Pfizer Under 17 Years Adverse Events Reported To CDC

The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=6016446...
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1 of 149 13/05/2021, 09:56

The Vaccine Adverse Event Reporting System (VAERS) Results
Vaccine Vaccine
Symptoms Age VAERS ID Adverse Event Description
Manufacturer Type
COVID19
6-17 Naeusa, abdominal pain, tiredness, general body
ABDOMINAL PAIN PFIZER\BIONTECH VACCINE 1210954-1
years aches
(COVID19)
Since receiving his second dose of COVID-19 vaccine
(Pfizer) on Sunday 2/21 he has had fever (tmax
103.0 F), headache, and stomach ache. His fever
started on 2/21 and had persisted through 2/24. He
woke up from a nap on 2/24 in the afternoon at 1600
had onset of severe chest pain. Then reoccurring
multiple times throughout the evening. He was taken
COVID19
6-17 to a local hospital and the transferred to another
ABDOMINAL PAIN UPPER PFIZER\BIONTECH VACCINE 1071409-1
years hospital for higher level of care. Pediatric cardiology
(COVID19)
was consulted and treatment was started for
suspected atypical pericarditis with colchicine 0.6mg
BID and ibuprofen 600mg QID w/ famotidine 40mg
QDay. His chest pain resolved the day of admission,
even prior to starting treatment. Patient was
discharged in clinically stable condition to follow up
with pediatric cardiology in 2 weeks as outpatient.
Dizziness and nausea 10 minutes after injection,
COVID19
6-17 continued to wax and wane over approx 90 minutes.
ABNORMAL BEHAVIOUR PFIZER\BIONTECH VACCINE 0912103-1
years No vitals taken. Patient ambulated back to work at
(COVID19)
1800.
"Patient said she lost her hearing last Thursday
(1/7/2021) around 6pm. She said she totally could
not hear anything at all and she went to the ER at
COVID19 11pm and stayed till 3am. Her hearing loss happened
ACOUSTIC STIMULATION 6-17
PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to
TESTS years
(COVID19) hear sounds since Sunday and recovered. She
described it as ""there was pressure inside the ear""
and she said she also went to her doctor and doctor
said she had her hearing back 90% to 96%."
Administered first dose of COVID19 vaccine at
1:29pm on 1/4/21. At approximately 11:00pm
resident exhibited acute respiratory decompensation
COVID19
ACUTE RESPIRATORY 6-17 with very limited air entry and hypoxemia. Patient
PFIZER\BIONTECH VACCINE 0921641-1
FAILURE years received Benadryl, steroids, epinephrine, and Duoneb
(COVID19)
without improvement. Resident was referred to the
emergency room and found to be COVID positive. No
fever or rash were reported.
2 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
was nursed by mother who received Pfizer COVID
vaccine; one twin who kind of gets allergic reactions
to vaccines; body rash; Low grade fever; fussy/
fussiness; This is a spontaneous report from a
contactable other health professional (HCP) (patient's
mother). This other HCP reported information for both
mother and babies (boy girl twins). This is a baby
report (girl twin). A 14-month-old female patient
received the first dose of BNT162B2 (Lot# EJ1685),
via transmammary on 16Dec2020 at single dose for
COVID-19 immunization. The patient medical history
included like for the 12 month appointment, she got 4
to 5 shots, and got a full body rash and fever for a
couple days, but it's hard to say, like she got a flu
shots and whatever ones that go with it. There were
no concomitant medications. The patient was nursed
by mother who received Pfizer COVID vaccine. The
patient's mother got her first dose of vaccine, later
clarified as the Pfizer COVID vaccine, on 16Dec2020,
and she was nursing twins, they are about 14 months
now. She had boy girl twins and the patient was
shorter than her brother, since she was a girl. She
was normal height, in the 50th percentile for age. The
patient's mother had no adverse effect, she had
normal side effects, and one twin (the girl) who kind
of gets allergic reactions to vaccines, like body rash
and fever, nothing serious, the other one (the boy)
has no issues. Afterwards the twin who gets side
effects, was fussy and had a low grade fever, but
COVID19 nothing serious, and she was encouraged to report to
1-2
ALLERGY TO VACCINE PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or
years
(COVID19) anything to worry about with the second dose. The
mother stated her daughter was fussy that afternoon,
on 16Dec2020, the mother had nursed before she
left, say around 10:30 AM, and probably nursed her
around 3 PM, afterwards, and the next time she
nursed, she was fussy, by early afternoon/evening a
couple hours after nursing, The fussiness was just
that day and evening, and her daughter has the low
grade fever that evening was 16Dec2020. Caller gave
her some infant tylenol and it went away, and
comforted her, since she got fussy, and it went away
that evening. Stated the next morning she gave her
the tylenol as well and she was fine. Stated the
pediatrician might have that if Pfizer wishes to
contact, but she thought maybe after MMR, probably
what she had gotten, the problem was she had so
many at once, so it's hard to say which ones, like for
the 12 month appointment, she got 4 to 5 shots, and
got a full body rash and fever for a couple days, but
it's hard to say, like she got a flu shots and whatever
ones that go with it. Stated it's interesting, the two
kids to compare, her son doesn't usually get vaccine
reactions, her daughter does, and it's interesting he
was completely fine and she was fussy. The outcome
of the events low grade fever and fussy/ fussiness
was recovered on 16Dec2020. The outcome of the
other events was unknown.; Sender's Comments:
Linked Report(s) : US-PFIZER INC-2020518603 baby
case (boy twin);US-PFIZER INC-2020518990
maternal case
17yr old patient with documented allergies tree nuts
(anaphylaxis), peanuts (anaphylaxis), chocolate
(anaphylaxis), and shellfish (abdominal pain)
presented to clinic for first dose of COVID-19 Pfizer
vaccine. No history of previous reactions to any
vaccines. RN administered PFIZER COVID-19
COVID19 VACCINE (EUA) (LOT # ER8729, exp 7/31/2021) IM
6-17
ALLERGY TO VACCINE PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
(COVID19) observation period, patient complained of throat
swelling ~ 1545. Patient with noted hives near
administration site and flushing on chest which
spread to face. Patient given epinephrine 0.3mg IM at
1553. Upon assessment, BP 139/111, HR 103, 100%
RA, lungs clear to auscultation bilaterally. Pharynx
not visualized due to tongue. Patien
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Vaccine Vaccine
Manufacturer Type
The teen had a history of autoimmune disorder,
alopecia areata for the past 2 years. When received
the first dose of pfizer COVID vaccine, she started
COVID19 losing hair rapidly after about 6 to 7 days. She was
6-17
ALOPECIA PFIZER\BIONTECH VACCINE 1175802-1 started on large dose of prednisone 100mg per day
years
(COVID19) after 2 weeks to slow down alopecia. However, in the
span of 4 days she lost most of her hair. We are
wondering if the vaccine could have exacerbated the
autoimmune disorder.
COVID19 Systemic: Anaphylaxis-Medium, Systemic: Rash
6-17
ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other-
years
(COVID19) wheezing, shortness of breath, coughing-Medium
multi-phase anaphylaxis/several anaphylactic
reactions; This is a spontaneous report from a
contactable consumer (parent) from a Pfizer-
sponsored program. A 17-year-old male patient
received the first dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 MRNA VACCINE),
intramuscularly in the right arm, on 17Mar2021 at
12:45 (at the age of 17-years-old) as a single dose
for COVID-19 immunization. Medical history included
allergies to sticking plaster (adhesive) and diabetes
type 1. Family history included allergies to some
antibiotics in the mother. The patient had no
concomitant medications. The patient did not receive
COVID19
6-17 any other vaccines within four weeks prior to the
ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1165996-1
years vaccination. The patient experienced multi-phase
(COVID19)
anaphylaxis/several anaphylactic reactions in
Mar2021, which caused hospitalization and was
reported as an important medical event and life-
threatening. The clinical course was reported as
follows: The patient had multi-phase anaphylaxis
following his first dose of vaccination. He went to
three different hospitals and was in the pediatric
intensive care unit (PICU) at the time of reporting.
The patient was heavily sedated, intubated, and on a
ventilator for 3 days. The clinical outcome of multi-
phase anaphylaxis/several anaphylactic reactions was
unknown. Follow-up attempts are completed. No
further information expected.
Anaphylaxis (hives, oropharyngeal swelling, cough,
shortness of breath) 20 mins following vaccine
administration. Patient given epinephrine at vaccine
COVID19 site 20min after symptom onset with significant
6-17
ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved
years
(COVID19) pharyngeal swelling and resolution of hives. Patient
presented to the emergency department 1.5 hours
following onset of anaphylaxis with mild cough and
mild pharyngeal swelling for observation.
6-17
ANAPHYLACTIC REACTION PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
severe reaction to the vaccine had a anaphylactic
shock had 2 more the next day; This is a
spontaneous report received from a contactable
consumer. A 17-year-old male patient received
bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an
unspecified route of administration on an unspecified
COVID19 date (Batch/Lot number was not reported) as SINGLE
6-17
ANAPHYLACTIC SHOCK PFIZER\BIONTECH VACCINE 1165997-1 DOSE for covid-19 immunization. The patient medical
years
(COVID19) history includes diabetic (reported as Takes diabetic
med humaran). It was reported that the patient
experienced severe reaction to the vaccine had an
anaphylactic shock had 2 more the next day. It was
added that very sedated fighting it so he dont die.
The outcome of the event was unknown. Information
on the lot/batch number has been requested.
4 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Anaphylactoid reaction; PHASE 1/2/3, PLACEBO-
CONTROLLED, RANDOMIZED, OBSERVER-BLIND,
DOSE-FINDING STUDY TO EVALUATE THE SAFETY,
TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF
SARS-COV-2 RNA VACCINE CANDIDATES AGAINST
COVID-19 IN HEALTHY INDIVIDUALS This is a report
from an interventional study source for sponsored by
BioNTech, managed and reported by Pfizer on the
sponsor's behalf. The subject was in the open-label
phase of the study when the event occurred. A 17-
year-old female subject with a past medical history
significant for multiple allergies with anaphylaxis
received first dose of blinded therapy
(BNT162;PLACEBO) on 20Nov2020 at 17:04 and
second dose on 15Dec2020 at 15:16. Per protocol,
the participant was unblinded and confirmed to have
received placebo and subsequently received third
dose of study vaccine (BNT162B2) on 25Jan2021 at
16:50, all via intramuscular route in left deltoid as
single doses for COVID-19 immunization. Ongoing
medical history included penicillin allergy from 2010,
peanut allergy from 2004, legume allergy from 2012,
chickpea allergy from 2012, chocolate allergy from
2012, flaxseed allergy from 2016, all with
anaphylaxis; pollen allergy from 2007, and asthma
and eczema both from 2003. Additional medical
history included: tree nuts allergy from 2004
(anaphylaxis). Ongoing concomitant medications
included salbutamol sulfate (PROAIR) from 2010 for
asthma, epinephrine (AUVI Q) from 2005 for penicillin
allergy, peanut allergy, tree nuts allergy, legume
allergy, chickpea allergy, flaxseed allergy and
chocolate allergy, cetirizine hydrochloride (ZYRTEC)
from 2007 for pollen allergy, loratadine (CLARITIN)
from 2007 for pollen allergy, and triamcinolone
acetonide from 2007 for eczema. There were no
concomitant vaccines administered on same date of
study vaccine and no prior vaccinations (within 4
weeks prior to the first administration date of study
drug). The subject experienced hives left arm on
27Jan2021 at 10:30, shortness of breath 27Jan2021
COVID19 at 11:00 and a diagnosis of anaphylactoid reaction on
6-17
ANAPHYLACTOID REACTION PFIZER\BIONTECH VACCINE 1114461-1 27Jan2021 at 10:30, which were considered as life
years
(COVID19) threatening (the event was considered life-
threatening as subject with known anaphylaxis with
tree nuts and subject reported similar symptoms).
Clinical course was reported as follows: On
27Jan2021 at 10:30 (2 days after receiving
BNT162B2 injection on her left arm) the subject
started developing hives on her left arm and used her
epinephrine pen at 10:54 and shortly after developed
shortness of breath at 11:00. The subject did not
touch or consume anything new prior to developing
the hives on her left arm and the shortness of breath.
The subject was not seen by a school nurse and self-
administered her epi-pen. The hives resolved at
11:04 and the shortness of breath resolved at 11:24.
The subject denied any other symptoms and did not
seek further medical attention. There were no
relevant tests done. The action taken in response to
the events for study vaccine (BNT162B2) was
permanently withdrawn (reported as not applicable as
per investigator). The subject was not dosed
vaccination 4 on 17Feb2021 (Visit 102). Outcome of
the events was recovered on 27Jan2021. The
investigator reported that there was a reasonable
possibility that the event anaphylactoid reaction was
related to Dose 3 of the study vaccine (BNT162B2),
but not related to dose 1 and dose 2 of blinded
therapy (BNT162;PLACEBO), concomitant drugs or
clinical trial procedure. Follow-up (27Jan2021 and
03Feb2021): Seriousness life-threatening
justification, additional medical history (tree nuts
allergy) and clinical course (did not touch or consume
anything new before SAE). Follow-up (18Feb2021):
New information reported includes: action taken with
the blinded study vaccine. Follow-up (02Mar2021):
New information reported includes: concomitant
medication and action taken with the blinded study
vaccine. Follow-up (11Mar2021): New information
reported includes: SAE term updated to
'anaphylactoid reaction'. This is a final report for
initial notification of a life threatening event. .;
Sender's Comments: The event 'anaphylactoid
reaction' is unlisted in the protocol's Single Reference
5 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Safety Document (IB). Pfizer's safety database was
reviewed for cases reporting PF-07302048 or blinded
therapy through 28-FEB-2021 for adverse events
encoding to MedDRA (v.23.1J) Preferred Term(s) of
Anaphylactoid reaction.Review of the database for the
PT Anaphylactoid reaction had the following results: 0
serious clinical trial cases (0 of which were attributed
to therapy) and 29 non clinical trial cases. The
information available in this report is very limited. The
Company considers that there is a reasonable
possibility that 'anaphylactoid reaction' is related to
the study product. There is a plausible, although
belated, time relationship between vaccination with
BNT162b2 and onset of the event in a subject with a
medical history of allergic diathesis; it is worth noting
that symptoms resolved rapidly upon self-medication.
From the available information for the rationale that
led to attribution of a life-threatening seriousness
criterion, it may not be justifiable based on past-
history of anaphylaxis alone The impact of this report
on the benefit-risk profile of the Pfizer product and on
the conduct of the study 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.
Sore arm on 3/20/2021. No other symptoms/signs.
Presented for routine heart transplant follow up visit
3/22/2021 and was found to have new decreased
cardiac function by echo, new 1st degree heart block
by ECG, and new gallop. Patient taken to cath lab
COVID19 3/22/2021 for biopsy and hemodynamic assessment,
ANTI-HLA ANTIBODY TEST 6-17
PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
POSITIVE years
(COVID19) After initiation of CPR, patient was placed on ECMO.
Biopsy shows ACR 2R (moderate cellular rejection)
and pAMR 2 (moderate antibody-mediated rejection).
Labs show new donor specific, complement-fixing
Antibody against the cardiac allograft. Patient is in
ICU being treated for acute rejection.
COVID19 Flushing, sweating, anxious, tingling in ears, nausea,
6-17
ANXIETY PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
(COVID19) stabilized.
Pt reported having an uncomfortable scratchy feeling
in back of throat. Pt has experienced anaphylaxis in
past and was anxious about experiencing it again. Pt
moved away from waiting area to be evaluated by
RN. RN Assessed pt. Lung sounds clear, Pt denies
having difficulty breathing, O2 sat remained 98% or
COVID19
6-17 better for the duration. BP initially 141/89 while
ANXIETY PFIZER\BIONTECH VACCINE 1171412-1
years sitting with HR at 75. Pt laid down with feet propped
(COVID19)
on chair. Vital signs reevaluated 15 min later: O2
98%, BP 118/89, HR 77. Pt still reports itchy throat
but does not have difficulty breathing. Contacted on-
call physician, recommended pt be evaluated at ED or
urgent care. Pt parent refused ambulance; opted to
drive pt to ED for further evaluation.
COVID19 Arm soreness Fatigue Appendicitis (unclear if directly
<6
APPENDICITIS PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if
months
(COVID19) increased risk due to vaccine)
COVID19
6-11
ARTHRALGIA PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain
months
(COVID19)
COVID19 Within one hour of vaccine, pain at sight of injection.
3-5
ARTHRALGIA PFIZER\BIONTECH VACCINE 1074334-1 Within three hours of receiving vaccine, body aches,
years
(COVID19) joint aches. Within 8 hours of vaccine, headache.
COVID19 Extreme arm pain alternating with numbness and
6-17
ARTHRALGIA PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
(COVID19) chills, low grade fever (100.5), fatigue
Pt is an 17 year old male who presents with a history
of left shoulder pain since 3/25. He has recently been
COVID19
6-17 vaccinated for SARS Co-V2 (First dose on March 5th
ARTHRALGIA PFIZER\BIONTECH VACCINE 1148292-1
years with second dose on March 27). He is currently
(COVID19)
hospitalized for elevated troponin and working up for
myocarditis.
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Vaccine Vaccine
Manufacturer Type
Patient described rapid onset sweating and flushing.
Said he felt light headed as well. Gave Benadryl 25
COVID19
6-17 mg with continued observation for 30 minutes and he
ASTHENIA PFIZER\BIONTECH VACCINE 0942502-1
years said he felt mostly better, but still tired and weak.
(COVID19)
Followed up next day and his mother said he was
doing better.
Patient felt dizziness, weakness, and a fast heartbeat
COVID19
6-17 immediately after receiving injection. Patient was
years observed by EMS onsite and then went to ED for visit.
(COVID19)
Patient discharged from ED with no issues.
Systemic: Allergic: Difficulty Breathing-Medium,
Systemic: Chest Tightness / Heaviness / Pain-Mild,
Systemic: Confusion-Medium, Systemic: Dizziness /
Lightheadness-Severe, Systemic: Exhaustion /
COVID19
6-17 Lethargy-Mild, Systemic: Fainting / Unresponsive-
years Severe, Systemic: Headache-Mild, Systemic:
(COVID19)
Hyperventilation-Medium, Systemic: Nausea-Severe,
Systemic: Shakiness-Medium, Systemic: Tachycardia-
Mild, Systemic: Visual Changes/Disturbances-Severe,
Systemic: Weakness-Mild
ATRIOVENTRICULAR BLOCK 6-17
FIRST DEGREE years
COVID19 Red round bump under his left armpit that is painful
6-17
AXILLARY PAIN PFIZER\BIONTECH VACCINE 0950793-1 to the touch Currently using Ibuprofen and ice packs
years
(COVID19) to help
COVID19 Initial reaction sore arm, off balance, tingling in arm,
<6
BALANCE DISORDER PFIZER\BIONTECH VACCINE 0918673-1 around 2 hours later lower extremities painful - body
months
(COVID19) aches
COVID19
6-11
BALANCE DISORDER PFIZER\BIONTECH VACCINE 0918683-1 Persistant symptoms of perception off and off-balance
months
(COVID19)
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Vaccine Vaccine
Manufacturer Type
Acute Infarct of R internal capsule and R basal
ganglia; Acute Infarct of R internal capsule and R
basal ganglia; Left (L) sided motor deficits; L facial
droop; This is a spontaneous report from a
contactable physician. A 16-year-old female patient
received bnt162b2 (PFIZER-BIONTECH COVID-19
VACCINE, solution for injection), dose 1
intramuscular, administered in left arm on 24Mar2021
(Batch/Lot number was not reported) as single dose
for COVID-19 immunisation. Medical history included
truncus arteriosus (status post (s/p) right ventricle-
to-pulmonary artery (RV-PA) conduit and prosthetic
aortic valve s/p automatic implantable cardioverter
defibrillator (AICD) placement) and arrhythmias. The
patient have no known allergies to medications, food,
or other products. The patient was not diagnosed with
COVID-19 prior to vaccination. The patient was not
pregnant at the time of vaccination. Concomitant
medications included sotalol taken for arrhythmias
and warfarin. The patient was therapeutic on warfarin
(INR 2.68) at admission and has been historically
very compliant with medication. On 29Mar2021
14:00, the patient experienced acute infarct of right
(R) internal capsule and R basal ganglia as diagnosed
(dx) on magnetic resonance imagine (MRI),
concerning for (C/f) cardio-embolic etiology in the
COVID19
BASAL GANGLIA 6-17 setting of patient's complex cardiac history. However,
INFARCTION years cannot rule out other causes of infarct. Left (L) sided
(COVID19)
motor deficits on exam, L facial droop. Transthoracic
echocardiogram (TTE) was unchanged from prior. The
patient was hospitalized for the events from
29Mar2021 to 05Apr2021. The patient underwent
other lab tests and procedures which included
COVID-19 nasal swab test was negative on
29Mar2021 and on 30Mar2021. Therapeutic measures
were taken as a result of the events and included
treatment with anticoagulation. Outcome of the
events was recovered with sequel on 2021. The
following information on the batch number has been
requested.; Sender's Comments: As there is limited
information in the case provided, the causal
association between the events and the suspect
vaccine BNT162B2 cannot be excluded. Consider also
possible contributory effects from patient's pre-
existing cardiac history. The case will be reassessed
once new information is available. 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.
