Adverse events following immunization of COVID‐19 (Covaxin) vaccine at a tertiary care center of India

• Published in: Journal of medical virology Vol. 94; no. 6; pp. 2453 - 2459
• Main Authors: Parida, Swayam Pragyan, Sahu, Dinesh Prasad, Singh, Arvind Kumar, Alekhya, G., Subba, Sonu Hangma, Mishra, Abhisek, Padhy, Biswa Mohan, Patro, Binod Kumar
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.06.2022; John Wiley and Sons Inc
• Subjects: Allergic reactions; Allergies; Chronic illnesses; Chronic infection; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; disease control; epidemiology; Female; Females; Fever; Humans; immunity/immunization; Immunization; Immunization - adverse effects; Infections; Male; Myalgia; Pain; SARS coronavirus; Tertiary Care Centers; Vaccination; Vaccination - adverse effects; Vaccines; vaccines/vaccine strains; Viral diseases; Virology; virus classification; disease control; epidemiology; vaccines/vaccine strains; virus classification; SARS coronavirus; immunity/immunization
• ISSN: 0146-6615; 1096-9071
• DOI: 10.1002/jmv.27655

The study aimed to assess the adverse events following COVID‐19 vaccine (Covaxin) immunization at a tertiary care institution and also assess the predictors of the adverse events following immunization (AEFI). The prospective observational study was conducted in a tertiary care institute among the Covaxin beneficiaries between June 28 and September 6, 2021. A total of 1826 participants were assessed for any local or systemic adverse events after seven days of vaccination. A telephonic interview was conducted, and the beneficiaries were assessed according to the adverse event grading. A total of 1826 participants were assessed for AEFI, and 544 (29.8%) reported at least one of the AEFI. No severe adverse events were reported, and about 1.6% had moderate AEFI. Pain at the injection site (14.6%), fever (9.7%), and myalgia (5.9%) were the common adverse events reported by the participants. AEFI incidence was higher in the first dose (38.1%) when compared to the second dose (26.4%), and this finding was significant with a p < 0.001. The major factors associated with AEFI were female sex, history of an allergic reaction, presence of comorbidities, acute infection in the past 3 months, and intake of chronic medications. Precaution needs to be taken while vaccinating individuals having allergies, comorbidities, acute infection in the last 3 months, and individuals on chronic medication. Highlights The study assessed adverse events following immunization of the COVID‐19 vaccine in a large‐scale sample. Adverse events following immunization were common after Covaxin (BBV152) vaccination, but a majority of the adverse events were mild. Adverse events were higher in the first dose as compared to the second dose. Females, individuals with a history of allergy, co‐morbidities, acute infection in the past 3 months, and individuals taking chronic disease medication were having a higher chance of adverse events.