Adverse Events Following COVID-19 Vaccination in Selected Apartments in Bangalore, India

Abstract

Background Vaccination has provided a ray of hope in combating the coronavirus disease 2019 (COVID-19). Vaccines were rolled out as an emergency measure, with an expedited approval process. The available clinical trial data reveals the fact that vaccines mostly produce mild adverse events following immunization (AEFIs). Since the experiences are relatively new, it is important to monitor safety in a real-world setting. With this background, this survey was conducted. Methods This cross-sectional study was approved by the institutional ethics committee (IEC) of Vydehi Institute of Medical Sciences and Research Centre. This was conducted over a period of four months at select apartment complexes around Whitefield, Bangalore. The participants were invited to fill up data through online Google Forms (Google, Mountain View, CA, USA). They were requested to provide demographic details, information related to vaccination, and AEFIs. Eligibility to participate included recipients of vaccines who received Emergency Use Authorization (EUA) in India. Data were analyzed using SPSS version 20.00 (IBM Corporation, Armonk, NY, USA). Results The total number of participants in the study was 322. Out of this, 37.6% (121) were males and 62.4% (201) were females. The mean age of the participants was 34.9 ± 12.4 (mean ± standard deviation (SD) years. About 30% (96) of the study participants had comorbidities. Overall, 67.4% (217) of the participants suffered from AEFI. Of them, immediate reactions were reported by 18.3% (59) and 10.2% (32) of the participants after the first and second doses, respectively. A total of 0.9% (3) of the participants had immediate allergic reactions. The most common local and systemic AEFIs were pain at the injection site and extreme tiredness. AEFIs were found to be mild and with a probable association with vaccination as per the WHO scale. The number of females experiencing AEFIs was found to be higher when compared with males for both local and systemic reactions. There was a statistically significant increase in the number of individuals experiencing general adverse effects following the first dose of Covishield^TM (Serum Institute of India Private Limited, Pune, India) when compared with Covaxin^TM (Bharat Biotech Limited, Hyderabad, India) (P < 0.05). Of the participants, 5.9% (19) were diagnosed with COVID-19 post-vaccination. Among them, 15.8% (3) required hospitalization, with 10.5% (2) of them requiring an oxygen bed. It was observed that 76.5% (166) of the participants did not report their reactions to concerned authorities. Conclusion Based on our sample, the study reflects that COVID-19 vaccination causes mild AEFI in most vaccine recipients. It also provides an insight that reporting of AEFI is very low. It is, therefore, important to take up more awareness campaigns about reporting of AEFIs through the COVID Vaccine Intelligence Network (CoWIN) portal.

Keywords: aefi; covaxin; covid vaccine; covishield; local aefi; systemic aefi.