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International Journal of Public Health Science (IJPHS)

Vol. 11, No. 2, June 2022, pp. 398~404


ISSN: 2252-8806, DOI: 10.11591/ijphs.v11i2.21111  398

Post-vaccination side effects following the second dose of


COVID-19 vaccine among health care workers

Timsi Jain1, Balaji Selvaraju1, Catherine Jude1, Ganesan Dinesh Kumar1, Yogesh Mohan1,
Anantha Eashwar2
1
Department of Community Medicine, Saveetha Medical College & Hospital, Chennai, India
2
Community Medicine Faculty, Sree Balaji Medical College & Hospital, Chennai, India

Article Info ABSTRACT


Article history: The coronavirus disease 2019 (COVID-19) vaccines were launched after
granting them ‘emergency use authorization’ approval. Beyond the clinical
Received Jul 5, 2021 trial, there was very limited data on the side effects following vaccination
Revised Dec 21, 2021 This is a longitudinal study among health care workers (HCWs) in a tertiary
Accepted Jan 28, 2022 care hospital. Information was also collected using a pre-tested semi-
structured questionnaire which included their demographic details, first dose
and second dose. Post-vaccination follow-up was done at the centre which
Keywords: was then followed up by telephonic monitoring after 48 hours. In the present
study 1,034 (65.6%) health care workers (HCWs) did not report any serious
COVID-19 vaccine reactions/symptoms. Pain and tenderness were the most commonly reported
Second dose delay side-effects in more than half. The severity of the symptoms following the
Vaccine hesitancy second dose of vaccine was compared with the first dose and it was found
Vaccine side-effects that the majority 653 (41.4%) had reported no symptoms/reactions following
both doses of vaccine. Every vaccine will have some side effects but it is
important to understand that in the ongoing pandemic, vaccines are our “best
shot” to fight against this virus.
This is an open access article under the CC BY-SA license.

Corresponding Author:
Ganesan Dinesh Kumar
Department of Community Medicine, Saveetha Medical College & Hospital
Saveetha Nagar, Thandalam, Chennai 602 105, India
Email: [email protected]

1. INTRODUCTION
The world health organization (WHO) had declared the coronavirus disease 2019 (COVID-19) as a
public health emergency due to the rapid spread from Wuhan to neighbouring parts of China and other
countries in 2020 [1], [2]. The new virus has challenged the economy, medical, and public health cadre of
countries globally. There is an epidemiological burden that is constantly evolving concerning the number of
people infected, hospital admissions, morbidity, and mortality [3], [4]. Vaccines were developed for this new
virus and vaccination drives were carried out in various countries to slow down the spread of this infection.
The Government of India had initially approved two vaccines, namely Covishield
(ChAdOx1 nCoV-19) and Covaxin (BBV152) for use from January 2021 [5]–[7]. Health care and frontline
workers were given the priority to be vaccinated first. This was followed by the elderly population, then
followed by people aged more than 45 [8]. Recently vaccination has been opened up for all people aged 18
and above. As of 30th June 2021 India’s cumulative vaccination coverage exceeded 33.57 crores with the
union government committed to accelerating the pace and expanding the scope of COVID-19 vaccination
throughout the country [9]. An interim data from the trial done in Brazil, the UK, and South Africa showed
that most of the adverse reactions were mild to moderate in severity and got resolved within a few days
following the vaccination [10]. Beyond this, there was very limited data on the side-effects following

Journal homepage: http://ijphs.iaescore.com


Int J Public Health Sci ISSN: 2252-8806  399

vaccination in our country and thus this study was carried out to determine the same. This paper in particular
focuses on the side effects after the second dose of Covishield vaccination and the severity of the symptoms
in comparison to that of the first dose among the recipients of Covishield vaccines.