Patient had a CVA (stroke) to the R internal capsule
and basal ganglia while therapeutic on warfarin. She
COVID19 has a history of Truncus Arteriosus s/p repair and has
6-17
BASAL GANGLIA STROKE PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue.
years
(COVID19) Stroke occurred 1 week after vaccine. She now has L
sided motor deficits which are likely permanent. Left
arm is flaccid. L leg with poor motor function.
Fever of 103 F, received Tylenol, then developed
COVID19
BASOPHIL PERCENTAGE 6-17 tonic-clonic seizure activity for about 20 minutes
DECREASED years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
buccal clonazepam while awaiting EMS)
6-17
BIOPSY HEART ABNORMAL PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
8 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
1. 48 hours after the first vaccine dose, she
developed a raised, red, bump ~4-5cm area on her
back with irregular borders. It was slightly itchy but
not painful. 2. The area on her back worsened over
COVID19 the next 2-3 weeks and developed dark black scabs.
6-17
BIOPSY SKIN PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
(COVID19) given on 2/20/21), she developed scattered lesions
on her neck, hairline, ear, face ? some with blisters,
some with scabbed tops. Again slightly itchy but not
painful. She also had a transient headache and chills
that resolved on their own that same day.
COVID19
6-17 tonic-clonic seizure activity for about 20 minutes
BLOOD CALCIUM NORMAL PFIZER\BIONTECH VACCINE 1096709-1
years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
COVID19
BLOOD CHLORIDE NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
BLOOD CREATINE COVID19
PHOSPHOKINASE MB PFIZER\BIONTECH VACCINE 1071409-1
INCREASED (COVID19)
COVID19
BLOOD CREATININE 6-17 tonic-clonic seizure activity for about 20 minutes
NORMAL years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
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Vaccine Vaccine
Manufacturer Type
Since the vaccination, has the patient been tested for
COVID-19?:Yes; Since the vaccination, has the
patient been tested for COVID-19?:Yes; Fever
101-104 ongoing 8 days after vaccine; rigors;
fatigue; This is a spontaneous report received from a
contactable consumer (patient, self-reported). A 16-
year-old male patient received first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE, Solution for
injection, lot number: ER8730 and expiry dates were
not reported), via unspecified route of administration
in left arm on 25Mar2021 at 02:30 PM, as single dose
for COVID-19 immunization. The patient's medical
history includes occasional migraine and remote
pneumonia. The concomitant medication included
Multivitamin and Vitamin D. It reported that, on
26Mar2021 the patient experienced Fever 101-104
ongoing 8 days after vaccine, rigors and fatigue. The
patient underwent lab test 24 hours post vaccine that
was COVID test negative, also negative COVID Ab,
increased inflammatory markers CRP, ESR, Ddimer,
abnormal CBC and large platelets, mild hemolyzed
blood in urine with otherwise negative UA, blood
cultures x 2 negative. Vaccination facility: Pharmacy
or Drug Store. The patient did not receive any other
vaccines within 4 weeks prior to the COVID vaccine.
COVID19 Prior to vaccination, the patient was not diagnosed
6-17
BLOOD CULTURE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
(COVID19) vaccination the patient been tested for COVID-19.
The patient received ongoing tx with antipyretics,
monitoring ongoing as corrective treatment for the
adverse event. The outcome of the patient's event
drug ineffective and COVID-19 was unknown and
other events (fever, rigors, and fatigue) were not
recovered. Follow-up (02Apr2021): This is a follow-up
physician. This physician reported for her son
(Patient). The non-significant information updated.
Additional information 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.
There is limited information provided in this report.
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
Overnight 2/27-2/28 had low rectal temperatures to
33.8C. Was also undergoing rectal irrigations and
bowel cleanout so unclear if low rectal temps due to
this as oral temperatures later obtained at the same
COVID19 time were normal while rectal temps remained low.
6-17
BLOOD CULTURE NEGATIVE PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures
years
(COVID19) UA; CXR not obtained as no respiratory symptoms).
May also be secondary to underlying autonomic
instability with neurologic dysfunction though
previously has not had hypothermia outside of
infections. Temperatures have since normalized
COVID19
BLOOD GLUCOSE 6-17 tonic-clonic seizure activity for about 20 minutes
INCREASED years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
Patient felt lightheaded and confused. He laid down
COVID19 and rested for about 5 minutes. The EMT took vitals
6-17
BLOOD GLUCOSE NORMAL PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was
years
(COVID19) transported by ambulance to Hospital for additional
observation because they are a minor.
10 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
He passed out; His blood sugar was 143; This is a
spontaneous report from a contactable consumer
(patient's parent). A 16-year-old male patient
BIONTECH COVID-19 VACCINE) (Batch/lot number:
EL3247) via an unspecified route of administration on
the right arm on 17Jan2021 at single dose for
COVID-19 immunisation. Medical history included
hypopituitarism. Concomitant medication included
somatropin (NORDITROPIN) taken for
hypopituitarism. He passed out (emergency room
visit needed) on 17Jan2021, his blood sugar was 143
in Jan2021. Caller stated that her son received his
first dose of the Pfizer COVID vaccine on 17Jan2021,
stated he passed out. Caller stated they had to drive
COVID19
6-17 3 hours away to get the vaccine and wanted to know
BLOOD GLUCOSE NORMAL PFIZER\BIONTECH VACCINE 0995255-1
years that if because he experienced this after the first dose
(COVID19)
if it would be possible to find somewhere closer to
home to get the second vaccine. Caller stated she is
in the trial as an adult, that she reached out to her
trial coordinator and they told her that they can only
administer to persons in the trial. Son feels like
maybe there is a drug interaction, caller stated she
was not sure about this. Stated after her son passed
out, they called an ambulance, states the Medic
watched him for about 45 minutes, stated they ran
some tests in Jan2021, he did go home that day. His
blood sugar was 143 in Jan2021. Heart Rate monitor
in Jan2021 she couldn't see so is unsure of the
readings. The outcome of the event passed out was
recovered on 17Jan2021, of other remain event was
unknown.
COVID19
BLOOD LACTIC ACID PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
COVID19
BLOOD POTASSIUM 6-17 tonic-clonic seizure activity for about 20 minutes
NORMAL years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
5:24pm Pt called staff over and sad he felt faint and
then fainted. Parent in car, layed pt back in car,
talking to him to help orient him. Vitals obtained,
COVID19 temp, 96.2 temporal, 62HR, 100 %spo2, 116/60 Bp.
BLOOD PRESSURE 6-17
PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed
MEASUREMENT years
(COVID19) for another 10 minutes. Pt stated he is fasting ad
thats probably why i fainted/ 5:47 pt awake and
stable enough to leave. Mother is ok with Pts
condition.
COVID19
BLOOD SODIUM NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
Approximately 20 hours after vaccination patient felt
faint, lost all color and fainted. She was in and out of
COVID19 responsiveness. Patient was transported to the ER.
6-17
BLOOD TEST PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
(COVID19) observation. According to patient's mom the EKG and
lab work were unremarkable. Patient has fully
recovered.
11 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Went to sit down and passed out; felt dizzy;
nausious/nausia; sweaty; sick feeling; as she was
ghost white; bad headache.; This is a spontaneous
report from a contactable other Health Professional
reported for herself. A 16-year-old female patient
received the second dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE, lot number: EN5318)
via intramuscular on left arm on 02Feb2021 03:45
PM, at age of 16 years old at single dose for Covid-19
immunization. Patient was not pregnant at the time
of vaccination. Medical history reported as allergies to
medications, food, or other products was reported as
none known. Prior to vaccination, patient was not
diagnosed with COVID-19. Other medications the
patient received within 2 weeks of vaccination
included multivitamin and melatonin gummies. The
patient previously received the first dose of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,
lot number: EL3248), via intramuscular at left arm on
12Jan2021 03:45 PM for Covid-19 immunization. The
patient did not receive any other vaccines within 4
weeks prior to the COVID vaccine. It was reported
morning after vaccine 03Feb2021 08:00 patient was
felt dizzy and nausious. Told her mom and her mom
ran over as she was ghost white. Went to sit down
and passed out. Patient experienced sweaty, nausia,
sick feeling and bad headache. Patient went to the
emergency room (ER), they gave fluids and blood
work. No heart issues noted. Felt better around 3
COVID19
6-17 hours after. Headache was bad and continued on
BLOOD TEST PFIZER\BIONTECH VACCINE 1040554-1
years 05Feb2021 (reported today). Also, still feel nausious
(COVID19)
and had to lay down. All events occurred on
03Feb2021 08:00 AM. Patient was recovering. It was
reported the adverse event result in emergency
room/department or urgent care. The seriousness
criteria were reported as not serious, no results in
death, no life threatening, no caused/prolonged
hospitalization, no disabling/incapacitating, no
congenital anomaly/birth defect. Patient was received
treatment for the adverse event included fluids and
heart monitoring. The patient underwent lab tests
and procedures which included blood work in
Feb2021. Since the vaccination, patient had not been
tested for COVID-19. Outcome of events bad
headache and nauseous was not recovered, for felt
dizzy, as she was ghost white, passed out, sweaty,
sick feeling was recovering.; Sender's Comments:
Based on the information provided and plausible
temporal association, a contributory of the suspect
drug to the reported events cannot be completely
excluded. Case will be reassessed when additional
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.
About ten minutes after injection, face and ears
became flush and throat became itchy. Complained of
mild dizziness and growing lump in her throat.
Medical staff checked throat, blood pressure, O2, laid
her down on cot with feet elevated. After 20 minutes
of stable BP called the chief of immunology who
recommended she go to Urgent Care for follow up.
COVID19
6-17 While waiting at Urgent Care for 30 minutes, her
BLOOD TEST PFIZER\BIONTECH VACCINE 1172466-1
years face, tongue, and throat became swollen, hives
(COVID19)
developed on face, and had increased difficulty in
swallowing and felt short of breath. She was taken to
a patient room, IV started and Epi-shot was given.
Additional allergy meds were given (Benadryl and
Solu-Medro). She the. Slept for the next 90 minutes.
Swelling decreased and throat felt better. Monitoring
for a couple hours and sent home.
12 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
"Stroke; severe allergic reaction; This is a
spontaneous report from a contactable consumer (the
patient's father) from the Pfizer-sponsored program.
A 16-year-old female patient received bnt162b2
(PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose
1 via an unspecified route of administration,
administered in the Right Arm (also reported as: right
shoulder) on 23Mar2021 (Batch/Lot Number:
ER8732; Expiration Date: 31Jul2021) at 16-years-old
as a single dose for COVID-19 immunisation. Medical
history included heart valve operation from an
unknown date and unknown if ongoing (Mechanical
heart valves). Concomitant medications included an
unspecified medication, taken for an unspecified
indication from an unspecified date to an unspecified
date, which was reported as: ""Yes she is taking
other medication."" On 29Mar2021, the patient
experienced stroke and severe allergic reaction
(medically significant). The clinical course was
reported as follows: On behalf of his 16-year-old
daughter, the patient's father reported that she had
the first dose administer in the right shoulder on
23Mar2021. On 29Mar2021, the patient had a stroke.
The patient's father stated, ""our lives have changed,
completely."" The patient's father reported that his
daughter was receiving medical care ever since then;
and was also being treated by a physician. The
patient's father was asking about compensation from
COVID19 Pfizer regarding his daughter's severe adverse event
6-17
BLOOD TEST PFIZER\BIONTECH VACCINE 1266007-1 (AE) that occurred after the first dose of vaccine. The
years
(COVID19) patient's father reported that the case had been
submitted by the (Name) healthcare team ""to the
FDA and to Pfizer, and I haven't heard back from
either."" The patient's father mentioned in passing,
that he ""could call (Name) and have this all over the
news"" but that he ""wants to be responsible"" and
doesn't want to do that. The patient's father stated
the concern, ""Well my concern I am not sure that
medical profession is what I really need to do, my
concern is that my daughter took the Pfizer COVID
vaccine on 23Mar2021 in (Name) in vaccination
location. On 29Mar2021, 6 days later, she had a
stroke, and that she is receiving a medical care ever
since then , now my question is like I said probably
for maybe for correlated relation type of person
define as well as for it there is a compensation for
adverse reaction to COVID vaccination being that this
was only thing that was introduce in her system as
far as doing that time the vaccination shot."" The
patient underwent lab tests and procedures which
included blood test: ""that's for 4/2 out of normal""
on an unknown date; also reported: ""Yes that's been
ongoing as far as giving blood. That's for 4/2 out of
normal"". Therapeutic measures were not taken and
was reported as ""no she isn't taking anything for it.""
The clinical outcome of the events, stroke and severe
allergic reaction, was unknown.; Sender's Comments:
Linked Report(s) : US-PFIZER INC-2021411875
Pfizer"
Blood clot in right calf. Noticed pain and knot in calf
on Sunday 3/14/2021. It worsened over the next few
COVID19 days. Went to Urgent care on 3/18 and they sent us
6-17
BLOOD TEST ABNORMAL PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
years
(COVID19) was a clot identified as deep vein thrombosis, and
started a treatment of blood thinner and pain
medication.
COVID19
BLOOD UREA NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
13 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
temperature 101; vaccine was administered to
7-year-old son; This is a spontaneous report from a
Pfizer sponsored program, received from a
contactable nurse. This nurse reported similar events
for two patients. This is the first of two reports. A
7-year-old male patient received BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE, lot/batch number and
expiry date were not provided) solution for injection,
via an unspecified route of administration on
12Jan2021 at a single dose for Covid-19
immunization. Medical history included respiratory
distress (at birth had persistent respiratory distress
requiring oxygen for 10-12 days), Febrile seizure in
Jan2017, and pneumonia in Jan2017. The patient's
COVID19 concomitant medications were not reported. A mother
6-17
BODY TEMPERATURE PFIZER\BIONTECH VACCINE 0976811-1 went to get vaccinated for Covid-19. She took her
years
(COVID19) kids ages 7 and 15. The kids were also vaccinated.
The vaccine was administered to the 7-year-old son
on 12Jan2021. Her son (patient) had a temperature
of 101 on 13Jan2021. The mother was concerned
because the vaccine was not recommended for his
age. She was wondering if he should be in the ER.
The reporter does not know if the child still has a
fever. She said that the vaccination providers went
ahead and gave the vaccine to the children as well
even if they were not scheduled to get them.
Outcome of the event was unknown. Information of
lot/batch number has been requested.; Sender's
Comments: Linked Report(s) : US-PFIZER
INC-2021041926 Same reporter, product, and event,
different patient
Rapid pulse 121-133; fever 101.3; chills; dizzy; body
aches; This is a spontaneous report from a
contactable consumer (parent). A 17-years-old male
patient received bnt162b2 (BNT162B2, lot
number=EM9709) second dose, vaccination location
of left arm, via an unspecified route of administration
on 14Feb2021 17:15 at SINGLE DOSE for covid-19
immunisation. Medical history was none. No Allergies
to medications, food, or other products. The patient's
concomitant medications were not reported. Historical
COVID19
6-17 vaccine included first dose of BNT162B2 on
BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1070696-1
years 24Jan2021 16:00 (lot number=EL9261; vaccine
(COVID19)
location=Left arm). The patient experienced rapid
pulse 121-133, fever 101.3, chills, dizzy and body
aches, all on 15Feb2021 14:30 with outcome of
recovering. No treatment received for events. The
patient underwent lab tests which included body
temperature: 101.3 on 15Feb2021, heart rate:
121-133 on 15Feb2021. The events reported as non-
serious. Prior to vaccination, the patient was not
diagnosed with COVID-19. Since the vaccination, the
patient not been tested for COVID-19.
14 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Began having seizures; Presented to the ER on 17
March 2021 for headache with blurry vision;
Presented to the ER on 17 March 2021 for headache
with blurry vision; Also had persistent nausea and
subsequent vomiting; Also had persistent nausea and
subsequent vomiting; Fever X1 to 100.4F on day of
presentation/no further sz; This is a spontaneous
report from a contactable physician. A 17-year-old
female patient (not pregnant) received the first dose
of BNT162B2 (PFIZER-BIONTECH COVID-19
VACCINE) intramuscularly in right arm on 08Mar2021
(lot number: EN6206) at single dose for COVID-19
immunization. Medical history included headache and
irregular periods, ongoing hospitalization. No known
allergies. Concomitant medications included birth
control pills. No other vaccine in four weeks. No
COVID prior vaccination. Vaccine received during
existing hospitalization. The patient began having
seizures (hospitalization prolonged, life threatening)
on 16Mar2021 12:00, presented to the ER on
17Mar2021 for headache with blurry vision
(hospitalization prolonged, life threatening) on
16Mar2021 12:00, also had persistent nausea and
subsequent vomiting (hospitalization prolonged, life
threatening) on 16Mar2021 12:00, fever x1 to 100.4F
on day of presentation/no further seizure
16Mar2021 12:00. Clinical course: Presented to the
COVID19
6-17 ER on 17March2021 for headache with blurry vision.
BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1135577-1
years Patient reported symptoms for 1 day prior. Also had
(COVID19)
persistent nausea and subsequent vomiting.
Presented to the ED at 23:00. Began having seizures.
EEG shows localized to the occipital region. Fever X1
to 100.4F on day of presentation no further sz. LP
shows 1 WBC, Gram stain negative. Cultures
negative. HSV pending. On ceftriaxone and acyclovir.
Continues to have focal sz on EEG now on 3 AEDs.
MRI with contrast negative. CBC unremarkable. CRP
elevated to 0.8 (normal less than 0.5). Tox screen
negative. COVID tested post vaccination: Nasal Swab
(SARS-CoV-2 Cepheid) with result of negative on
17Mar2021. Therapeutic measures were taken as a
result of all the events which included treatment with
IVIG, Antibiotics, Steroids, Antiepileptics. The
outcome of the events was not recovered.; Sender's
Comments: Based on the information currently
available, a possible contributory role of the suspect
excluded based on temporal association and known
drug safety profile. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated
appropriate.
