A prospective and observational study to evaluate short-term adverse event following immunization of COVID-19 vaccination

ABSTRACT

Background: COVID-19 severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) was declared Pandemic by the World Health Organization on January 30, 2020. Vaccination represents the best possibility to resolve this pandemic. The current global challenge is the immunization against the SARS-CoV-2. However, the adverse events following immunization (AEFI) of the corona vaccine remains unclear. Aim and Objectives: This observational study aims to represent an accountable data of the AEFI between Covaxin and Covishield in North Indian population. Materials and Methods: The hospital-based prospective and observational study was employed from January 2021 to December 2021 for detecting and monitoring of AEFI in adults. All population vaccinated either covishield or covaxin with both doses were enrolled in the study as targeted population. Post-vaccination vaccinated population were telephonic follow-up with prior consent. Results: A total of 1015 vaccinated individuals were included in this study for assessment of AEFI. After statistical analysis of AEFI between both vaccination at 24 h P = 0.13, 3-7 days 0.4 and complete AEFI P = 0.06 observed. There is no association that was found significant P < 0.05 with the incidence of AEFI. Conclusion: The short-term outcome has not attribute any serious AEFI. This study demonstrated that both vaccines were well-tolerated and safe in generalized population.