2. RESEARCH METHOD
This was longitudinal study among those who have received their Covishield vaccine at a tertiary
care hospital in Thiruvallur, Tamil Nadu, India. The study participants included all healthcare workers
(HCWs) at the hospital who had taken their vaccine at this centre. The participants were followed up after the
first and second doses respectively. The first dose of vaccination had begun on January 20, 2021 and the
second dose of vaccination had begun on February 19, 2021 in the hospital. This particular paper is a follow-
up study that focuses on the second dose side effects after vaccination. A total of 1,659 participants had taken
their second dose during the study period between February 15 to April 30, 2021. All the HCWs who
received the Second dose were followed at the vaccination centre. Only the Participants who attended the
follow-up calls were included in the final analysis and thus we ended up with a sample size of 1,577.
Information was also collected using a pre-tested semi-structured questionnaire which included their
demographic details, date of first dose vaccination, any delay in the second dose of COVID-19 vaccination
and the reasons for the same, severity of the reactions if any, and comparing them to the first dose reactions
and medications taken to alleviate the symptoms. At the vaccination centre, the patients were first screened
and then their height, weight, and vitals were noted before the vaccination. Post-vaccination, the HCWs were
observed at the vaccination centre for a brief period of 30 minutes, and their vitals were noted again.
Any reaction that occurred at the moment of vaccination was termed as “immediate reactions” and
those that occurred during the 30 minutes (observation period) were termed as “reactions during
observation”. Participants were followed up with the help of phone calls, 48 hours post-vaccination, and
reactions occurring then were termed as “delayed reactions” and symptoms if any, were treated adequately.
Perception of the vaccine reactions was termed as mild, moderate, and severe. If the reactions did not affect
or interfere with their daily activities, they were termed as ‘mild reactions’ and if it interfered with their daily
activities, were termed as ‘moderate reactions’. Any reactions that required hospital admission were termed
as a ‘severe reaction’ [10].
Data collected were entered into an Excel spreadsheet (Microsoft, Redmond, WA, USA). Data were
analyzed using statistical package for the social sciences (SPSS) version 20 (IBM, Armonk, NY, USA).
Proportions were used to describe the socio-demographic variables and the Chi-square test was used to
measure the association between the study variables, p-values<0.05 were considered statistically significant.
Ethical clearance for this study has been obtained from the institutional ethical committee.

3. RESULTS AND DISCUSSION


In the present study, 1,577 vaccine recipient HCWs were observed for reactions following
vaccination. The majority of the subjects were females 933 (59.2%) and more than half 845 (53.6%) of the
study participants belong to less than 25 years of age. Obesity was observed in nearly 1/3 rd (496) of the
participants as shown in Table 1.
Among the 1,577 participants who took the vaccines, it was observed that 453 participants delayed
their gap of second dose vaccination in which the majority of the participants had a delay of fewer than seven
days (Mean 6.9, SD=7.67). Scheduling issues (63.3%) was found to be the main reason for vaccination delay.
38 (8.3%) HCWs felt that they would have a better immune response if they delayed their dose.

3.1. Immediate reactions


We observed that 37/1,577 (2.34%) of the HCWs reported ‘immediate reactions’ following
vaccination and 26/37 (70.2%) were females. Non-obese individuals (83.7%) experienced more reactions
than obese (16.3%) individuals and this difference was found to be statistically significant (p<0.05) as
presented Table 2. Pain and tenderness (59.4%) were the most commonly reported side-effects in this period
as shown in Table 3. On grading the severity of symptoms, it was found that 31/37 (83.7%) of the vaccine
recipients reported ‘mild’ reactions’, while one female participant experienced severe allergic reactions for
which she was treated appropriately as described in Table 4. The present study revealed 1,034 (65.6%)
HCWs did not report any reactions/symptoms following their second dose of vaccination.

Table 1. Socio-demographic details of the study participants


Post-vaccination side effects following the second dose of ChAdOx1 nCoV-19 vaccine … (Timsi Jain)
400  ISSN: 2252-8806

No Variable Frequency (N) Percentage (%)


1 Age
<25 years 845 53.6
26-40 463 29.4
41-55 151 9.6
>55 118 7.5
2 Gender
Female 933 59.2
Male 644 40.8
3 Designation
Doctor 248 15.7
Nursing staff 381 24.2
Student 646 41
Other hospital staff 302 19.1
4 Body mass index
Underweight 17 1.1
Obese 496 31.4
Normal 1,064 67.5

