lesion
(AVM vs tumor). BRIEF SUMMARY OF HOSPITALIZATION: Patient was intubated prior to
arrival to the ED. Upon arrival he was started on epinephrine and norepinephrine
drips to maintain perfusion and was administered bicarbonate x2. Head CTA was
obtained and was notable for midbrain hemorrhage and tonsillar herniation, and no
contrast enhanced blood flow in the brain. Brain death exams were completed at
09:59 and 14:20. APNEA test was performed at 13:30, which is the official time of
brain death. Official cause of death was brainstem herniation from intracranial
hemorrhage. Mechanical ventilation was continued to allow family time to grieve
and perform last rites. Time of cardiac death after mechanical ventilation
withdrawal was 18:36. HOSPITAL COURSE BY PROBLEM: FEN/Renal/Endo: #Central
DI He received 1.5 L of normal saline bolus in the ED and an additional 3 L of
ringers lactate bolus overnight in the ICU to maintain perfusion and decrease heart
rate. His sodium was 141 upon presentation but reached a maximum of 160 due to
central diabetes insipidus. He was started on 0.45% normal saline at 100 mL/hr to
improve hypernatremia, which was monitored Q1h until normonatremic. He
additionally required vasopressin drip to be started due to central DI, which was
increased to a maximum of 20 mU/kg/hr. CV: At time of admission, epinephrine was
running at 0.1 mcg/kg/min and norepinephrine was 0.1 mcg/kg/hr. Norepinephrine was
increased shortly thereafter to 0.12 mcg/kg/min. In the morning after admission,
he had tachycardia to the 190s, which appeared to be narrow complex. Epinephrine
and norepinephrine were discontinued. Two doses of adenosine were administered (6
mg first dose, 12 mg second dose) due to suspected SVT. The rate decreased for ~4
seconds after the second dose however returned to ~180. EKG arrived which showed
sinus tachycardia so no further medications or cardiac interventions were done.
Fluid rates were increased to 2x MIVF rate and additional 500 mL bolus of LR was
administered. Norepinephrine and epinephrine were restarted and escalated due to
low blood pressures in the early afternoon.to allow family time with patient. Both
titrated to effect. Pulm: Patient was mechanically ventilated to achieve normal
pH, normocarbia, and high arterial oxygen tension per brain death protocol. He had
no primary pulmonary disease during this admission. Neuro: #Intraparenchymal
hemorrhage #Tonsillar herniation Neurosurgery was consulted. Mannitol x1 and
hypertonic saline 23% x1 were administered to decrease intracranial pressures.
Keppra 2g was administered for seizure prophylaxis. No sedation was needed during
patient's hospitalization. PERTINENT STUDIES & CONSULTS: Pediatric neurology
Neurosurgery PENDING TESTS RESULTS: None RECOMMENDATIONS AND FOLLOWUP: None
No future appointments. PHYSICAL EXAMINATION: BP 108/78 | Pulse (!) 144 | Temp
36.5 �C (97.7 �F) | Resp (!) 15 | Ht 1.65 m (5' 4.96"") | Wt 46.5 kg (102 lb 8.2
oz) | SpO2 99% | BMI 17.08 kg/m� Estimated body mass index is 17.08 kg/m� as
calculated from the following: Height as of this encounter: 1.65 m (5' 4.96"").
Weight as of this encounter: 46.5 kg (102 lb 8.2 oz). ALLERGIES No Known Drug
Allergies"" "No prior vaccinations for this event."
"1431522-1" "1431522-1" "Pt's cause of death was due to COIVD -19 illness. No
one believes that the vaccine was part of the death. The patient was fully
vaccinated with 2 doses of Pfizer vaccine." "No prior vaccinations for this
event."
"1431548-1" "1431548-1" "Patient died due to COVID-19 illness after being
fully vaccinated. no one believes the death to be related to the vaccine." "No
"1431730-1" "1431730-1" "Patient died due to COVID-19 illness after being
fully vaccinated. no one believes the death to be related to the vaccine." "No
"1433128-1" "1433128-1" "Patient developed dyspnea, diarrhea, chills and
cough. Presented at the ED on 06/11 and was found to be COVID-19 positive.
Admitted to ICU Despite maximal medical intervention; including deep sedation, NMB,
flolan, intermittent pronation, steroids, a second round of Remdesivir, multiple
pressors, and full vent support, the patient continued to decline and remained with
increasing pressor requirements. He suffered severe pneumomediastinum and bilateral
pneumothoraces requiring bilateral chest tubes" "No prior vaccinations for this
event."
"1433164-1" "1433164-1" "Patient diagnosed with COVID on 6/6/21. Patient was
fully vaccinated. Patient admitted to our hospital with respiratory failure and
COVID-19 pneumonia on 6/9/21. Patient was treated with oxygen, remdesivir,
dexamethasone, and antibiotics. His pneumonia progressed, oxygen requirements
increased, and chest xray showed worsening airspace opacities and decreased
aeration. Patient's code status was updated to DNR/DNI per family request.
Patient's condition continued to deteriorate and patient expired on 6/13/21."
"1433312-1" "1433312-1" "Died of COVID-19 illness 05/14/2021" "No prior
"1433345-1" "1433345-1" "Died of COVID-19 Illness on 05/13/2021" "No prior
"1433374-1" "1433374-1" "Died of COVID-19 illness on 05/17/2021" "No prior
"1433753-1" "1433753-1" "dry cough, difficulty breathing, SOB, fatigue,
certificate: 1) COVID 19" "No prior vaccinations for this event."
certificate: 1) Acute Myocardial Infarction 2) Acute Coronary Artery Thrombosis
3) COVID-19 Other: Acute Respiratory Failure" "No prior vaccinations for this
event."
"1434441-1" "1434441-1" "Vaccination failure; serious covid; This is a
spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-
2021069690. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via
intramuscular, administered in Arm Left on 02Apr2021 (Lot Number: ET7205), dose 1
via an unspecified route of administration in Mar2021 (Batch/Lot number was not
reported), both at single dose for COVID-19 immunisation. Medical history included
COVID-19 from an unknown date and unknown if ongoing (as reported), chronic
obstructive pulmonary disease (under 1.5L of O2 at home), silicosis, prostate
cancer, radiotherapy (Mar2021), right hip prosthesis (2014) and high blood
pressure/hypertension arterial. The patient was considered as at risk for chronic
respiratory failure. The patient's concomitant medications were not reported. On
29May2021 (day 57 of Dose 2), the patient experienced vaccination failure: serious
COVID, putting on optiflow (in intensive care). The event was serious for
hospitalization and fatal. IgM + IgG negative serology on 30May2021 despite two
injections. The PCR test on 30May2021 showed positive SARS CoV2 detection (SARS
CoV2 RNA detected), conclusion: profile compatible with a 20l / 501y variant (says
English). The patient died on 07Jun2021. It was not reported if an autopsy was
performed. NB: Accountability without prejudice to the elements of investigation
which could be carried out within the framework of legal or amicable compensation
procedures. Information on the batch number has been requested. ; Reported
Cause(s) of Death: serious covid; Vaccination failure" "No prior vaccinations
for this event."
"1434474-1" "1434474-1" "Vaccination failure; COVID-19 aggravated;
hypothermia; asthenia; desaturation; This is a spontaneous report from a
contactable physician downloaded from the Agency Regulatory Authority-WEB FR-
AFSSAPS-BS20211005. Safety Report Unique FR-AFSSAPS-2021074926. A 91-year-old
female patient received bnt162b2 (COMIRNATY COVID-19 vaccine, Solution for
injection, Batch/Lot Number: EM0477), dose 2 intramuscular, administered in arm on
02Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history
and concomitant medications were not reported. Historical vaccine included bnt162b2
(COMIRNATY COVID-19 vaccine, Solution for injection, Batch/Lot Number: EM0477,
Expiry date: unknown), dose 1 intramuscular, administered in arm on 12Jan2021 as
single for covid-19 immunisation. Patient resident of a retirement home in which
several cases of COVID-19 infection were observed. The patient was not in a double
room. The patient had no history of COVID-19. The patient had not tested with
COVID-19. The was considered at risk of developing a severe form of COVID-19
disease. Day 88 (01May2021) the patient experienced, appearance of symptoms such as
hypothermia, asthenia and desaturation. A severe alteration of the patient's
general condition was observed within 24 hours. Day 93 (06May2021) a positive PCR
(polymerase chain reaction) test was performed. On 06May2021, the patient
experienced vaccination failure and covid-19 aggravated. Day 96 (09May2021): Death
of the patient due to her COVID-19 infection. Confirmed vaccine failure with COVID-
19 aggravated with indeterminate variant in an elderly subject at D88 (01May2021)
of COMIRNATY dose 2 with patient death at Day 96 (09May2021). On 01May2021, the
patient lab tests included body temperature was hypothermia, oxygen saturation was
desaturation. On 06May2021, the patient lab data included sars-cov-2 test (PCR
test) was positive. The patient died on 09May2021 and the cause of death was
vaccination failure and COVID-19, An autopsy was not performed. The outcome of the
events vaccination failure and COVID-19 aggravated was fatal. The outcome of the
events hypothermia, asthenia and desaturation was resolved on an unknown date 2021.
