COVID-19 vaccines safety: Spontaneous notification data
Revue Francaise d'Allergologie
; Conference: 18e Congres Francophone d'Allergologie. Palais des Congres de la Porte Maillot, 2023.
Article
in English
| EMBASE | ID: covidwho-2293079
ABSTRACT
Introduction (contexte de la recherche) Although the SARS-CoV-2 vaccines have undergone preclinical tests and clinical trials evaluating their efficacy and safety, few data have been reported in the post-licensure real-world setting. Objectif We aimed to assess the safety of COVID-19 vaccines among a Tunisian Pharmacovigilance database. Methodes An exhaustive observational study including all adverse events following COVID-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital. Resultats A total of 336 events were collected. The patients' sex ratio was 1.4. Elderly patients (>= 65-years-old) represented 54% of cases. The most common adverse reaction was fatigue and fever (30%, respectively), followed by headache (21%), muscle soreness (15%) and localized pain at the injection site (13%). Skin eruptions accounted for 14% of the reported events and anaphylaxis was noted in 0.6% of cases. The most reported events were mild. However, 15 patients developed serious events [anaphylaxis (seven cases), thrombotic reactions (seven cases), and thrombocytopenia (one case)]. The event was fatal in five patients. Pfizer-BioNTech vaccine was implicated in 65% of reported events, followed by AstraZeneca vaccine (11%). Pfizer-BioNTech vaccine was implicated in 9/15 serious events. Fatal events were observed with Pfizer-BioNTech vaccine in three cases, and AstraZeneca and CoronaVac vaccines in one case each. Conclusion(s) Our study implies that the COVID-19 vaccines have a favorable safety profile due to the low incidence of self-reported adverse reactions. Further large-scale studies are needed to confirm the safety of COVID-19 vaccines.Copyright © 2023
adverse drug reaction; aged; anaphylaxis; case report; clinical article; clinical trial; conference abstract; coronavirus disease 2019; delayed onset muscle soreness; fatality; fatigue; female; fever; headache; human; incidence; injection site pain; male; observational study; pharmacovigilance; rash; sex ratio; side effect; thrombocytopenia; thrombosis; vaccination; coronavac
Full text:
Available
Collection:
Databases of international organizations
Database:
EMBASE
Topics:
Vaccines
Language:
English
Journal:
Revue Francaise d'Allergologie
Year:
2023
Document Type:
Article
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