Vaccine Safety and Surveillance for Adverse Events Following Immunization (AEFI) for COVID-19 Vaccine in a Tertiary Care Hospital-Kerala

Introduction: The meteoric spread of COVID-19 had facilitated the researchers to develop vaccines. One among the most recommended, Covishield requires further investigations for lighting up the society towards the immunization program. The study has determined the severity and frequency of adverse event following immunization concerning the first and booster dose of the Covishield vaccine. Also, we investigated the relationship between the participant’s demographic characteristics with the adverse events encountered due to the two doses. Materials and Methods: An observational cross-sectional study was conducted over 6 months among the individuals who were administered with Covishield vaccine registered via Indian government website, COWIN. Results: The study constituted of 2470 participants among them the frequency of females who received the vaccine (55.18%; 62.36%) was more significant than the males, so as the adverse events (Female, first dose: 51.41%, Second dose: 64.92%). We observed participants with chronic diseases (39,5%) and had long term medications (15.57%). Those with age greater than 45 years (61.15%) were discerned by the unfavorable episodes of the vaccine compared to the youngsters. First dose predominantly spawn pain at the injection site (40.15%) whereas, fever (34.72%) was the major concern in the second. The causality assessment scale put forward by World Health Organization stated all the reported adverse events following immunization in the first (62.90%) and the second dose (30.28%) was allied to the same category, consistent causal association to immunization. Conclusion: The safety surveillance study helped in the investigation wherein the adverse event profile of Covishield vaccine was causal or coincidental. We intend the generated data would reduce the fear and augment the acceptance rate of COVID-19 vaccine among the mass population.