No follow-up attempts possible. No further information expected. ; Sender's
Comments: Linked Report(s) : FR-AFSSAPS-2021074837 ;FR-AFSSAPS-2021074856 ;FR-
AFSSAPS-2021074849 ;FR-AFSSAPS-2021074891 ;FR-PFIZER INC-2021758495 Same reporter,
different patient, different events, same vaccine;FR-PFIZER INC-2021761330 Same
reporter, different patient, different events, same vaccine;FR-PFIZER INC-
2021761343 Same reporter, different patient, different events, same vaccine;FR-
PFIZER INC-2021761348 Same reporter, different patient, different events, same
vaccine; Reported Cause(s) of Death: COVID-19 aggravated; vaccination failure"
certificate: 1) COVID 2) ATRIAL FIB 3) CKD 3 4) Hypertension" "No prior
certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19
pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal
failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure" "No
"1437946-1" "1437946-1" "COVID-19 infection resulting in severe ARDS
requiring intubation and ultimately death from COVID-19 infection." "No prior
"1438978-1" "1438978-1" "broncho-pneumonia; COVID-19; This is a spontaneous
Authority-WEB, regulatory authority number IE-HPRA-2021-073779. An 83-year-old male
patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified
route of administration on 17Jan2021 (batch/lot number and expiry date unknown) as
dose number unknown, single for covid-19 immunization. Medical history included
hypertension, aortic stenosis, dementia with lewy bodies from Mar2020. The
patient's concomitant medications were not reported. On 19Jan2021, the patient
experienced covid-19. On an unspecified date, the patient experienced broncho-
pneumonia. The physician informed that the patient experienced COVID-19 and
pneumonia following vaccination with Comirnaty for COVID-19 immunization. On
17Jan2021, the patient was vaccinated with Comirnaty and two days later
(19Jan2021), the patient experienced bronchopneumonia and tested positive for
COVID-19. The patient died due to the events on 23Jan2021 (also reported as seven
days after vaccine). It was unknown if an autopsy was performed. No follow-up
attempts are possible. Information about batch no cannot be obtained.; Reported
Cause(s) of Death: broncho-pneumonia; COVID-19" "No prior vaccinations for this
event."
"1440148-1" "1440148-1" "Body pain; Dyspnea; COVID PCR swab positive; COVID
PCR swab positive; Death; This is a spontaneous report from a contactable Other HCP
(Other Health Professional). A 74-year-old male patient received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA5715; Expiration
Date: 31May2021) at single dose on 27May2021 09:37 at age of 73-year-old for covid-
19 immunization. Medical history included hypertensive. Concomitant medications
included simvastatin, doxycycline, enoxaparin sodium (CLEXANE), oseltamivir
phosphate (TAMIFLU), chlorphenamine maleate (ALLERGEX), betamethasone
acetate/betamethasone sodium phosphate (CELESTONE). On 10Jun2021, the patient was
reported to have experienced body pain and dyspnea and patient was hospitalized
from 11Jun2021. Patient had COVID PCR swab positive on 13Jun2021. The patient died
on 13Jun2021. An autopsy was not performed. Lab results included ABG: metabolic
acidosis noted; chest presented bilateral crepitation's; oxygen saturation: 52-63
%, 88-92 %; COVID Ag test negative. The outcome of event death was fatal. The
outcome of rest events was unknown. The information on the lot/batch number has
been requested.; Sender's Comments: Based on information currently available a
causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE) cannot be completely excluded. The case will be reevaluated should
additional information including the cause of death become available. The impact of
Reported Cause(s) of Death: Death" "No prior vaccinations for this event."
"1440303-1" "1440303-1" "Severe ARDS to SARS-CoV-2 post vaccination; Severe
ARDS to SARS-CoV-2 post vaccination; Severe ARDS to SARS-CoV-2 post vaccination;
This is a spontaneous report received via medic, the regulatory authority.
Regulatory authority report number CH-SM-2021-15474. A contactable physician
reported that an 84-years-old male patient received his second dose of BNT162B2
(COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EL8723), via an
intramuscular on 19Feb2021 (at the age of 84-years-old), as 1DF, single, dose 1,
via an intramuscular route of administration on 22Jan2021 (Lot Number: E0477) as
single for covid-19 immunisation. Medical history included Arterial hypertension,
ongoing urinary incontinence, Ex-smoker (5 per day and stopped 50 years ago). The
patient had no known allergies, not alcohol consumer, not hepatopathic. The patient
had no renal disease, no kidney disease, and no liver disease. Concomitant
medications included Olmesartan medoxomil (VOTUM [OLMESARTAN MEDOXOMIL]) taken for
Arterial hypertension, start and stop date were not reported; mirabegron (BETMIGA)
taken for overactive bladder, start and stop date were not reported; zolpidem
tartrate (ZOLDORM) taken for an unspecified indication, start and stop date were
not reported. On 16Apr2021, the patient experienced severe ARDS (Acute respiratory
distress syndrome) to sars-cov-2 post vaccination. On 23Apr2021, the patient was
NSIP (Nonspecific interstitial pneumonia) admitted because of hypoxemic respiratory
failure on COVID-19 whose symptomatology begins on 16Apr2021. The patient was
hospitalized for severe ARDS (Acute respiratory distress syndrome) to sars-cov-2
post vaccination on 23Apr2021. The patient underwent lab tests and procedures which
included, blood culture: negative on 23Apr2021. X-ray thorax (26Apr2021): Compared
to the X-ray of 23Apr2021, the poorly delineated, binasal infiltrates in the right
upper lobe are progressing, suggesting a progression of the pulmonary infectious
process with possible bacterial superinfection. Blunting of the left costo-
diaphragmatic sinus in relation to a possible pleural effusion. The rest is
superimposable with respect to the comparative. computerized tomogram thorax on
23Apr2021, showed absence of pulmonary embolism visualized up to segmental. Ground
glass infiltrates, subpleural reticulations and discrete bronchiectasis speaking
primarily for fibrotic involvement of NSIP pattern. However, the radiological
pattern may correspond to an infectious viral lung disease of the SARS-Cov-2 type.
Thoracic angio-CT 23Apr2021, X-ray of Acute respiratory distress syndrome, DVT of
the muscular Bedside echocardiography on 30Apr2021, did not show indirect signs of
pulmonary hypertension suggestive of pulmonary embolism with cardiac repercussion.
The antilogical assessment on 30Apr2021 of the lower limbs shows a DVT (Deep vein
thrombosis) of muscular veins of the right and left calves, indicating
anticoagulation for 3 months. Legionella infection was negative on 26Apr2021.
Pneumonia pneumococcal was negative. Echocardiogram on 30Apr2021 LVEF 55 percent,
no dilatation of the right chambers, no LV dysfunction, no indirect signs of PH
(PAPs estimated at 35mmHg), IVC collapsed on inspiration and fibrin d dimer: 26793
ng/ml. A treatment with Ceftriaxone from 26Apr2021 (dosage regimen unknown) and
Dexamethasone from 25Apr2021, (dosage regimen unknown) is instituted. Due to an
increase in oxygen requirements, the patient was transferred to the Intensive Care
Unit at the hospital in the context of ARDS (Acute respiratory distress syndrome)
on COVID-19 for further management on 29Apr2021. On admission, the patient was in
respiratory distress and required high flow oxygen therapy and intermittent non-
invasive ventilation. Antibiotic therapy was replaced by piperacillin - tazobactam
from 30Apr2021 (dosage regimen unknown). Therapeutic anticoagulation (type of drug,
posology, dosage unknown) was empirically introduced in view of very increased D-
dimer 26793 ng/ml, making suspect a venous thromboembolic disease. A positivity for
SARS-CoV-2 IgG antibodies with positivity threshold of greater than 33.8 BAU/ml was
identified at the laboratory: 100.4 BAU/ml (30Apr2021) and 345.8 BAU/ml
(04May2021). Virus variants were not researched by the infectiologists. The patient
died on 05May2021 following the rapid deterioration of respiratory failure. It was
not reported if an autopsy was performed. The outcome of all the events was fatal.
A causal relationship between Comirnaty and COVID-19 respiratory infection and Deep
vein thrombosis was assessed as being unlikely. A causal relationship between
Comirnaty and Vaccination failure was assessed as being certain. Medic assessed
this case as serious with fatal outcome. Sender comment (Medic): Pulmonary
infection with Covid-19 ARDS (Acute respiratory distress syndrome) with admission
to intensive care and subsequent death, deep vein thrombosis, in an 84-year-old
patient in good general health except for an arterial hypertension and urinary
incontinence who had received both doses of Comirnaty (22Jan201, 19Feb2021). In
the Comirnaty monograph, it is reported that the duration of protection offered by
the vaccine was unknown, as it was still being determined in ongoing clinical
trials, and, as with any vaccine, vaccination with Comirnaty may not protect all
recipients. In particular, it is reported that subjects may not be fully protected
until 7 days after the second dose of the vaccine. In the case of this patient who
finished his vaccination cycle on 19Feb2021 and develops the first symptoms of
Covid-19 disease confirmed at the laboratory on 16Apr2021 we judge the
ineffectiveness of the vaccine as certain. In order to increase the knowledge of
the case it would have been interesting to determine the variant of the virus but
the infectivologists involved did not consider necessary this additional analysis.
Pulmonary infection with Covid-19 ARDS (Acute respiratory distress syndrome) that
led to the death of the patient, this is not a side effect noted for Comirnaty. We
therefore enter the causal role of the vaccine in Covid-19 infection as unlikely.
Finally, with regard to the deep vein thrombosis manifested by the patient, they
are not currently counted among the possible adverse events to Comirnaty either in
the monograph or in the international literature. The literature reports a first
case report of deep vein thrombosis diagnosed a few days after the second dose of
Comirnaty in a 66-year-old woman. The authors hypothesize: the intense
immunological response evoked by the second dose of vaccine could be a trigger for
the thrombotic event described, a mechanism recognized in many clinical conditions
(1). However, given the long temporal latency between vaccination and DVT, the
other possible concomitant causes most likely Covid-19 disease, immobilization for
hospitalization, we consider the causal role of the vaccine in the DVT presented by
the patient as unlikely. No follow-up attempts are possible. No further
information is expected.; Reported Cause(s) of Death: Severe ARDS to SARS-CoV-2
post vaccination; rapid deterioration of respiratory failure; Severe ARDS to SARS-
CoV-2 post vaccination" "No prior vaccinations for this event."
"1440746-1" "1440746-1" "Pneumonia, SOB, and Fatigue" "No prior vaccinations
for this event."
"1441193-1" "1441193-1" "SARS-CoV-2 test positive; Vaccination failure;
congestion with desaturation; hyperthermia; asthenia; This is a spontaneous report
from Other Health Professional downloaded from the Agency Regulatory Authority-WEB
FR-AFSSAPS-2021052593. A 90-year-old female patient received second dose of
bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number:
EJ6788), intramuscularly on 03Feb2021 as single dose and first dose of bnt162b2
(COMIRNATY, Formulation: Solution for injection Batch/Lot Number: EM0477), via an
unspecified route of administration on 13Jan2021 as single dose for covid-19
immunisation. Medical history included HTN (Hypertension), dyslipidemia,
subarachnoid hemorrhage started in 2013 (Polytrauma with subarachnoid hemorrhage
and left hemispherical subdural blade in 2013) and behavioral disorders in 20213.
