A longitudinal study to estimate adverse events following two doses of COVID-19 vaccination

Abstract

Background: On March 30, 2020, coronavirus disease 19 was declared pandemic and many countries of the world started working on the development of vaccine soon after China released the genetic structure of severe acute respiratory syndrome coronavirus 2. Drugs Controller General of India on January 3, 2021, accorded emergency use authorization to Oxford-AstraZeneca's ChAdOx1 nCoV-19 vaccine and vaccination drive commenced in India on January 16, 2021. The present study was conducted to determine the incidence adverse event following immunization (AEFI) among recipients of the first and second dose of the vaccine. Materials and Methods: A longitudinal descriptive study was conducted among 2529 vaccine beneficiaries who were asked about the side effects at 24 and 72 h after the first dose and second dose of vaccination with ChAdOx1 nCoV-19 vaccine. Passive surveillance was also done for 4 months. Results: AEFI was reported in 27.59%, 38.4%, and 19.96% of vaccines after both doses, first dose, and second dose, respectively. 14% did not report any AEFI with either dose of vaccine. Younger people had higher rates of AEFIs with both the doses. Pain at injection site and fever <102°F were the most common symptoms. Only three patients required admission after first dose and nil required admission after second dose, all three were discharged after 24 h observation without any complication or sequelae. Conclusion: The results of our study indicate that the vaccine has good safety profile and is recommended for use among 18–60 years. However, since majority of individuals in our study were young, studies may be undertaken in more than 60 years of age, persons with a history of allergy, and comorbidities to further evaluate safety profile of the vaccine among these groups of people.

Keywords

• adverse event following immunization
• coronavirus disease 19
• vaccination