An Assessment of the Reporting Pattern of Adverse Events Following Immunizations in VigiAccess

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.