A study on adverse effect following immunization COVID-19 vaccination Covishield among MBBS student s of a tertiary care institution in a rural area of Chhattisgarh, India

INTRODUCTION

India has granted emergency use authorization to two COVID-19 vaccines ,Pune based Serum Institute of India’s Covishield and Hyderabad- based Bharat Biotech International Ltd.’s Covaxin, for the vaccination drive.¹ India has vaccinated the highest number of persons on the first day under its COVID-19 vaccination programme, the world’s largest such exercise. This is much higher than many other countries including the US, the UK and France.¹ Tracking of vaccinated person is ongoing to lookout safety and efficacy.² In view of above context present study was conducted with the objective to determine the adverse effect following immunization (AEFI) among study subject. It will help to policy maker to conclude based on the observation.

METHODS

A cross sectional observational study was carried out on total of 400 MBBS Students of Chandulal Chandrakar Memorial Medical College at district Durg, Chhattisgarh, India, during January 2021to March 2021 using semi-open questionnaire. Sample size was obtained using formula 4pq/L². Where p was taken as 50% and q =100˗p, L (allowable error) = 10% of p. Study protocol was approved by the institutional ethics committee and written informed consent obtained from the participants.

Exclusion criteria

Those who were not willing to participate in study were excluded from study.

Data was analysed using SPSS software and information obtained were interpreted in context to above aim and objective.

RESULTS

In present study sex ratio was 1.08 (Table 1). Study shows most common adverse effect was pain at injection site (86%), followed by fever (76%), joint ache (40%), Headache (30%), chills (22%), tachycardia (10%), motor weakness (6%) and 4% of people experienced numbness, 4% urticaria, 4% rashes respectively, and others 4% including congested eyes and fatigue (many subject experienced more than one adverse effect) (Figure 1). Among the entire participant 32% received treatment; female received more (69%) compare to male (31%) (Table 2).

(Same subject experienced more than one adverse effect).

Almost 100% of subject experienced AEFI following first dose administration whereas about 20% only experienced adverse effect following administration of second dose (Table 3). Here we observed 42% of people had fever for 1-2 days, 32% for 0-1 days, 18% for 2-3 days and rest 8% for 3-4 days (Figure 2). Concerned to pain at local injection site persisted following immunization, study observe that, 47% people experienced pain for 2-3 days, 40% 0-1 days, 9% 4-5 days and 2% for 8-9 days respectively (Figure 3).

DISCUSSION

As we know there is limited study so far on AEFI, in present study sex ratio was 1.08 (Table 1). Study shows most common adverse effect was pain at injection site (86%), followed by fever (76%), joint ache (40%), Headache (30%), chills (22%), tachycardia (10%), motor weakness (6%) and 4% of people experienced numbness, 4% urticaria, 4% rashes respectively, and others 4% including congested eyes and fatigue (Figure 1). Among the entire participant 32% received treatment; female received more (69%) compare to male (31%) (Table 2). In a similar study, adverse effect was seen in 75.5% of the women and 45% of the men. The most common ones were pain at the injection site (76.1%) followed by body ache (46.8%), headache (30.3%), and fever (22%). The respondent also complained of stiffness in the arm (11.5%), swelling in the arm (16.5%), and GI symptoms and vomiting (4.1%). But there was no case of serious adverse event following immunization.³ This observation is almost similar to present study except fever which was second most common side effect (about 76%) whereas in this study it was only 22%. In present study, 100% of subject experienced adverse effect following immunization (AEFI) following first dose administration whereas about 20% only experienced adverse effect following administration of second dose (Table 3). Here we observed 42% of people had fever for 1-2 days, 32% for 0-1 days, 18% for 2-3 days and rest 8% for 3-4 days (Figure 2). Concerned to pain at local injection site persisted following immunisation, study observe that, 47% people experienced pain for 2-3 days, 40% 0-1 days, 9% 4-5 days and 2% for 8-9 days respectively (Figure 3). In a similar study, after four hours of vaccination, some health workers complained about irritability in mood, six hours after vaccines, some complained of myalgia, nausea, tenderness at the injection site and feverish feeling. After 12 hours, fever with chills developed which required paracetamol to resolve. By the second day of vaccination, fever and headache were resolved, however myalgia and tenderness at the injection site persisted. On the third day, early morning awakening and head heaviness and tenderness at the injection site persisted. Paracetamol (NSAID) seems to be required with the Oxford vaccine compared to Pfizer or Moderna vaccines to resolve the individuals’ common symptoms.⁴ In another study it was observed that, fever, fatigue, body ache and nausea were some of the most common adverse effect whereas soreness at the site of vaccination, lethargy/malaise are other common symptoms experienced by few individuals post their vaccination. While the post vaccination side effects may linger on for a day or two, experts believe it is highly manageable at home.⁵ In another study, it was noted that over 53.1 per cent did not encounter any side effects. While 20.4 per cent had tenderness, pain and warmth, 18.9 per cent had chills and felt feverish, including a small group who complained of swelling, lump and redness at the injection site.⁶ This study is dissimilar to present study where 100% subject experienced adverse effect although none was serious to get hospitalised. India has reported 234 adverse events following immunisation (AEFIs), including 71 deaths, for both the vaccines as per Dr N K Arora, an advisor to the national AEFI committee.⁶ There is a need for long-term monitoring of adverse drug reactions and an urgent need for monitoring by pharmacovigilance centres within a country. The central government decided to conduct a deeper review of post-vaccination side-effects from the Oxford-AstraZeneca corona virus vaccine news agency AFP reported. The news came after several countries had suspended rollout of AstraZeneca shot over blood clot fears. However, no cases of blood clots have been reported so far in the country, AFP said. Denmark, Norway and Iceland paused use of Oxford-AstraZeneca corona virus vaccine as a precaution after isolated reports of recipients developing blood clots.⁷

As the study was conducted on MBBS students who attended institution physically, less number of participants were available for study.

CONCLUSION

Majority had minor adverse effect and maximum shows adverse effect following first dose of administration. About 3:1 ratio F:M observed concerning treatment received for adverse effect.

ACKNOWLEDGEMENTS

Authors acknowledge to all the participants who voluntarily participated and given consent for such an important study. Very limited study has been conducted till date.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

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