The patient had no history of covid-19. The patient had no PCR test history.
Allergic history was unknown. The patient's concomitant medications were not
reported. On 15Apr2021 (onset 71 days after 2nd injection of SARS-COV-2 infection),
the patient experienced sars-cov-2 test positive, vaccine failure and congestion
with desaturation, hyperthermia, asthenia on an unspecified date. The patient
underwent lab tests and procedures which included RT-PCR (sars-cov-2 test):
positive on 15Apr2021. The patient died on 29Apr2021. An autopsy was not performed.
The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was
investigated. The investigation included reviewing the involved batch records,
deviation investigation and an analysis of the complaint history for the reported
lot and product type. The final scope was determined to be the associated lot(s) of
the reported lot EJ6788. A complaint sample was not returned. No related quality
issues were identified during the investigation. There is no impact on product
quality, regulatory, validation and stability. Regulatory Authority concludes that
the reported defect is not representative of the quality of the batch and the batch
remains acceptable. The investigative process determined that no regulatory
notification was required. The reported defect could not be confirmed. No root
cause or CAPA were identified as the complaint was not confirmed. For this lot
Adverse Event Safety Request For Investigation and/or Lack of Effect was previously
investigated. A sample was not sent to the QC-lab to determine the amount of active
ingredient since the complaint was received within six months after the release
date of the involved batch. All analytical results were checked and were within
registered limits. The investigation of the referenced PR ID resulted in the
following conclusion: Reference PR ID 5595397 (see File attachment in this
investigation record) The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-
19 VACCINE was investigated. The investigation included reviewing the involved
batch records, deviation investigation, an analysis of the complaint history for
the reported lot and product type. The final scope was determined to be the
associated lot(s) of the reported lot EM0477. A complaint sample was not returned.
No related quality issues were identified during the investigation. There is no
impact on product quality, regulatory, validation and stability. Regulatory
Authority concludes that the reported defect is not representative of the quality
of the batch and the batch remains acceptable. The investigative process determined
that a regulatory notification was required. The reported defect could not be
confirmed. No root cause. Outcome of event was fatal. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death:
infection covid-19" "No prior vaccinations for this event."
"1441262-1" "1441262-1" ""Vaccination failure/ Covid-19 infection (PCR
positive on 25May2021); Vaccination failure/ Covid-19 infection (PCR positive on
25May2021); This is a spontaneous report from a contactable other healthcare
professional (HCP), downloaded from the Regulatory Authority-WEB. The regulatory
authority number is FR-AFSSAPS-2021065718. The case was originating from a
professional health report via the agency portal number 20210527130252537. A 79-
year-old female patient received bnt162b2 (COMIRNATY, Solution for injection),
intramuscularly (IM), administered in the left arm on 05Feb2021 (Batch/Lot Number:
EJ6788, Expiration date: unknown) as dose 1, single and IM, administered in the
left arm on 19Mar2021 (Batch/Lot Number: ER9470, Expiration date: unknown) as dose
2, single, for COVID-19 immunization. Relevant medical history included atrial
fibrillation, cardiac failure (heart failure), sleep apnea, ankylosing spondylitis,
congestive (dilated) cardiomyopathy, breast cancer (neoplasm breast), stroke
(history of multiple strokes), insufficiency renal (kidney failure), hypertension
arterial (hta, high blood pressure), and colonic diverticulosis (bowel
diverticulosis, diverticulosis of the intestine). The patient had no history of
allergy or long-term treatment informed. The patient's concomitant medications were
not reported. The patient experienced vaccination failure, further reported as
Covid-19 infection with polymerase chain reaction (PCR) positive on 25May2021. It
was further reported that the patient had COVID-19 vaccination for D1 + D2;
confirmed vaccination failure. The patient tested positive for COVID-19 on
25May2021. On 26May2021, the patient presented with a Covid-19 infection (PCR
positive on 25May2021) with respiratory decompensation and tachycardia. On
27May2021, she was hospitalized urgently. The patient died on 29May2021. An autopsy
was not performed. On 21Jun2021, investigation result was received from Product
Quality Complaints Group. The complaint for adverse event/LOE of ""PFIZER-BIONTECH
COVID-19 VACCINE"" was investigated. The investigation included reviewing the
involved batch records, deviation investigation and an analysis of the complaint
history for the reported lot and product type. The final scope was determined to be
the associated lot(s) of the reported lot EJ6788. A complaint sample was not
returned.No related quality issues were identified during the investigation. There
is no impact on product quality, regulatory, validation and stability. The company
concludes that the reported defect is not representative of the quality of the
batch and the batch remains acceptable.The NTM process determined that no
regulatory notification was required. The reported defect could not be confirmed.
No root cause or CAPA were identified as the complaint was not confirmed. For this
lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was
previously investigated. A sample was not sent to the QC-lab to determine the
amount of active ingredient since the complaint was received within six months
after the release date of the involved batch. All analytical results were checked
and were within registered limits. The investigation of the Reference PR ID 5832496
resulted in the following conclusion: The complaint for PFIZER-BIONTECH COVID-19
VACCINE was investigated. The investigation included reviewing the involved batch
records, deviation investigation and an analysis of the complaint history for the
reported lot and product type. The final scope was determined to be the associated
lot(s) of the reported lot ER9470. A complaint sample was not returned. No related
quality issues were identified during the investigation. There is no impact on
product quality, regulatory, validation and stability. The company concludes that
the reported defect is not representative of the quality of the batch and the batch
remains acceptable. The NTM process determined that no regulatory notification was
required. The reported defect could not be confirmed. No root cause or CAPA were
identified as the complaint was not confirmed. No follow-up attempts are
possible. No further information is expected.; Reported Cause(s) of Death:
Vaccination failure/ Covid-19 infection (PCR positive on 25May2021); Vaccination
failure/ Covid-19 infection (PCR positive on 25May2021)"" "No prior vaccinations
for this event."
"1441289-1" "1441289-1" "COVID-19 aggravated; drug ineffective; Neurological
impairment; comatose; poor communication; respiratory impairment; This is a
Authority-WEB, regulatory authority number FR-AFSSAPS-2021072167. A 89-years-old
male patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19
VACCINE, Formulation: Solution for injection, Lot Number: EX0893; Expiration Date:
unknown) intramuscular, administered in Arm Left on 21Apr2021 as 0.3 mL single dose
for COVID-19 immunization. Medical history included chronic kidney disease,
depression, hypertension, type 2 diabetes mellitus, cardiac failure, dementia and
obesity from an unknown date and unknown if ongoing and also included ethylism from
an unknown date to unknown date. The patient's concomitant medications were not
reported. During the course of the injection, no manifestation of adverse effects
and patient was clinically stable. On 11May2021 the patient experienced COVID-19
aggravated, drug ineffective, neurological impairment, comatos, poor communication
and respiratory impairment. The patient underwent lab tests and procedures which
included SARS-COV-2 test which positive on 11May2021. The outcome of events
neurological impairment, comatos, poor communication and respiratory impairment was
unknown. The patient died on 23May2021 due to COVID-19 infection. An autopsy was
not performed. No follow-up attempts possible. No further information expected.;
Reported Cause(s) of Death: COVID-19 infection" "No prior vaccinations for this
event."
"1444329-1" "1444329-1" ""Vaccination failure; COVID-19 confirmed by positive
COVID-19 test; This is a spontaneous report from a contactable consumer downloaded
from the WEB, regulatory authority number FR-AFSSAPS-AN20212122. Safety Report
Unique Identifier FR-AFSSAPS-2021067825. An 85-year-old male patient received
BNT162B2 (COMIRNATY), via intramuscular on 26Jan2021 (Batch/Lot Number: UNK) as
dose 1, single, then via an unspecified route of administration on 16Feb2021 (Lot
Number: EJ6789) as dose 2, single for COVID-19 immunisation. Medical history
included cancer of lung from an unknown date (also reported as pulmonary neoplasia)
and living in nursing home from 18Jan2021. The patient's concomitant medications
were not reported. Patient information regarding COVID-19 virus: person at risk of
developing a severe form of COVID-19 disease was answered as yes / no (as
reported), previous Covid-19: yes (pulmonary neoplasia), Covid-19 test: PCR /
serology: positive on 22Apr2021, unknown allergy / hypersensitivity medical
history. It was reported that the patient presented vaccination failure 2 months
after first and second administration (also reported as more than 2 months after a
complete vaccination schedule) of COMIRNATY. It was stated that patient was
vaccinated with a first and a second dose of COMIRNATY vaccine on 26Jan2021 and
16Feb2021. More than 2 months later, on 22Apr2021 the PCR was positive. It was
further reported that the patient was already very fragile because he arrived in
the nursing home for the end of life of a pulmonary neoplasia. His condition was
already degraded when he entered on 18Jan2021. According to the director, her death
was more related to her pulmonary neoplasia than to COVID. The patient underwent
lab tests and procedures which included Covid-19 PCR test: positive on 22Apr2021.
