Title:ADR Profile of the Covishield Vaccine Among Healthcare Workers in a
Tertiary Care Teaching Hospital in India
Volume: 17
Issue: 4
Author(s): Tirthankar Deb*, Rajesh Garg, Manmeet Kaur, Ankita Beniwal and Varsha Gupta
Affiliation:
- Adverse Drug Reaction Monitoring Centre, Department of Pharmacology, Kalpana Chawla Govt. Medical College,
Karnal, Haryana, India
Keywords:
Covishield, COVID-19, healthcare workers, ADRs, vaccination, beneficiaries.
Abstract:
Background: Coronavirus disease 2019 (COVID-19) is caused by Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2/2019-nCoV). Though many classes of drugs have
been advocated/used for the treatment of this disease, vaccines are being targeted for its ultimate
prevention. Indian Government has approved Covishield (ChAdOx1 nCoV19 Corona Virus
Vaccine-Recombinant) for restricted use in emergency circumstances.
Objective: This study is aimed at evaluating the safety profile of the Covishield vaccine among
healthcare workers in a tertiary care hospital.
Methods: All Adverse Drug Reactions (ADRs) reported to the ADR monitoring centre by healthcare
workers who received the Covishield vaccine during the study period of 3 months were analysed
on various parameters, and the assessment was done using the WHO-UMC scale.
Results: During the study period, a total of 1216 beneficiaries were vaccinated with 1st dose of Covishield,
and out of these, 727 beneficiaries also received 2nd dose of the vaccine. Out of the 1216
beneficiaries vaccinated, 69 ADRs were reported in 24 healthcare workers. The most common
ADR reported was fever (24.64%), followed by myalgia (18.84%). No death or any serious anaphylactic
reaction was observed. None of the healthcare workers experienced any adverse event during
the observation period of 30 minutes. Serious reactions were reported in 4 healthcare workers as
per the Pharmacovigilance Programme of India (PvPI) criteria of serious AEFI. 92% of healthcare
workers recovered from ADRs during the study period. 84% of ADRs were classified as probable
as per the WHO-UMC scale.
Conclusion: As per the Government of India directives, all the healthcare workers in the institute
were encouraged to take both doses of the Covishield vaccine. The beneficiaries were kept under
observation for 30 minutes and monitored for any adverse drug reaction following vaccination. The
vaccine was found to be safe with a very low incidence of ADRs.