Table 2. Association between timing of adverse reactions following COVID-19 vaccination and related
variables among study participants
No Variable Immediate reaction Reaction within 30 mins Reaction after observation period Total
n=37 n=106 n=400 N=1,577
n (%) n (%) n (%) n (%)
1 Gender
Female 26 (2.7) 72 (7.7) 265 (28.4) 933 (59.16)
Male 11 (1.7) 34 (5.2) 135 (20.96) 644 (40.84)
χ2=1.935 χ2=3.611 χ2=12.96
p=0.103 p=0.057 p=0.02*
2 Age
<25 years 25 (2.8) 65 (7.6) 239 (28.3) 845 (53.6)
26-40 11 (2.4) 23 (4.9) 100 (21.6) 463 (29.4)
41-55 1 (0.66) 13 (8.6) 36 (23.8) 151 (9.6)
>55 0 5 (4.2) 24 (20.3) 118 (7.4)
χ2-5.62 χ2-2.681 χ2-2.763
p=130 p=0.443 p=0.838
3 Designation
Doctor 6 (2.4) 12 (4.83) 57 (23) 248 (15.7)
Nursing staff 11 (2.9) 30 (7.9) 106 (27.8) 381 (24.2)
Student 13 (2.01) 52 (8.04) 160 (24.7) 646 (41)
Other hospital staff 7 (2.31) 12 (3.97) 76 (25.16) 302 (19.1)
χ2=0.808 χ2=7.664 χ2=7.387
p=0.84 p=0.053 p=0.287
4 Obesity
Yes 6 (1.2) 25 (5.1) 135 (27.2) 496 (31.4)
No 31 (2.86) 81 (7.46) 265 (24.5) 1,081 (68.6)
χ2=4.079 χ2=0.129 χ2=1.564
p=0.043* p=0.719 p=0.457
*p-value<0.05. (Statistically Significant)

Table 3. Side effects after COVID-19 vaccination among study participants (multiple response)
Immediate reaction Reaction within 30 mins* Reaction after observation period
No Variable n=37 n=106 n=400
N (%) N (%) N (%)
1 Headache 2 (5.4) 8 (7.5) 50 (12.5)
2 Pain/Tenderness at injection site 22 (59.4) 63 (59.4) 180 (45)
3 Giddiness/Dizziness 4 (10.8) 10 (9.4) 6 (1.5)
4 Fever 3 (8) 8 (7.5) 98 (24.5)
5 Swelling/Lump on site of injection 0 (0) 1 (0.9) 3 (0.75)
6 Unwell/Tiredness 0 (0) 1 (0.9) 3 (0.75)
7 Body pain 1 (2.7) 4 (3.8) 85 (21.25)
8 Stomach pain 2 (5.4) 0 7 (1.75)
9 Nausea/Vomiting 0 6 (5.6) 12 (3)
10 Anxiety 0 1 (0.9) 2 (0.5)
11 Allergic reaction 1 (2.7) 2 (1.8) 5 (1.25)
*Observation period

Int J Public Health Sci, Vol. 11, No. 2, June 2022: 398-404
Int J Public Health Sci ISSN: 2252-8806  401

Table 4. Severity of reactions following COVID-19 vaccination


No Variable Total N=1,577 Severity of reaction
1 Immediate reaction 37 (2.34%) Mild – 31 (83.7%)
Moderate – 5 (13.5%)
Severe – 1 (2.7%)
2 Reaction in waiting room (<30 mins) 106 (6.78%) Mild – 88 (83%)
Moderate – 16 (15%)
Severe – 2 (2%)
3 Reaction after observation period 400 (25.3%) Mild – 336 (84%)
Moderate – 63 (15.7%)
Severe – 1 (0.3%)

3.2. Reactions during the observation period


The 106/1,577 (6.7%) HCWs reported reaction during the ‘observation period’ after vaccination.
Among them, it was found that the females (68%) and non-obese (76.4%) individuals reported the most
symptoms. However, this was not found to be statistically significant as shown in Table 2. Pain and
tenderness was the most commonly reported side-effects in more than half (59.4%) of the vaccine recipients
during this period, which was followed by giddiness/dizziness (9.4%) as shown in Table 3.
The grading of severity during the observation period (within 30 mins) showed that 88/106 (83%)
had mild reactions, while 2/106 (1.8%) of study participants experienced severe reactions. Among them, one
male individual was found to have palpitations and high blood pressure for which electrocardiogram (ECG)
was taken and found to be normal. He was kept under observation for another 30 minutes after which his
blood pressure came to normal and there was one more female, who had nausea and vomiting with giddiness
for which antiemetic and IV fluids were given.

