Assessment of minor side effects of COVID-19 vaccination among health care students.

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION &

RESEARCH, PUDUCHERRY-605006.
(An Institution of National Importance under the Ministry of Health & Family Welfare,
Govt. of India)
FORMAT FOR SUBMITTING PROPOSAL OF M.Sc. NURSING DISSERTATION,
B.Sc. NURSING & POST BASIC DIPLOMA IN NURSING PROJECTS
(Adopted JIPMER IEC Application Form Version 3.0 & ICD Version 3.0 dated 27 th July 2018)

SECTION- 1
PART A – GENERAL INFORMATION

1. Title of the dissertation: Assessment of minor side effects of COVID- 19 vaccination among health
care students.
2. Name of the Student Researcher with mobile numbers and email ID:
S. Mobile
Name of the student Email id
No. number
1 Richa Rathore richa.rathore97@gmail.com 8954381302
2 S Sreepriya sreepriyamazing@gmail.com 9188216085
3 Sadhana K sadhanakitcha@gmail.com 6385138955
4 Salini Santhosh hema23177@gmail.com 8113843153
5 Saranya S C saranyasc1998@gmail.com 9605548746
6 Saravanan S ssssaravanan14@gmail.com 9791579505
7 Shivani Chandel chandelshivani039@gmail.com 8544779083
8 Snega K snegakarunakaran@gmail.com 9629897633
9 Sneha Sahoo piusneha70@gmail.com 7318613274

3. Name of the course studying:

B.Sc. Nursing III Year
4. Year of admission:
2018
5. Month and year of appearing for final examination:
September, 2021
6. Month and year of submitting dissertation:
March, 2021

7. Name (s), Designation(s) & Addresses of the guide and co-guide (s) with mobile
numbers and email ID:
Mrs. N. Vanitha,

1
 Assessment of minor side effects of COVID-19 vaccination among health care students.

Tutor,
College of Nursing, JIPMER.
Mobile Number: 8056886180
Email ID:vanithasrinivasan22@gmail.com

8. A. State whether it is intradepartmental or interdepartmental:

Intradepartmental
B. If the study is interdepartmental

I. State the names of collaborating departments:

NA
II. State whether consent has been obtained from them :
NA

9. Total funds required for the study (in rupees):

NA
10. Source of funding:
NA

2
 Assessment of minor side effects of COVID-19 vaccination among health care students.

PART B – TECHNICAL DETAILS

1. Title of the dissertation :

Assessment of minor side effects of COVID- 19 vaccination among health care students.
2. Introduction:
Corona Virus is a common virus that causes upper throat infections and infections of nose and
sinuses. In early 2020, after the outbreak in China, the World Health Organization identified SARS
CoV-2 as a new type of corona virus. This virus has rapidly become a major global threat, affecting
more than 185 countries and 3,500,000 people and leading to nearly 250,000 deaths worldwide.
Over the centuries, vaccinations have become an effective preventive measure in reducing the rate of
spread and eradication of certain viral illnesses. Besides providing direct immunity, vaccines have
been shown to reduce infections through herd immunity, if a sufficient proportion of population is
immune. In response to massive global effects of COVID-19, multiple laboratories worldwide has
been working hand-to-hand to create an effective vaccine.
Health care workers represent high risk group for SARS CoV-2 infection. Vaccination of health care
workers is of utmost importance to prevent the spread of virus, especially in the health care settings
with the patients. The reluctance of health care workers to vaccinate against COVID-19 could
diminish the trust of individuals and trigger a ripple effect in general public.
India commenced the rollout of COVID-19 vaccines on January 16 th amidst concerns about the lack
of transparency around protocols, the approval of vaccines and adverse events in clinical trials.
While the World Health Organization is clamoring to provide vaccines to priority groups in other
nations, our health care workers are declining the vaccine, considering its side effects. Hence, our
study aims at assessing the minor side effects of COVID-19 vaccination.
a. Problem statement:

India has administered 44 million Covishield and 4.2 million Covaxin until March 23 and
the government expects Bharat Biotech to step up its efforts and deliver 120 million doses
of Covaxin and Serum Institute to deliver 480 million doses of Covishield. India is also
supplying millions of doses of COVID – 19 vaccine to other countries. Earlier this month
Bharat biotech had conducted phase 3 clinical trials involving 25,800 subjects in partnership
with the ICMR (Indian council medical research) and showed that the efficacy of vaccine is
81%.There are many minor side effects reported from both the vaccine. So current study
aim to assess the minor side effects of Covishield & Covaxin Vaccine.
 Assessment of minor side effects of COVID-19 vaccination among health care students.

