A Review of COVID-19 Vaccine Adverse Event Following Immunization Case Reports by four CARICOM Countries to VigiBase

Abstract

The World Health Organization declared COVID-19 a pandemic on 12 March 2020. One of the strategies to combat the pandemic was the development of novel COVID-19 vaccines. Once these vaccines were deployed, immunizations followed. The objective of this study was to identify the characteristics of case reports of adverse events following immunization (AEFIs) with COVID-19 vaccines based on Individual Case Safety Reports (ICSRs) in VigiBase, submitted by four CARICOM countries: Barbados, Haiti, Jamaica and St. Vincent and the Grenadines. A review of the publicly available data on AEFIs with COVID-19 vaccines based on ICSRs in VigiBase was conducted from March 1, 2021 to December 14, 2022. A total of 1,582 AEFI case reports were identified for this period. Most of these were non-serious events, involving persons under 65 years (84.9%), and females (74.1%); 19% were classified as serious events. The top age group reported for AEFIs in VigiBase were 18-44 years (46.6%). The most frequently reported reactions were headache (29.3%), pyrexia (19.3%), dizziness (19.3%). Altogether for the four countries, the AEFIs per 100,000 doses was 64.1 and 12.2 serious AEFIs per 100,000 doses. Recommended actions identified were strengthening national pharmacovigilance regulatory frameworks, establishing robust national pharmacovigilance centres, capacity building of professionals, enhancing communication with key stakeholders and consider relying in a regional pharmacovigilance system.