Spontaneous reporting of COVID-19 vaccine-related adverse events following immunization (AEFI) in Ghana.

Description

A cross-sectional data involving voluntary reporting of COVID-19 vaccine-related adverse events following immunization (AEFI) in the safety database of the Ghana Food and Drugs Authority (FDA). The reports in the database were a collection of AEFIs received through the passive or spontaneous reporting system using various reporting tools; phone calls, paper reporting forms, mobile application (Med Safety App) and online reports. The data was received between 2nd March 2021 and 30th June 2022 from healthcare professionals and vaccine recipients aged 18 years or older who had received at least one dose of any of the five COVID-19 vaccines (AstraZeneca, Sputnik-V, Moderna, Pfizer-BioNTech and Johnson and Johnson) deployed in the nationwide mass vaccination campaign during the pandemic. The data obtained included demographic, the existence of a chronic medical condition, type of vaccine and dose received and the type and seriousness of AEFI experienced. Causality assessment reports on all serious AEFIs which occurred over the same period were obtained from the FDA’s Joint COVID-19 Vaccine Safety Review Committee. A total of 8,498 AEFI reports were obtained of which 4,295 were identified by their unique codes as having been spontaneously reported by vaccine recipients and healthcare professionals. The AEFI data were coded with their Preferred Terms using the Medical Dictionary for Regulatory Activities (MedDRA).

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