Abstrait

Assessment of adverse events following immunization with COVID-19 vaccination: An observational study at a tertiary care hospital.

Imran Khan, Padmaja M, Ramanjaneyulu P, Bhuvana Sri M, Usha Rani P

Introduction: The COVID-19 pandemic continues to ravage the whole world, causing a dramatic impact on the health, social and economic well-being of the people. Vaccines are key tools in the battle against COVID-19. As anticipated with any drug or biological product, vaccines also may cause some adverse events. There is a need to address the safety concerns of COVID-19 vaccines in our population.

Objectives: To assess the pattern of adverse events associated in the beneficiaries receiving COVID-19 vaccination.

Methodology: The study was conducted on eligible beneficiaries receiving COVID-19 vaccine at a tertiary care hospital in south India. AEFI were collected by active and passive methods. Beneficiary details, data of the events were recorded in the case report form and analysed for the pattern, age and gender preponderance, severity, and causality with the COVID-19 vaccine.

Observations: Five hundred and fifty-four beneficiaries reported a total of 1529 events, with a mean age of 26.9 (± 7.2) years. 57.4% were female and 42.6% were male. Fever was the most reported adverse event, followed by body pains and headache 20 (3.52%) cases of AEFI were categorized as serious, which required hospitalization. Outcome of all the events was resolved within a median duration of 4 days from the day of appearance. 99% of the events were assessed to be causally related with the vaccines

Conclusion: Majority of the observed AEFI with COVID-19 vaccinations were non-serious, of mild to moderate severity, hence the COVID-19 vaccines are safe when compared to the risk of severe COVID-19 infection in non-vaccinated.