Rationale:
In 2019, 11.4 million individuals were affected by corona virus worldwide. This virus has rapidly
become a major global threat, instigating a pandemic affecting more than 185 countries. Lack of
awareness of the nature of the disease and the risk factors of the disease as well as the preventive
measures are the reasons for the widespread of pandemic disease such as COVID- 19. By knowing
the minor side effects of COVID- 19 vaccine among the Health care students, counseling will be
given and awareness will be created.

Novelty:
Considering the crucial importance of COVID-19 vaccination in health care students and lack of
studies in this regard, identifying the minor side effects of COVID-19 vaccine can improve care
plans and preserve vaccination safety.
b. Expected outcome and application:
The study finding will help us to understand the importance of COVID- 19 vaccine and its minor
side effects.. This will help in appropriate patient education and in creating awareness about
COVID- 19 vaccine which might positively affect the students to adhere to COVID vaccination.
3 Research question(s):
 Do the people receiving Covishield vaccine experience any minor side effects?
4 Research hypothesis (es), if any
NA
5 Aim and objectives:
 To identify the side effects following Covishield Vaccine among health care students.
 To associate side effects with demographic variables of health care students.

6 Review of literature:
a) Studies related to COVID-19 vaccine:-
Fernando Polack et al conducted a cross sectional study to determine the safety and efficacy of the
BNT162bz mRNA COVID-19 vaccine. In this study, randomly assigned persons 16 years of age in a
1:1 ratio receive 2 doses, 21 days apart. A total 43,548 participants underwent randomization, of
whom 43,448 received injections: 21,720 with BNT162bz and 21,728 with placebo. There were 8
cases of COVID-19 with onset at least 7 days after second dose among participants assigned to
receive BNT162bz and 162 cases among dose assigned to placebo. It was found that a 2 dose
regimen of BNT162bz conferred 95% protection against COVID-19 in persons 16 years of age or
older.
Kimberly A Fisher et al(2020) conducted a study on attitude towards a potential SARS CoV-2
vaccine in 991 Ameri Speak panel member respondent. A cross sectional study was conducted using
Assessment of minor side effects of COVID-19 vaccination among health care students.

structured questionnaire to determine attitude towards potential SARS CoV-2 vaccine. The results
revealed that approximately 3 in 10 adults were not sure that they would accept vaccination and 1 in
10 did not intent to be vaccinated against COVID-19. Targeted and multipronged efforts will be
needed to increase acceptance of COVID-19 vaccine when one becomes available.
Adva Gadoth, Megan Halbrook, Rachel Martin-Blais, et al conducted a cross sectional study on
assessment of COVID-19 vaccine acceptance among health care workers. The study setting was
University of California, Los Angeles. The study population consisted of UCLA health system
employees. The sample size included a total of 609 participants. A 9-statement Likert scale matrix
scored from 1(‘strongly disagree’) to 5 (‘strongly agree’). The study found respondents’
overwhelming confidence about vaccine safety (4.47); effectiveness (4.44); importance, self-
protection and community health (4.67). The odds of reporting indent to delay corona virus vaccine
uptake were 1.15 times higher among nurses, 2.45 times higher among other personnel with patient
contact roles and 2.15 times higher among those without patient contact compared to doctors.
Evolving SARS CoV-2 signs (76%), current political estimate (57.6%) and fast tracked vaccine
development timeline (83.4%) were cited as primary variables impacting health care worker decision
to undergo vaccination.
A.Gagneux-Brunon, M.Detoc, S.Bruel et al conducted a cross sectional study on intention to get
vaccinations against COVID-19 in French healthcare workers during the first pandemic wave. Two
thousand and forty seven HCWs answered the survey. Woman accounted for 74%. Vaccine
hesitancy was associated with a decrease in COVID-19 vaccine acceptance .Flu vaccine rate was
57.3% during the previous season, and 54.6% of the respondents had the intention to get a flu
vaccine during the next season. Intention to get vaccinated against COVID-19 reached 75% in
HCWs with discrepancies between occupational categories .COVID-19 pandemic had no positive
effect on flu vaccine acceptance rate.

