A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study
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...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-02-01
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| Series: | Journal of Pharmaceutical Policy and Practice |
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| Online Access: | https://doi.org/10.1186/s40545-023-00528-1 |
| _version_ | 1797327111324696576 |
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| author | Abeer Zeitoun Souheil Hallit Sirine Chehade Aya Ibrahim Maya Helali Carla Allam Rita Karam |
| author_facet | Abeer Zeitoun Souheil Hallit Sirine Chehade Aya Ibrahim Maya Helali Carla Allam Rita Karam |
| author_sort | Abeer Zeitoun |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-08T06:33:45Z |
| format | Article |
| id | doaj.art-cf56175753894c90aa05008c00966af8 |
| institution | Directory Open Access Journal |
| issn | 2052-3211 |
| language | English |
| last_indexed | 2024-03-08T06:33:45Z |
| publishDate | 2023-02-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Journal of Pharmaceutical Policy and Practice |
| spelling | doaj.art-cf56175753894c90aa05008c00966af82024-02-03T10:55:49ZengTaylor & Francis GroupJournal of Pharmaceutical Policy and Practice2052-32112023-02-0116111210.1186/s40545-023-00528-1A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective studyAbeer Zeitoun0Souheil Hallit1Sirine Chehade2Aya Ibrahim3Maya Helali4Carla Allam5Rita Karam6Quality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthFaculty of Medicine and Medical Sciences, Holy Spirit University of KaslikQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthQuality Assurance of Pharmaceutical Products Department, National Pharmacovigilance Program, Lebanese Ministry of Public HealthAbstract 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.https://doi.org/10.1186/s40545-023-00528-1PharmacovigilanceCOVID-19 vaccinesAdverse event following immunizationSARS-CoV-2 |
| spellingShingle | Abeer Zeitoun Souheil Hallit Sirine Chehade Aya Ibrahim Maya Helali Carla Allam Rita Karam A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study Journal of Pharmaceutical Policy and Practice Pharmacovigilance COVID-19 vaccines Adverse event following immunization SARS-CoV-2 |
| title | A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study |
| title_full | A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study |
| title_fullStr | A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study |
| title_full_unstemmed | A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study |
| title_short | A 1-year analysis of adverse events following COVID-19 vaccination in Lebanon: a retrospective study |
| title_sort | 1 year analysis of adverse events following covid 19 vaccination in lebanon a retrospective study |
| topic | Pharmacovigilance COVID-19 vaccines Adverse event following immunization SARS-CoV-2 |
| url | https://doi.org/10.1186/s40545-023-00528-1 |
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