3.3. Delayed reactions after vaccination


Only 1/4th (400/1,577) HCWs experienced ‘delayed reactions’ after the vaccination and among them
females (66.3%), non-obese individuals (66.3%), and those aged less than 25 (59.8%) reported symptoms.
Statistical significance was observed only in females as presented Table 2. Less than half (45%) of the
vaccine recipients reported pain and tenderness, while nearly 1/4 th (24.5%) complained of fever and 85 (21%)
complained of body pain. Only 3 (0.75%) reported a lump at the site of injection as shown in Table 3. The
grading of symptoms revealed that 336/400 (84%) had mild reactions and only one female recipient
experienced a severe reaction. She was a known case of bronchial asthma and had shortness of breath after
eight hours of vaccination for which she underwent treatment in a hospital and was under observation for two
hours as shown in Table 4. Overall, 111/1,577 study participants (7%) took medications following
COVID-19 vaccination among which antipyretics (95.4%) were most commonly used to alleviate the
symptoms

3.4. Comparison of first dose versus second dose severity


The severity of the symptoms following the second dose of vaccine was compared with the first
dose and it was found that the majority 653 (41.4%) had reported no symptoms/reactions following both
doses of vaccine and 456 (29%) reported that they had symptoms following the first dose of vaccination. The
280 (17.8%) reported their symptoms to be mild compared to their first dose of vaccination and only
54 (3.4%) reported that their symptoms were ‘more severe’ when compared to their first dose symptoms.
Finally, there were no deaths related to COVID-19 vaccination as shown in Table 5.

Table 5. First dose versus second dose severity comparison of COVID-19 vaccine side effects
N-1,577 Percentage
Severity
Frequency (N)
No symptoms for both doses 653 41.4
Symptoms only for the first dose 456 29
Symptoms only for the second dose 63 4
Mild symptoms compared to the first dose 280 17.8
Severe symptoms compared to the first dose 54 3.4
Same severity as the first dose 71 4.4

Vaccines of varied origin have adverse events which are mainly due to the immune response and not
the allergic reaction [11], [12]. This implies that every vaccine is associated with side effects which is not a
new phenomenon. Though the development of the COVID-19 vaccine was fast, it did not skip the steps of
testing its safety and efficacy. Covishield is based on viral vector technology and this has been used earlier in
Post-vaccination side effects following the second dose of ChAdOx1 nCoV-19 vaccine … (Timsi Jain)
402  ISSN: 2252-8806

the production of the Ebola virus vaccine [13]. This implies that the Covishield vaccine was not developed in
a hurry and the safety and efficacy were not compromised. Nevertheless, there is a misinterpretation
regarding the COVID-19 vaccines and their adverse effects. Hence this study was done to explore the extent
of adverse events related to the second dose of COVID-19 vaccination.

3.5. Incidence and side-effects after vaccination


In the present study, the overall incidence of adverse events following vaccination was found to be
29.8% which is in contrast to a study conducted in Bangladesh [14]. The incidence of adverse events
following vaccination was found to be 2.47% immediately following vaccination, 6.78% experienced adverse
reactions in the observation room, and 25.3% experienced reactions after the observation period. Many
reported the adverse reactions to be between mild to moderate severity and had subsided within one or two
days of vaccination with adequate rest or medications. This was consistent with the ChAdOx1 nCoV-19
vaccine trial done in Brazil, the UK, and South Africa [15]. Among other demographic factors, non-obese
individuals and younger age group individuals had documented to have experienced more reactions when
compared to the others. Further research is required to elicit both immune response and adverse effects
among obese and non-obese individuals. In this study, the prevalence of side effects was more in females
when compared to males. This was similar to another study reported in South India [16].
Pain and tenderness at the injection site were the most common events following vaccination which
were found to be consistent with several studies in many parts of the world [17]–[20]. In the present study
among the participants who had side effects majority reported that they had milder side effects after getting
the second dose of Covishield than compared to the first dose. This finding is however in contrast to the
recipients of the Pfizer-BioNTech COVID-19 vaccine who showed that the number of persons who reported
symptoms after receiving the second dose of the vaccine is more compared to the number of persons who
reported after receiving the first dose in Saudi Arabia [21].

