Active surveillance of adverse events following the first dose of COVID-19 vaccination – Oxford–AstraZeneca (Covishield) vaccine

Abstract

Background: COVID-19 vaccines have been the most rapidly developed vaccines in history and consequently, fears of its safety and efficacy intrigue the minds of the common man. Aims: This study was intended to determine the adverse events following COVID-19 vaccination and thereby reduce vaccine hesitancy in the people. Methods and Materials: An active vaccine safety surveillance study was carried out on health-care workers of a tertiary care center in Central Kerala using a prestructured interview schedule documenting a description of adverse events following immunization (AEFI), time of occurrence, management and outcome of AEFI, knowledge about AEFIs, and fear of COVID-19 vaccination. A telephonic survey was carried out on 475 randomly selected COVID vaccine beneficiaries. Results: Overall, 86% of the participants reported at least one postvaccination symptom. Fever (51.8%), injection-site pain (46.9%), headache (29.3%), myalgia (28.4%), and fatigue/tiredness (25.1%) were the most common symptoms. None of the symptoms were severe/serious to warrant hospital admission. Side effects were more common in females (P = 0.003) and reactogenicity of the COVID-19 vaccine decreased with advancing age (P = 0.001). The vaccine did not have any difference in side effects among those who had previous COVID-19 infection. Conclusion: This study shows that COVID vaccines are safe in the Indian population and the side effects are similar to any other vaccine. It may help to dispel any fear and misinformation regarding COVID-19 vaccination and thus maximize the benefit of the nationwide immunization program.