Evidence map›Paper›PMID 39434043›Full record

Observational studyBMC public health2024

Serious adverse events following immunization with COVID-19 vaccines in Lebanon: a retrospective analysis of the National Pharmacovigilance Database.

Rita Karam, Katia Iskandar, Myriam Watfa, Abeer Zeitoun

Abstract readObservational Study
In one paragraph

Observational study in BMC public health, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Rita KaramDepartment of Chemistry and Biochemistry, Faculty of Science, Section 1, Lebanese University, Beirut, Lebanon.
Katia IskandarDepartment of Pharmaceutical Sciences, Faculty of Pharmacy, Lebanese University, P.O. Box 6573/14, Beirut, Lebanon.
Myriam WatfaQuality Assurance of Pharmaceutical Products Department, Lebanese Ministry of Public Health, Beirut, Lebanon.
Abeer ZeitounQuality Assurance of Pharmaceutical Products Department, Lebanese Ministry of Public Health, Beirut, Lebanon. abeer.zeitoun@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Continuous surveillance and risk assessment of inactivated Coronavirus Disease 2019 (COVID-19)) vaccines provide an understanding of their safety profiles, guide vaccination strategy and public health policy. This study aims to analyze the characteristics and prevalence of officially reported serious adverse events following immunization (AEFIs) with inactivated COVID-19 vaccines by System Organ Class (SOC), age, and sex.To achieve this aim, a retrospective observational study was conducted between February 14th, 2021, and June 30th, 2022. Reported AEFIs were evaluated for data completeness. Causality assessment adhered to the World Health Organization guidelines.Findings revealed that the AEFIs occurrence did not significantly differ between vaccines used (ChAdOx1 vs. BNT162b2), sex, or SOC. The most prevalent AEFIs were vascular disorders (37%), followed by cardiac (25%) and nervous system disorders (14%). The adverse events were predominantly reported post-vaccination with the BNT162b2 vaccine, mainly after the first dose. The mean age was highest for miscellaneous disorders (70 ± 21.7 years) and the lowest for nervous system (46 ± 22 years) and immune system disorders (45 ± 19 years). Age differences were statistically different for vascular disorders (p = 0.003) and immune system disorders (p = 0.012).In conclusion, ongoing surveillance and risk assessment of the vaccine's safety profile is crucial for detecting potential safety signals. Active surveillance of the reported serious AEFIs is highly needed to support evidence-based vaccination strategies and maintain public confidence in immunization programs.

Indexed as

BNT162 VaccineCOVID-19 VaccinesPharmacovigilanceAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overChAdOx1 nCoV-19COVID-19Databases, FactualDrug-Related Side Effects and Adverse ReactionsFemaleHumansLebanonMaleBNT162 VaccineChAdOx1 nCoV-19COVID-19 VaccinesAdverse events following immunizationCOVID-19 vaccinesPharmacovigilance

Identifiers

PMID39434043
PMCPMC11495130

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.