15 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
BODY TEMPERATURE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
Vaccination occurred on 1/12 at 13:00. A few hours
after the vaccination, I experienced muscle pain in
the vaccinated arm. 1/13: I had trouble sleeping; left
arm was in immense pain. 07:00: experiencing arm
soreness, muscle pain, nausea, hot flashes;
temperature = 99.5 08:20: experiencing arm
soreness, muscle pain, hot flashes, chills, sensitivity
to light; temperature = 100.6. Took 650mg
acetaminophen. 09:00: experiencing arm soreness,
muscle pain, sensitivity to light; temperature = 100.8
10:30: experiencing arm soreness, muscle pain;
soreness, muscle pain; temperature = 99.0 12:20:
experiencing arm soreness, muscle pain; temperature
COVID19 = 98.0 Extremely fatigued; took nap (13:00-17:00)
BODY TEMPERATURE 6-17
PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
INCREASED years
(COVID19) headache; temperature = 99.3 18:00: experiencing
arm soreness, muscle pain, headache; temperature =
99.2. Took 650mg acetaminophen. 19:00:
experiencing arm soreness, muscle pain, headache;
= 100.6 21:30: experiencing arm soreness, muscle
pain; temperature = 99.2 22:20: experiencing arm
soreness, muscle pain; temperature = 100.1. Took
400mg Ibuprofen. 1/14: 07:00: woke up
experiencing pain at the injection site, neck pain,
headache. These events continued throughout the
day. No temperature over 99.5. 18:30: Took 650mg
acetaminophen for headache.
16 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
C-REACTIVE PROTEIN PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
17 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
C-REACTIVE PROTEIN PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
COVID19
C-REACTIVE PROTEIN 6-17 tonic-clonic seizure activity for about 20 minutes
(COVID19)
one day of fever found to have elevated inflammatory
markers, LV dysfunction (now resolved), elevated
COVID19 troponin and ST elevation in EKG concerning for
C-REACTIVE PROTEIN 6-17
PFIZER\BIONTECH VACCINE 1127200-1 myopericarditis. Admitted to hospital. No documented
INCREASED years
(COVID19) fever in hospital, no rash, no GI symptoms, no other
criteria met for MIS-C. Unclear etiology of
myopericaraditis.
COVID19
CARBON DIOXIDE NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
6-17
CARDIAC ARREST PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
18 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
6-17 Patient reported difficulty breathing and chest pain;
CARDIAC ARREST PFIZER\BIONTECH VACCINE 1199455-1
years suffered cardiac arrest and death
(COVID19)
Patient was a 16yr female who received Pfizer vaccine
3/19/21 at vaccine clinic and presented with ongoing
CPR to the ED 3/28/21 after cardiac arrest at home.
COVID19 Patient placed on ECMO and imaging revealed
6-17
CARDIAC ARREST PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
(COVID19) of arrest. Risk factors included oral contraceptive use.
Labs have since confirmed absence of Factor V leiden
or prothrombin gene mutation. Patient declared dead
by neurologic criteria 3/30/21.
6-17
CARDIAC DYSFUNCTION PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
COVID19
6-17
CARDIAC FAILURE PFIZER\BIONTECH VACCINE 1242573-1 Heart failure
years
(COVID19)
COVID19
CARDIOVASCULAR 6-17 vaccinated for SARS Co-V2 (First dose on March 5th
EVALUATION years with second dose on March 27). He is currently
(COVID19)
myocarditis.
CEREBRAL 6-17
PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue.
MICROHAEMORRHAGE years
CEREBROVASCULAR 6-17
ACCIDENT years
19 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
CEREBROVASCULAR 6-17
PFIZER\BIONTECH VACCINE 1266007-1 (AE) that occurred after the first dose of vaccine. The
ACCIDENT years
Pfizer"
COVID19
1-2
CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 0939839-1 warm sensation chest area
years
(COVID19)
20 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
"Patient in clinic for chief complaint of possible side
effect of the covid vaccine which she received
yesterday. She states that she woke up at 0200 with
chest tightness, achyness and headache. She rates
the discomfort 7/10 last night and improved now to
5/10. She denies any worsening with any type of
exertion and states that she can do simple things like
take a shower, walk across the room, down the street
or even stairs without any worsening. She denies any
SOB or chest pain--just feels tight. Doesn't feel like
she can't get a full breath or get the air out of her
lungs either. She received her first of two doses of
the Pfizer vaccine yesterday (4:23pm) and had no
difficulty with the injection itself and then 9.5 hours
COVID19
6-17 later woke up from sleep with this chest tightness as
CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 0930353-1
years well as achyness and headache. áShe states that she
(COVID19)
had the exact same symptoms when she had positive
covid test back in August of this year with the
addition of fatigue which lasted for 5 days. At that
time it was not felt necessary to do any further
testing nor treat with steroids according to
cardiology. She does have history of LV non-
compaction cardiomyopathy and her last visit with
cardiology was about 2 years ago and she had a
normal EKG and echo only showed ""mild LV non
compaction at the apex"" at that time. He did not
need to see her again until she is 18 unless she has
problems. She states that she generally does very
well and other than this tightness she does not have
any other significant symptoms."
COVID19
CHEST DISCOMFORT PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
COVID19
CHEST PAIN PFIZER\BIONTECH VACCINE 1071409-1
(COVID19)
Chest pain developed 3 days following vaccine
administration. Presented to ED the morning of
4/11/2021, and was found to have diffuse ST
elevation on ECG, and troponin level of 0.52.
Received dose of aspirin, and then was transferred to
Hospital for treatment and monitoring of pericarditis
the afternoon of 4/11. Echo at Hospital with good LV
COVID19 function. Repeat EKG demonstrated ST elevation
6-17
CHEST PAIN PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every
years
(COVID19) 6 hours. Chest pain recurred in the evening of 4/11,
but resolved some time after administration of
ibuprofen. Troponin level upon arrival to Hospital
were 3.92 at 17:11 on 4/11, then rose 8.68 at 23:42
on 4/11 at the time of his worsening chest pain.
Chest pain still resolved by morning of 4/12, and
troponin level downtrended to 5.87 at 6:22 on 4/12.
Diagnosis consistent with myopericarditis.
COVID19
(COVID19)
21 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
6-17 Shortness of breath, fatigue, tachycardia - persisting
CHEST X-RAY NORMAL PFIZER\BIONTECH VACCINE 1013212-1
years since vaccination
(COVID19)
COVID19
6-11
CHILLS PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain
months
(COVID19)
COVID19 Myalgia, CoughWheeze, chills, sore throat, fatigue Did
1-2
CHILLS PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
(COVID19) symptoms to subside.
22 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Around 4:00 pm on 4/12/2021 I began to feel a slight
headache and my side effects worsened that evening.
I lost my appetite due to the muscle pain, aches,
fatigue, and chills that I felt. After taking a nap, I did
not feel rested but instead restless. Because of the
chills, I put on joggers and a sweatshirt, then
proceeded to try and read a book while sitting under
a blanket. I was unable to concentrate or focus on my
book because of the chills, so I instead watched
television. By 9:00 pm, I tried to go to sleep and took
my last remaining dose of Tylenol. The aches and
chills had only gotten worse and I was still dressed in
joggers and sweatshirt as I tried to fall asleep
underneath two blankets and quilt. All night long I
tossed and turned because of the shivers, aches, and
chills. I was unable to sleep for more than 45 to 60
minutes at a time before I woke up again. This
happened repeatedly all night and it was very painful.
On 4/13/2021 around 8:00 am, I got out of bed with
continued shivers, aches, pain, fatigue, headache,
and chills. I suffered from these symptoms all day
long. Around 3:00 pm I tried to eat spaghetti with
meatballs and steamed vegetables, but the spaghetti
tasted like cardboard and I was only able to eat come
of the vegetable mix. All day long I kept drinking
water to stay hydrated and spent most of my time
switching from my couch to my bed with restlessness,
aches, shivers, and chills. The chills started to
subside around 2:00 am on 4/14/2021 after I took a
hot shower for about 15 to 20 minutes. Still dressed
in joggers and a sweatshirt, this time I tried to sleep
COVID19 under two blankets, but the shivers and chills kept
3-5
CHILLS PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
(COVID19) around 10:00 am, I finally felt well enough to be able
to drive to a store to by ibuprofen. When I got home,
I took some and was finally able to take a nap and
get some rest. I felt much better after my nap, was
able to eat, and go for a small walk. This was my
Pfizer second shot and it is worth mentioning that I
live alone with no friends or family and I am an
COVID-19. I had nobody to call and ask for help or to
take care of me. I had to deal with the additional
psychological trauma of not being able to ask anyone
for help as I worried how long the adverse effects
would last. I did not call my doctor because the last
time I went in to see him, the facility charged me
$170 for a 20-minute appointment and decided to
take more than two months to let me know that I still
owed $119. Everyone at the CDC and other agencies
have failed those of us who live alone, especially
public health officials, who did absolutely nothing to
prepare to help and support people like me during
this pandemic. Your ideals of individualism are bad
public health policy for those of us who are alone,
have nobody to turn do, and do all the right things by
wearing masks, getting vaccinated, and staying six
feet away from everybody. Yet, we are the ones who
suffer the most and have to struggle with adverse
effects of pandemic trauma, depression, and other
mental health issues in addition to loss of taste and
smell. I have not enjoyed food in over six months. It
sure would be nice if for the next pandemic you also
put together a plan for people who live alone and
have nobody to turn to for help because you've failed
us in this pandemic.
6-17
CHILLS PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
COVID19 DEVELOPED HEADACHE, FEVER, CHILLS, BODY
6-17
CHILLS PFIZER\BIONTECH VACCINE 0920541-1 ACHES, NAUSEA. RESOLVED BY MORNING OF
years
(COVID19) 12/31/20
COVID19 Late at night patient began having chills and extreme
6-17
CHILLS PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
(COVID19) extreme fatigue. She also had a fever of 102.
COVID19 30 mins after IM injection: Left arm tingling 45 mins
6-17
CHILLS PFIZER\BIONTECH VACCINE 0951087-1 after IM injection: Left arm, Left shoulder, Left upper
years
(COVID19) back tingling, Headache, chills, fatigue
COVID19
6-17
CHILLS PFIZER\BIONTECH VACCINE 0957769-1 body aches, nausea, vomiting, and chills
years
(COVID19)
COVID19
6-17 DEVELOPED BODY ACHES, FEVER, HEADACHE, AND
CHILLS PFIZER\BIONTECH VACCINE 0974439-1
years CHILLS
(COVID19)
23 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
CHILLS PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
"The child was administered the vaccine at about
11:15 a.m on 2/7/2021. She woke up about 14 hours
later with vaccine side effects the family was
prepared for, including headache, chills, nausea,
vomiting and fatigue. This all resolved within 48
COVID19
6-17 hours. Approximately one week later, the child woke
years up again in the night with severe chills in the middle
(COVID19)
of the night. It was a sudden onset following a week
of feeling well. She had to sit in a warm/hot shower
for an hour to get warm. She described it as
""freezing to death."" She has never experienced
anything like this before."
COVID19
(COVID19)
Chills; body aches; This is a spontaneous report from
a contactable consumer (patient parent). A 17-year-
old (17-year-old age at vaccination) female patient
received second dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE, Solution for injection)
via unknown route of administration on 27Jan2021
01:00 PM at single dose in left arm for COVID-19
immunization at clinic. Medical history was none. The
patient was not pregnant at time of vaccination. No
other vaccines received by patient within 4 weeks
prior to the COVID vaccine. Prior to vaccination, the
COVID19
6-17 patient was not diagnosed with COVID-19. No
years Allergies to medications, food, or other products.
(COVID19)
Concomitant medication was not reported. The
patient previously took (at age 17-year-old) first dose
VACCINE, Lot number: E1014D) on 06Jan2021 in left
arm for COVID-19 immunization. The patient
experienced chills, body aches on 28Jan2021 01:15
AM. No treatment received for the adverse events.
Since the vaccination, it was unknown whether the
patient been tested for COVID-19. The outcome of
events was recovering. Information on the lot/batch
number for 2nd dose has been requested.
24 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
CHILLS PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
Passed out right after vaccine; muscle aches; tired;
chills; migraine; This is a spontaneous report from a
non-contactable consumer (patient). A 17-year-old
female patient received bnt162b2 (PFIZER-BIONTECH
COVID-19 VACCINE), dose 2 via an unspecified route
of administration, administered in the left arm on
14Apr2021 at 14:15 (Batch/Lot number was not
reported) as single dose for covid-19 immunization,
administered at the Pharmacy or Drug store. The
patient received the first dose of bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE) on 17Mar2021 at
COVID19
6-17 14:15 in the left arm for covid-19 immunisation. The
years patient's medical history was not reported. There
(COVID19)
were no concomitant medications. The patient was
not pregnant at the time of report and vaccination.
The patient did not receive other vaccines in four
weeks. The patient had no COVID prior to vaccination
and was not tested for COVID post vaccination. The
patient passed out right after vaccine, also
experienced muscle aches, tired, chills, and migraine;
all on 14Apr2021 with outcome of unknown. No
follow-up attempts are possible, information about
batch number cannot be obtained. No further
information is expected.
25 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COMPLEMENT FIXATION 6-17
TEST POSITIVE years
COVID19 death by suicide Narrative: death by suicide;
1-2
COMPLETED SUICIDE PFIZER\BIONTECH VACCINE 0958443-1 12/26/20, self inflicted gun shot wound; found
years
(COVID19) deceased by family member
COVID19
6-17
COMPLETED SUICIDE PFIZER\BIONTECH VACCINE 1243487-1 Patient Committed Suicide with a firearm.
years
(COVID19)
COMPUTERISED <6
PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if
TOMOGRAM months
Diagnosed w/ severe pneumomediastinum involving
COVID19
COMPUTERISED 6-17 base of neck and right upper extremity.
TOMOGRAM years Emphysematous changes in the airway and vascular
(COVID19)
structures of the neck.
Severe, debilitating fatigue to the point of not being
able to stay awake for more than a couple of hours a
COVID19 day. This continues, although minimally improved, 1
COMPUTERISED 6-17
PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
TOMOGRAM HEAD years
(COVID19) daily, continues 1 month out Dizziness
Thrombophlebitis Initial low-grade fever and arm
soreness resolved within 2 days
The teen had a history of autoimmune disorder,
alopecia areata for the past 2 years. When received
the first dose of pfizer COVID vaccine, she started
COVID19 losing hair rapidly after about 6 to 7 days. She was
6-17
CONDITION AGGRAVATED PFIZER\BIONTECH VACCINE 1175802-1 started on large dose of prednisone 100mg per day
years
(COVID19) after 2 weeks to slow down alopecia. However, in the
span of 4 days she lost most of her hair. We are
wondering if the vaccine could have exacerbated the
autoimmune disorder.
6-17
CONFUSIONAL STATE PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was
years
COVID19
CONFUSIONAL STATE PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
"Entered observation @ 1935. Mother stated to this
nurse @ 1950, that daughter felt ""light-headed"".
Water was given. @ 1954, patient started to gag.
Went to restroom. @ 1958, she was walked with this
nurse and others to ""bed"" that's located in
COVID19
6-17 vaccination clinic. Mother explained to this nurse and
COOLING THERAPY PFIZER\BIONTECH VACCINE 0927167-1
years others that her daughter shows s/s of these
(COVID19)
symptoms upon each vaccination. Lightheadedness
and nausea lasted for about 10-15 minutes. Cold
compress was applied to help relieve s/s from
vaccine. States she felt better around 2005. Left
observation @ 2005, showed no s/s of distress."
1-2
COUGH PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
6-17
COUGH PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other-
years
26 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
COUGH PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved
years
COVID19
6-17 with very limited air entry and hypoxemia. Patient
COVID-19 PFIZER\BIONTECH VACCINE 0921641-1
years received Benadryl, steroids, epinephrine, and Duoneb
(COVID19)
6-17
COVID-19 PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
6-17
CULTURE URINE NEGATIVE PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures
years
27 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
DEAFNESS PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to
years
Patient received second dose of Pfizer vaccine on
March 17, 2020 while at work. March 18, 2020 her 5
month old breastfed infant developed a rash and
within 24 hours was inconsolable, refusing to eat, and
COVID19 developed a fever. Patient brought baby to local ER
<6
DEATH PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
(COVID19) revealed elevated liver enzymes. Infant was
hospitalized but continued to decline and passed
away. Diagnosis of TTP. No known allergies. No new
exposures aside from the mother's vaccination the
previous day.
1-2
DEATH PFIZER\BIONTECH VACCINE 0958443-1 12/26/20, self inflicted gun shot wound; found
years
she was going to die/dies after vaccine; 2-year-old
patient; This is a spontaneous report from a non-
contactable consumer via a Pfizer-sponsored
program. A 2-year-old female patient received
bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),
second dose at the age of 2-years-old via an
unspecified route of administration on 25Feb2021
for covid-19 immunisation. The patient's medical
COVID19 history and concomitant medications were not
1-2
DEATH PFIZER\BIONTECH VACCINE 1255745-1 reported. It was reported that the 2-year-old dies
years
(COVID19) after vaccine on 03Mar2021. Reported on VAERS.
Look for the researchers to exclude her from the
study, probably claiming her death had nothing to do
with the shot, she was going to die that day, five
days after vaccination anyway. That's how they roll.
The patient died on 03Mar2021. The outcome of the
event was fatal. No follow-up attempts are possible.
Information on lot/batch cannot be obtained. No
further information is expected.; Reported Cause(s)
of Death: she was going to die
COVID19
DEATH PFIZER\BIONTECH VACCINE 1199455-1
(COVID19)
6-17
DEATH PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
COVID19
6-17
DEATH PFIZER\BIONTECH VACCINE 1242573-1 Heart failure
years
(COVID19)
28 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
DECREASED APPETITE PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
6-17
DEEP VEIN THROMBOSIS PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
years
medication.
29 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
She became very red; Dizziness; Vomiting; Diarrhea;
Hypotension; This is a spontaneous report from a
contactable healthcare professional. A 17-year-old
female patient received the first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE, solution for
injection, Batch/Lot Number: EW0158),
intramuscular, administered in left arm on 09Apr2021
16:30 as single dose for COVID-19 immunization.
Medical history included 3 weeks of urticaria prior to
vaccination. The patient has had no COVID history
COVID19 prior vaccination. The patient has not been tested for
6-17
DIARRHOEA PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications
years
(COVID19) included fish oil; diphenhydramine hydrochloride
(BENADRYL); cetirizine hydrochloride (ZYRTEC);
ibuprofen (MOTRIN), and an unspecified multivitamin.
The patient previously took Amoxicillin and
experienced drug allergies. After vaccine, the patient
became very red, had dizziness, vomiting and
diarrhea and hypotension on 09Apr2021. The events
resulted in an emergency room/department or urgent
care visit and hospitalization for 1 day. Treatment
included epi, Benadryl, steroids, Pepcid, and fluid
boluses. The outcome of the events was not resolved.
passing out; Vomiting; diarrhea; This is a
(patient). A non-pregnant 17-year-old female patient
MRNA VACCINE), dose 1 via an unspecified route of
administration, administered in the left arm on
13Apr2021 at 13:45 (Batch/Lot Number: Ew0161) at
17-years-old as a single dose for COVID-19
immunization. The patient did not receive any other
vaccine within four weeks of the suspect vaccine. The
COVID19
6-17 patient's medical history was reported as none (no
DIARRHOEA PFIZER\BIONTECH VACCINE 1266009-1
years known allergies). The patient did not have COVID
(COVID19)
prior to the vaccination. Concomitant medications
included ethinylestradiol, ferrous fumarate,
norethisterone acetate (LO LOESTRIN FE) taken for
an unspecified indication, start and stop date were
not reported. On 14Apr2021 at 13:15, the patient
experienced passing out (medically significant),
vomiting (non-serious), and diarrhea (non-serious).