3.6. Hesitancy and delay in the second dose of vaccination


The gap between the first and second dose of the Covishield vaccine was initially decided as four
weeks by the Government of India at the time of the launch of the vaccine. However, the guidelines were
later on changed to 4-8 weeks and then 8-12 weeks [22]. Various studies have reported better vaccine
efficacy if the gap between two doses is more than 8 weeks [23].
In our institution, we followed the guidelines by the Government of India regarding the gap between
the two doses of Covishield. In this study, we observed that 28.7% of the participants had delayed the second
dose of the vaccine, and a majority of them delayed the vaccine because of scheduling issues. Delay was
found to be highest among nurses. Only 4.8% of participants delayed the second dose vaccination for more
than 21 days. This negligible percentage in delay could be due to the active vaccination drive, prompt
response at the vaccination centre, and motivation by the institutional infection control department which had
led to the decrease in vaccination delay.
Initially, there was vaccine hesitancy among in India as opposed to other countries due to various
factors. This was present in all the strata of the population [24]–[27]. This hesitancy was also observed
among HCWs of our institute and has been alleviated with frequent follow-up, counselling, and reassurance.
Trials in June 2020 have shown that recommendation of the vaccine was only 61.4% which had later shown
an increasing trend with the decrease in vaccine hesitancy [28]. In this study, 91.3% of HCWs would
recommend the vaccine to their friends and family which infers that there’s now vaccine acceptance among
this population which in turn will influence the vaccine uptake in the community. A similar study done in the
UK in February 2021 showed nearly four-fifths of HCWs would recommend the vaccine, while a study
among the French-speaking HCWs showed only 48.6% would ‘highly recommend’ the vaccine to others
[29], [30]. The strengths of our study include the large sample size and the robust follow-up protocol of the
vaccinated participants. The major limitation of the study however is that the study is limited to only one
vaccination site and thus the external validity may be limited.

4. CONCLUSION
Every vaccine will have some side effects but it is important to understand that in the COVID-19
pandemic, vaccines are our “best shot” to fight against this virus. Though no vaccine is 100% effective, they
do play a major role in limiting the severity of the illness. On weighing the pros and cons of the vaccine side
effects, these symptoms contribute to a smaller percentage or severity when compared to the disease
outcome.

Int J Public Health Sci, Vol. 11, No. 2, June 2022: 398-404
Int J Public Health Sci ISSN: 2252-8806  403

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Post-vaccination side effects following the second dose of ChAdOx1 nCoV-19 vaccine … (Timsi Jain)
404  ISSN: 2252-8806

BIOGRAPHIES OF AUTHORS

Timsi Jain is Professor and Head in the Department of Community Medicine at


Saveetha Medical College, Thandalam, Chennai. Her educational qualification includes
Masters in Social and Preventive Medicine. She has also finished Advanced course in Medical
Education by National Medical Commission. She has more than 70 publications in reputed
national and international Journals. Her area of interest is maternal and child health,
occupational health, infectious diseases and nutrition. She can be contacted at email:
[email protected].

Balaji Selvaraju is a post graduate student in the Department of Community


Medicine, Saveetha Medical College. He had completed his MBBS degree from Sri
Muthukumaran Medical College. He has been involving in various research projects related to
mental health, maternal and child health and non-communicable diseases. This article has been
his first to be published. He can be contacted at email: [email protected].

Catherine Jude is a post graduate in the Department of Preventive and Social


medicine at Saveetha Medical College, Thandalam. Dr. Catherine had completed her Bachelor
of Medicine and Bachelor of Surgery (MBBS) at Chettinad Academy of Research and
Education. She has embarked on this journey to find answers in new and uncharted territories.
She can be contacted at email: [email protected].

Ganesan Dinesh Kumar is an Associate Professor in Deptement of Community


Medicine at Saveetha Medical College, Thandalam, Chennai, India. He has expertise in the
field of tropical medicine, public health and biostatics and has been part of several research
publications related to communicable and non-communicable diseases in national and
international journals. He has also mentored several undergraduate and post graduate research
projects. He can be contacted at email: [email protected].

Yogesh Mohan is Professor in the Department of Community Medicine at


Saveetha Medical College, Thandalam, Chennai. His educational qualification includes
Masters in Social and Preventive Medicine. He has also finished post graduate Diploma in
Management from ISB Hyderabad. He has more than 20 publications in reputed national and
international journals. His area of interest is management, spiritual health, adolescent health,
occupational health and infectious diseases. He can be contacted at email:
[email protected].

Anantha Eashwar is working as an Assistant Professor in the Department of


Community Medicine, Sree Balaji Medical College and Hospital, Chennai. He had completed
his MD Community medicine from the same institution. He has over 40 indexed publications
covering various domains of health with special emphasis on mental health. He has been
awarded “Young Scientist Award” for his research contributions. He can be contacted at email:
[email protected].

Int J Public Health Sci, Vol. 11, No. 2, June 2022: 398-404

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