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Observational Study
. 2022 Jun;94(6):2453-2459.
doi: 10.1002/jmv.27655. Epub 2022 Feb 21.

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

Affiliations
Observational Study

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

Swayam Pragyan Parida et al. J Med Virol. 2022 Jun.

Abstract

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.

Keywords: SARS coronavirus; disease control; epidemiology; immunity/immunization; vaccines/vaccine strains; virus classification.

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Conflict of interest statement

The authors declare no conflict of interest.

References

    1. WHO. Coronavirus Disease (COVID‐19) Dashboard WHO Coronavirus Disease (COVID‐19) Dashboard. Accessed September 20, 2021. https://covid19.who.int/
    1. Ministry of Health and Family Welfare Government of India . COVID‐19 India. Accessed September 20, 2021. https://www.mohfw.gov.in/
    1. Ministry of Science and Technology . DBT‐BIRAC supported ZyCoV‐D developed by Zydus Cadila Receives Emergency Use Authorization. Press Information Bureau. Accessed September 20, 2201. https://pib.gov.in/PressReleasePage.aspx?PRID=1747669
    1. Press Information Bureau . PIB'S bulletin on COVID‐19. PIB headquarters. Accessed September 20, 2021. https://pib.gov.in/PressReleasePage.aspx?PRID=1743567
    1. Ministry of Health and Family Welfare . The national regulator grants permission for restricted use in emergency situations to Sputnik‐V vaccine. Press Information Bureau. Accessed September 20, 2021. https://pib.gov.in/PressReleasePage.aspx?PRID=1711342

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