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Post-authorization safety of COVID-19 vaccine: A prospective and observational study among health-care workers in Tumakuru

Nandini T, Swamy R M, Manjunath G N, Nagendrappa M B, Riyaj Ahmad Kalaburgi.


Background: SARS-COV-2, a virus that causes coronavirus disease 2019 (COVID-19) was first identified in Wuhan, China, is a highly pathogenic and has spread globally. Numerous vaccines such as Covaxin, Covishield, Sputnic, and Moderna are available for use in Indian population for prophylaxis and treatment of the same. As vaccine campaign kickoff worldwide and with several doses predicted to be administered in near future, there are more possibilities of vaccine related adverse drug reactions. By and large the benefits of vaccinations clearly outweigh the risks.

Aim and Objectives: The aim of the study was to identify the possible adverse events following COVID-19 vaccine immunization (AEFI) in Tumkur district, Karnataka.

Materials and Methods: Following Ethics Committee approval and permission from District Health Officer (DHO), Tumkur, Karnataka, telephonic interview of 2650 health-care workers who had received their first dose of Covisheild vaccine and willing to respond was done. A follow-up telephonic interview was done after the second dose as well. Their answers were noted, tabulated, and analyzed.

Results: About 98% of HCW who received the first dose received the second dose. Following the first dose, 55.3% showed symptoms whereas only 11% showed symptoms after the second. About 81.4% of individuals who showed symptoms post first dose had no symptoms after the second. The most commonly reported symptoms were pain at site of jab, fever, myalgia, cough, and headache. The majority of the individuals recovered with OTC medications.

Conclusion: ChAdOx1 nCoV-19 coronavirus vaccine was first administered in health-care workers. There was no study published on the vaccination related ADR in Tumkur population. The vaccination rates were high among HCW with frequency of adverse events following first dose were higher, which was almost similar to the AEFI from the innovator prescribing information.

Key words: SARS-COV-2; COVID-19; Covishield; Health-care Workers; Adverse Events Following Immunization

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