A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study

Abstract

Abstract Background Since the deployment of Coronavirus Disease 2019 (COVID-19) vaccines, skepticism about the safety, incidence, and severity of Adverse Events Following Immunization (AEFI) was a concern. The study has two main objectives. First, to analyze AEFIs following COVID-19 vaccines (Pfizer-BioNTech, AstraZeneca, Sputnik, and Sinopharm) during the vaccination campaign in Lebanon and correlate them with age and gender. Second, to correlate Pfizer-BioNTech and AstraZeneca vaccines’ AEFI with the dose administered. Methods A retrospective study was carried out between February 14th, 2021, and February 14th, 2022. AEFI case reports received to the Lebanese Pharmacovigilance (PV) Program were cleaned, validated, and analyzed using SPSS software. Results A total of 6808 AEFI case reports were received to the Lebanese PV Program during the period of this study. Case reports were mostly received from females (60.7%) and from vaccine recipients aged 18–44 years. As for the vaccine type, AEFIs occurred more frequently with the AstraZeneca vaccine compared to the Pfizer-BioNTech vaccine. The latter had AEFIs mainly following dose 2, whereas AEFIs with the AstraZeneca vaccine were more frequently reported after dose 1, with general body pain being the most reported systemic AEFI with PZ (34.6%), while fatigue was the most reported AEFI with AZ vaccine (56.5%). Conclusions The AEFI reported with COVID-19 vaccines in Lebanon were aligned with those reported worldwide. The incidence of rare serious AEFIs should not discourage the public from getting vaccinated. Further studies are needed to evaluate their long-term potential risk.

Keywords

• Pharmacovigilance
• COVID-19 vaccines
• Adverse event following immunization
• SARS-CoV-2