The outcome of the events was fatal. The patient died on 28Apr2021. An autopsy was
not performed. Investigational results received on 21Jun2021 regarding the
complaint for this lot Adverse Event Safety Request For Investigation and/or Lack
Of Effect was previously investigated. A sample was not sent to the QC-lab to
determine the amount of active ingredient since the complaint was received within
six months after the release date of the involved batch. All analytical results
were checked and were within registered limits. The investigation of the referenced
ID resulted in the following conclusion: Reference PR ID 5732035 (see File
attachment in this investigation record) The complaint for LOE/adverse event of
""PFIZER-BIONTECH COVID-19 VACCINE"" was investigated. The investigation included
reviewing the involved batch records, deviation investigation and an analysis of
the complaint history for the reported lot and product type. The final scope was
determined to be the associated lot(s) of the reported lot EJ6789. A complaint
sample was not returned. No related quality issues were identified during the
investigation. There is no impact on product quality, regulatory, validation and
stability. PGS concludes that the reported defect is not representative of the
quality of the batch and the batch remains acceptable. The NTM process determined
that no regulatory notification was required. The reported defect could not be
confirmed. No root cause or CAPA were identified as the complaint was not
confirmed. No follow-up attempts are possible; information about lot/batch number
cannot be obtained.; Reported Cause(s) of Death: cancer pulmonaire"" "No prior
"1444447-1" "1444447-1" ""PCR COVID-19 positive/fever of 39�, respiratory
congestion and a neurological delay; Vaccination failure/PCR COVID-19
positive/fever of 39�, respiratory congestion and a neurological delay; fall with
subsequent onset of vomiting; fall with subsequent onset of vomiting; This is a
spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-
2021065905. A 92-years-old female patient received bnt162b2 (COMIRNATY), dose 2
intramuscular on 18Feb2021 (Lot Number: EK9788) as DOSE 2, SINGLE, dose 1
intramuscular on 14Jan2021 (Lot Number: unknown) as DOSE 1, SINGLE for COVID-19
immunisation. Medical history included chronic myelomonocytic leukaemia (chronic
myelomonocytic leukaemia with chronic multitransfuse anaemia, no immunosuppressive
treatment), Type II diabetes mellitus, polymyalgia rheumatica, Pneumopathy from
May2014 (Right basal pneumopathy), Hypertension arterial, atrial fibrillation,
hypercholesterolaemia, Cognitive disturbance from May2014 (Moderate cognitive
impairment with mini-mental state at 20/30 in May2014), Arthrosis, Epilepsy
(Sequelae vascular epilepsy), Ischaemic stroke from 2012 (Sylvian superficial left
stroke), Thrombosis venous deep (Left twin deep vein thrombosis), Sleep apnoea
syndromes (not treated with a device), Rhizomelic pseudopolyarthritis (Rhizomelic
pseudopolyarthritis secondary to chronic myelomonocytic leukaemia), bimalleolar
fracture (Left bi-malleolar fracture), chronic multitransfuse anaemia,
Osteoarthritis. Concomitant medications included folic acid (FOLIC ACID);
lamotrigine (LAMOTRIGINE); warfarin sodium (COUMADIN); risperidone (RISPERDAL);
cholecalciferol (CHOLECALCIFEROL); alendronic acid (ALENDRONIC ACID); bisoprolol
(BISOPROLOL); esomeprazole (ESOMEPRAZOLE); oxazepam (OXAZEPAM); paracetamol
(PARACETAMOL); calcium, colecalciferol (CALCIUM VITAMIN D3); ferrous sulfate
(FERRO-GRAD); ascorbic acid (VITAMIN C). The patient experienced PCR covid-19
positive on 20Apr2021, vaccination failure on 21Apr2021, fall with subsequent onset
of vomiting of food on 20Apr2021. The patient died on 30May2021. Outcome of fall
and vomiting was recovered. It was not reported if an autopsy was performed. The
clinical course was reported as follows: Patient on 20Apr2021 suffered a fall with
subsequent onset of vomiting of food on several occasions. Referred to the
emergency department at the end of the day in view of a fever of 39�, respiratory
congestion and a neurological delay. Covid19 polymerase chain reaction test
performed that came back positive with the variant. Computerised tomography brain
and chest scan did not show recent intracranial bleeding but moderate Covid19
involvement between 25 and 50%. Patient hospitalized on 21Apr2021. Dual antibody
therapy on 21Apr2021 (bamlanivimab and etesevimab). Antibiotic initially introduced
with amoxicillin;clavulanic acid (AUGMENTIN) then piperacillin sodium;tazobactam
sodium (TAZOCILLIN) due to the persistence of fever and inflammatory syndrome. In
view of a suspicion of deterioration related to Covid19, treatment of 7 days with
Dexamethasone from 27Apr2021 to 03May2021. Eventually favourable evolution with
decrease in C-reactive protein and oxygen weaning. Discharge from the hospital on
10May2021. Afterward, deterioration of her general condition with confinement to
bed, increase in cognitive problems and appearance of awareness problems. The
patient was described as uncomfortable at the residential care home: Transfer to a
palliative care department on 22May2021. Deceased on 30May2021. Investigation
result received from Product Complaint Team: For this lot Adverse Event Safety
Request For Investigation and/or Lack Of Effect was previously investigated. A
sample was not sent to the QC-lab to determine the amount of active ingredient
since the complaint was received within six months after the release date of the
involved batch. All analytical results were checked and were within registered
limits. The investigation of the referenced PR ID resulted in the following
conclusion: The complaint for ""PFIZERBIONTECH COVID-19 VACCINE"" was investigated.
The investigation included reviewing the involved batch records, deviation
investigation and an analysis of the complaint history for the reported lot and
product type. The final scope was determined to be the associated lot(s) of the
reported lot EK9788. A complaint sample was not returned. No related quality issues
were identified during the investigation. There is no impact on product quality,
regulatory, validation and stability. PGS concludes that the reported defect is not
representative of the quality of the batch and the batch remains acceptable. The
NTM process determined that no regulatory notification was required. The reported
defect could not be confirmed. No root cause or CAPA were identified as the
complaint was not confirmed. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: PCR COVID-19 positive/fever of
39�, respiratory congestion and a neurological delay; Vaccination failure/PCR
COVID-19 positive/fever of 39�, respiratory congestion and a neurological delay""
"1444648-1" "1444648-1" "Vaccination failure; Covid-19; This is a spontaneous
report from a contactable pharmacist downloaded from the Regulatory Authority-WEB,
regulatory authority number FR-AFSSAPS-NT20211545, Safety Report Unique Identifier
FR-AFSSAPS-2021053045. A 92-year-old male patient received bnt162b2 (COMIRNATY),
intramuscular on 09Feb2021 (lot number: EJ6789) as dose 2, single and on 19Jan2021
(lot number: EJ6795) as dose 1, single for COVID-19 immunisation. Medical history
included skull trauma on road accident. Concomitant medications included
risperidone and potassium chloride (DIFFU K). The patient had the 1st dose on
19Jan2021 and 2nd dose on 09Feb2021. The patient had a vaccination failure and the
patient presented with fever on 02May2021, then desaturated on 05May2021 and he
died on 06May2021. It was not reported if an autopsy was performed. The patient
underwent lab tests and procedures which included positive polymerase chain
reaction (PCR) test on 03May2021. As of 21Jun2021, investigational result from
regulatory authority team was reported as follows: a sample was not sent to the QC-
lab to determine the amount of active ingredient since the complaint was received
within six months after the release date of the involved batch. All analytical
results were checked and were within registered limits. The investigation resulted
in the following conclusion: the investigation included reviewing the involved
batch records, deviation investigation and an analysis of the complaint history for
the reported lot and product type. The final scope was determined to be the
associated lot of the reported lots EJ6789 and EJ6795. A complaint sample was not
returned. No related quality issues were identified during the investigation. There
is no impact on product quality, regulatory, validation and stability.
Manufacturing site concludes that the reported defect is not representative of the
quality of the batch and the batch remains acceptable. The regulatory authority
process determined that no regulatory notification was required. The reported
defect could not be confirmed. No root cause or corrective action were identified
as the complaint was not confirmed.; Sender's Comments: Linked Report(s) : FR-
PFIZER INC-2021718442 Diffrent patient, same reporter, same event, same suspected
drug;FR-PFIZER INC-2021718399 Diffrent patient, same reporter, same event, same
suspected drug;FR-PFIZER INC-2021718925 Diffrent patient, same reporter, same
event, same suspected drug;FR-PFIZER INC-2021718387 Diffrent patient, same
reporter, same event, same suspected drug;FR-PFIZER INC-2021718379 Diffrent
patient, same reporter, same event, same suspected drug;FR-PFIZER INC-2021718931
Diffrent patient, same reporter, same event, same suspected drug;FR-PFIZER INC-
2021729179 Diffrent patient, same reporter, same event, same suspected drug;FR-
PFIZER INC-2021718394 Diffrent patient, same reporter, same event, same suspected
drug;FR-PFIZER INC-2021718431 Diffrent patient, same reporter, same event, same
suspected drug; Reported Cause(s) of Death: COVID-19" "No prior vaccinations for
this event."
"1446875-1" "1446875-1" "Patient is an 83 year old male admitted with COVID
respiratory failure who has end stage COPD. His condition declined throughout
hospitalization and expired 7/2/2021." "No prior vaccinations for this event."
"1454004-1" "1454004-1" "covid19 pneumonia; (positive test) PCR; COVID-19
infection after vaccination; Death; drug ineffective; This is a spontaneous report
from a contactable physician downloaded from the Regulatory Agency-WEB BE-FAMHP-
DHH-N2021-95404. A 88-year-old male patient received bnt162b2 (COMIRNATY Solution
for injection Batch/Lot Number was not reported) via an unspecified route of
administration on 30Apr2021 as dose 1, single for COVID-19 immunisation. Medical
history included double bypass, nephrectomy, hypertension, diabetic, overweight
(BMI 29), all from an unknown date and unknown if ongoing. Concomitant medications
included ticlopidine hydrochloride (TICLID); allopurinol (ZYLORIC); omeprazole
(OMEPRAZOLE); tamsulosin (TAMSULOSIN); simvastatin (SIMVASTATIN); metoprolol
fumarate (LOPRESOR [METOPROLOL FUMARATE]); molsidomine (CORUNO), all taken for an
unspecified indication, start and stop date were not reported. On 19May2021, the
patient experienced COVID-19 infection after vaccination, death. On 28May2021,
patient had (positive test) PCR. On 28May2021, the patient was hospitalized for
covid19 pneumonia with severe parenchymal involvement of around 50%. The patient
was already on antibiotic therapy, anticoagulation therapy and corticosteroids
before admission. Intensive care hospitalization, ventilation under LNHD (high flow
nasal cannula). The patient underwent lab tests and procedures which included CT
Scan resulted as parenchymal involvement of around 50% on 28May2021, COVID-19 PCR
resulted as positive on 28May2021. The patient died on 05Jun2021 and the cause of
death was COVID-19. It was not reported if an autopsy was performed. The clinical
outcome of the event was fatal and outcome of the event drug ineffective was
unknown. Sender's comments: Covid after first dose.; Reporter's Comments: Summary
of reporter's comments: description of medications used prior to admission,
description of hospitalization workup, description of event, lab data, diagnostic
procedures, date of vaccination and onset of symptoms; Reported Cause(s) of Death:
patient. Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was
admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen
(75%) and tested positive for COVID-19 via a PCR test. The patient passed away on
07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573." "No
"1454278-1" "1454278-1" "Breakthrough death resulted from COVID." "No prior
"1454364-1" "1454364-1" "~5 months following vaccination, COVID-19 infection:
Abnormal CXR, fatigue, cough, shortness of breath, confusion, COVID RNA positive;
Patient died as result of illness 4 days after admittance to hospital from nursing
home." "No prior vaccinations for this event."