The clinical outcome of the events was recovering.
The patient was not tested for COVID post
vaccination.
<6
DIET REFUSAL PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
previous day.
30 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
DISCOMFORT PFIZER\BIONTECH VACCINE 0930353-1
(COVID19)
05:02PM MOM STATES PT 'FEELS NAUSEA AND
HEADACHE'. (PT HAS DIFFICULTY DESCRIBING HOW
HE FEELS). PT ALERT, PINK,W/D, RESP REG WITH
EASE. 05:06PM COOL CLOTH PLACED ON BACK OF
NECK, TUMS GIVEN PO, LIQUID BENADRYL 25MG
GIVEN PO. 05:20PM 'FEELS A LITTLE BETTER, LESS
NAUSEA.' NOW HAS RT CLAVICLE PAIN. ALERT, PINK,
W/D, RESP WITH EASE. 05:30PM STILL C/O
COVID19 HEADACHE, NAUSEA AND RT CLAVICLE PAIN.
6-17
DISCOMFORT PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER
years
(COVID19) MOM. NO ACUTE DISTRESS NOTED. ALERT, PINK,
W/D, RESP WITH EASE. 2-25-21 10AM TC- MOM
STATES SHE GAVE PT LIQUID TYLENOL LAST NIGHT
FOR DISCOMFORT. STATES HE DOES FEEL BETTER
TODAY BUT STILL HAS HEADACHE AND RT CLAVICLE
PAIN- NO NAUSEA. SHE STATES SHE DID KEEP HIM
HOME FROM SCHOOL TODAY. HE HAS HIS REG APPT
WITH HIS PCP ON 3-1-21 AND WILL ASK ABOUT HIM
GETTING DOSE #2.
31 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
DISTURBANCE IN 3-5
PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
ATTENTION years
Sitting post vaccine, started to feel light headed. EE
COVID19
6-11 was given an ice pack, had sit down in floor.
DIZZINESS PFIZER\BIONTECH VACCINE 0906846-1
months Prolonged monitoring, no additional side effect. EE
(COVID19)
returned to work.
COVID19
(COVID19)
1800.
32 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
(COVID19)
doing better.
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 0963612-1 and they improved with rest. The patient was
years
COVID19 nausea, vomiting, sensitivity to light, hearing was
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a
years
(COVID19) span of 30 minutes.
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
recovered.
33 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
"""Pfizer-Bio-Tech COVID-19 Vaccine EUA"" :
Individual received the Pfizer Covid-19 vaccine. She
began to feel dizzy and flushed at 1:00 pm. Her vitals
were 82/46, 22, 68, 98% RA at1:00 pm. We applied
ice to back of neck. B/P 72/42,20, 76 P, 98 % RA.
COVID19 1:20 pm. Individual report that he had not drink any
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1049830-1 fluids and only had a few bites to eat. Patient
years
(COVID19) swallowing intact. She was given bottle of water.
1:46 pm vitals were 82/54, 100% SATS, 81, 14.
Individual stated she felt better and was not longer
dizzy. 1:55 pm vitals 79/54. 14, 78, 98% RA.
Individual went home with family with no noted
distress."
COVID19 Felt light headed, ringing in her ears, c/o nauseated.
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water.
years
(COVID19) Offered oxygen but refused.
COVID19
(COVID19)
34 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
17 yo F in post vac are reports nausea, dizziness,
headache 4 mins after vaccination. Denies other s/s,
speaks clear and complete. No respiratory distress
COVID19
6-17 noted. Two set of vitals taken, WNLs. . Monitored for
years 30 mins, s/s continued and have increased, post vac
(COVID19)
nurse recommended medical attention. Mom declined
EMS transport. Mom stated she would take pt to a
local urgent care.
My daughter became very dizzy, pale, and hot
(sweating through her clothing) almost passing out
after receiving her first dose . Paramedics were
COVID19 called, vitals taken, and she was taken to an
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
(COVID19) about 15 minutes. She was observed by paramedics
and a nurse for another 30 mins and we were able to
leave and go home. At home she was exhausted the
remainder of the night.
Patient started to feel strange within 1 minute of
receiving the vaccine. Within 5 minutes of receiving
the vaccine, patient felt very faint, dizzy, nauseous,
tingly, lost feeling in lower body, blurry vision, and
started shaking. EMS was called at vaccination site.
EMS arrived about 5 minutes later and took patient's
COVID19 blood pressure. First reading was 102/70, second
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
(COVID19) time, patient could sit up and was alert and oriented.
Patient never lost consciousness. Patient was not
taken to the ER. Patient remained on-site for another
45 minutes until symptoms resolved enough that she
felt it was safe to leave. Patient has not had a
reaction to vaccines or other medical treatment in the
past.
Fatigue; Headache; Fever; Dizziness; This is a
spontaneous report from a non-contactable consumer
(patient). A 17-year-old female patient (not
pregnant) received the second dose bnt162b2
(BNT162B2, lot/batch number and expiry date were
not reported), via an unspecified route of
administration in left arm on 29Jan2021 13:00 at
SINGLE DOSE for Covid-19 immunisation. The
COVID19
6-17 patient's medical history and concomitant
years medications were not reported. She had her first dose
(COVID19)
of bnt162b2 on 08Jan2021 in the left arm. The
patient did not received any other vaccines within 4
weeks prior to the COVID vaccine. On 29Jan2021
17:00, the patient had deadache, fever, dizziness and
fatigue. No treatment was reported. The outcome of
events was recovered. No follow-up attempts are
possible; information about lot/batch number cannot
be obtained.
35 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
seizure like symptoms; Dizziness; lethargy; fatigue;
This is a spontaneous report from a contactable
pharmacist. A 16-year-old male patient received first
dose of intramuscular BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE) on 02Mar2021 at 12:00 at
single dose in left arm for COVID-19 immunisation at
the age of 16-year-old. Lot number was EN6205.
Medical history and concomitant medications were
unknown. On 02Mar2021 at 12:00, the patient
experienced Dizziness, seizure like symptoms,
lethargy, fatigue. It was unknown if the patient was
treated due to the events. The patient recovered from
the events in Mar2021. It was unknown if the patient
COVID19 had COVID prior vaccination; it was unknown if the
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1115268-1 patient was tested for COVID post vaccination.;
years
(COVID19) Sender's Comments: 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
event Seizure cannot be excluded. 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.
COVID19
(COVID19)
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
COVID19
6-17 Systemic: Dizziness / Lightheadness-Mild, Systemic:
years Fainting / Unresponsive-Mild
(COVID19)
COVID19
years Seizure-Mild
(COVID19)
COVID19
(COVID19)
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed
years
condition.
36 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications
years
was sweating profusely and breathing heavy then he
passed out; was sweating profusely and breathing
heavy then he passed out; was sweating profusely
and breathing heavy then he passed out; he started
getting dizzy; felt nauseated; This is a spontaneous
report from a contactable consumer (patient's
parent). A 16-years-old male patient received
dose 1 via an unspecified route of administration,
administered in Arm Right on 11Apr2021 14:30 (Lot
Number: EW0150) (age at vaccination: 16-year-old)
as SINGLE DOSE for covid-19 immunisation. Medical
history was reported as no. No COVID prior
COVID19 vaccination, no COVID tested post vaccination, no
6-17
DIZZINESS PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
(COVID19) medications (no other vaccine in four weeks and no
other medications in two weeks). Right after the
patient was administered the vaccine, he started
getting dizzy and felt nauseated, was sweating
profusely and breathing heavy then he passed out.
They were in the car so the nurse reclined his chair.
He passed out and then woke up and then passed out
(twice) -They gave him water and gum to chew and
remained laying flat. After about 20 or so minutes he
felt better and nurse checked his pulse and heart rate
during the ordeal. The adverse events start date was
reported as 11Apr2021 14:30. No treatment received
for the events. The outcome of the events was
recovered.
37 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
DRUG INEFFECTIVE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
38 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
DRUG SCREEN PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
COVID19 metallic taste immediately; last for several hours--
1-2
DYSGEUSIA PFIZER\BIONTECH VACCINE 0971259-1 resolved. swelling/tenderness anterior neck/most
years
(COVID19) likely lymphadenopathy Narrative: phone call
bilateral numbness cheeks and jaw, difficulty
swallowing Narrative: College med student received
COVID19
1-2 COVID vaccine 30mins later had numbness in both
DYSPHAGIA PFIZER\BIONTECH VACCINE 0940015-1
years cheeks and jaw, 40mins after vaccine he had
(COVID19)
difficulty swallowing. No SOB, No resp distress, no
noticeable swelling of tongue
COVID19
DYSPHAGIA PFIZER\BIONTECH VACCINE 1172466-1
(COVID19)
39 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
DYSPNOEA PFIZER\BIONTECH VACCINE 0930353-1
(COVID19)
6-17
DYSPNOEA PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other-
years
COVID19
(COVID19)
Dad says 5-10 minutes after vaccine patient started
COVID19 having symptoms. Patient said it felt like she couldn't
6-17
DYSPNOEA PFIZER\BIONTECH VACCINE 1049139-1 breathe, like her throat was closing off. Patient
years
(COVID19) walked with staff member to EMS ambulance ~50
feet away.
COVID19
6-17 Patient complained of shortness of breath, heart
years racing. EMS cleared and released to home.
(COVID19)
Patient was normal and little nervous before
vaccination. After receiving vaccinations about 2
minutes patient stated he could get up and was
shaking. He was pale and sweating. Pharmacist Rima
COVID19 left the room to get another pharmacist. Patient mom
6-17
DYSPNOEA PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling.
years
(COVID19) Patient was conscious after and had difficulty
breathing but return to normal after a few minutes.
We gave him a ice pack and called 911 to be ready on
hand but was not dispatched. Patient rested in the
room and left on their own.
COVID19
(COVID19)
6-17
DYSPNOEA PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved
years
40 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
(COVID19)
6-17
DYSSTASIA PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling.
years
6-17
EAR DISCOMFORT PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to
years
COVID19
EAR PAIN PFIZER\BIONTECH VACCINE 1058308-1
(COVID19)
41 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
6-17 setting of patient's complex cardiac history. However,
ECHOCARDIOGRAM PFIZER\BIONTECH VACCINE 1227884-1
years cannot rule out other causes of infarct. Left (L) sided
(COVID19)
ECHOCARDIOGRAM 6-17
ABNORMAL years
COVID19
ECHOCARDIOGRAM 6-17 to a local hospital and the transferred to another
NORMAL years hospital for higher level of care. Pediatric cardiology
(COVID19)
42 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
ECHOCARDIOGRAM 6-17 vaccinated for SARS Co-V2 (First dose on March 5th
NORMAL years with second dose on March 27). He is currently
(COVID19)
myocarditis.
EJECTION FRACTION 6-17
DECREASED years
myopericaraditis.
6-17
ELECTROCARDIOGRAM PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
recovered.
ELECTROCARDIOGRAM 6-17
ABNORMAL years
myopericaraditis.
ELECTROCARDIOGRAM 6-17
ABNORMAL years
COVID19
ELECTROCARDIOGRAM 6-17 Shortness of breath, fatigue, tachycardia - persisting
NORMAL years since vaccination
(COVID19)
COVID19
ELECTROCARDIOGRAM ST 6-17 to a local hospital and the transferred to another
SEGMENT ELEVATION years hospital for higher level of care. Pediatric cardiology
(COVID19)
ELECTROCARDIOGRAM ST 6-17
SEGMENT ELEVATION years
myopericaraditis.
43 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
ELECTROCARDIOGRAM ST 6-17
PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every
SEGMENT ELEVATION years
COVID19
ELECTROENCEPHALOGRAM PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
44 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
<6
EMOTIONAL DISTRESS PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
previous day.
COVID19
EOSINOPHIL PERCENTAGE 6-17 tonic-clonic seizure activity for about 20 minutes
(COVID19)
6-17
ERYTHEMA PFIZER\BIONTECH VACCINE 0950793-1 to the touch Currently using Ibuprofen and ice packs
years
(COVID19) to help
6-17
ERYTHEMA PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
6-17
ERYTHEMA PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications
years
EXPOSURE VIA BREAST <6
PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
MILK months
previous day.
45 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
ate more than usual; vomited; refused to take any
daytime naps; Baby had 3 breast feeding sessions
after patient received vaccine; This is a spontaneous
report from a contactable consumer. This consumer
reported information for both mother and baby. This
case is the baby report. A 9-month-Old male patient
received BNT162B2 (lot number EL0104),
transmammary on 30Dec2020 18:45 at 9 Months at
single dose for COVID-19 immunization. The medical
history was not reported. The patient was not
allergies to medications, food, or other products. The
concomitant medications were levothyroxine sodium
(SYNTHROID), calcitriol, calcium, fish oil and
multivitamin. On the day following the vaccine, the
baby refused to take any daytime naps, ate more
COVID19
EXPOSURE VIA BREAST 6-11 than usual, and vomited on 31Dec2020 10:00 AM.
MILK months None of these were typical behavior for the baby.
(COVID19)
Baby had 3 breast feeding sessions after patient
received vaccine, and then was eating frozen
reserves. We do not know at this point whether the
baby will revert to his norm or whether the change in
behavior will continue. The patient did not receive
any other vaccines within 4 weeks prior to the COVID
vaccine. There was no treatment received for the
adverse events. Prior to vaccination, the patient was
not diagnosed with COVID-19. Since the vaccination,
the patient had not been tested for COVID-19. The
patient was not allergies to medications, food, or
other products. The outcome of the events was
unknown.; Sender's Comments: Linked Report(s) :
US-PFIZER INC-2020521814 same vaccine, different
patient and AE.
"I am nursing. My son (7 months old) developed a
rash and fussiness. No fever. I do not have any
symptoms myself.; rash; fussiness; This is a
spontaneous report from a contactable physician. This
physician reported events for 2 patients (herself and
baby). This is the baby report. A 7-month old male
patient received bnt162b2 (PFIZER-BIONTECH
COVID-19 VACCINE, lot number: EJ1685, expiry date
not reported), transmammary on 22Dec2020 14:30
at a single dose for COVID-19 immunisation. Medical
history was none. Concomitant medication included
levothyroxine. The patient's mother reported that ""I
am nursing. My son (7 months old) developed a rash
COVID19
EXPOSURE VIA BREAST 6-11 and fussiness. No fever. I do not have any symptoms
MILK months myself"". The events started from 06Jan2021.
(COVID19)
Patient's mother had no COVID prior vaccination. No
COVID tested post vaccination. The event was
assessed non-serious. Facility where the most recent
COVID-19 vaccine was administered was hospital.
The patient's mother did not receive any other
No treatment was received for the adverse event.
Prior to vaccination, the patient's mother was not
patient's mother had not been tested for COVID-19.
Clinical outcome of the events was not recovered.;
Sender's Comments: Linked Report(s) : US-PFIZER
INC-2021007817 mother/baby case"
fever; rash; nursing mom/ didn't know if it was from
the vaccine or not; This is a spontaneous report from
a contactable consumer (patient's mother). A 11-
month-old patient received the first does of
BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
transmammary single dose for COVID-19
immunization in Mar2021, at 11-month-old. Medical
history included: 'allergy to pen' and concomitant
medication was not reported. The patient's mother
COVID19 was 28-year-old and was a nursing mom. The
EXPOSURE VIA BREAST 6-11
PFIZER\BIONTECH VACCINE 1224688-1 morning after patient received his mother's shot
MILK months
(COVID19) (31Mar2021), the patient woke up with a rash and
fever. The patient's mother didn't know if it was from
the vaccine or not. The patient was given
paracetamol (TYLENOL) and he felt better. As of not
the rash that behind his leg and on his thigh was
going away. Outcome of the event was resolving. No
follow-up attempts are possible; information about
lot/batch number cannot be obtained.; Sender's
INC-2021368558 mother and baby case
46 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
my 6 month old, whom I am breastfeeding, became
sick with a moderate fever for 3 days and then a rash
about a week about 10 days later; my 6 month old,
whom I am breastfeeding, became sick with a
moderate fever for 3 days and then a rash about a
week about 10 days later; my 6 month old, whom I
am breastfeeding, became sick with a moderate fever
for 3 days and then a rash about a week about 10
days later; my 6 month old, whom I am
breastfeeding, became sick with a moderate fever for
3 days and then a rash about a week about 10 days
later; This is a spontaneous report received from a
contactable other healthcare professional. This
reporter reported information for both mother and
fetus/baby. This is the baby report. Only this case is
serious. A 6-months-old patient of an unspecified
gender received second dose bnt162b2 (PFIZER-
BIONTECH COVID-19 VACCINE), via other routed of
administration on 22Mar2021 10:00 (Batch/Lot
Number: ER8727) as single dose for covid-19
COVID19 immunisation. Patient received the first dose on
PFIZER\BIONTECH VACCINE 1254975-1 01Mar2021 10:00 with lot number EN6202. The
MILK months
(COVID19) patient medical history was not reported. The
patient's concomitant medications were not reported.
The patient's mother reported that separately, her 6
month old, whom she was breastfeeding, became sick
with a moderate fever for 3 days and then a rash
about a week about 10 days later. Outcome of events
was unknown. No follow-up attempts are needed. No
further information is expected; Sender's Comments:
Based on the information available, a possible
contributory role of the suspect BNT162B2 cannot be
excluded for the reported events. The impact of this
report on the benefit/risk profile of the Pfizer product
is evaluated as part of Pfizer procedures for safety
and Investigators, as appropriate.,Linked Report(s) :
US-PFIZER INC-2021387880 same reporter/drug,
different patient/event(mother case)
47 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or
MILK years
maternal case
currently nursing my baby who is 14 months old.;
This is a spontaneous report from a contactable nurse
practitioner. This nurse practitioner reported
information for both mother (Self) and her 14-month-
old patient infant. A 14-months-old of an unspecified
gender started to the first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 MRNA VACCINE), (age
at vaccination 14-month-old) transmammary on an
unspecified date in Dec2020. The infant's mother
COVID19 received the vaccine for COVID-19 immunisation. The
PFIZER\BIONTECH VACCINE 0923608-1 infant's mother reported she was a nurse practitioner
MILK years
(COVID19) working at a local urgent care center. She was
currently nursing her baby who is 14 months old. Due
to the high risk of getting COVID19, the mother
decided to get COVID 19 vaccination despite lack of
data on lactating women. She received my Pfizer
COVID 19 vaccination 3 days ago (Dec2020).
Outcome of the event was unknown. Information on
the lot/batch number has been requested.; Sender's
INC-2021001535 mother case
48 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19 patient was vaccinated in the morning at a clinic at a
EXTRA DOSE 6-11
PFIZER\BIONTECH VACCINE 0914919-1 LTCF in the left arm and then vaccinated a second
ADMINISTERED months
(COVID19) time in the right arm on the floor in her room
6-17
EYE MOVEMENT DISORDER PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling.
years
At approximately 7:30 AM the following day, the
patient woke up with the left eye being swollen and
COVID19
6-17 puffy as well as tender and slightly painful. Felt weird
EYE PAIN PFIZER\BIONTECH VACCINE 0968248-1
years to blink but only in left eye. Took Acetaminophen
(COVID19)
500mg and swelling decreased significantly around 2
hours later from the time it was first noticed.
