Abstract

PURPOSE: Globally, adverse events following immunization (AEFI) reporting continues to be a challenge. It is estimated that about 95% of AEFIs never get reported after vaccinations necessitating strategies to improve it. The introduction of databases such as VigiAccess in which AEFI data from Pharmacovigilance centres around the world can be assessed is an important step towards improving AEFI reporting and enhancing vaccine safety. This study assessed the reporting pattern of AEFIs from the various continents of the world in VigiAccess, an open-access pharmacovigilance database. 
 
 METHODS: VigiAccess was thoroughly searched on the 5th of February 2018 for the categories of reported AEFIs and number and types of AEFIs reported for measles vaccine, oral polio vaccine, yellow fever vaccine, pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine, tetanus vaccine and BCG vaccine. 
 
 RESULTS: After a thorough search through VigiAccess, 27 categories of reported AEFIs were retrieved. The total number of AEFIs for the 8 vaccines was 813,973. General disorders and administration site conditions were the highest number of AEFIs (251,405 representing 30.9%) followed by skin and subcutaneous tissue disorders (93,011 representing 11.4%) and nervous system disorders (89,077 representing 10.9%). With the continental data, the Americas recorded the highest number of AEFIs followed by Europe, Oceania, Asia and Africa. 
 
 CONCLUSION: General and vaccine administration site conditions were the highest number of AEFIs. The Americas recorded the highest number of AEFIs whereas Africa recorded the least. VigiAccess needs improvement in data synchronization to enhance its reliability.

Highlights

  • 1.1 BackgroundThe importance of vaccines in preventing deaths resulting from infectious diseases cannot be overemphasized (Lei, Balakrishnan, Gidudu, & Zuber, 2018)

  • Over a half of adverse events following immunization (AEFI) associated with the nervous system, pregnancy, and vascular disorders were associated with the pneumococcal vaccine, OPV and meningococcal vaccine whereas over half of the gastrointestinal AEFIs were caused by pneumococcal vaccine, rotavirus vaccine, meningococcal vaccine and OPV

  • This may not be necessary in minor AEFIs such as pain, swelling and redness of site of vaccination which are almost always expected after every vaccination

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Summary

Introduction

The importance of vaccines in preventing deaths resulting from infectious diseases cannot be overemphasized (Lei, Balakrishnan, Gidudu, & Zuber, 2018). It is estimated that about 2.5 million child deaths alone are prevented by vaccines annually (World Health Organization, 2009). Out of these preventable deaths, a larger proportion is likely to occur in low and middle income countries (LMIC) where more doses of vaccines are used compared to the developed world (WHO, 2012a). As more doses of vaccines are administered, the risk of adverse events following immunization increases. Vaccines are potent agents which are rigorously tested before approval for disease prevention There is the need to intensify the reporting of AEFIs in LMIC in order to improve vaccine safety.

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