"1454552-1" "1454552-1" "Patient vaccinated with pfizer COVID vaccines
02/26/21 and 03/18/21 Patient presented to ER due to nonhealing lesion of right
heel as well as erythema and was admitted on 06/15/21 Patient tested negative for
COVID-19 on 06/15/21 Patient deteriorated and tested again for COVID-19 and
positive on 06/28/21 Patient expired on 07/01/21" "No prior vaccinations for
this event."
"1454753-1" "1454753-1" "Pt had long complicated course spanning almost a
month. He was initially admitted for right intertrochanteric hip fracture
(following a fall at home) for which he required surgery. Also had bacterial
pneumonia and received Zosyn. He was close to discharge at 1 point but then had
Covid testing done which came back positive. He gradually worsened from there with
acute hypoxic respiratory failure and very poor oral intake. He had multiple
episode of hypoglycemia and required D5. He was made care only but improved on his
own and was back on medical Mx. It did not last long and he again became very
tachypnic in 60s and hypoglycemic. He was made care again. Pt passed away
peacefully with his daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1.
Cardiopulmonary arrest due to reason #2 2. Failure to thrive due to reason #3 3.
Old age and COVID-19 No autopsy performed." "No prior vaccinations for this
event."
"1454790-1" "1454790-1" "Patient tested positive for COVID-19 on 03/29/2021
via both antigen and PCR despite being fully vaccinated. She was subsequently
hospitalized and then died on 03/30/2021. Symptom onset for COVID-19 was
03/23/2021, with symptoms of fever (101.8) and respiratory distress which required
an increase in oxygen. Per the death certificate, causes of death are as follows:
Part 1: Cause of Death: A. Multi organ failure B. COVID-19 infection Part 2: Other
Significant Conditions: Congestive Heart Failure, Diastolic Heart Failure with
Preserved Ejection, history of cerebrovascular accident, diabetes mellitus type 2,
and morbid obesity" "No prior vaccinations for this event."
"1454812-1" "1454812-1" "Patient admitted to the hospital with shortness of
breath and cough after being diagnosed with pneumonia in the clinic. He was
found to have Covid pneumonia and was treated with maximal support but
unfortunately became profoundly delirious and developed worsening hypoxia
associated with Covid pneumonia. Family was called to the bedside due to
progression in his illness and concerns for cardiac dysrhythmias occurring in the
setting of worsening hypoxia on maximal support. Decision was made to
transition to comfort care and aggressive life-prolonging interventions were
discontinued for primary focus on comfort. Patient subsequently expired at
1810 on 04/18/2021. Patient was vaccinated against COVID 19. Death
Certificate Information: Part 1: Cause of Death: A. COVID B. SARS COVID 19 Part
2: Other Significant Conditions: Diabetes Mellitus Type 2, Coronary Artery Disease,
Hypertension, Hyperlipidemia" "No prior vaccinations for this event."
"1454861-1" "1454861-1" "Patient admitted to hospital on 03/24/2021 for high
fever and shortness of breath; these symptoms began in 3/17. Patient tested
positive for COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully
vaccinated against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the
death certificate. Death Certificate Information: Part I Cause of Death: A.
Acute Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II:
Significant Other Conditions: COVID 19 subacutely" "No prior vaccinations for
this event."
"1454878-1" "1454878-1" "65-year-old with history of TBI and end-stage renal
disease subsequently initially admitted to the floor secondary to fever and chills.
Found to have COVID-19 pneumonia. On June 13 a rapid response was called for
worsening respiratory failure. Subsequently transferred to ICU. Initially on CPAP
at 100% FiO2. CTA negative for PE but did show diffuse ground glass infiltrates.
Completed 10 days of dexamethasone. Not a candidate for remdesivir given end-stage
renal disease. Additionally on cefepime and Rocephin for 10 days subsequently
restarted on meropenem. Fortunately patient continued to have hypoxemia
unresponsive to noninvasive ventilation. He was intubated on June 19. At the time
of intubation he expresses desire not to be intubated for an extended period of
time. Unfortunately they are unable to wean from ventilator. Remains on 100% FiO2
with PEEP of 18 and was on nitric oxide. In addition was on paralytics. Remained on
prednisone taper off of dexamethasone. In addition to above patient had
complications A. fib with RVR further complicated by hypotension. Was on 3
pressors. Suspect multifactorial to sedation and patient with severe Covid who also
has end-stage renal disease. SLED initiated while in-house. On the afternoon of
June 23 palliative team did meet with patient's siblings. That time determined to
transition to comfort care. Compassionate extubation performed. Patient passed away
shortly after extubation. Patient died of COVID-19 despite being fully vaccinated
against it. Death Certificate Information: Part I: Cause of Death A. Respiratory
Failure B. Pneumonia C. COVID-19 Part II Other Significant Conditions:
Hypertension, Diabetes Mellitus Type 2, End Stage Renal Disease" "No prior
"1454969-1" "1454969-1" "COVID-19; This is a spontaneous report from a non-
contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB,
regulatory authority number DE-PEI-CADR2021107017. A 74-years-old female patient
received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection,
lot number: ET3045 expiry date Unknown) via unspecified route of administration, on
14Apr2021 (age at vaccination: 74-years-old ) at 0.3 mL as single dose for COVID-19
immunization. Medical history and concomitant medications were not reported. The
patient became ill with Covid-19, 2 days after the first vaccination and there was
development of first symptoms on 16Apr2021. From 25Apr2021 she had to be
ventilated, and from 17May2021 Palliative care was given. The affected person died.
The outcome of event was fatal. Senders comments: The affected person became ill
with Covid-19 2 days after the first vaccination, development of first symptoms on
16Apr2021. From 25Apr2021 she had to be ventilated, from 17May2021 Palliative care.
The affected person died. Result of Assessment: Comirnaty/event(s): COVID-
19/Regulatory Authority: D. Unclassifiable No follow-up attempts possible. No
further information expected.; Reported Cause(s) of Death: COVID-19" "No prior
"1455396-1" "1455396-1" "Vaccination failure; Test Covid-19 : PCR : positive;
This is a spontaneous report from a contactable pharmacist downloaded from the
Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-
2021079944. A 92-year-old male patient received BNT162B2 (COMIRNATY, PFIZER-
BIONTECH COVID-19 VACCINE, formulation; solution for injection, Batch/Lot number:
EJ6788, Expiration date: Not reported), dose 2 intramuscular, administered in Arm
Left on 26Jan2021 as DOSE 2, SINGLE and dose 1 intramuscular, administered in Arm
Left on 05Jan2021 (Batch/Lot Number: EJ 6795) as dose 1, single for covid-19
immunisation. Medical history included diabetes, arterial hypertension,
haemorrhagic stroke and cognitive disorders of vascular origin with behavioural
disorder (degree of dependence GIR 2). The patient's concomitant medications were
not reported. Patient had no history of allergy/ hypersensitivity and COVID-19. On
11May2021, the patient experienced vaccination failure and test covid-19 : pcr :
positive. It was reported that person at risk of development of severe form of
COVID-19. On 11May2021, no clinical changes for the resident, no respiratory signs.
On 14May2021, asthenia with swallowing difficulties, moderate fatty cough,
Peripheral circulatory insufficiency and crackles at right base. Hypothesis of
inhalation pneumonia with septic syndrome. It was reported that in accordance with
family, decision not to hospitalize, no relentless treatment and comfort care. On
14May2021, treatment by subcutaneous hydration, preventive Lovenox, oxygen,
ceftriaxone. On 15May2021, fatty cough. Presence of abnormal movements, improved by
bolus of midazolam. Patient also treated with scopolamine patch, electric syringe
pump of midazolam 1mg/24h and bolus of 1mg midazolam if needed. Stop of treatments
via oral route. On 17May2021, Patient calm, conscious, bronchopulmonary congestion.
Patient Oxygen increased to 3L/min Then in the evening: very severe vomiting with a
sign of shock (marbling) and acute respiratory distress. Agitation, desaturation.
Increase of oxygen to 6 L / min. Increase of midazolam to 1mg/h, electric syringe
pump of morphine to 1mg/h. On 18May2021, Stationary clinical state without
improvement. On the request of the family and after collegial advice,
implementation of deep sedation and cessation of all treatments: oxygen, hydration,
antibiotics. CONCLUSION: Patient with Covid-19 pneumonia leading to death after two
doses of COMIRNATY vaccine. Summary: Man who has Covid-19 pneumonia resulting in
his death after 2 administrations of COMIRNATY. Time interval between beginning of
drug administration and start of reaction was 127 days; Time interval between last
dose of drug and start of reaction was 106 days. The patient underwent lab tests
and procedures which included blood pressure measurement: 87/50 on 14May2021, body
temperature: 38.2 Celsius on 14May2021, body temperature: 37.6 Celsius on
17May2021, heart rate: 95 on 14May2021 /min , oxygen saturation: 89-91 % on
14May2021, oxygen saturation: 80 % on 17May2021 under 2L of O2/min , sars-cov-2
test: positive (screening following contamination of a caregiver) on 11May2021.
