ABSTRACT
Background: The ubiquitous elixir for mortality and morbidity inflicted by severe acute respiratory syndrome virus (SARS-CoV-2) has been a vaccine. These vaccines were approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there was a need for active surveillance of vaccinees to monitor for safety. Objective(s): This study reports adverse events following immunization with Oxford-AstraZeneca's COVID-19 vaccine (COVISHIELD). Material(s) and Method(s): The present study is an observational follow- up study to assess any adverse event occurrence following immunization (AEFI) within 7 days of vaccination among all eligible participants who were vaccinated. A structured safety surveillance questionnaire was administered consecutively to 714 participants. Vaccinees were observed for thirty minutes and followed telephonically for adverse events. Result(s): The overall incidence of any AEFI within 7 days was found to be 136/1000 vaccinations for the first dose. Out of total, 97 recipients reported with adverse events, 76.3% had AEFI within 24 h with fever as the most common symptom reported. The incidence of AEFI's was found to be associated with gender (P<0.02), age group (P<0.05) and occupation (P<0.05). No cases of hospitalization, disability or death were reported. Conclusion(s): Most of the adverse events were short-lived and observed in the first 24 h of vaccination. Incidence decreased in subsequent days and as no significant life-threatening adverse event was observed, this study might help reduce hesitancy for vaccination among the population and thus help reduce transmission of this highly contagious disease.