My left eye was pretty well swollen and puffy, it hurts
to blink and stuff and it was pretty tender; My left
eye was pretty well swollen and puffy, it hurts to
blink and stuff and it was pretty tender; My left eye
was pretty well swollen and puffy, it hurts to blink
and stuff and it was pretty tender; This is a
(patient). A 17-year-old male patient received
bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE;
lot EL3247, expiration date unspecified), via an
COVID19 unspecified route of administration on 21Jan2021 at
6-17
EYE PAIN PFIZER\BIONTECH VACCINE 1019115-1 single dose (left arm) for COVID-19 immunization.
years
(COVID19) Medical history included mood disorder or attention
deficit hyperactivity disorder (ADHD). Concomitant
medications included aripiprazole (ABILIFY), and
gabapentin, both for mood or ADHD. The patient
reported that he got the shot on his left arm last
Thursday, 21Jan2021 and woke up the next morning,
22Jan2021, and his left eye was pretty well swollen
and puffy, it hurts to blink, and stuff and it was pretty
tender. The patient stated that he believe he took
acetaminophen or the tylenol. Outcome of events was
unknown.
COVID19
EYE SWELLING PFIZER\BIONTECH VACCINE 0968248-1
(COVID19)
6-17
EYE SWELLING PFIZER\BIONTECH VACCINE 1019115-1 single dose (left arm) for COVID-19 immunization.
years
unknown.
49 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
FACIAL PARALYSIS PFIZER\BIONTECH VACCINE 1227884-1
(COVID19)
<6
FAILURE TO THRIVE PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
previous day.
<6
FATIGUE PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if
months
1-2
FATIGUE PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
50 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
FATIGUE PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
6-17
FATIGUE PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
6-17
FATIGUE PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
COVID19
6-17
FATIGUE PFIZER\BIONTECH VACCINE 0938297-1 C/O Tiredness, and Headache
years
(COVID19)
COVID19
FATIGUE PFIZER\BIONTECH VACCINE 0942502-1
(COVID19)
doing better.
51 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
FATIGUE PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
6-17
FATIGUE PFIZER\BIONTECH VACCINE 0951087-1 after IM injection: Left arm, Left shoulder, Left upper
years
COVID19
(COVID19)
COVID19
(COVID19)
6-17
FATIGUE PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
COVID19
(COVID19)
be obtained.
52 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
FATIGUE PFIZER\BIONTECH VACCINE 1115268-1 patient was tested for COVID post vaccination.;
years
Rash all over face and arms appeared 3 days later. It
is now the 5th day and the rash has spread to my
legs and stomach/very itchy and irritating; fatigue;
This is a spontaneous report received from a
contactable consumer (Reporting for herself). A 17-
years-old female patient received Second dose of
Formulation: Solution for injection, Lot number:
EM9810, Expiration date: not reported) via an
unspecified route of administration in Arm Left on
13Feb2021 12:45 (At the age of 17 years-old) as
single dose for COVID-19 vaccination. The patient
medical history was not reported and no known
allergies. The historical vaccine included first dose of
COVID19 BNT162B2 received via an unspecified route of
6-17
FATIGUE PFIZER\BIONTECH VACCINE 1183846-1 administration in Arm Left on 23Jan2021 12:30 for
years
(COVID19) COVID-19 vaccination. The patient's concomitant
medications were not reported. The patient was not
pregnant at the time of vaccination. The patient did
not receive any other vaccines within 4 weeks prior to
the COVID vaccine. No COVID prior vaccination. No
COVID tested post vaccination. It was reported that
patient had no symptoms after the 1st dose. On
16Feb2021 she had fatigue (the first 1-2 days after
getting the 2nd dose of Pfizer) that got better. Rash
all over face and arms appeared 3 days later. It is
now the 5th day and the rash has spread to legs and
stomach. It was beginning to get very itchy and
irritating. Patient was treated with hydrocortisone 3-4
times a day and it was not of much help. The
outcome of the events was not recovered.
6-17
FATIGUE PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
COVID19
years aches
(COVID19)
53 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
FATIGUE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
COVID19
(COVID19)
COVID19
6-17 EXTREME NAUSEA AND SEVERE FATIGUE AS WELL
years AS SHAKINESS
(COVID19)
54 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
FEELING ABNORMAL PFIZER\BIONTECH VACCINE 0968248-1
(COVID19)
6-17
FEELING ABNORMAL PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
past.
NauseaVomiting History of vasovagal episodes; c/o
warm feeling and nausea without vomiting.
COVID19
1-2 Recovered Narrative: 10 minutes after vaccine admin.
FEELING HOT PFIZER\BIONTECH VACCINE 0932383-1
years c/o/ warmth and nausea. Triaged by the ER nurse
(COVID19)
and observed for 45 minutes. Discharged in stable
condition 133/84, 104, 18
COVID19
1-2
FEELING HOT PFIZER\BIONTECH VACCINE 0939839-1 warm sensation chest area
years
(COVID19)
6-17
FEELING HOT PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water.
years
6-17
FEELING HOT PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
55 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-11
FEVER NEONATAL PFIZER\BIONTECH VACCINE 1224688-1 morning after patient received his mother's shot
months
6-11
FEVER NEONATAL PFIZER\BIONTECH VACCINE 1254975-1 01Mar2021 10:00 with lot number EN6202. The
months
56 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
FIBRIN D DIMER PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
COVID19
FLUSHING PFIZER\BIONTECH VACCINE 0942502-1
(COVID19)
doing better.
6-17
FLUSHING PFIZER\BIONTECH VACCINE 1049830-1 fluids and only had a few bites to eat. Patient
years
distress."
6-17
FLUSHING PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
57 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
6-17
FLUSHING PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
COVID19
6-17 Systemic: Fainting / Unresponsive-Mild, Systemic:
years Flushed / Sweating-Mild
(COVID19)
58 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
FULL BLOOD COUNT PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
COVID19
6-17 base of neck and right upper extremity.
FULL BLOOD COUNT PFIZER\BIONTECH VACCINE 1193717-1
years Emphysematous changes in the airway and vascular
(COVID19)
59 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
FULL BLOOD COUNT PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
COVID19
GENERALISED TONIC- 6-17 tonic-clonic seizure activity for about 20 minutes
CLONIC SEIZURE years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
1-2
GUN SHOT WOUND PFIZER\BIONTECH VACCINE 0958443-1 12/26/20, self inflicted gun shot wound; found
years
COVID19
HAEMATOCRIT NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
COVID19
HAEMOGLOBIN NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
Systemic: Fainting/Unresponsive-Medium. Additional
Details: Patient fainted about 5 minutes after
COVID19
6-17 receiving 2nd dose of vaccine. Pt hit his head on a
HEAD INJURY PFIZER\BIONTECH VACCINE 1059253-1
years table on way down. EMS called. PT was alert and
(COVID19)
oriented, but was taken to the hospital for evaluation
by ambulance.
COVID19
6-11
HEADACHE PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain
months
(COVID19)
3-5
HEADACHE PFIZER\BIONTECH VACCINE 1074334-1 Within three hours of receiving vaccine, body aches,
years
60 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
HEADACHE PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
6-17
HEADACHE PFIZER\BIONTECH VACCINE 0920541-1 ACHES, NAUSEA. RESOLVED BY MORNING OF
years
(COVID19) 12/31/20
61 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
HEADACHE PFIZER\BIONTECH VACCINE 0930353-1
(COVID19)
COVID19
6-17
HEADACHE PFIZER\BIONTECH VACCINE 0938297-1 C/O Tiredness, and Headache
years
(COVID19)
6-17
HEADACHE PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
6-17
HEADACHE PFIZER\BIONTECH VACCINE 0951087-1 after IM injection: Left arm, Left shoulder, Left upper
years
COVID19
years CHILLS
(COVID19)
62 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
6-17
HEADACHE PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER
years
GETTING DOSE #2.
63 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HEADACHE PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
COVID19
(COVID19)
COVID19
6-17
HEADACHE PFIZER\BIONTECH VACCINE 1060665-1 Nausea, emesis, HA, shaky. Cleared by EMS
years
(COVID19)
COVID19
(COVID19)
COVID19
(COVID19)
local urgent care.
COVID19
(COVID19)
be obtained.
64 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
COVID19
(COVID19)
65 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
HEART RATE PFIZER\BIONTECH VACCINE 0995255-1
(COVID19)
unknown.
COVID19
HEART RATE PFIZER\BIONTECH VACCINE 1070696-1
(COVID19)
6-17
HEART RATE PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed
years
condition.
66 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HEART RATE PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
recovered.
COVID19
HEART RATE INCREASED PFIZER\BIONTECH VACCINE 1069293-1
(COVID19)
COVID19
HEART RATE INCREASED PFIZER\BIONTECH VACCINE 1070696-1
(COVID19)
6-17
HEART SOUNDS ABNORMAL PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
HEPATIC ENZYME <6
PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
INCREASED months
previous day.
67 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HOT FLUSH PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
COVID19
HYPERHIDROSIS PFIZER\BIONTECH VACCINE 0942502-1
(COVID19)
doing better.
68 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
6-17
HYPERHIDROSIS PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
6-17
HYPERHIDROSIS PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
COVID19
(COVID19)
69 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HYPERHIDROSIS PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
recovered.
Rash all over face and arms appeared 3 days later. It
is now the 5th day and the rash has spread to my
legs and stomach/very itchy and irritating; fatigue;
This is a spontaneous report received from a
contactable consumer (Reporting for herself). A 17-
years-old female patient received Second dose of
Formulation: Solution for injection, Lot number:
EM9810, Expiration date: not reported) via an
unspecified route of administration in Arm Left on
13Feb2021 12:45 (At the age of 17 years-old) as
single dose for COVID-19 vaccination. The patient
medical history was not reported and no known
allergies. The historical vaccine included first dose of
COVID19 BNT162B2 received via an unspecified route of
6-17
HYPERSENSITIVITY PFIZER\BIONTECH VACCINE 1183846-1 administration in Arm Left on 23Jan2021 12:30 for
years
(COVID19) COVID-19 vaccination. The patient's concomitant
medications were not reported. The patient was not
pregnant at the time of vaccination. The patient did
not receive any other vaccines within 4 weeks prior to
the COVID vaccine. No COVID prior vaccination. No
COVID tested post vaccination. It was reported that
patient had no symptoms after the 1st dose. On
16Feb2021 she had fatigue (the first 1-2 days after
getting the 2nd dose of Pfizer) that got better. Rash
all over face and arms appeared 3 days later. It is
now the 5th day and the rash has spread to legs and
stomach. It was beginning to get very itchy and
irritating. Patient was treated with hydrocortisone 3-4
times a day and it was not of much help. The
outcome of the events was not recovered.
70 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HYPERSENSITIVITY PFIZER\BIONTECH VACCINE 1266007-1 (AE) that occurred after the first dose of vaccine. The
years
Pfizer"
COVID19
HYPERVENTILATION PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
71 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HYPERVENTILATION PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
recovered.
6-17
HYPOACUSIS PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a
years
bilateral numbness cheeks and jaw, difficulty
swallowing Narrative: College med student received
COVID19
1-2 COVID vaccine 30mins later had numbness in both
HYPOAESTHESIA PFIZER\BIONTECH VACCINE 0940015-1
years cheeks and jaw, 40mins after vaccine he had
(COVID19)
difficulty swallowing. No SOB, No resp distress, no
noticeable swelling of tongue
6-17
HYPOAESTHESIA PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
6-17
HYPOAESTHESIA PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
past.
6-17
HYPOTENSION PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications
years
72 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
HYPOTONIA PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue.
years
COVID19
HYPOXIA PFIZER\BIONTECH VACCINE 0921641-1
(COVID19)
6-11
ILLNESS PFIZER\BIONTECH VACCINE 1254975-1 01Mar2021 10:00 with lot number EN6202. The
months
COVID19
6-11
ILLUSION PFIZER\BIONTECH VACCINE 0918683-1 Persistant symptoms of perception off and off-balance
months
(COVID19)
IMMEDIATE POST-INJECTION 6-17
PFIZER\BIONTECH VACCINE 1049139-1 breathe, like her throat was closing off. Patient
REACTION years
feet away.
COVID19
IMMEDIATE POST-INJECTION 6-17 immediately after receiving injection. Patient was
REACTION years observed by EMS onsite and then went to ED for visit.
(COVID19)
INAPPROPRIATE SCHEDULE COVID19
6-17
OF PRODUCT PFIZER\BIONTECH VACCINE 0946849-1 Error: Booster Given Too Early
years
ADMINISTRATION (COVID19)
INAPPROPRIATE SCHEDULE COVID19
6-17 No adverse event. Reporting patient received vaccine
OF PRODUCT PFIZER\BIONTECH VACCINE 0950649-1
years at 15 yes 26 days old... under 16 year old guideline
ADMINISTRATION (COVID19)
COVID19
INCORRECT DOSE 6-17 Wrong Dose of Vaccine - Too High; symptoms lasted
ADMINISTERED years 0 days
(COVID19)
73 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
6-11 than usual, and vomited on 31Dec2020 10:00 AM.
INCREASED APPETITE PFIZER\BIONTECH VACCINE 0927664-1
months None of these were typical behavior for the baby.
(COVID19)
patient and AE.
74 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
1-2
INFANT IRRITABILITY PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or
years
maternal case
INFLAMMATORY MARKER 6-17
INCREASED years
myopericaraditis.
COVID19
6-17
INJECTION SITE MASS PFIZER\BIONTECH VACCINE 0929277-1 lump in arm pit of injection arm
years
(COVID19)
3-5
INJECTION SITE PAIN PFIZER\BIONTECH VACCINE 1074334-1 Within three hours of receiving vaccine, body aches,
years
75 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
INJECTION SITE PAIN PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
Itching and rash to the injection site, left deltoid.
Down left arm shoulder and chest. After a few
COVID19
6-17 minutes patient was stable and sent home after
INJECTION SITE PRURITUS PFIZER\BIONTECH VACCINE 1045800-1
years monitoring patient. Benadryl was administered at
(COVID19)
12:17pm. Patient advised to take Benadryl prior to
2nd dose.
COVID19
6-17 1/6 a rash developed at the injection site and by 1/7
INJECTION SITE RASH PFIZER\BIONTECH VACCINE 0926611-1
years it had spread to the belly and chest.
(COVID19)
COVID19
INJECTION SITE RASH PFIZER\BIONTECH VACCINE 1045800-1
(COVID19)
2nd dose.
6-17
INJECTION SITE URTICARIA PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
76 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
INSOMNIA PFIZER\BIONTECH VACCINE 0927664-1
(COVID19)
patient and AE.
6-17
INTENSIVE CARE PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
6-17
INTENSIVE CARE PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
COVID19 Pzifer COVID 19 vaccine vial had white speck floater
INTERCEPTED PRODUCT 1-2
PFIZER\BIONTECH VACCINE 0920403-1 after dilution with NS 1.8 ml. Saw upon inspection
DISPENSING ERROR years
(COVID19) and zero doses were utilized from this vial.
Administration error: Patient incorrectly given
COVID19 Moderna as first dose on 2/5/21 despite being
INTERCHANGE OF VACCINE 6-17
PFIZER\BIONTECH VACCINE 1073184-1 <18y/o. Error was detected when patient presented
PRODUCTS years
(COVID19) for second dose. Patient given Pfizer at that time due
to age <18y/o which resulted in a mixed-dose series.
INTERNAL CAPSULE 6-17
INFARCTION years
77 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
INTERNATIONAL 6-17 setting of patient's complex cardiac history. However,
NORMALISED RATIO years cannot rule out other causes of infarct. Left (L) sided
(COVID19)
78 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
INVESTIGATION PFIZER\BIONTECH VACCINE 1227884-1
(COVID19)
COVID19
6-11 and fussiness. No fever. I do not have any symptoms
IRRITABILITY PFIZER\BIONTECH VACCINE 0939409-1
months myself"". The events started from 06Jan2021.
(COVID19)
79 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
ISCHAEMIC CEREBRAL 6-17 setting of patient's complex cardiac history. However,
INFARCTION years cannot rule out other causes of infarct. Left (L) sided
(COVID19)
I am a 74 year old male in good health with NO prior
reactions to the annual flu, pneumonia, or shingles
vaccinations. Because of a scheduled prostate biopsy
in early April 2021, I wanted to complete the
vaccination for COVID-19 in advance of this
procedure. Within 5 mins of receiving the vaccination
COVID19
<6 shot in my left arm, my left elbow and forearm began
JOINT SWELLING PFIZER\BIONTECH VACCINE 1061353-1
months to swell into a large ball shape near the elbow joint.
(COVID19)
At the same time, my left hand became noticeably
swollen as well. Fortunately, I did not experience
trouble breathing or have any numbness in my
fingers at that time. The observation staff nurses took
me to a separate room to check my blood pressure
and heart rate which were both in the normal range.
6-17
LABORATORY TEST PFIZER\BIONTECH VACCINE 0935956-1 in her left ear and lasted for 5 days and started to
years
6-17
LABORATORY TEST PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
80 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
LABORATORY TEST PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
LEFT VENTRICULAR 6-17
DYSFUNCTION years
myopericaraditis.
6-17
LETHARGY PFIZER\BIONTECH VACCINE 1115268-1 patient was tested for COVID post vaccination.;
years
COVID19
LETHARGY PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
81 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
She tore her ACL, Needing surgery; This is a
spontaneous report from a contactable Pharmacist
(Mother) via Pfizer-sponsored program COVAX US
Support. A 17-year-old female patient received first
dose of bnt162b2 (PFIZER-BIONTECH COVID-19
mRNA VACCINE, Formulation: Solution for injection),
03Apr2021 as a single dose for COVID-19
immunization and the patient scheduled to receive
her second vaccine on 25Apr2021, but last Thursday
the patient tore her ACL and will be needing surgery
on 30Apr2021. Concerned about possible side effects.
Husband received Pfizer doses. Trying to determine
what the patient should do for the daughter to
prevent blood clotting like what happened with
COVID19 (withheld) patients. Outcome of event was
6-17
LIGAMENT RUPTURE PFIZER\BIONTECH VACCINE 1255734-1 unknown.~ Additional information required. ;
years
(COVID19) Sender's Comments: Based on the current limited
available information and the plausible drug-event
temporal association, a possible contributory role of
the suspect product BNT162B2 to the development of
events cannot be totally excluded/assessed. the case
will be reassessed after additional information is
received on the causal factor for the event such as
incidents of trauma or accidents. The impact of this
notified to RAs, Ethics Committees, and Investigators,
as appropriate
COVID19
6-17
LIP SWELLING PFIZER\BIONTECH VACCINE 1064279-1 Swelling in lips and burning in throat.
years
(COVID19)
COVID19 Pzifer COVID 19 vaccine vial had white speck floater
LIQUID PRODUCT PHYSICAL 1-2
PFIZER\BIONTECH VACCINE 0920403-1 after dilution with NS 1.8 ml. Saw upon inspection
ISSUE years
(COVID19) and zero doses were utilized from this vial.
He passed out, he couldn't stay awake/ passing out;
consumer. An 80-year-old male patient received the
1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19
VACCINE), via an unspecified route of administration
administered in arm left on 29Mar2021 10:45
(Batch/Lot Number: ER8132) as SINGLE DOSE for
COVID-19 immunization at the hospital. Medical
COVID19
<6 history reported as none. Concomitant medications
LOSS OF CONSCIOUSNESS PFIZER\BIONTECH VACCINE 1205235-1
months were not reported. The patient also had no prior
(COVID19)
vaccinations (within 4 weeks). On 29Mar2021 around
6:30 or 7 PM, the was at the house when the passing
out began where he couldn't stay awake. The patient
was brought to emergency room and was admitted in
the hospital on that same day of 29Mar2021.
Outcome of the event was not recovered. No follow-
up attempts are possible. No further information is
expected.
82 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
unknown.