Patient was received treatment for event. The patient died on 19May2021 at 8h
40min.. An autopsy was not performed. No follow-up attempts are possible. No
further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonitis"
"1455999-1" "1455999-1" "COVID-19 pneumonia; Covid positivity; Drug
ineffective; This is a spontaneous report received from a contactable physician
HU-OGYI-484121. A 62-year-old female patient received first dose of BNT162B2
(COMIRNATY, formulation: Solution for injection, Batch/lot number: ET7205) via an
intramuscular route of administration on 01Apr2021 as O.3 ml single dose and second
dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number:
EX6537) via an intramuscular route of administration in the left arm on 06May2021
as 0.3ML single dose for covid-19 immunisation. The patient's medical history and
concomitant medications were not reported. On 07May2021, the had drug ineffective
and had covid positivity. On 15May2021, the experienced covid-19 pneumonia. The
patient underwent lab tests and procedures which included sars-cov-2 test was
positive on 07May2021. The patient died on 04Jun2021. It was not reported if an
autopsy was performed. The outcome of the events was fatal. Sender Comment:
second dose of the vaccine. The patient got infected with the virus 1 day after the
second dose, therefore immunity may have not developed yet. Based on the above, the
causal relationship is unlikely between the suspected drug and the adverse events.
The case is considered serious because the outcome was fatal. Further information
is not expected. No follow-up attempts possible. No further information expected.
Information on batch/lot number already obtained.; Reported Cause(s) of Death:
"1457207-1" "1457207-1" "Patient was fully vaccinated. Doses on 1/14/21 and
2/4/21. Diagnosed with COVID-19 on 6/21/2021 and passed away on 7/3/2021." "No
"1458406-1" "1458406-1" "drug ineffective; covid-19; covid-19 pneumonia;
pulmonary embolism; This is a spontaneous report received from a contactable
physician downloaded from the Regulatory Authority-WEB. The regulatory authority
report number is HU-OGYI-520221. An 85-year-old male patient received the first
dose of BNT162B2 (COMIRNATY concentrate for dispersion for injection, Batch number:
ET3620 and Expiry date: Not reported) via intramuscular route of administration, in
the right arm on 23Mar2021 as single dose for COVID-19 immunisation. The patient
medical history included hypertension, ischaemic heart disease and post
cholecystectomy syndrome. The patient concomitant medications were not reported.
From 09Apr2021, the patient experienced weakness, cough, chills and dyspnoea. On
16Apr2021, the patient was hospitalized. His COVID-19 rapid POC test was positive.
Chest CT showed pulmonary embolism and COVID-19 pneumonia. Despite medical
treatment, on 21Apr2021, the patient died. Cause of death reported as drug
ineffective, COVID-19, COVID-19 pneumonia and pulmonary embolism. Autopsy was
performed, the results were not provided. Outcome of the events was fatal. Sender
Comment: COVID-19, COVID-19 pneumonia and pulmonary embolism after vaccination with
Comirnaty was not expected. TTO was 2 weeks 3 days until development of symptoms
and 3 weeks 4 days until hospitalization. TTO was calculated based on the first
dose of the vaccine. Dechallenge and rechallenge were not applicable. The causal
relationship between the suspected drug and the events was considered not
assessable per lack of information. The case was considered serious due to
hospitalization and fatal outcome. No follow-up attempts possible. No further
information expected.; Reported Cause(s) of Death: drug ineffective; COVID-19;
COVID-19 pneumonia; Pulmonary embolism" "No prior vaccinations for this event."
"1459409-1" "1459409-1" "Died of COVID-19 on 05/26/2021 Symptoms: Dyspnea
(shortness of breath), Fatigue" "No prior vaccinations for this event."
"1459444-1" "1459444-1" "Died of COVID-19 illness on 06/02/2021 Symptoms: low
oxygen levels" "No prior vaccinations for this event."
"1459461-1" "1459461-1" "From EMR: Immediate cause of death: acute hypoxemic
respiratory failure (2 days from onset to death) Secondary conditions leading to
death: pneumonia (2 days from onset to death) COVID-19 (2 weeks) Other conditions
present at time of death: coronary artery disease, Parkinson dementia, pulmonary
embolism Was smoking a factor: no COD listed as COD listed as CARDIAC ARREST,
COVID-19 PNEUMONIA, HYPOXIC ISCHEMIC ENCEPHALOPATHY, ASPIRATION PNEUMONIA Died of
COVID-19 illness on 06/13/2021" "No prior vaccinations for this event."
"1459478-1" "1459478-1" "Died of COVID-19 illness on 06/14/2021 Immediate
Cause of Death: Acute respiratory distress syndrome with respiratory failure Due To
or as a Consequence Of: COVID-19 infection Interval between Onset & Death: 4 days
COD listed as ACUTE RESPIRATORY DISTRESS SYNDROME WITH RESPIRATORY FAILURE INTERVAL
BETWEEN ONSET & DEATH and COVID-19 INFECTION INTERVAL BETWEEN ONSET & DEATH" "No
"Total" "COVID-19" "10084268" "COVID19 (COVID19 (PFIZER-BIONTECH))" "1200"
� �
"COVID-19" "10084268" "COVID19 (COVID19 (UNKNOWN))" "1202" "1247588-1"
"1247588-1" "Shortness of breath in early March, hospitalized on 3/17/2021,
was COVID positive and was found to have pulmonary emboli" "No prior vaccinations
for this event."
"COVID-19" "10084268" "COVID19 (COVID19 (UNKNOWN))" "1202" "1413624-1"
"1413624-1" "COVID-19 PCR test positive; Covid-19; This initial Information
regarding this unsolicited valid serious death case was received on 14-Jun-2021
from a non-healthcare professional (unknown relationship with patient) through
Business Partner, which was forwarded to Regulatory Authority on 15-Jun-2021. On
14Jun2021, Regulatory Authority received a report of a serious adverse event after
the use of influenza vaccine through the customer service. The reporter, profession
not informed, reports that the patient, (comorbidity, continuous medication use,
and unknown demographics), received the first dose of the adsorbed covid-19
(inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. On 16/May/2021 the
patient had the first symptom of Covid-19 [Covid-19] (patient had unspecified
treatment for 7 days), and on 24/May/2021 the patient underwent PCR (Polymerase
chain reaction) test: positive. On an unspecified date the patient had to be
admitted to the ICU (intensive care unit) and died on 07/Jun/2021 as a result of
complications in the disease-related condition. On 14/Jun/2021 after receiving the
initial e-mail, we received more information about the case, in which data from the
reporter, the patient, medical history, concomitant and treatment medications, and
the evolution of the patient's condition were reported. On the same date, we
received information about the patient's vaccination status, in which he reports
receiving the influenza vaccine in 2021, batch not informed. Here is additional
information: reporter, biochemical engineer. Patient: 174 cm, weight 89 kg, It was
reported that the patient was medicated with influenza vaccine in 2021, after
administration of covid-19 (inactivated) adsorbed vaccine, within the recommended
interval between vaccine administration (more than 15 days). For treatment of the
serious adverse event, the patient was medicated from 17/Mai/2021, with Zinnat
(Cefuroxime), 1g/day; Atrovent (ipratropium bromide), 1 drop/mL, 5 mL, inhalation
with saline. Beginning on 21/May/2021, with a positive result for COVID, he was
medicated with moxifloxacin hydrochloride 400 mg/day; Atrovent (ipratropium
bromide), 5 drops/mL, 5 mL serum; and beginning on 24/May/2021 the patient was
hospitalized at Hospital, in which the patient underwent submitted to unspecified
tests. The reporter reported that on 21/May/2021 the patient had a pharmacy test
for COVID (corona virus disease) with a positive result. It is unknown if the
patient experienced any additional symptoms/events. Medication Details and reason
for taking the medicine: Concomitant medications: Prolopa BD (levodopa and
benserazide hydrochloride), Syntroid (levothyroxine sodium), Mantidam (amantadine
hydrochloride), Vitaxon(multivitamin), Omega 3, Magnesium, propolis, Oscal (calcium
and vitamin D), Aspirin Prevent (acetylsalicylic acid), Dastene (Dutasteride),
Centrum tabs man (multivitamin), Magnen B6(magnesium glycinate), Glifage
(metformin), and simvastatin, without further information about the therapies. The
patient received the first dose of the adsorbed covid-19 (inactivated) vaccine on
12/Feb/2021 and on 10/Mar/2021. Patient medical history, concomitant disease, risk
factor: Medical history of surgery for placing a saphenous vein graft more than 10
years ago, but with cardiologist follow-up, led a healthy and normal life and
atypical Parksonism, since date not informed. It is unknown if the patient had
any additional medical history, concomitant disease or risk factor. Lab
data/results: Exam: SARS-COV-2 (Severe acute respiratory syndrome coronavirus 2)
TEST Date: 24 May 2021 Result: positive. It is unknown if there were additional lab
data/results available.; Sender's Comments: This case concerns 86-year-old male
patient who had Covid-19 (corona virus disease), COVID-19 PCR (Polymerase chain
reaction) test positive and died after vaccination with INFLUENZA VACCINE
(TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE INACT (not produced by
sanofi pasture). The time to onset is unknown. Medical condition at the time of
vaccination was Parkinson's disease. The patient's past vaccinations and tolerance,
autopsy result and other laboratory test ruling out alternate etiologies were
needed to fully assess the case. Based upon the reported information, the role of
an individual vaccine cannot be assessed.; Reported Cause(s) of Death: COVID-19;
COVID-19 PCR test positive" "No prior vaccinations for this event."
