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

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.

Adverse events following immunization of COVID-19 vaccine among children aged 6–11 years

“…Symptoms of AEFI mostly appear on the same day after receiving the first dose and recover within 1–4 days. This finding is slightly different from findings of other COVID-19 inactivated virus vaccine that reports that many AEFIs occur in 1–7 days and recover in 2 days ( 13 , 24 , 35 ).…”

“…However, no severe symptoms found ( 36 ). Another study in the community also found the same results for the symptoms, although it was conducted in an older age ( 26 , 35 ).…”

Evaluation of Short-Term Side Effects Following the First Dose of COVID-19 Vaccines Among Physicians and Dentists: A Cross-Sectional Study from India

“… 45 The available clinical trial data for various COVID-19 vaccines support our findings that reported side effects were mild/moderate, self-limiting, and did not require any further treatment. 44 , 46–52 As in other studies of HCWs in India, 37–40 , 53 Nepal, 41 , 42 and Bangladesh, 16 most of our respondents experienced mild to moderate symptoms (93.4%), which were self-limiting and resolved within a few days.…”

Assessment of safety and adverse drug reactions of COVID vaccination in the South Indian population: An observational prospective cross-sectional study

“…Furthermore, an observational study on surveillance of adverse events of Covishield conducted by Dhanya Jose et al [ 15 ], a cross-sectional study conducted on ADRs of Covishield by Sukhpal Kaur et al [ 16 ], A comparative study conducted on adverse events of Covishield by Sushil Rayamajhi et al [ 17 ] has shown the ADRs of fever, headache, weakness, pain at the injection site as the most common ADRs of Covishield which were similar to our studies. However, the data was different in the research reported by Dr Rajeev et al [ 18 ] and a study conducted at the tertiary care institute of Eastern Uttar Pradesh by Bhushan Kamble et al [ 19 ], which showed that Myalgia and tiredness were high.…”