She passed out.; This is a spontaneous report from a
contactable consumer (parent). A 17-year-old female
patient (daughter) received first dose of BNT162B2
(PFIZER-BIONTECH COVID-19 VACCINE, lot number=
EL1284) on 22Jan2021 11:45 AM at left arm at single
dose for COVID-19 immunisation. Medical history and
COVID19 concomitant medications were none. No known
6-17
LOSS OF CONSCIOUSNESS PFIZER\BIONTECH VACCINE 1004437-1 allergies. Patient was not pregnant. Patient did not
years
(COVID19) have COVID prior vaccination, and did not have other
vaccine in four weeks, did not other medications in
two weeks. The patient experienced passed out on
22Jan2021 12:00 PM. Treatment included they had
her lay on the ground with her knees up and cold
compresses. Patient did not test COVID post
vaccination. The outcome of event was recovering.
83 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
6-17
LOSS OF CONSCIOUSNESS PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling.
years
84 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Lost consciousness approximately 3 minutes after
receiving first dose of vaccine. was feeling fine after
vaccine until they stood up.; This is a spontaneous
report received from a contactable consumer
(patient). A 17-year-old female patient (non-
pregnant) received first dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 mRNA VACCINE, lot number:
EW0153, expiration date unknown), via unspecified
route of administration in left arm on 05Apr2021 at
11:30 AM at a single dose for COVID-19
immunization. The medical history was not reported.
Patient did not receive any other vaccine in four
COVID19 weeks. No allergies to medications, food, or other
6-17
LOSS OF CONSCIOUSNESS PFIZER\BIONTECH VACCINE 1235756-1 products No known allergies. Concomitant
years
(COVID19) medications included birth control pills (other
medications in two weeks). On 05Apr2021 at 11:30
AM, the patient lost consciousness approximately 3
minutes after receiving first dose of vaccine and was
feeling fine after vaccine until they stood up.
Treatment included the emergency room/department
or urgent care, treatment was EKG, concussion test.
No covid prior vaccination. There was no covid test
performed post vaccination. The patient considered
the event as non-serious. The patient recovered from
the event on 05Apr2021. Information on Lot/Batch
number was available. Additional information has
been requested.
COVID19
(COVID19)
vaccination.
6-17
LOSS OF CONSCIOUSNESS PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
recovered.
85 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
LUMBAR PUNCTURE PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
86 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
LUNG ASSIST DEVICE 6-17
THERAPY years
LUNG ASSIST DEVICE 6-17
PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
THERAPY years
COVID19
LYMPHADENOPATHY PFIZER\BIONTECH VACCINE 1058308-1
(COVID19)
COVID19
LYMPHOCYTE PERCENTAGE 6-17 tonic-clonic seizure activity for about 20 minutes
(COVID19)
87 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
MAGNETIC RESONANCE 6-17 ER on 17March2021 for headache with blurry vision.
IMAGING years Patient reported symptoms for 1 day prior. Also had
(COVID19)
appropriate.
88 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
MAGNETIC RESONANCE 6-17 setting of patient's complex cardiac history. However,
IMAGING years cannot rule out other causes of infarct. Left (L) sided
(COVID19)
MAGNETIC RESONANCE 6-17
IMAGING HEAD ABNORMAL years
89 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
MALAISE PFIZER\BIONTECH VACCINE 1040554-1
(COVID19)
appropriate.
COVID19
6-17
MEDICATION ERROR PFIZER\BIONTECH VACCINE 0943708-1 Error: Wrong Patient (documentation in EMR)
years
(COVID19)
COVID19
6-17 Wrong Dose of Vaccine - Too High; symptoms lasted
MEDICATION ERROR PFIZER\BIONTECH VACCINE 0944191-1
years 0 days
(COVID19)
COVID19
6-17
MEDICATION ERROR PFIZER\BIONTECH VACCINE 1000757-1 Error: Too Young for Vaccine
years
(COVID19)
COVID19
METABOLIC FUNCTION TEST PFIZER\BIONTECH VACCINE 1193717-1
(COVID19)
6-17
MIGRAINE PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
90 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
MIGRAINE PFIZER\BIONTECH VACCINE 1269727-1
(COVID19)
COVID19
MONOCYTE PERCENTAGE PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
6-17
MOTOR DYSFUNCTION PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue.
years
91 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
MOTOR DYSFUNCTION PFIZER\BIONTECH VACCINE 1227884-1
(COVID19)
COVID19
6-11
MYALGIA PFIZER\BIONTECH VACCINE 0968464-1 Headache,chills,muscle/joint pain
months
(COVID19)
1-2
MYALGIA PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
COVID19
1-2
MYALGIA PFIZER\BIONTECH VACCINE 0940836-1 Myalgia Throbbing pain on both arms
years
(COVID19)
92 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
MYALGIA PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
6-17
MYALGIA PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
93 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
MYALGIA PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
COVID19
MYALGIA PFIZER\BIONTECH VACCINE 1269727-1
(COVID19)
6-17
MYOCARDITIS PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every
years
COVID19
6-17
NASAL PRURITUS PFIZER\BIONTECH VACCINE 0954211-1 Runny and itchy nose, lasting for about a day.
years
(COVID19)
COVID19
NAUSEA PFIZER\BIONTECH VACCINE 0932383-1
(COVID19)
condition 133/84, 104, 18
94 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
1800.
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0920541-1 ACHES, NAUSEA. RESOLVED BY MORNING OF
years
(COVID19) 12/31/20
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
COVID19
(COVID19)
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
COVID19
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0957769-1 body aches, nausea, vomiting, and chills
years
(COVID19)
COVID19
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0970410-1 Nausea causing vomiting 15 hours after injection
years
(COVID19)
6-17
NAUSEA PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a
years
95 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water.
years
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER
years
GETTING DOSE #2.
96 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1060665-1 Nausea, emesis, HA, shaky. Cleared by EMS
years
(COVID19)
COVID19
(COVID19)
local urgent care.
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
past.
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
97 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
COVID19
years aches
(COVID19)
COVID19
(COVID19)
COVID19
years AS SHAKINESS
(COVID19)
98 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
NAUSEA PFIZER\BIONTECH VACCINE 1269700-1 Known allergies. There were no concomitant
years
recovered.
6-17
NECK PAIN PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
COVID19
6-17
NERVOUSNESS PFIZER\BIONTECH VACCINE 1060665-1 Nausea, emesis, HA, shaky. Cleared by EMS
years
(COVID19)
COVID19
NEUTROPHIL PERCENTAGE 6-17 tonic-clonic seizure activity for about 20 minutes
(COVID19)
This individual was given the Covid-19 vaccine at on
COVID19
6-17 offsite clinic at the age of 15 when the vaccine is only
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 0915584-1
years approved for 16 and older. No adverse reaction
(COVID19)
reported.
COVID19
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 0929153-1 no a/e, pt is under the age limit
years
(COVID19)
On January 12, at an unknown time, a family went to
COVID19 receive COVID-19 vaccines. They were told that
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 0956979-1 everyone in the car could get vaccinated. The Pfizer
years
(COVID19) BioNTech Covid-19 vaccine is not authorized for use
in those who are less than 16 years of age.
99 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
No Adverse event, reporting age differential from
approved. During a covid vaccine clinic vaccinated.
COVID19 While processing the vaccine, the vaccine was given
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 0965669-1 to the patient and it wasn't until later they saw the
years
(COVID19) rejection for the patient that she was not 16. Patient
had no adverse reaction and patient and facility are
aware she cannot get second dose until she is 16.
COVID19
6-17 minor age 15 received COVID vaccine. no adverse
years reaction
(COVID19)
Patient accompanied his father to the clinic for a
routine appt. to give his father IV fluids. When they
arrived they both asked when they were going to get
their Covid 19 vaccine. The clinic was running a
COVID19 vaccine clinic that day and we had extra doses. I
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 0986738-1 asked how old he was and he said 16. His father was
years
(COVID19) sitting next to him. I gave his Covid 19 vaccine and
then realized that his DOB he was not yet 16. He and
his dad are aware of this incident and he denies any
adverse affects from the vaccine at the time of this
report.
Patient identified himself as 19 years of age and
appropriate for vaccine at an offsite drive through
mass immunization event . Upon returning to the
clinic to enter the information into the computer it
was found by the injector that the patient was
COVID19
6-17 actually 15 years and 8 months old rather than the
years 16 years required for the Pfizer COVID-19 vaccine. No
(COVID19)
adverse problems from the vaccine administration.
This RN called the mother of the patient and verified
birthdate and informed her that he will not be eligible
for the second dose until after he turns 16 years old.
Mother verbalized understanding.
Patient is not in the recommended age range for the
COVID19
6-17 vaccine. The recommended age is 16 years and older
years and this patient is 15 years old. Patient has had no
(COVID19)
adverse reaction to the vaccine at this time.
COVID19 Pfizer vaccine was reconstituted with sterile water
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 1053009-1 instead of normal saline and administered. Patient
years
(COVID19) has not reported any adverse effects
No known adverse event, but we wanted to report
COVID19 that the immunization was given to someone who
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 1058946-1 was only 15 years of age. The VAR was signed off on
years
(COVID19) by we assume a parent, and the patient additionally
signed the back of the VAR.
COVID19 Too young to receive vaccine Received 2nd dose on
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 1073222-1 2/13/21 Lot EL3246 of Pfizer vaccine also in R deltoid,
years
(COVID19) IM
COVID19 no known adverse event. Too young to receive the
6-17
NO ADVERSE EVENT PFIZER\BIONTECH VACCINE 1073247-1 vaccine. received on on 1/23/2021 and 2nd on
years
(COVID19) 2/11/2021
"After patient received his vaccination it was
discovered that he was only 15 years old (patient will
turn 16 tomorrow 3/6/2021), this technically resulted
in a medication administration error. Patient's parents
were on-site and were advised of the error, there was
COVID19
6-17 no concern expressed by the parents. Patient was
years observed for 15 minutes and no reactions were
(COVID19)
noted. Steps have been taken to avoid similar
mistakes in the future. Staff at all levels have been
directed to be more diligent in checking ages, signs
have been developed to be posted with the ?must
have been born before"" date."
6-17
NODULE PFIZER\BIONTECH VACCINE 0950793-1 to the touch Currently using Ibuprofen and ice packs
years
(COVID19) to help
6-17
NODULE PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
years
medication.
100 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
ORAL CONTRACEPTION PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
COVID19
OROPHARYNGEAL 6-17 better for the duration. BP initially 141/89 while
DISCOMFORT years sitting with HR at 75. Pt laid down with feet propped
(COVID19)
1-2
OROPHARYNGEAL PAIN PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
6-17
OROPHARYNGEAL PAIN PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
COVID19
OROPHARYNGEAL PAIN PFIZER\BIONTECH VACCINE 1058308-1
(COVID19)
OROPHARYNGEAL 6-17
PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved
SWELLING years
<6
PAIN PFIZER\BIONTECH VACCINE 0918673-1 around 2 hours later lower extremities painful - body
months
(COVID19) aches
COVID19
1-2
PAIN PFIZER\BIONTECH VACCINE 0940836-1 Myalgia Throbbing pain on both arms
years
(COVID19)
3-5
PAIN PFIZER\BIONTECH VACCINE 1074334-1 Within three hours of receiving vaccine, body aches,
years
101 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
PAIN PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
102 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
PAIN PFIZER\BIONTECH VACCINE 0930353-1
(COVID19)
COVID19
6-17
PAIN PFIZER\BIONTECH VACCINE 0957769-1 body aches, nausea, vomiting, and chills
years
(COVID19)
COVID19
years CHILLS
(COVID19)
6-17
PAIN PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER
years
GETTING DOSE #2.
COVID19
(COVID19)
103 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Chills; body aches; This is a spontaneous report from
a contactable consumer (patient parent). A 17-year-
old (17-year-old age at vaccination) female patient
received second dose of BNT162B2 (PFIZER-
BIONTECH COVID-19 VACCINE, Solution for injection)
via unknown route of administration on 27Jan2021
01:00 PM at single dose in left arm for COVID-19
immunization at clinic. Medical history was none. The
patient was not pregnant at time of vaccination. No
other vaccines received by patient within 4 weeks
prior to the COVID vaccine. Prior to vaccination, the
COVID19
6-17 patient was not diagnosed with COVID-19. No
years Allergies to medications, food, or other products.
(COVID19)
Concomitant medication was not reported. The
patient previously took (at age 17-year-old) first dose
VACCINE, Lot number: E1014D) on 06Jan2021 in left
arm for COVID-19 immunization. The patient
experienced chills, body aches on 28Jan2021 01:15
AM. No treatment received for the adverse events.
Since the vaccination, it was unknown whether the
patient been tested for COVID-19. The outcome of
events was recovering. Information on the lot/batch
number for 2nd dose has been requested.
COVID19
years aches
(COVID19)
<6
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0918673-1 around 2 hours later lower extremities painful - body
months
(COVID19) aches
<6
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0952106-1 related to vaccine but need to report to determine if
months
COVID19
1-2
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0940836-1 Myalgia Throbbing pain on both arms
years
(COVID19)
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
Pfizer COVID-19 Vaccine is authorized for use in
COVID19 individuals less than 16 years of age. The 7 year old
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0956768-1 had a sore arm along with fever and fatigue starting
years
(COVID19) about 24 hours after the vaccine that lasted for 2
days.
Patient received vaccine without age
COVID19
6-17 verification.Patient was 14 years and 10 months.
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 0992036-1
years After 50 hours, patient has sore ULE, but no other
(COVID19)
symptoms.
104 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
years
medication.
6-17
PAIN IN EXTREMITY PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
COVID19
<6 Sore jaw across the bottom around noon - seeing
PAIN IN JAW PFIZER\BIONTECH VACCINE 0918824-1
months lights
(COVID19)
6-17
PALLOR PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
recovered.
105 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
PALLOR PFIZER\BIONTECH VACCINE 1040554-1
(COVID19)
appropriate.
6-17
PALLOR PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
COVID19
6-17 Patient complained of shortness of breath, heart
PALPITATIONS PFIZER\BIONTECH VACCINE 1053095-1
years racing. EMS cleared and released to home.
(COVID19)
<6
PARAESTHESIA PFIZER\BIONTECH VACCINE 0918673-1 around 2 hours later lower extremities painful - body
months
(COVID19) aches
COVID19
6-11
PARAESTHESIA PFIZER\BIONTECH VACCINE 0918691-1 tingling in left fingers
months
(COVID19)
6-17
PARAESTHESIA PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
106 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
PARAESTHESIA PFIZER\BIONTECH VACCINE 0951087-1 after IM injection: Left arm, Left shoulder, Left upper
years
6-17
PARAESTHESIA PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
COVID19
6-17 Started rash on arms and neck, lips fuzzy, no
PARAESTHESIA ORAL PFIZER\BIONTECH VACCINE 1073009-1
years swelling, no SOB
(COVID19)
COVID19
PERICARDITIS PFIZER\BIONTECH VACCINE 1071409-1
(COVID19)
6-17
PERICARDITIS PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every
years
Last night I broke out into a bunch of itchy spots that
COVID19
6-17 resemble hives all over my body. The hives went
PERIORBITAL SWELLING PFIZER\BIONTECH VACCINE 0950711-1
years away in the morning. Just now, 3:57pm today, I have
(COVID19)
puffy eyes and a swollen throat.
6-17
PERIORBITAL SWELLING PFIZER\BIONTECH VACCINE 1019115-1 single dose (left arm) for COVID-19 immunization.
years
unknown.
107 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
I am a 74 year old male in good health with NO prior
reactions to the annual flu, pneumonia, or shingles
vaccinations. Because of a scheduled prostate biopsy
in early April 2021, I wanted to complete the
vaccination for COVID-19 in advance of this
procedure. Within 5 mins of receiving the vaccination
COVID19
<6 shot in my left arm, my left elbow and forearm began
PERIPHERAL SWELLING PFIZER\BIONTECH VACCINE 1061353-1
months to swell into a large ball shape near the elbow joint.
(COVID19)
At the same time, my left hand became noticeably
swollen as well. Fortunately, I did not experience
trouble breathing or have any numbness in my
fingers at that time. The observation staff nurses took
me to a separate room to check my blood pressure
and heart rate which were both in the normal range.
COVID19
PHARYNGEAL SWELLING PFIZER\BIONTECH VACCINE 0950711-1
(COVID19)
COVID19
PHARYNGEAL SWELLING PFIZER\BIONTECH VACCINE 1172466-1
(COVID19)
6-17
PHARYNGEAL SWELLING PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
6-17
PHOTOPHOBIA PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
6-17
PHOTOPHOBIA PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a
years
108 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
<6 Sore jaw across the bottom around noon - seeing
PHOTOPSIA PFIZER\BIONTECH VACCINE 0918824-1
months lights
(COVID19)
6-17
PLATELET COUNT PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
COVID19
PLATELET COUNT NORMAL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
COVID19
PNEUMOMEDIASTINUM PFIZER\BIONTECH VACCINE 1193717-1
(COVID19)
109 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
POLYMERASE CHAIN 6-17
PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
REACTION years
COVID19 Vasovagal. Legs elevated then proceeded to med bay.
6-17
PRESYNCOPE PFIZER\BIONTECH VACCINE 1211213-1 VS stable. BP 125/59; 114/60, HR 85; 77, RR 12 x2,
years
(COVID19) SpO2 100% RA x2
she was going to die/dies after vaccine; 2-year-old
patient; This is a spontaneous report from a non-
contactable consumer via a Pfizer-sponsored
program. A 2-year-old female patient received
second dose at the age of 2-years-old via an
unspecified route of administration on 25Feb2021
for covid-19 immunisation. The patient's medical
PRODUCT ADMINISTERED COVID19 history and concomitant medications were not
1-2
TO PATIENT OF PFIZER\BIONTECH VACCINE 1255745-1 reported. It was reported that the 2-year-old dies
years
INAPPROPRIATE AGE (COVID19) after vaccine on 03Mar2021. Reported on VAERS.
Look for the researchers to exclude her from the
study, probably claiming her death had nothing to do
with the shot, she was going to die that day, five
days after vaccination anyway. That's how they roll.
The patient died on 03Mar2021. The outcome of the
event was fatal. No follow-up attempts are possible.
Information on lot/batch cannot be obtained. No
further information is expected.; Reported Cause(s)
of Death: she was going to die
110 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Incident Description: On 2/24/21 at about 10am, a
family of 5 (2 parents and their 3 kids) approached
me asking for COVID-19 vaccinations. The parents
provided signed, informed consent forms and
paperwork for all 5 individuals. Against the parent's
initial request, I denied the COVID-19 vaccination to
the 13 year old patient. In accordance with the
parents? initial request, I administered the vaccine to
the other 4 family members, including the 4 year old
patient. Active clinical trials and articles with data to
support the use of the COVID-19 vaccination in
PRODUCT ADMINISTERED COVID19
3-5 children are below. During my years working at acute
TO PATIENT OF PFIZER\BIONTECH VACCINE 1060218-1
years care facilities where successful use of medications
INAPPROPRIATE AGE (COVID19)
were often supported by primary literature and
clinical trials, I made a judgment decision to
administer the vaccination to the 4 year old citing
previous success from previous experiences and the
below references. References: 1.
https://clinicaltrials.gov/ct2/show/record
/NCT04581148 2. https://clinicaltrials.gov/ct2/show
/NCT04330261 3. https://abcnews.go.com/Health
/holiday-covid-19-surge-blame-rising-mis-
cases/story?id=75928794 4.
https://pubmed.ncbi.nlm.nih.gov/33278108/
This individual was given the Covid-19 vaccine at on
6-17 offsite clinic at the age of 15 when the vaccine is only
years approved for 16 and older. No adverse reaction
reported.
