Adverse Events Following Immunization to CovId-19 vaccines in A Tertiary Care Hospital – A descriptive Study

Abstract

Introduction: The pandemic due to Coronavirus disease 2019 (COVID-19) is a major health issue resulting in mortality across the globe. Multiple newer medications are being tried in treatment but with minimal success. The development of vaccines is occurring with unprecedented speed using different platforms with collaborations of academia and the pharmaceutical industries globally. These vaccines are approved for emergency use authorization by health authorities based on limited data from clinical trials. Hence, there is a need for active surveillance of vaccine recipients to monitor for safety. Methods: Adverse drug reaction monitoring centre (AMC) of our institute is actively involved in surveillance of recipients for adverse events following immunization (AEFI) who received vaccines for COVID-19 from the vaccination centre of the institute. As per the guidelines of National Coordinating Centre (NCC), Pharmacovigilance Programme of India (PvPI), designated staff of AMC follows up vaccine recipients over their registered mobile number post-vaccination for AEFI if any. This is a descriptive study of all the AEFI reported to NCC, PvPI between 16th January 2021 and 31st March 2021. Results: Of the 5793 doses of vaccination administered during the study period, 59.4% (3443) responded to follow up and 8.6% (299 of 3443) recipients reported 509 AEFI. The most common reported AEFI include fever, generalized body pains, and headache constituting 36.1%, 30.5%, and 18.5% respectively. 64.2% (327 of 509) of AEFI were reported from people younger than 45 years of age. Though females constituted 53.8% (161 of 299) of people who reported AEFI, total number of events reported from this group was 58% (295 of 509). More number of AEFI were observed after first dose of COVISHIELD compared to second dose. Conclusion: COVID-19 vaccination drive is rolled out in multiple phases for different age groups across the country. Many vaccinations are being approved for use in general public with limited data from clinical trials. Active surveillance of COVID-19 vaccines for AEFI helps us in further understanding safety issues beyond the clinical trial environment.