"Total" "COVID-19" "10084268" "COVID19 (COVID19 (UNKNOWN))" "1202"
� �
"COVID-19" "10084268" "INFLUENZA (SEASONAL) (NO BRAND NAME)" "44"
"1413624-1" "1413624-1" "COVID-19 PCR test positive; Covid-19; This initial
Information regarding this unsolicited valid serious death case was received on 14-
Jun-2021 from a non-healthcare professional (unknown relationship with patient)
through Business Partner, which was forwarded to Regulatory Authority on 15-Jun-
2021. On 14Jun2021, Regulatory Authority received a report of a serious adverse
event after the use of influenza vaccine through the customer service. The
reporter, profession not informed, reports that the patient, (comorbidity,
continuous medication use, and unknown demographics), received the first dose of
the adsorbed covid-19 (inactivated) vaccine on 12/Feb/2021 and on 10/Mar/2021. On
16/May/2021 the patient had the first symptom of Covid-19 [Covid-19] (patient had
unspecified treatment for 7 days), and on 24/May/2021 the patient underwent PCR
(Polymerase chain reaction) test: positive. On an unspecified date the patient had
to be admitted to the ICU (intensive care unit) and died on 07/Jun/2021 as a result
of complications in the disease-related condition. On 14/Jun/2021 after receiving
the initial e-mail, we received more information about the case, in which data from
the reporter, the patient, medical history, concomitant and treatment medications,
and the evolution of the patient's condition were reported. On the same date, we
received information about the patient's vaccination status, in which he reports
receiving the influenza vaccine in 2021, batch not informed. Here is additional
information: reporter, biochemical engineer. Patient: 174 cm, weight 89 kg, It was
reported that the patient was medicated with influenza vaccine in 2021, after
administration of covid-19 (inactivated) adsorbed vaccine, within the recommended
interval between vaccine administration (more than 15 days). For treatment of the
serious adverse event, the patient was medicated from 17/Mai/2021, with Zinnat
(Cefuroxime), 1g/day; Atrovent (ipratropium bromide), 1 drop/mL, 5 mL, inhalation
with saline. Beginning on 21/May/2021, with a positive result for COVID, he was
medicated with moxifloxacin hydrochloride 400 mg/day; Atrovent (ipratropium
bromide), 5 drops/mL, 5 mL serum; and beginning on 24/May/2021 the patient was
hospitalized at Hospital, in which the patient underwent submitted to unspecified
tests. The reporter reported that on 21/May/2021 the patient had a pharmacy test
for COVID (corona virus disease) with a positive result. It is unknown if the
patient experienced any additional symptoms/events. Medication Details and reason
for taking the medicine: Concomitant medications: Prolopa BD (levodopa and
benserazide hydrochloride), Syntroid (levothyroxine sodium), Mantidam (amantadine
hydrochloride), Vitaxon(multivitamin), Omega 3, Magnesium, propolis, Oscal (calcium
and vitamin D), Aspirin Prevent (acetylsalicylic acid), Dastene (Dutasteride),
Centrum tabs man (multivitamin), Magnen B6(magnesium glycinate), Glifage
(metformin), and simvastatin, without further information about the therapies. The
patient received the first dose of the adsorbed covid-19 (inactivated) vaccine on
12/Feb/2021 and on 10/Mar/2021. Patient medical history, concomitant disease, risk
factor: Medical history of surgery for placing a saphenous vein graft more than 10
years ago, but with cardiologist follow-up, led a healthy and normal life and
atypical Parksonism, since date not informed. It is unknown if the patient had
any additional medical history, concomitant disease or risk factor. Lab
data/results: Exam: SARS-COV-2 (Severe acute respiratory syndrome coronavirus 2)
TEST Date: 24 May 2021 Result: positive. It is unknown if there were additional lab
data/results available.; Sender's Comments: This case concerns 86-year-old male
patient who had Covid-19 (corona virus disease), COVID-19 PCR (Polymerase chain
reaction) test positive and died after vaccination with INFLUENZA VACCINE
(TRIVALENT) (unknown manufacturer) and COVID-19 VACCINE INACT (not produced by
sanofi pasture). The time to onset is unknown. Medical condition at the time of
vaccination was Parkinson's disease. The patient's past vaccinations and tolerance,
autopsy result and other laboratory test ruling out alternate etiologies were
needed to fully assess the case. Based upon the reported information, the role of
an individual vaccine cannot be assessed.; Reported Cause(s) of Death: COVID-19;
COVID-19 PCR test positive" "No prior vaccinations for this event."
"Total" "COVID-19" "10084268" "INFLUENZA (SEASONAL) (NO BRAND NAME)" "44"
� �
"COVID-19" "10084268" "VACCINE NOT SPECIFIED (NO BRAND NAME)" "999"
"1069615-1" "1069615-1" "58-year-old male, history of Down syndrome, who
presented from his care facility for approximately one week of progressive fatigue,
lethargy, reduced mentation, along with reduced intake, who was found to be less
responsive. He was brought to the emergency department where he was found to be
hypothermic, hypotensive, hypoxic, and bradycardic. Upon admission to the ED,
POLST form discovered _____ DNR, but limited medical interventions. He was then
discovered to have COVID-19 pneumonia, likely driving this entire process." "No
"1155643-1" "1155643-1" "Patient had Covid in November 2020. Received a dose
of covid vaccine in January 2021 and February 2021. Arrived to Regional with SOA .
Covid-19 (NAA) was positive on 03/29/2021 10:17am -repeat Sars-Cov-2 (PCR)-negative
on 03/29/2021 14:30 negative. Patient expired on 3/30/2021 at o146" "No prior
"1213315-1" "1213315-1" "Patient received Covid vaccine (Jansen) in early
March. Patient was diagnosed 7 to 10 days later with Covid. Patient self
quarantined for 14 days. One week prior to ED visit patient had exertional dyspnea
and SOB. Came to hospital ED and admitted to floor. Twelve hours later patient
coded and expired of PE" "No prior vaccinations for this event."
"1282774-1" "1282774-1" "death" "No prior vaccinations for this event."
"1294259-1" "1294259-1" "Her initial shot was 1/6/21. 7 days later tested
positive for Covid through 2 rapid tests at the facility. They also sent 1 culture
to the lab which confirmed positive on 1/18/21. I visited her on 1/18 and 1/20 and
noticed something extremely wrong with her. She couldn't communicate. I called her
PCP who immediately called the facility to rush her to the ER. Her Test results
showed a small stroke on the front right lobe. She was hospitalized for about 10
days. She never regained her strength and her accomplishment in physical therapy of
125 feet, being reduced to never walking over 25 feet again. When her time was up,
she transferred to a memory care unit. She just passed away 5/5/21." "No prior
"1347948-1" "1347948-1" ""received the first dose of the BNT162b2 mRNA COVID-
19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; received the first
dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-
2 positive; the patient died from acute renal and respiratory failure on the
following day; the patient died from acute renal and respiratory failure on the
following day; hypernatremia; Anemia; worsening diarrhea; This is a literature
report from a publication. We report on an 86-year-old male resident of a
retirement home who received vaccine against SARS-CoV-2. Past medical history
included systemic arterial hypertension, chronic venous insufficiency, dementia and
prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-
formulated, nucleosidemodified RNA vaccine BNT162b2 in a 30 mg dose. On that day
and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On
day 18 (26Jan2021), he was admitted to hospital for worsening diarrhea. Since he
did not present with any clinical signs of COVID- 19, isolation in a specific
setting did not occur. Laboratory testing revealed hypochromic anemia and increased
creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for
SARSCoV-2 were negative. Gastroscopy and colonoscopy were performed to investigate
the cause of diarrhea further. Colonoscopy, in particular, demonstrated an
ulcerative lesion of the left colonic flexure, which was histologically diagnosed
as ischemic colitis. PCR-analysis on biopsy specimens, following a previously
reported method, was negative for SARS-CoV-2. Treatment was supportive with
mesalazine and intravenous iron substitution. Subsequently, the patient's condition
deteriorated under the development of renal insufficiency. On day 24 (01Feb2021), a
patient in the same hospital room as our case tested positive for SARS-CoV-2. On
day 25 (02Feb2021), our patient tested SARS-CoV-2 positive by real-time PCR (RT-
PCR), with a low cycle threshold (Ct) value indicating high virus load. On further
analysis of the swab sample, there was no evidence for mutant SARS-CoV-2 variants
B.1.1.7, B.1.351 or B.1.1.28.1. Taken together, it appears the patient became
infected from the patient in his hospital room. Our patient now presented with
fever and respiratory discomfort, and lung auscultation displayed crackles. Despite
starting supplemental oxygen (2L per minute) and antibiotic therapy by ceftriaxone,
the patient died from acute renal and respiratory failure on the following day.
Immunogenicity assessment by measuring spike protein (S1) antigen-binding
immunoglobulin (Ig) G in the serum samples obtained at day 25 (02Feb2021) showed
antibody response (8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM), while
(nucleocapsid) NCP- IgG/IgM was not elicited (<0.1 U/ml, reference value >1.0 U/ml;
Roche ECLIATM). These results indicate that the patient had already developed
relevant immunogenicity through vaccination. Postmortem study revealed acute
bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial
cocci (Figure 1). There were no findings of commonly described manifestations of
COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy
(weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We
detected amyloidosis of the transthyretin type in the heart and to a lesser extent
in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and
interstitial fibrosis, and acute renal failure with hydropic tubular degeneration.
The examination of the brain revealed a left parietal pseudocystic tissue necrosis,
which was diagnosed as an old infarction area. Figure 1 showed that synopsis of
the relevant histological findings and the results of molecular mapping is
presented. The histomorphology is obtained by standard hematoxylin and eosin
reaction, except for the myocardium on the right side (Congo red staining). The
magnification is shown by bars. Note that in the lungs, we also observed colonies
of cocci (arrow) in granulocytic areas. In addition, the results of molecular
mapping are given as evaluated cycle threshold values of the real-time polymerase
chain reaction for SARSCoV- 2. Note that only in the olfactory bulb and the liver
SARS-CoV-2 could not be detected. Table 1 showed Summary of major features of the
patient's history, clinical symptoms and laboratory findings, including SARS-CoV-2
testing (reference values given in brackets). On day1 (09Jan2021), the patient
vaccination, No relevant symptoms recorded. On day 15 (23Jan2021), the patient
collapse during breakfast and no further relevant symptoms recorded, blood pressure
(mmHg) 130/70. On day 18 (26Jan2021), the patient admission to hospital;
gastroscopy (mild gastritis) and diarrhea. The temperature (C) was 36.4, blood
pressure (mmHg) 187/83, Oxygen saturation (SpO2) 97%, SARS-CoV-2 test: Antigen-
test: negative PCR-test: negative. White-cell count (4-9/nl): 6.6. Platelet count
(140-400/nl): 267. Hemoglobin (14.0-8.0 g/dl): 7.4. Lactate dehydrogenase (135-250
U/L): 179. Creatinine (0.7-1.2 mg/dl): 1.91. C-reactive protein (<0.5 mg/dl): 1.0.
