Incidence, Pattern and Severity of Adverse Events Following Immunization (AEFIs) Associated With Chadox1 nCOV-19 Corona Virus Vaccine (Recombinant) Among the Healthcare Workers of a Tertiary Care Institute of Eastern Uttar Pradesh, India.

Bhushan Kamble,Md Abu Bashar,Chandra Pati Mishra

doi:10.7759/cureus.21848

Abstract

BackgroundIn January 2020, the Government of India based on the recommendation of the Drugs Controller General of India (DCGI) and National Technical Advisory Group on Immunization (NTAGI) started the rollout of the COVID-19 vaccine in the country. Two vaccines, ChAdOx1 nCoV-19 coronavirus vaccine (recombinant), i.e., COVISHIELD produced by Serum Institute of India and COVAXIN developed indigenously by Bharat Biotech, were given emergency use authorisation (EUA) by the DCGI.MethodsIn this cohort study, we assessed the incidence, pattern and severity of adverse events following immunization (AEFI) observed among the healthcare workers of a large tertiary care institute in eastern U.P., India vaccinated with ChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) within 30 minutes of vaccination by direct observation.ResultsOut of the total 836 healthcare workers who were vaccinated with the first dose of the vaccine, around 10% experienced any AEFI within the directly observed period. The most common AEFI was pain/tenderness at the injection site experienced by 59.3% of those who experienced any AEFI followed by headache/dizziness (35.3%), itching/rashes at the injection site (8.1%), nausea/vomiting (5.8%) and fever/chills (4.7%). The majority (95.3%) of the AEFIs observed were of minor severity with no serious AEFIs observed as per the WHO severity classification.ConclusionChAdOx1 nCoV-19 Coronavirus vaccine (recombinant) is proven to be safe based on our findings as the majority of AEFIs observed were of minor grade only. However, the vaccine beneficiaries should be strictly observed for a minimum of 30 minutes at the vaccination site to look for any serious AEFI with arrangements to manage the same.

Highlights

As of June 30th, 2021, coronavirus disease 2019 (COVID-19) has been reported in more than 180 million individuals, and there have been more than 3 million deaths worldwide [1]
The most common adverse events following immunization (AEFI) was pain/tenderness at the injection site experienced by 59.3% of those who experienced any AEFI followed by headache/dizziness (35.3%), itching/rashes at the injection site (8.1%), nausea/vomiting (5.8%) and fever/chills (4.7%)
We aimed to evaluate the incidence, pattern and severity of AEFIs associated with the ChAdOx1 nCoV-19 vaccine (AstraZeneca/Serum Institute of India) among the healthcare workers (HCWs) vaccinated at a single center situated in a tertiary care institute of North India during the first phase of vaccination so as to provide a basis to ensure safety of this vaccine during the future national vaccination against COVID-19

Summary

Introduction

As of June 30th, 2021, coronavirus disease 2019 (COVID-19) has been reported in more than 180 million individuals, and there have been more than 3 million deaths worldwide [1]. Various strategies such as tracking, tracing, testing, quarantine, and lockdown were implemented to combat the pandemic in many countries [2]. In India, the COVID-19 vaccination drive was initiated on January 16th, 2021 after approval of two COVID19 vaccines by the Drugs Controller General of India (DCGI) for restricted emergency use in the country [3].

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