Adverse Events among Beneficiaries who Received a Dose of Sputnik V Vaccine at a Tertiary Care Hospital in Coastal Karnataka, India

Abstract

Introduction: Vaccination has played a vital role in containing the COVID-19 pandemic. Sputnik V was the third vaccine approved for emergency use in India. The objectives of the present study were to document the adverse events following Sputnik V vaccination and the factors associated with adverse events.

Methodology: This cross-sectional study was conducted during September and October 2021 in a teaching hospital of Karnataka. Ethics approval and CTRI registration were obtained before collecting the data. All persons receiving at least one dose of vaccine were invited to participate and baseline information was collected after written informed consent. They were contacted telephonically to enquire about the adverse events. Data were entered in Microsoft Excel and analyzed using SPSS Version 23 to describe percentages and proportions.

Results: The median age of 2532 participants was 31 (IQR 25-39) years and 60.4% were males. Minor adverse events were seen among 29.4% participants. Most common symptoms with first dose were fever, vaccination site tenderness, myalgia and headache, and with second dose were fever, myalgia, headache, and vaccination site tenderness. No severe adverse events were reported in our study. The adverse events were seen more among females (P < 0.05) and with the first dose (P < 0.05).

Conclusion: Most common adverse events were similar to symptoms suggested by the vaccine manufacturers with fever being the most common one. A follow-up after a longer lag time may be recommended to enquire whether the vaccinees developed serious adverse events.

Keywords: Adverse events; COVID-19; Sputnik V; vaccination.