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0929153-1 no a/e, pt is under the age limit
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0946849-1 Error: Booster Given Too Early
years
PRODUCT ADMINISTERED COVID19 After vaccine had been administered it was
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0947074-1 discovered that patient was under the age of 16.
years
INAPPROPRIATE AGE (COVID19) Parent was present at time of vaccination.
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0949690-1 None. Gave 12 days before 16th birthday
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0956076-1 Error: Wrong Patient (documentation in EMR)
years
PRODUCT ADMINISTERED COVID19 individuals less than 16 years of age. The 7 year old
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0956768-1 had a sore arm along with fever and fatigue starting
years
INAPPROPRIATE AGE (COVID19) about 24 hours after the vaccine that lasted for 2
days.
On January 12, at an unknown time, a family went to
PRODUCT ADMINISTERED COVID19 receive COVID-19 vaccines. They were told that
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0956979-1 everyone in the car could get vaccinated. The Pfizer
years
INAPPROPRIATE AGE (COVID19) BioNTech Covid-19 vaccine is not authorized for use
in those who are less than 16 years of age.
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0957001-1 minor received vaccine
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0961601-1 Error: Too Young for Vaccine
years
6-17
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0964349-1 Vaccine given to someone less than 16 years of age.
years
PRODUCT ADMINISTERED COVID19 The 14 year old patient received the Pfizer BioNTech
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0965130-1 Vaccine; this vaccine is not authorized for use in
years
INAPPROPRIATE AGE (COVID19) individuals less than 16 years of age.
PRODUCT ADMINISTERED COVID19 The 10 year old patient, received the Pfizer BioNTech
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0965149-1 Vaccine; this vaccine is not authorized for use in
years
INAPPROPRIATE AGE (COVID19) individuals less than 16 years of age.
No Adverse event, reporting age differential from
approved. During a covid vaccine clinic vaccinated.
PRODUCT ADMINISTERED COVID19 While processing the vaccine, the vaccine was given
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0965669-1 to the patient and it wasn't until later they saw the
years
INAPPROPRIATE AGE (COVID19) rejection for the patient that she was not 16. Patient
had no adverse reaction and patient and facility are
aware she cannot get second dose until she is 16.
111 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17 minor age 15 received COVID vaccine. no adverse
years reaction
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0966425-1 minor of 15 years received COVID vaccination
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0966517-1 minor of 15 years old received COVID vaccination
years
6-17
years
6-17
years
6-17
years
6-17
years
6-17
years
PRODUCT ADMINISTERED COVID19 concomitant medications were not reported. A mother
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0976811-1 went to get vaccinated for Covid-19. She took her
years
INAPPROPRIATE AGE (COVID19) kids ages 7 and 15. The kids were also vaccinated.
different patient
6-17
years
Patient mistakenly was administered the Covid-19
(Pfizer) vaccine at age 15 years old. Patient will turn
6-17 16 on 2/15/21 and will be 16 years of age at that
years point and eligible to receive dose #2 at this time.
Patient's mother was notified and did not report any
adverse effects from the vaccine.
Patient accompanied his father to the clinic for a
routine appt. to give his father IV fluids. When they
arrived they both asked when they were going to get
their Covid 19 vaccine. The clinic was running a
PRODUCT ADMINISTERED COVID19 vaccine clinic that day and we had extra doses. I
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0986738-1 asked how old he was and he said 16. His father was
years
INAPPROPRIATE AGE (COVID19) sitting next to him. I gave his Covid 19 vaccine and
then realized that his DOB he was not yet 16. He and
his dad are aware of this incident and he denies any
adverse affects from the vaccine at the time of this
report.
6-17 Patient was 15 years old when administered a covid
years vaccine. Not for use in less than 16.
6-17
years
112 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 0991705-1 Below age range for vaccine
years
Patient received vaccine without age
6-17 verification.Patient was 14 years and 10 months.
years After 50 hours, patient has sore ULE, but no other
symptoms.
patient is under the FDA approval use of 16 years of
6-17 age and older. Contacted CDC, Pfizer, and NDDOH.
years CDC stated to not give another dose until the patient
turns 16 years of age.
6-17
years
6-17
years
Patient identified himself as 19 years of age and
appropriate for vaccine at an offsite drive through
mass immunization event . Upon returning to the
clinic to enter the information into the computer it
was found by the injector that the patient was
6-17 actually 15 years and 8 months old rather than the
years 16 years required for the Pfizer COVID-19 vaccine. No
adverse problems from the vaccine administration.
This RN called the mother of the patient and verified
birthdate and informed her that he will not be eligible
for the second dose until after he turns 16 years old.
Mother verbalized understanding.
Patient is not in the recommended age range for the
6-17 vaccine. The recommended age is 16 years and older
years and this patient is 15 years old. Patient has had no
adverse reaction to the vaccine at this time.
Medication administration error. This healthcare
worker is a minor. Per our standing orders for clinic
6-17 vaccination we are only able to provide
years immunizations to adults. This healthcare worker's age
was missed by our registration and vaccination
stations.
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1019672-1 Error: Too Young for Vaccine.
years
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1049591-1 Error: Patient Too Young for Vaccine Administered
years
PRODUCT ADMINISTERED COVID19 15 year old vaccinated due to Nurse not catching age
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1052218-1 of the patient prior. DOB was listed incorrectly and
years
INAPPROPRIATE AGE (COVID19) patient vaccinated before correction.
6-17 Patient is 15 yrs of age and was given 1st dose of
years COVID vaccine
Mother was untruthful about age until after vaccine
6-17 was administered. She told us he was 16 and signed
years for him to get it. We caught it once we figured his
age.
PRODUCT ADMINISTERED COVID19 HEADACHE, NAUSEA AND RT CLAVICLE PAIN.
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1054615-1 05:55PM TO EXIT PER W/C TO BE DRIVEN HOME PER
years
INAPPROPRIATE AGE (COVID19) MOM. NO ACUTE DISTRESS NOTED. ALERT, PINK,
GETTING DOSE #2.
113 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
No known adverse event, but we wanted to report
PRODUCT ADMINISTERED COVID19 that the immunization was given to someone who
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1058946-1 was only 15 years of age. The VAR was signed off on
years
INAPPROPRIATE AGE (COVID19) by we assume a parent, and the patient additionally
signed the back of the VAR.
The assigned Medical Assistant administered the
PRODUCT ADMINISTERED COVID19 vaccine to the 10 year old after the parents signed
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1061157-1 the consent and policy stating the patient was 18
years
INAPPROPRIATE AGE (COVID19) years or greater. The patient has not reported any
side effects or issues.
The patient received the vaccine despite being too
6-17 young to be eligible for the vaccine based upon
years current recommendations/approval. The patient had
no reaction to the vaccine.
6-17 Patient was below the age of 16, unbeknownst to us.
years DOB was not checked by facility..
Administration error: Patient incorrectly given
PRODUCT ADMINISTERED COVID19 Moderna as first dose on 2/5/21 despite being
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1073184-1 <18y/o. Error was detected when patient presented
years
INAPPROPRIATE AGE (COVID19) for second dose. Patient given Pfizer at that time due
to age <18y/o which resulted in a mixed-dose series.
PRODUCT ADMINISTERED COVID19 Too young to receive vaccine Received 2nd dose on
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1073222-1 2/13/21 Lot EL3246 of Pfizer vaccine also in R deltoid,
years
INAPPROPRIATE AGE (COVID19) IM
PRODUCT ADMINISTERED COVID19 no known adverse event. Too young to receive the
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1073247-1 vaccine. received on on 1/23/2021 and 2nd on
years
INAPPROPRIATE AGE (COVID19) 2/11/2021
6-17 No known adverse event. vaccine given to someone
years who was too young to receive (age 15)
Too young to receive vaccine. The year of birth on
6-17 screening form was 2003 both for the first dose(lot
years EL9261) on 1/21/2021 and for the second dose (lot
EL9269)on 2/11/21.
local urgent care.
PRODUCT ADMINISTERED COVID19 called, vitals taken, and she was taken to an
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1074203-1 observation area. She started to feel a bit better after
years
INAPPROPRIATE AGE (COVID19) about 15 minutes. She was observed by paramedics
"After patient received his vaccination it was
discovered that he was only 15 years old (patient will
turn 16 tomorrow 3/6/2021), this technically resulted
in a medication administration error. Patient's parents
were on-site and were advised of the error, there was
6-17 no concern expressed by the parents. Patient was
years observed for 15 minutes and no reactions were
noted. Steps have been taken to avoid similar
mistakes in the future. Staff at all levels have been
directed to be more diligent in checking ages, signs
have been developed to be posted with the ?must
have been born before"" date."
PRODUCT ADMINISTERED COVID19 Pfizer Covid vaccine was given to 15 year old under
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1076179-1 EUA which only authorizes 16 year and above for
years
INAPPROPRIATE AGE (COVID19) eligibility
114 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
"patient under 16 years of age who received 1st dose
of COVID19 vaccine on 12FEB21. patient was 15
years and 9 months at time of vaccination. NOTE:
ample information available to patient/guardian on
vaccine including FACT SHEET FOR RECIPIENTS AND
CAREGIVERS; as well as local screening form which
has patient/caregiver sign the following statement:
""I have read or had explained to me the information
in the Coronavirus Vaccine Emergency Use
PRODUCT ADMINISTERED COVID19 Authorization (EUA) Fact Sheet. I have also had a
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1076808-1 chance to ask questions, and they were answered to
years
INAPPROPRIATE AGE (COVID19) my satisfaction"". Patient/Guardian attempted to
make an appointment for 2nd dose; Appointment line
clerk was able to screen patient and advice that
patient was not eligible for vaccination per
manufacturer recommendation and EUA
authorization. Officer in charge of site attempted to
contact parent/guardian but upon attempts only was
able to leave voice messages. Parent/guardian given
a number for callback. at the time of this report no
callback was received."
The vaccination was given to her when she was still
15 years old, however, she will be 16 years of age on
PRODUCT ADMINISTERED COVID19 3/25/21 which will be the date she is planning on
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1077108-1 receiving her 2nd Pfizer COVID vaccination. We
years
INAPPROPRIATE AGE (COVID19) verified with our district manager that we needed to
report the incident, but that we should proceed with
the continued dosing schedule.
PRODUCT ADMINISTERED COVID19 has a history of Truncus Arteriosus s/p repair and has
6-17
TO PATIENT OF PFIZER\BIONTECH VACCINE 1155731-1 been anticoagulated for >10 years without issue.
years
INAPPROPRIATE AGE (COVID19) Stroke occurred 1 week after vaccine. She now has L
Patient was vaccinated on 04/01/2021. Patient is 15
years old and was not supposed to be vaccinated on
that day, she should have been refused. It is
unknown as to what occurred on that day that patient
was vaccinated even though she is 15 years old. It
was not brought to the attention of the site lead or
charge nurse on 04/01/21. Patient returned to the
6-17 site on 04/22/2021 for second dose. Vaccinating
years nurse and scribe asked the patient and looked at her
date of birth which states she is 15 years old. It was
brought to the attention of the charge nurse and site
lead that the patient had been incorrectly vaccinated
3 weeks ago. Patient was not given second dose and
educated that she may not receive it until she is 16
years old. Patient and mother understood and left site
without incident.
COVID19
PRODUCT PREPARATION 6-17
PFIZER\BIONTECH VACCINE 1019272-1 Error: Incorrect Reconstitution
ISSUE years
(COVID19)
COVID19 Pfizer vaccine was reconstituted with sterile water
PRODUCT PREPARATION 6-17
PFIZER\BIONTECH VACCINE 1053009-1 instead of normal saline and administered. Patient
ISSUE years
(COVID19) has not reported any adverse effects
COVID19
PRURITUS PFIZER\BIONTECH VACCINE 0950711-1
(COVID19)
6-17
PRURITUS PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
COVID19
6-17
PRURITUS PFIZER\BIONTECH VACCINE 1077068-1 Itching and rash to neck
years
(COVID19)
115 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
PRURITUS PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
COVID19
6-17
PRURITUS PFIZER\BIONTECH VACCINE 1245289-1 Itchy rashy skin, bumps, hives
years
(COVID19)
6-17
PULMONARY EMBOLISM PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
<6
PYREXIA PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
previous day.
116 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
1-2
PYREXIA PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or
years
maternal case
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0907181-1 tingling, joint pain in shoulder, elbow, and wrist,
years
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0920541-1 ACHES, NAUSEA. RESOLVED BY MORNING OF
years
(COVID19) 12/31/20
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0924171-1 muscle pain all over her body, sore throat, nausea,
years
COVID19 individuals less than 16 years of age. The 7 year old
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0956768-1 had a sore arm along with fever and fatigue starting
years
(COVID19) about 24 hours after the vaccine that lasted for 2
days.
COVID19
PYREXIA PFIZER\BIONTECH VACCINE 0974439-1
years CHILLS
(COVID19)
117 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19 concomitant medications were not reported. A mother
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0976811-1 went to get vaccinated for Covid-19. She took her
years
(COVID19) kids ages 7 and 15. The kids were also vaccinated.
different patient
COVID19
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0979029-1 DEVELOPED FEVER OF 103
years
(COVID19)
COVID19
6-17
PYREXIA PFIZER\BIONTECH VACCINE 0979036-1 DEVELOPED FEVER OF 103
years
(COVID19)
COVID19
(COVID19)
COVID19
(COVID19)
118 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
be obtained.
COVID19
(COVID19)
6-17
PYREXIA PFIZER\BIONTECH VACCINE 1127200-1 myopericarditis. Admitted to hospital. No documented
years
myopericaraditis.
119 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
6-17
PYREXIA PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
120 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
PYREXIA PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
<6
RASH PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
previous day.
121 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
6-11 and fussiness. No fever. I do not have any symptoms
RASH PFIZER\BIONTECH VACCINE 0939409-1
months myself"". The events started from 06Jan2021.
(COVID19)
6-11
RASH PFIZER\BIONTECH VACCINE 1254975-1 01Mar2021 10:00 with lot number EN6202. The
months
122 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
1-2
RASH PFIZER\BIONTECH VACCINE 0921052-1 Pfizer, she didn't know if this is significant, or
years
maternal case
COVID19
6-17 1/6 a rash developed at the injection site and by 1/7
years it had spread to the belly and chest.
(COVID19)
Red rash appeared in both arms from shoulders to
COVID19
6-17 almost the elbows. No itching. Nurse gave Benadryl &
years Pepcid to slow symptoms. Rash went away within half
(COVID19)
an hour. No other symptoms.
Pt developed a bilateral rashes on the arms 10 min
s/p COVID vaccine administration. No other
COVID19
6-17 symptoms were experienced. Pt received 20 mg of
years Famotidine and 25 mg of Diphenhydramine. Rash
(COVID19)
improved. Pt was monitored for 30 minutes, and was
able to return home with no issues
6-17
RASH PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other-
years
COVID19
(COVID19)
2nd dose.
123 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
6-17 Started rash on arms and neck, lips fuzzy, no
years swelling, no SOB
(COVID19)
COVID19
6-17
RASH PFIZER\BIONTECH VACCINE 1077068-1 Itching and rash to neck
years
(COVID19)
COVID19
6-17 4/18 received COVID vaccine 4/20 developed rash
years 4/22 was seen in office - full body rash, hives on face
(COVID19)
COVID19
6-17
RASH PFIZER\BIONTECH VACCINE 1245289-1 Itchy rashy skin, bumps, hives
years
(COVID19)
6-11
RASH NEONATAL PFIZER\BIONTECH VACCINE 1224688-1 morning after patient received his mother's shot
months
6-17
RASH PAPULAR PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
124 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
RED BLOOD CELL COVID19 Prior to vaccination, the patient was not diagnosed
6-17
SEDIMENTATION RATE PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
INCREASED (COVID19) vaccination the patient been tested for COVID-19.
COVID19
RESPIRATORY VIRAL PANEL PFIZER\BIONTECH VACCINE 1096709-1
(COVID19)
125 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
3-5
RESTLESSNESS PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
6-17
RESUSCITATION PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
126 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
RESUSCITATION PFIZER\BIONTECH VACCINE 1225942-1 bilateral large pulmonary embolism as likely etiology
years
COVID19
RETCHING PFIZER\BIONTECH VACCINE 0927167-1
(COVID19)
COVID19
6-17
RHINORRHOEA PFIZER\BIONTECH VACCINE 0954211-1 Runny and itchy nose, lasting for about a day.
years
(COVID19)
SARS-COV-2 ANTIBODY 6-17
TEST years
COVID19
SARS-COV-2 TEST PFIZER\BIONTECH VACCINE 1058308-1
(COVID19)
127 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
appropriate.
who received the first dose of the Pfizer vaccine on
3Mar2021 and since tested positive for covid; This is
a spontaneous report received from a contactable
pharmacist. A 17-years-old male patient received first
VACCINE, Solution for injection), via an un-specified
route of administration on 03Mar2021 (Batch/Lot
number was not re-ported) at a single dose for
and concomitant medications were not reported. The
COVID19
6-17 patient underwent lab tests and procedures which
years includes COVID test and resulted a week later as
(COVID19)
positive for COVID. On unspecified date patient tested
negative to COVID. Therapeutic measures were taken
as a result of who received the first dose of the Pfizer
vaccine on 3Mar2021 and since tested positive for
COVID. It was reported that patient had not received
any antivirals therapies. States the patient has been
riding it out with Tylenol. Reporter declines to
complete a safety report at this time. The outcome of
the event was recovered. Information on the
lot/batch number has been requested.
128 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
SARS-COV-2 TEST PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
129 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
SARS-COV-2 TEST 6-17 Shortness of breath, fatigue, tachycardia - persisting
NEGATIVE years since vaccination
(COVID19)
COVID19
SARS-COV-2 TEST 6-17 tonic-clonic seizure activity for about 20 minutes
NEGATIVE years (received 10mg intranasal midazolam and 0.5mg
(COVID19)
SARS-COV-2 TEST 6-17
NEGATIVE years
myopericaraditis.
NEGATIVE years
130 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
NEGATIVE years
medication.
COVID19
SARS-COV-2 TEST POSITIVE PFIZER\BIONTECH VACCINE 0921641-1
(COVID19)
who received the first dose of the Pfizer vaccine on
3Mar2021 and since tested positive for covid; This is
a spontaneous report received from a contactable
pharmacist. A 17-years-old male patient received first
VACCINE, Solution for injection), via an un-specified
route of administration on 03Mar2021 (Batch/Lot
number was not re-ported) at a single dose for
and concomitant medications were not reported. The
COVID19
6-17 patient underwent lab tests and procedures which
SARS-COV-2 TEST POSITIVE PFIZER\BIONTECH VACCINE 1182761-1
years includes COVID test and resulted a week later as
(COVID19)
positive for COVID. On unspecified date patient tested
negative to COVID. Therapeutic measures were taken
as a result of who received the first dose of the Pfizer
vaccine on 3Mar2021 and since tested positive for
COVID. It was reported that patient had not received
any antivirals therapies. States the patient has been
riding it out with Tylenol. Reporter declines to
complete a safety report at this time. The outcome of
the event was recovered. Information on the
lot/batch number has been requested.
6-17
SCAB PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
COVID19
SCAN WITH CONTRAST PFIZER\BIONTECH VACCINE 1193717-1
(COVID19)
COVID19
6-17
SEIZURE PFIZER\BIONTECH VACCINE 0943307-1 Systemic: Seizure-Severe
years
(COVID19)
131 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
SEIZURE PFIZER\BIONTECH VACCINE 1115268-1 patient was tested for COVID post vaccination.;
years
132 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
SEIZURE PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
133 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
seizure; This is a spontaneous report from a
contactable consumer. A 17-year-old male patient
received first dose of BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE, solution for injection Batch/Lot
Number: EP6955; Expiration Date: 30Jun2021), via
an unspecified route of administration on 17Mar2021
as single dose for covid-19 immunisation.
