A participant centered surveillance of adverse events following coronavirus disease immunization phase 1 at a tertiary care teaching hospital

ABSTRACT

Background: Coronavirus disease (COVID-19) pandemic is caused by severe acute respiratory syndrome coronavirus. Vaccines could play an important role in increasing population immunity. Adverse events following immunization (AEFI) is a recent development to improve the speed and transparency of vaccine safety post-marketing. Aim and Objective: To describe adverse events following COVID-19 immunization phase 1. Materials and Methods: An observational primary questionnaire-based study was conducted regarding AEFI after getting approval from Institutional Ethics Committee. Total 241 health care providers were sent pretested and validated questionnaires through SMS containing online Google form link, data were collected. AEFI was classified and percentage value calculated, association between age and gender difference established by Chi-square test. Results: Among 241 health care providers 103 were voluntarily participated. Following 1st dose of vaccination, out of 103 healthcare provider 45 (44%) experienced local as well as systemic kind of reactions. Most common local and systemic reaction were pain at injection site and fever respectively. Following 2nd dose of vaccination, out of 103 healthcare providers, 29 (28.40%) experienced local as well as systemic reaction. Most common local and systemic reaction were pain at injection site and headache respectively. NSAIDS were most commonly used medication to resolve AEFI after 1st and 2nd dose of vaccine. Conclusion: Vaccine have side effects, but none of them are as severe as the disease itself. Active surveillance for adverse events to vaccine is a good method for detecting and quantifying mild adverse events.