Methodology
a. Study design: Cross-Sectional Study
b. Study participants: Human
i. Inclusion criteria:
 Health care students who have been vaccinated against COVID-19.
 Students who are willing to participate.

ii. Exclusion criteria: NIL

iii. Withdrawal criteria, if any (trial-related therapy, follow-up and documentation are
terminated prematurely as it is indicated to ensure safety of the participants): NA
iv. Rescue criteria, if applicable (starting symptomatic therapy either to control
symptoms of disease or to overcome lack of adequate efficacy of the study drug
Assessment of minor side effects of COVID-19 vaccination among health care students.

or placebo): NA :
v. Number of groups to be studied, identify groups with definition: 2groups. Health care
students with and without side effects.
c. Sampling
i. Sampling population: Health care students.
ii. Sample size calculation:
50% of anticipated proportion of people having minor side effects after COVID-19 vaccination
with 5% absolute precision and 5% level of significance.
Sample size is estimated as, n=384
iii. Sampling technique: Convenient sampling technique
iv. Analysis
All the categorical variables will be exposed as frequency/proportion. All the continuous
variables will be summarized as mean with standard deviation/mean with interquarter range.
The association of demographic variables with side effects will be assessed using chi square
test or fisher’s exact test.

d. Randomization details (for interventional studies)- Intervention details

with standardization techniques (drugs / devices / invasive
procedures /non-invasive procedures /others): NA

e. Study procedure:
- The study will be conducted after obtaining ethical clearance from the institution‘s ethic
committee.
- Permission will be obtained from study participant by written consent.
- Assurance will be given to the study participant that anonymity and confidentiality will be
maintained.
- The Participants will be interviewed using a structured questionnaire about minor side
effects of Covishield vaccine.
f. Data collection methods including settings and periodicity:
The study will be conducted among the health care students getting COVID- 19 vaccine at
JIPMER hospital.
g. If the clinical trial, whether registration with CTRI will be done: NA
h. Are the drugs/devices to be used approved for these indications by Drug Controller
General of India (DCG-I)? (Enclose the approval letter for the drug/device from DCG-I
for trial on humans or give undertaking to get the approval from DCGI; For all drugs and
devices submit documents showing DCGI approval for the proposed indication of the
study): NA
 Assessment of minor side effects of COVID-19 vaccination among health care students.

i. List of variables and their measurement methods with standardization techniques

a) Independent variables:
 Age
 Gender
 BMI
 Vaccination status
 Previous COVID Exposure status

b) Outcome variables: Percentage of students who developed minor side effects.

j. Confounding and interacting variables: Co- morbidities( if any )

7 List risks and benefits of the study:

This study has minimal risk. This study will help the investigator to assess the minor side effects of
COVID- 19 vaccine among health care student.. According to the findings, if needed, the students
will be given counseling regarding COVID vaccination so that awareness will be created.
8 Relevant references for the project:
 Li YD, Chi WY, Su JH, Ferrall L, Hung CF, Wu TC. Coronavirus vaccine development:
from SARS and MERS to COVID-19. J Biomed Sci. 2020 Dec 20;27:104.
 Gadoth A, Halbrook M, Martin-Blais R, Gray A, Tobin NH, Ferbas KG et al. Cross-
sectional Assessment of COVID-19 Vaccine Acceptance Among Health Care Workers in
Los Angeles. Ann Intern Med. 2021 Feb 9. M20-7580.
 Fisher KA, Bloomstone SJ, Walder J, Crawford S, Fouayzi H, Mazor KM. Attitudes Toward
a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults. Ann Intern Med. 2020 Dec
15;173:964-973.
 Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S et al; C4591001
Clincal Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N
Engl J Med. 2020 Dec 31; 383: 2603-2615.
 Sharma O,Sultan AA,Ding H,Triggle CR. A Review of the progress and Challenges of
Developing a Vaccine for COVID-19.Front Immunol .2020 Oct 14;11:585354.
 Haynes BF, Corey L, Fernandes P, Gilbert PB, Hotez PJ, Rao S et al. Prospects for a safe
COVID-19 vaccine. Sci Transl Med. 2020 Nov 4;12:eabe0948.
 Lazarus JV, Ratzan SC, Palayew A, Gostin LO, Larson HJ, Rabin K et al. A global survey
of potential acceptance of a COVID-19 vaccine. Nat Med. 2021 Feb;27:225-228.
 Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R et al. Efficacy and Safety of
the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384:403-416.
 Assessment of minor side effects of COVID-19 vaccination among health care students.

 Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q. Prevalence of comorbidities and its effects
in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect
Dis. 2020 May;94:91-95.
 Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y. Clinical features of patients infected with
2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395:497-506.

