COVID-19 vaccines safety: Spontaneous notification data

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. MÉTHODES: An exhaustive observational study including all adverse events following COVID-19 vaccination notified to the pharmacovigilance unit of the Monastir Hospital. RÉSULTATS: 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. CONCLUSIONS: 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.