ABSTRACT
Background: Coronavirus disease 2019 (COVID-19) vaccines are essential to tear out the COVID-19 pandemic. COVAXIN and COVISHIELD were the first licensed vaccines in India for public use. For safety surveillance reporting, adverse events following immunization were an essential and integral part of the postlicensure phase for benefit- risk analysis of vaccines. Public trust in newly introduced vaccines will be strengthened by monitoring vaccine safety. So this study was planned to find out adverse events following COVISHIELD vaccination and the association of some factors with adverse events following COVISHIELD vaccination among vaccinees at vaccination centers of tertiary care hospitals. Materials and Methods: A cross-sectional study was carried out among vaccinees at vaccination centers in tertiary care hospitals. Data was collected through Google forms containing a structured questionnaire. Results: A total of 530 adverse events following immunization (AEFI) were reported by 146 (39.46%) participants, where one participant experienced more than one AEFI with the COVISHIELD vaccine. The most common reported AEFI were myalgia (104 [19.62%]), fever (104 [19.62%]), and fatigue/lethargy (104 [19.62%]), followed by pain at the injection site (80 [15.09%]). Participants who experienced AEFI with other vaccines and had a previous history of COVID-19 infection were found to be significant independent predictors of AEFI with the COVISHIELD vaccine. Conclusion: Most AEFIs were mild and lasted for a short duration, subsiding on symptomatic treatment. We found only the history of AFFI with other vaccines and previous infection with COVID-19 as significant predictors for the occurrence of AEFI with the COVISHIELD vaccine.