9 Enclosures:

a. Brief CV of guide : Enclosed

b. Data collection Performa: Enclosed

c. Questionnaires: Enclosed

d. Consent form (English version): Enclosed

e. Other relevant papers:

10 Undertaking for DCGI approval

Assessment of minor side effects of COVID-19 vaccination among health care students.

Declaration by the Guide:

I take full responsibility and accountability for planning, execution and adverse events
occuring during the study. The data collected and records will be retained by me for the period of
three years.

Signature of the Student Researcher: Signature of the guide:

Ms. Richa Rathore Mrs. N. Vanitha,

Ms. S Sreepriya Tutor,

Ms. Sadhana K College of Nursing, JIPMER.

Ms. Salini Santhosh

Ms. Saranya S C

Mr. Saravanan S

Ms. Shivani Chandel

Ms. Snega K

Ms. Sneha Sahoo Signature of the Head of the

B.Sc Nursing III year Department of the Candidate:

College of Nursing, JIPMER Dr. M. J. Kumari

Professor cum Principal,

College of Nursing, JIPMER.

 Assessment of minor side effects of COVID-19 vaccination among health care students.

PARTICIPANT DATA SHEET– ENGLISH

STRUCTURED QUESTIONNAIRE TO ASSESS THE SIDE EFFECTS OF COVID-19
VACCINATION AMONG HEALTH CARE STUDENTS

SECTION-A: SOCIO-DEMOGRAPHICDATA
1. Participant ID:
2. Age:
3. Gender: Male/Female
4. Studying Institution:
5. Course:
6. Year of course:
7. Any Co-morbidities: DM/HTN/Others
8. Any allergies:
9. On any medications:
SECTION B: CLINICAL DATAs
1) Have you anytime become COVID positive and recovered?
2) If so, when have you recovered from COVID positive?
3) Have you been hospitalized for COVID?
4) Type of vaccine received: Covishield/Covaxin.
5) Have you taken both the doses of the vaccine?
6) Did you develop any side effects within 30 minutes? Yes /No. If yes, specify.

During 1st dose During 2nd dose

1.
2.
3.

7) Have you had side effects after 30 minutes of vaccination?

8) Mention the side effects which you developed after 24 hours.

Side effects First 24 hours After 24 hours Duration( in days)

Myalgia
Fever
Vomiting
Headache
Sore throat
 Assessment of minor side effects of COVID-19 vaccination among health care students.

Restlessness
Any other Symptoms

9) Have you been admitted due to minor side effects?

10) When were you able to resume your normal work after vaccination? Immediately after/ After 1
day/After 2 days/After 4 days/After 1 week

During 1st dose During 2nd dose

11) Have you taken any drugs for the minor side effects? Specify.

Name of the drug Dose Frequency

12) How will you rate the severity of side effects?

1 2 3 4 5 6 7 8 9 10
13) Do you consider the vaccine safe?
14) Would you recommend the vaccine to other people?

Curriculum Vitae of Guide

1. Name N. Vanitha

2. Designation Tutor
Assessment of minor side effects of COVID-19 vaccination among health care students.

Department College of Nursing

Institution/organization JIPMER

3. Mobile number 8056886180

4. Email ID vanithasrinivasan22@gmail.com

5. Qualifications M.Sc. Nursing

6. Projects undertaken in the last 5 years (brief title, funding source, amount, status)

7. Relevant research training/experience in the area

OBG & Pediatrics Nursing.

8. Relevant publications:
(All publications in the last five years and other publications relevant to the current study;
Vancouver format)
1. Vanitha .N. An experimental study to evaluate the effectiveness of application of almond oil
massage on breast feeding among postnatal mothers undergone LSCS at MGMCRI
Puducherry. IJCR .2018:10(10)74435-39.
2.
Vanitha .N. Assessment of knowledge on Baby Friendly Hospital Initiative (BFHI) among
staff nurses in MCH unit at MGMCRI Puducherry.IJCR.2019:11(10)7759-60.

3. Vanitha .N.The breast milk secretion and its associates among postnatal mothers undergone
LSCS at MGMCRI Puducherry.IJAR.2019:7(10) 615-21.

Declaration
Assessment of minor side effects of COVID-19 vaccination among health care students.

I hereby declare that the above particulars given by me are true and correct to the best of my
knowledge and belief.

Signature of the Guide:

Mrs. N. Vanitha

Tutor,

College of Nursing, JIPMER.