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Drug Res (Stuttg) 2022; 72(08): 435-440
DOI: 10.1055/a-1852-5335
Original Article

Adverse Event Following Immunization (AEFI) in Children: An Analysis of Reporting in VigiAccess

Diksha Pandey
1   Department of Pharmacology, Raj Kumar Goel Institute of Technology (Pharmacy), Ghaziabad, Uttar Pradesh, India
,
Geetika Mehta
1   Department of Pharmacology, Raj Kumar Goel Institute of Technology (Pharmacy), Ghaziabad, Uttar Pradesh, India
,
Monika Sachdeva
1   Department of Pharmacology, Raj Kumar Goel Institute of Technology (Pharmacy), Ghaziabad, Uttar Pradesh, India
,
Rashmi Tripathi
1   Department of Pharmacology, Raj Kumar Goel Institute of Technology (Pharmacy), Ghaziabad, Uttar Pradesh, India
› Author Affiliations Funding This study did not receive any specific grant from funding agencies in the public, commercial or not-for-profit sectors.
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Abstract

Introduction It is an indubitable fact that vaccination has been instrumental in the eradication and prevention of the deadliest diseases worldwide. Continuous vaccine safety surveillance is helpful to counter the negative perception and thus allay the fear of Adverse Events Following Immunization (AEFI) in the general public. VigiAccess, the WHO global database of reported side effects of medicinal products, can be accessed by the public at large. The objective of this study is to assess the characteristics of AEFIs of the commonly used vaccines in children in VigiAccess.

Materials and Methods VigiAccess was thoroughly explored for the categories, number, and types of AEFIs of commonly used vaccines among children that are reported in five continents between 2011 and 2021.

Results After a comprehensive analysis in VigiAccess, 27 kinds of AEFIs were discovered. For the nine vaccines, a total of 1,412,339 AEFIs were found. The most prevalent AEFIs were general disorder and administration site condition (436,199 or 30%). The majority of AEFIs are found in America, with Europe, Oceania, Asia, and Africa following closely behind. Girls of age from 27 days to 23 months had the highest number of AEFIs. The highest number of AEFIs was recorded in the year 2018.

Conclusion America has the maximum, whilst Africa has the least AEFI. Few AEFIs were caused by the measles vaccination, while the majority were related to the general disorder and administration site condition. Data synchronization in VigiAccess needs to be enhanced to improve its dependability.

Key words

Adverse reactions - VigiAccess - pharmacovigilance - adverse event following immunization


Publication History

Received: 14 January 2022

Accepted: 13 May 2022

Article published online:
20 June 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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