Zonisamide, via an unspecified route of
administration from an unspecified date (Batch/Lot
number was not reported) to an unspecified date, at
800 mg, (600 mg at night and 200 mg on the
morning) for an unspecified indication; cannabidiol
(CBD OIL), via an unspecified route of administration
from an unspecified date (Batch/Lot number was not
COVID19 reported) to an unspecified date, at 7 mL, daily (4ml
6-17
SEIZURE PFIZER\BIONTECH VACCINE 1153556-1 at night and 3 ml on the morning) for an unspecified
years
(COVID19) indication. The patient medical history included
ongoing seizure PMH of temporal epilepsy who has
been having break through seizures since July 2020.
The patient's concomitant medications were not
reported It was reported that patient had received
vaccine on Wednesday 17 2021 with no complaints
after it until today Friday 19, 2021 at around 7 pm
when he developed a seizure while working at his
desk. We (the parents saw the end of it which looked
more generalized than usual) and gave him 2 mg of
Clonazepam, which is his usual rescue medication. He
was awake after it and was able to do homework. The
action taken in response to the events for Zonisamide
and Cannabidiol was unknown. The outcome of the
event was unknown.
COVID19
SEIZURE PFIZER\BIONTECH VACCINE 1241577-1
years Seizure-Mild
(COVID19)
(name) had a seizure within 5 minutes or less of the
first dose.; This is a spontaneous report from a
contactable consumer or other non-HCP. A 16-years-
old non-pregnant female patient received the first
VACCINE, Solution for injection, Lot Number:
COVID19 ER8729) via an unspecified route of administration in
6-17
SEIZURE PFIZER\BIONTECH VACCINE 1255133-1 Right Arm on 09Apr2021 00:30 as single dose for
years
(COVID19) covid-19 immunization. Medical history included
depression and seizure. The patient's concomitant
medications were not reported. On 09Apr2021 00:30,
the patient had a seizure within 5 minutes or less of
the first dose. Therapeutic measures were taken as a
result of had a seizure within 5 minutes or less of the
first dose. The outcome of event was recovering.
COVID19
SENSATION OF FOREIGN 6-17 While waiting at Urgent Care for 30 minutes, her
BODY years face, tongue, and throat became swollen, hives
(COVID19)
6-17
SKIN DISCOLOURATION PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
134 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
SKIN LESION PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
3-5
SLEEP DISORDER PFIZER\BIONTECH VACCINE 1236420-1 waking me up every 60 to 90 minutes. On 4/14/2021
years
135 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
SLEEP DISORDER PFIZER\BIONTECH VACCINE 0945646-1 17:00: experiencing arm soreness, muscle pain,
years
6-17
SOMNOLENCE PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
COVID19
STREPTOCOCCUS TEST 6-17 hours. Approximately one week later, the child woke
NEGATIVE years up again in the night with severe chills in the middle
(COVID19)
COVID19
SUBCUTANEOUS 6-17 base of neck and right upper extremity.
EMPHYSEMA years Emphysematous changes in the airway and vascular
(COVID19)
1-2
SWELLING PFIZER\BIONTECH VACCINE 0971259-1 resolved. swelling/tenderness anterior neck/most
years
6-17
SWELLING PFIZER\BIONTECH VACCINE 1055003-1 3. 24 hours after the second vaccine dose (which was
years
136 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
SWELLING FACE PFIZER\BIONTECH VACCINE 1172466-1
(COVID19)
COVID19
SWOLLEN TONGUE PFIZER\BIONTECH VACCINE 1172466-1
(COVID19)
6-17
SYNCOPE PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
recovered.
COVID19
6-17
SYNCOPE PFIZER\BIONTECH VACCINE 1004854-1 Systemic: Fainting-Severe
years
(COVID19)
COVID19
SYNCOPE PFIZER\BIONTECH VACCINE 1059253-1
(COVID19)
by ambulance.
COVID19
6-17
SYNCOPE PFIZER\BIONTECH VACCINE 1076995-1 Syncope post vaccine
years
(COVID19)
COVID19
(COVID19)
COVID19
(COVID19)
COVID19
(COVID19)
6-17
SYNCOPE PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed
years
condition.
137 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
Fainted; This is a spontaneous report from a
contactable consumer (patient). A 17-year-old female
patient received BNT162B2 (PFIZER-BIONTECH
COVID-19 VACCINE, Batch/Lot number was not
reported), dose 1 via an unspecified route of
administration, administered in Arm Left on
07Apr2021 15:30 (at the age of 17years) as single
dose for Covid-19 immunization. The patient is not
pregnant at the time of vaccination. Medical history
included asthma, pediatric Kawasaki disease from
2006 to an unknown date, known allergies: Sulfa
drugs, and Covid-19 from an unknown date and
COVID19
6-17 unknown if ongoing (Covid prior vaccination: Yes).
years Concomitant medications included sertraline
(COVID19)
hydrochloride (ZOLOFT) and ethinylestradiol, ferrous
fumarate, norethisterone acetate (BLISOVI FE 1/20),
both taken for an unspecified indication, start and
stop date were not reported. The patient did not
receive any other vaccines within 4 weeks prior to the
COVID vaccine. It was reported that the patient
fainted the following morning on 08Apr2021 10:00.
There was no treatment received for the adverse
event. The patient has not been tested for COVID-19
since the vaccination. The outcome of event was
recovering. Information on the lot/batch number has
been requested.
COVID19
TACHYCARDIA PFIZER\BIONTECH VACCINE 1013212-1
(COVID19)
COVID19
TACHYCARDIA PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
1-2
TENDERNESS PFIZER\BIONTECH VACCINE 0971259-1 resolved. swelling/tenderness anterior neck/most
years
6-17
THERMOMETRY ABNORMAL PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures
years
COVID19
6-17
THROAT IRRITATION PFIZER\BIONTECH VACCINE 0905644-1 """felt like throat scratching"""
years
(COVID19)
COVID19
6-17
THROAT IRRITATION PFIZER\BIONTECH VACCINE 1064279-1 Swelling in lips and burning in throat.
years
(COVID19)
COVID19
6-17 better for the duration. BP initially 141/89 while
THROAT IRRITATION PFIZER\BIONTECH VACCINE 1171412-1
years sitting with HR at 75. Pt laid down with feet propped
(COVID19)
138 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
THROAT IRRITATION PFIZER\BIONTECH VACCINE 1172466-1
(COVID19)
6-17
THROAT TIGHTNESS PFIZER\BIONTECH VACCINE 1049139-1 breathe, like her throat was closing off. Patient
years
feet away.
6-17
THROAT TIGHTNESS PFIZER\BIONTECH VACCINE 1202766-1 to patient's left deltoid on 4/12 at 1529. During
years
6-17
THROMBOPHLEBITIS PFIZER\BIONTECH VACCINE 1207321-1 month out from 2nd vaccine Migraine-type headache-
years
6-17
THROMBOSIS PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
years
medication.
THROMBOTIC COVID19 developed a fever. Patient brought baby to local ER
<6
THROMBOCYTOPENIC PFIZER\BIONTECH VACCINE 1166062-1 where assessments were performed, blood analysis
months
PURPURA (COVID19) revealed elevated liver enzymes. Infant was
previous day.
6-17
TINNITUS PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water.
years
6-17
TRANSPLANT REJECTION PFIZER\BIONTECH VACCINE 1136945-1 but he had V fib arrest with anesthesia induction.
years
139 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
TREMOR PFIZER\BIONTECH VACCINE 1055411-1 reported she saw him passing out and eyes rolling.
years
6-17
TREMOR PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
past.
COVID19
TREMOR PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
COVID19
TREMOR PFIZER\BIONTECH VACCINE 1245331-1
years AS SHAKINESS
(COVID19)
COVID19
TROPONIN INCREASED PFIZER\BIONTECH VACCINE 1071409-1
(COVID19)
6-17
TROPONIN INCREASED PFIZER\BIONTECH VACCINE 1127200-1 myopericarditis. Admitted to hospital. No documented
years
myopericaraditis.
COVID19
6-17 vaccinated for SARS Co-V2 (First dose on March 5th
TROPONIN INCREASED PFIZER\BIONTECH VACCINE 1148292-1
years with second dose on March 27). He is currently
(COVID19)
myocarditis.
140 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
TROPONIN INCREASED PFIZER\BIONTECH VACCINE 1197826-1 again, and he was started on ibuprofen 600 mg every
years
COVID19
TROPONIN T INCREASED PFIZER\BIONTECH VACCINE 1071409-1
(COVID19)
ULTRASOUND SCAN 6-17
PFIZER\BIONTECH VACCINE 1206421-1 straight to ER for Ultrasound. In hospital they found it
ABNORMAL years
medication.
COVID19 Patient received the 1st dose of Moderna on
6-17
UNEVALUABLE EVENT PFIZER\BIONTECH VACCINE 1051818-1 1/22/2021; on 2/22/2021, the patient arrived for his
years
(COVID19) 2nd dose and was admisitered the Pfizer vaccine.
"The adolescent and mother misrepresented patients
age at time of vaccination. At an outreach clinic one
dose of Pfizer was remaining. Vaccine coordinator for
site/office asked if this individual could receive a the
last dose to exhaust and not have a wastage. The
coordinator was informed they could as long as the
person was at least 16 y/o old. He was reported as
being 16 so mother brought him to site to receive
vaccination. Before administering the vaccinator
asked patient if he had just turned 16 and he
COVID19
6-17 reported ""yes"". On the consent form his birthday
UNEVALUABLE EVENT PFIZER\BIONTECH VACCINE 1074863-1
years was clearly written. Which would have made him 16
(COVID19)
at time of administration. Vaccine was given and
individual had no issues on site. While trying to
document in patients online/electronic shot record
staff could not locate him under the date of birth
written and verified by mother and patient. It was
later verified by mother that his year was 2006 and
not 2005. State immunization MD notified and was
informed to administer the second dose when the 21
days is due and to file a Vaers report since adolescent
was under 16."
6-17
UNRESPONSIVE TO STIMULI PFIZER\BIONTECH VACCINE 1003503-1 Patient was treated with fluids and discharged after
years
recovered.
Patient is 17yo here for COVID 19 Pfizer Vaccine;
Within 15 minutes of the shot, she developed
unresponsiveness. She has snoring, seizure disorders,
OSA, hypertension, developmental delay, elective
COVID19
6-17 mutism. Her mother called us to the room Per mother
UNRESPONSIVE TO STIMULI PFIZER\BIONTECH VACCINE 1049902-1
years , She was unresponsive, her lips were blue and she
(COVID19)
was pale She has had no recent seizure; compliant
with Keppra She was very anxious prior to the
vaccine. She was at baseline this am per mom prior
to the shot.
141 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
female here with mom mom multiple siblings for
Covid vaccine. Within 30 minutes of the Covid vaccine
patient had a vomiting episode. Pulse ox was 99.
There is no labored respirations. She did not respond
to commands but according to his sibling she does
not always respond to commands. However when I
took her hand to get her to squeeze my hand and
gave it back to her she purposefully put it back on a
CD which she was holding to her chest. Blood
pressure was stable heart rate was approximately
130. The home care aide was not able to tell me
COVID19
6-17 whether or not this was her baseline. Her brother said
years that she does not does not answer questions
(COVID19)
depending on the day. However I am not sure he is
the appropriate historian. She has a history of
multiple medical issues including autism,
quadriplegia, asthma, and food allergies. As such she
was kept here for a full 30 minutes. At no time was
there any color change. No labored breathing or
wheezing on exam. There is a little bit of nystagmus
and appeared to focus when questioned about how
she was doing but without a verbal response. She will
be transferred to the emergency room in stable
condition emergency room has been notified.
COVID19
(COVID19)
by ambulance.
COVID19
(COVID19)
COVID19
(COVID19)
COVID19
(COVID19)
142 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
URINE ANALYSIS PFIZER\BIONTECH VACCINE 1224600-1 with COVID-19 (Nasal Swab) and after the
years
6-17
URINE ANALYSIS NORMAL PFIZER\BIONTECH VACCINE 1064049-1 Infectious work up negative (blood, urine cultures
years
COVID19
URTICARIA PFIZER\BIONTECH VACCINE 0950711-1
(COVID19)
COVID19
(COVID19)
143 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
URTICARIA PFIZER\BIONTECH VACCINE 1198675-1 improvement in symptoms including improved
years
COVID19
6-17 4/18 received COVID vaccine 4/20 developed rash
years 4/22 was seen in office - full body rash, hives on face
(COVID19)
COVID19
6-17
URTICARIA PFIZER\BIONTECH VACCINE 1245289-1 Itchy rashy skin, bumps, hives
years
(COVID19)
Vaginitis; This is a spontaneous report from a
contactable healthcare professional. A 22-month-old
(PFIZER-BIONTECH COVID-19 VACCINE), via an
unspecified route of administration at the left arm
from 23Dec2020 13:00 at a single dose for COVID-19
immunization at a hospital. The patient medical
COVID19 history was not reported. The patient's concomitant
1-2
VAGINAL INFECTION PFIZER\BIONTECH VACCINE 0912550-1 medications were not reported. The patient
years
(COVID19) experienced vaginitis on 24Dec2020 13:00 which was
reported to be treated with an unspecified OTC. The
weeks prior to the COVID vaccine. The patient was
not diagnosed with COVID-19 prior to vaccination and
was not tested for it since the vaccination. The
patient was recovering from the event. Information
on the batch number has been requested.
6-17
VIRAL TEST PFIZER\BIONTECH VACCINE 1127200-1 myopericarditis. Admitted to hospital. No documented
years
myopericaraditis.
6-17
VISION BLURRED PFIZER\BIONTECH VACCINE 1075055-1 reading a few minutes later was 108/76. By that
years
past.
6-17
VISION BLURRED PFIZER\BIONTECH VACCINE 1080286-1 blurry vision. Vitals within normal limits. Patient
years
144 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
VISION BLURRED PFIZER\BIONTECH VACCINE 1135577-1
(COVID19)
appropriate.
COVID19
VISUAL IMPAIRMENT PFIZER\BIONTECH VACCINE 1241599-1
(COVID19)
VITAL SIGNS 6-17
PFIZER\BIONTECH VACCINE 1049830-1 fluids and only had a few bites to eat. Patient
MEASUREMENT years
distress."
VITAL SIGNS 6-17
PFIZER\BIONTECH VACCINE 1052856-1 BP 110/68 Pulse 68. Removing Jacket. Offered water.
MEASUREMENT years
145 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
VITAL SIGNS 6-17
PFIZER\BIONTECH VACCINE 1241721-1 116/60. 5:32 Pt awake enough, stable to be observed
MEASUREMENT years
condition.
COVID19
VOMITING PFIZER\BIONTECH VACCINE 0927664-1
(COVID19)
patient and AE.
COVID19
(COVID19)
condition 133/84, 104, 18
COVID19
6-17
VOMITING PFIZER\BIONTECH VACCINE 0957769-1 body aches, nausea, vomiting, and chills
years
(COVID19)
COVID19
6-17
VOMITING PFIZER\BIONTECH VACCINE 0970410-1 Nausea causing vomiting 15 hours after injection
years
(COVID19)
6-17
VOMITING PFIZER\BIONTECH VACCINE 0971606-1 muffled, a bit of dizzines. She vomited 3 times. in a
years
female here with mom mom multiple siblings for
Covid vaccine. Within 30 minutes of the Covid vaccine
patient had a vomiting episode. Pulse ox was 99.
There is no labored respirations. She did not respond
to commands but according to his sibling she does
not always respond to commands. However when I
took her hand to get her to squeeze my hand and
gave it back to her she purposefully put it back on a
CD which she was holding to her chest. Blood
pressure was stable heart rate was approximately
130. The home care aide was not able to tell me
COVID19
6-17 whether or not this was her baseline. Her brother said
years that she does not does not answer questions
(COVID19)
depending on the day. However I am not sure he is
the appropriate historian. She has a history of
multiple medical issues including autism,
quadriplegia, asthma, and food allergies. As such she
was kept here for a full 30 minutes. At no time was
there any color change. No labored breathing or
wheezing on exam. There is a little bit of nystagmus
and appeared to focus when questioned about how
she was doing but without a verbal response. She will
be transferred to the emergency room in stable
condition emergency room has been notified.
146 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
COVID19
(COVID19)
COVID19
6-17
VOMITING PFIZER\BIONTECH VACCINE 1060665-1 Nausea, emesis, HA, shaky. Cleared by EMS
years
(COVID19)
COVID19
(COVID19)
appropriate.
COVID19
6-17
VOMITING PFIZER\BIONTECH VACCINE 1241593-1 Systemic: Vomiting-Severe
years
(COVID19)
147 of 149 13/05/2021, 09:56

Vaccine Vaccine
Manufacturer Type
6-17
VOMITING PFIZER\BIONTECH VACCINE 1255191-1 COVID post vaccination. Concomitant medications
years
COVID19
(COVID19)
vaccination.
1-2
WHEEZING PFIZER\BIONTECH VACCINE 0933538-1 not have to seek medical care, just waiting for
years
6-17
WHEEZING PFIZER\BIONTECH VACCINE 0981762-1 (other than injection site)-Mild, Systemic: Other-
years
COVID19
WHITE BLOOD CELL COUNT 6-17 tonic-clonic seizure activity for about 20 minutes
(COVID19)
COVID19
6-17
WRONG PATIENT PFIZER\BIONTECH VACCINE 0943708-1 Error: Wrong Patient (documentation in EMR)
years
(COVID19)
COVID19
WRONG PATIENT RECEIVED 6-17
PFIZER\BIONTECH VACCINE 0955506-1 Error: Wrong Patient (documentation in EMR)
PRODUCT years
(COVID19)
COVID19
WRONG PATIENT RECEIVED 6-17
PFIZER\BIONTECH VACCINE 0956076-1 Error: Wrong Patient (documentation in EMR)
PRODUCT years
(COVID19)
Note: Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to
the adverse event (possible side effect).
Notes:
148 of 149 13/05/2021, 09:56

Caveats: 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:
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.
Reports may include incomplete, inaccurate, coincidental and unverified information.
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.
VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for
which data are available.
VAERS data do not represent all known safety information for a vaccine and should be interpreted in the
context of other scientific information.
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. (/wonder/help/vaers.html#Suppress)
These items in the results table are not fully selected: COVID19 VACCINE. The Query Description lists the actual
values selected.
Data contains VAERS reports processed as of 4/30/2021. 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. (/wonder
/help/vaers.html#Reporting)
For more information on how many persons have been vaccinated in the US for COVID19 to date, see
https://covid.cdc.gov/covid-data-tracker/#vaccinations/ (https://covid.cdc.gov/covid-data-tracker/#vaccinations/)
Help: See The Vaccine Adverse Event Reporting System (VAERS) Documentation (/wonder/help/vaers.html) for more
information.
Query Date: May 13, 2021 9:52:38 AM
Suggested Citation:
United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) /
Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - 4/30/2021, CDC WONDER On-line
Database. Accessed at http://wonder.cdc.gov/vaers.html on May 13, 2021 9:52:38 AM
Query Criteria:
Age: < 6 months; 6-11 months; 1-2 years; 3-5 years; 6-17 years
State / Territory: The United States/Territories/Unknown
Vaccine Products: COVID19 (COVID19 (PFIZER-BIONTECH)) (1200)
VAERS ID: All
Group By: Symptoms; Age; Vaccine Manufacturer; Vaccine Type; VAERS ID
Show Totals: False
Show Zero Values: Disabled
149 of 149 13/05/2021, 09:56

Pfizer Under 17 Years Adverse Events Reported To CDC

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The Vaccine Adverse Event Reporting System (VAERS) Results

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