Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India

Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported follo...

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Autores principales:	Chetak Kadabasal Basavaraja, Juny Sebastian, Mandyam Dhati Ravi, Sheba Baby John
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Therapeutics. Pharmacology RM1-950 Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/f142b2d90c86429cace9bca2299fa1d7
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spelling	oai:doaj.org-article:f142b2d90c86429cace9bca2299fa1d72021-11-22T23:03:19ZAdverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India2515-136310.1177/25151355211055833https://doaj.org/article/f142b2d90c86429cace9bca2299fa1d72021-11-01T00:00:00Zhttps://doi.org/10.1177/25151355211055833https://doaj.org/toc/2515-1363Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported following COVID-19 vaccination in a tertiary care teaching hospital. Materials and methods: The spontaneous reporting method was used for data collection for a period of 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment team performed causality assessment of the AEFIs using the World Health Organization’s causality assessment algorithm. Results: A total of 11,656 doses of COVID-19 vaccine were administered at the study site during the study period, of which 9292 doses were COVISHIELD™ and 2364 doses were COVAXIN™. In all, 445 AEFIs were reported from 269 subjects with an incidence rate of 3.48%. The majority of the subjects with AEFIs belonged to the age group of 18–45 years. Out of the total 445 AEFIs, 418 AEFIs were expected as per the fact sheets, 409 with COVISHIELD™ and 9 with COVAXIN™. Most of the AEFIs [62.02% ( n = 276)] were observed at the system organ class of ‘General disorders and administration site conditions’. After the causality assessment, out of 433 AEFIs to COVISHIELD TM vaccine, 94.22% ( n = 408) of events were categorized to have ‘consistent causal association with immunization’. Out of 12 adverse events following COVAXIN™, 8 (66.66%) events were categorized as ‘consistent causal association with immunization’. All of them recovered from their adverse events without any sequelae. Conclusion: Spontaneous reporting is one of the cheapest methods that can be used for the reporting of AEFI. This method helps health care professionals to identify rare events and potential signals.Chetak Kadabasal BasavarajaJuny SebastianMandyam Dhati RaviSheba Baby JohnSAGE PublishingarticleTherapeutics. PharmacologyRM1-950Immunologic diseases. AllergyRC581-607ENTherapeutic Advances in Vaccines and Immunotherapy, Vol 9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Therapeutics. Pharmacology RM1-950 Immunologic diseases. Allergy RC581-607
spellingShingle	Therapeutics. Pharmacology RM1-950 Immunologic diseases. Allergy RC581-607 Chetak Kadabasal Basavaraja Juny Sebastian Mandyam Dhati Ravi Sheba Baby John Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
description	Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported following COVID-19 vaccination in a tertiary care teaching hospital. Materials and methods: The spontaneous reporting method was used for data collection for a period of 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment team performed causality assessment of the AEFIs using the World Health Organization’s causality assessment algorithm. Results: A total of 11,656 doses of COVID-19 vaccine were administered at the study site during the study period, of which 9292 doses were COVISHIELD™ and 2364 doses were COVAXIN™. In all, 445 AEFIs were reported from 269 subjects with an incidence rate of 3.48%. The majority of the subjects with AEFIs belonged to the age group of 18–45 years. Out of the total 445 AEFIs, 418 AEFIs were expected as per the fact sheets, 409 with COVISHIELD™ and 9 with COVAXIN™. Most of the AEFIs [62.02% ( n = 276)] were observed at the system organ class of ‘General disorders and administration site conditions’. After the causality assessment, out of 433 AEFIs to COVISHIELD TM vaccine, 94.22% ( n = 408) of events were categorized to have ‘consistent causal association with immunization’. Out of 12 adverse events following COVAXIN™, 8 (66.66%) events were categorized as ‘consistent causal association with immunization’. All of them recovered from their adverse events without any sequelae. Conclusion: Spontaneous reporting is one of the cheapest methods that can be used for the reporting of AEFI. This method helps health care professionals to identify rare events and potential signals.
format	article
author	Chetak Kadabasal Basavaraja Juny Sebastian Mandyam Dhati Ravi Sheba Baby John
author_facet	Chetak Kadabasal Basavaraja Juny Sebastian Mandyam Dhati Ravi Sheba Baby John
author_sort	Chetak Kadabasal Basavaraja
title	Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
title_short	Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
title_full	Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
title_fullStr	Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
title_full_unstemmed	Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India
title_sort	adverse events following covid-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in south india
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/f142b2d90c86429cace9bca2299fa1d7
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Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India

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