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J Med Virol . Adverse Events Following Immunization of COVID-19 (Covaxin) vaccine at a Tertiary Care Center of India

tetano

Editor, Senior Moderator
J Med Virol


. 2022 Feb 11.
doi: 10.1002/jmv.27655. Online ahead of print.
Adverse Events Following Immunization of COVID-19 (Covaxin) vaccine at a Tertiary Care Center of India


Swayam Pragyan Parida[SUP] 1 [/SUP], Dinesh Prasad Sahu[SUP] 1 [/SUP], Arvind Kumar Singh[SUP] 1 [/SUP], G Alekhya[SUP] 1 [/SUP], Sonu Hangma Subba[SUP] 1 [/SUP], Abhisek Mishra[SUP] 1 [/SUP], Biswa Mohan Padhy[SUP] 2 [/SUP], Binod Kumar Patro[SUP] 1 [/SUP]



Affiliations

Abstract

Introduction: The study aimed to assess the adverse events following Covaxin immunization at a tertiary care institution and also assess the predictors of the adverse events following immunization (AEFI).
Methodology: The prospective observational study was conducted in a tertiary care institute among the COVID-19 vaccine (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.
Results: 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-value of <0.001. The major factors associated with AEFI were female sex, history of an allergic reaction, presence of comorbidities, acute infection in the past three months, and intake of chronic medications.
Conclusion: Precaution needs to be taken while vaccinating individuals having allergies, comorbidities, acute infection in the last three months and individuals on chronic medication. This article is protected by copyright. All rights reserved.

Keywords: Disease control; Epidemiology; Immunity/Immunization; SARS coronavirus; Vaccines/Vaccine strains; Virus classification.
 
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