Sodium (135-145 mmol/l): 138. On day 19 (27Jan2021), the patient had abdominal
ultrasound, initiating intravenous iron application. The patient had anemia. White-
cell count (4-9/nl): 7.1. Platelet count (140-400/nl): 263. Hemoglobin (14.0-8.0
g/dl): 7.1. Lactate dehydrogenase (135-250 U/L): 165. Creatinine (0.7-1.2 mg/dl):
1.78. C-reactive protein (<0.5 mg/dl): 0.8. Sodium (135-145 mmol/l): 138. On day 20
(28Jan2021): the patient had colonoscopy (ischemic colitis), initiating mesalazine.
Still had anemia. SARS-CoV-2 test: PCR-test: negative. White-cell count (4-9/nl):
12.1. Platelet count (140-400/nl): 262. Hemoglobin (14.0-8.0 g/dl): 7.2. On day 23
(31Jan2021): the patient had acute renal insufficiency, initiating intravenous
glucose application. Lung uscultation with any pathological signs, hypernatremia.
The temperature (C) was 36.8. Blood pressure (mmHg) 180/80. White-cell count (4-
Creatinine (0.7-1.2 mg/dl): 2.04. C-reactive protein (<0.5 mg/dl): 2.0. Sodium
(135-145 mmol/l): 154. On day 24 (01Feb2021): Patient in same hospital room has
positive SARS-CoV-2 RT-PCR test (Ct,15) and hypernatremia. The temperature (C) was
36.2. Blood pressure (mmHg) 166/73. Sodium (135-145 mmol/l): 155. On day 25
(02Feb2021): Patient somnolent, initiating antibiotic therapy, chest radiograph
with minimal infiltrates. Dehydration, lung auscultation with crackles. The
temperature (C) was 38.8, blood pressure (mmHg) 160/80, Oxygen saturation (SpO2)
97% + 2l O2, SARS-CoV-2 test: RT-PCR-test: positive (Ct, 20). White-cell count (4-
Creatinine (0.7-1.2 mg/dl): 2.17. On day 26 (03Feb2021): the patient death at 14:30
due to acute renal and respiratory failure. White-cell count (4-9/nl): 15.2.
Platelet count (140-400/nl): 196. Hemoglobin (14.0-8.0 g/dl): 9.3. Lactate
dehydrogenase (135-250 U/L): 439. Creatinine (0.7-1.2 mg/dl): 3.23. C-reactive
protein (<0.5 mg/dl): 8.8. Sodium (135-145 mmol/l): 156. We conducted molecular
mapping of 9 different anatomical parts of formalin-fixed paraffin-embedded tissue
as previously described. RNA was extracted from paraffin sections using the
specific method. Multiplex RT-PCR analysis targeted 2 independent genes of the
SARS-CoV-2-genome (Fluorotype SARS-CoV-2 plus Kit): RNA-dependent RNA polymerase
(Target 1) and nucleopeptide (Target 2). The negative cut-off value was Ct >45. We
examined 9 different tissue samples for known and relevant pathways of virus
spreading in the human body (Figure 1). To prevent cross-contamination, each
specimen was directly embedded in separate tissue cassettes and separately fixed in
4% phosphate-buffered saline-buffered formalin. We demonstrated viral RNA in nearly
all organs examined except for the liver and the olfactory bulb (Figure 1). A
detailed autopsy study including molecular virus mapping of a patient vaccinated
against SARS-CoV-2 with a positive SARS-CoV-2 test post-vaccination has not
previously been reported, to the authors' knowledge. We suggest that a single
treatment with BNT162b2 RNA vaccine elicited significant immunogenicity, as
reflected in the reported spike proteinbased neutralizing IgG serum values. From
the weeks before vaccination, through vaccination (day 1), to shortly before death
(day 24), the patient was free of any clinical symptoms typically ascribed to
COVID-19. Furthermore, blood work did not show an IgM titer that is generally
observed 7-14 days after symptom onset (Kim et al., 2020). However, the patient
tested SARS-CoV-2 positive. Both the Ct value measured in nasopharyngeal swab and
values measured in formalin-fixed paraffinembedded autopsy specimens indicate viral
load and suggest transmissibility. Because our patient died approximately 2 days
after his first positive SARS-CoV-2 test result, we suppose that the molecular
mapping data reflects an early stage of viral infection. An early stage of
infection might also explain why different regions such as the olfactory bulb and
liver were not (yet) affected by systemic viral spread. We did not observe any
characteristic morphological features of COVID-19 reported in comprehensive
morphological autopsy studies so far. We did not find any typical signs of diffuse
alveolar damage in the lungs, but we identified extensive acute bronchopneumonia,
possibly of bacterial origin. We concluded that the In summary, the results of our
autopsy case study in a patient with mRNA vaccine confirm the view that by first
dose of vaccination against SARS-CoV-2
immunogenicity can already be induced, while sterile immunity is not adequately
developed.; Sender's Comments: The efficacy of a drug varies from patient to
patient and can be affected by different factors; however, a contributory role of
BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out. There
is a reasonable possibility that the event diarrhea is related to BNT162b2 based on
known drug safety profile. Based on the temporal relationship, the association
between the events ""renal failure, respiratory failure, hypernatremia, and
anemia"" with BNT162b2 cannot be completely excluded. Possible contribution from
patient's advanced age and underlying medical conditions are assessed as possible.
The impact of this report on the benefit/risk profile of the Pfizer product is
part of this review as well as any appropriate action in response, will be promptly
notified to regulatory authorities, Ethics Committees, and Investigators, as
appropriate.; Reported Cause(s) of Death: the patient died from acute renal and
respiratory failure on the following day; the patient died from acute renal and
respiratory failure on the following day; COVID-19; received the first dose of the
BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks l"" "No prior vaccinations for
this event."
"Total" "COVID-19" "10084268" "VACCINE NOT SPECIFIED (NO BRAND NAME)" "999"
� �
"Total" "COVID-19" "10084268" � �
"Total" � �
"---"
"Dataset: The Vaccine Adverse Event Reporting System (VAERS)"
"Query Parameters:"
"Date Died: 2021"
"Date of Onset: 2021"
"Date Report Completed: 2021"
"Date Report Received: 2021"
"Date Vaccinated: 2021"
"Symptoms: COVID-19"
"VAERS ID: All"
"Group By: Symptoms; Vaccine; VAERS ID"
"Show Totals: True"
"Show Zero Values: Disabled"
"---"
"Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information."
"---"
"Query Date: Jul 20, 2021 6:48:19 PM"
"---"
"Suggested Citation: Accessed at http://wonder.cdc.gov/vaers.html on Jul 20, 2021
6:48:19 PM"
"---"
Messages:
"1. The full results are too long to be displayed, only non-zero rows are
available."
"2. VAERS data in CDC WONDER are updated every Friday. Hence, results for the same
query can change from week to week."
"3. These results are for 719 total events."
"4. When grouped by VAERS ID, results initially don't show Events Reported,
Percent, or totals. Use Quick or More Options to"
"restore them, if you wish."
"5. Click on a VAERS ID to see a report containing detailed information for the
event."
"---"
Footnotes:
"1. Submitting a report to VAERS does not mean that healthcare personnel or the
vaccine caused or contributed to the adverse"
"event (possible side effect)."
"---"
Caveats:
"1. VAERS accepts reports of adverse events and reactions that occur following
vaccination. Healthcare providers, vaccine"
"manufacturers, and the public can submit reports to VAERS. While very important in
monitoring vaccine safety, VAERS reports"
"alone cannot be used to determine if a vaccine caused or contributed to an adverse
event or illness. The reports may contain"
"information that is incomplete, inaccurate, coincidental, or unverifiable. Most
reports to VAERS are voluntary, which means they"
"are subject to biases. This creates specific limitations on how the data can be
used scientifically. Data from VAERS reports"
"should always be interpreted with these limitations in mind. The
strengths of VAERS are that it is national in scope"
"and can quickly provide an early warning of a safety problem with a vaccine. As
part of CDC and FDA's multi-system approach to"
"post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect
unusual or unexpected patterns of adverse events,"
"also known as ""safety signals."" If a safety signal is found in VAERS, further
studies can be done in safety systems such as"
"the CDC's Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety
Assessment (CISA) project. These systems do not have"
"the same limitations as VAERS, and can better assess health risks and possible
connections between adverse events and a vaccine."
" Key considerations and limitations of VAERS data: <ul><li> Vaccine
providers are encouraged to report any clinically"
"significant health problem following vaccination to VAERS, whether or not they
believe the vaccine was the cause. </li><li>"
"Reports may include incomplete, inaccurate, coincidental and unverified
information. </li><li> The number of reports alone"
"cannot be interpreted or used to reach conclusions about the existence, severity,
frequency, or rates of problems associated"
"with vaccines. </li><li> VAERS data are limited to vaccine adverse event reports
received between 1990 and the most recent date"
"for which data are available. </li><li> VAERS data do not represent all known
safety information for a vaccine and should be"
"interpreted in the context of other scientific information. </li></ul> "
"2."
"3. Some items may have more than 1 occurrence in any single event report, such as
Symptoms, Vaccine Products, Manufacturers, and"
"Event Categories. If data are grouped by any of these items, then the number in
the Events Reported column may exceed the total"
"number of unique events. If percentages are shown, then the associated percentage
of total unique event reports will exceed 100%"
"in such cases. For example, the number of Symptoms mentioned is likely to exceed
the number of events reported, because many"
"reports include more than 1 Symptom. When more then 1 Symptom occurs in a single
report, then the percentage of Symptoms to"
"unique events is more than 100%. More information:
http://wonder.cdc.gov/wonder/help/vaers.html#Suppress."
"4. Data contains VAERS reports processed as of 07/09/2021. The VAERS data in
WONDER are updated weekly, yet the VAERS system"
"receives continuous updates including revisions and new reports for preceding time
periods. Duplicate event reports and/or"
"reports determined to be false are removed from VAERS. More information:
http://wonder.cdc.gov/wonder/help/vaers.html#Reporting."

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"Notes" "Symptoms" "Symptoms Code" "Vaccine" "Vaccine Code" "VAERS ID"

"VAERS ID Code" Adverse Event Description Adverse Events After Prior

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