Oral Adverse Events of COVID-19 Vaccines in Europe: Analysis of EudraVigilance Database
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Masaryk University Czech Republic
Justus-Liebig-University Germany
Dziedzic Poland
Publication date: 2023-04-26
Popul. Med. 2023;5(Supplement):A1964
The recent reports of oral adverse events (AEs) following COVID-19 vaccination warrant further investigation into their prevalence, severity and aetiology. This study was conducted to synthesise the first-ever population-level evidence about oral SEs of COVID-19 vaccines in Europe.

The European Union Drug Regulating Authorities Pharmacovigilance (EudraVigilance) database was accessed in August 2022 to extract summary data of all potential oral AEs reported after COVID-19 vaccination. The data were reported descriptively and cross-tabulated to facilitate sub-group analysis per vaccine type, sex, and age group.

Dysgeusia was the most commonly reported oral AE (0.381 cases per each 100 received reports), followed by oral paraesthesia (0.315%), ageusia (0.296%), lip swelling (0.243%), dry mouth (0.215%), oral hypoaesthesia (0.210%), swollen tongue (0.207%) and taste disorder (0.173%). Females had significantly (Sig. < 0.001) a higher prevalence of all most common (top twenty) oral AEs, except for salivary hypersecretion, which was equally prevalent among females and males.

The present study revealed a low prevalence of oral AEs, with taste-related, other sensory and anaphylactic AEs being the most common AEs in Europe, similar to what was found earlier among the US population. Future studies should explore the potential risk factors of oral sensory and anaphylactic AEs to verify whether they are causally linked to COVID-19 vaccines.

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