Journal of Pharmacology and Pharmacotherapeutics

RESEARCH PAPER
Year
: 2021  |  Volume : 12  |  Issue : 3  |  Page : 131--136

A pharmacovigilance study of covishield in a tertiary care teaching hospital in Tamil Nadu


T J Ainsy Goldlin1, Shantaraman Kalyanaraman2, M Ravichandran3, J Ezhil Ramya4 
1 Department of Pharmacology, Kanyakumari Government Medical College, Kanyakumari, Tamil Nadu, India
2 Department of Pathology, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India
3 Department of Medicine, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India
4 Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, Tamil Nadu, India

Correspondence Address:
J Ezhil Ramya
Department of Pharmacology, Tirunelveli Medical College, Tirunelveli, Tamil Nadu
India

Objective: To study the adverse events following immunization (AEFI) with Covishield, a coronavirus disease– 2019 (COVID-19) vaccine. Materials and Methods: A prospective observational study was conducted among 422 Covishield vaccinees based on the inclusion and exclusion criteria after the institutional ethics committee approval. They were followed up at the end of 1 and 2 weeks following the first dose of Covishield vaccine, and the details of adverse events were collected. AEFIs were classified using system organ classification, World Health Organization-Uppsala Monitoring Center (WHO-UMC) causality assessment, AEFI causality assessment, and Modified Hartwig Severity Scale. Various classifications of AEFI were analyzed using descriptive statistics. ANOVA and independent t-test were used for age group and gender comparison of the duration and number of AEFI, respectively. Results: Around 625 AEFIs were reported by 422 vaccinees. Majority of the vaccinees (62.8%) developed adverse events on the day of vaccination. The mean duration of AEFI was 2.52 ± 0.871 days. On WHO-UMC causality assessment, 98.08% were found to be probable, 1.12% possible, and 0.8% unclassifiable. AEFI causality assessment revealed 98.88% vaccine product-related reactions and 1.12% anxiety-related reactions. Regarding the severity, 83.52% of AEFIs were mild and 16.32% were moderate. On comparison of mean duration of AEFI (P = 0.298) and mean number of AEFI (P = 0.569) between different age groups, no statistical significance was observed. Conclusion: The majority of AEFIs reported in this study were mild to moderate in severity for a short duration. The protection offered against the deadly disease and its complication potentially outweighs the mild AEFIs or inconvenience caused by them. Hence, covid-19 vaccination is an important tool to break the pandemic chain.


How to cite this article:
Goldlin T J, Kalyanaraman S, Ravichandran M, Ramya J E. A pharmacovigilance study of covishield in a tertiary care teaching hospital in Tamil Nadu.J Pharmacol Pharmacother 2021;12:131-136


How to cite this URL:
Goldlin T J, Kalyanaraman S, Ravichandran M, Ramya J E. A pharmacovigilance study of covishield in a tertiary care teaching hospital in Tamil Nadu. J Pharmacol Pharmacother [serial online] 2021 [cited 2022 Jan 28 ];12:131-136
Available from: http://www.jpharmacol.com/article.asp?issn=0976-500X;year=2021;volume=12;issue=3;spage=131;epage=136;aulast=Goldlin;type=0