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

Abeer Zeitoun; Souheil Hallit; Sirine Chehade; Aya Ibrahim; Maya Helali; Carla Allam; Rita Karam

doi:10.1186/s40545-023-00528-1

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

J Pharm Policy Pract. 2023 Feb 21;16(1):24. doi: 10.1186/s40545-023-00528-1.

Authors

Abeer Zeitoun¹, Souheil Hallit², Sirine Chehade¹, Aya Ibrahim¹, Maya Helali¹, Carla Allam¹, Rita Karam^{3

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Affiliations

¹ Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, Lebanon.
² Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik, Jounieh, Lebanon.
³ Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public Health, Beirut, Lebanon. ritakmouawad@hotmail.com.
⁴ Department of Chemistry and Biochemistry, Faculty of Sciences, Lebanese University, Beirut, Lebanon. ritakmouawad@hotmail.com.
⁵ Pharmacology Department, Faculty of Medical Sciences, Lebanese University, Beirut, Lebanon. ritakmouawad@hotmail.com.

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: Adverse event following immunization; COVID-19 vaccines; Pharmacovigilance; SARS-CoV-2.