Oral side effects of COVID‐19 vaccines in 32 European countries: Analysis of EudraVigilance reports

The recent reports of oral side effects (SEs) following COVID‐19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize the first‐ever population‐level evidence about oral SEs of COVID‐19 vaccines in Europe. The European Union...

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Bibliographic Details
Published in:Journal of medical virology 2023-05, Vol.95 (5), p.e28771-n/a
Main Authors: Riad, Abanoub, Schulz‐Weidner, Nelly, Dziedzic, Arkadiusz, Howaldt, Hans‐Peter, Attia, Sameh
Format: Article
Language:English
Subjects:
Adverse Drug Reaction Reporting Systems
Anaphylaxis
COVID-19
COVID-19 - epidemiology
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - adverse effects
Drug-Related Side Effects and Adverse Reactions
Europe - epidemiology
Female
Females
Humans
Immunization
Male
oral manifestations
Pharmacovigilance
Population studies
Risk factors
Side effects
Taste
Vaccines
Virology
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Summary:The recent reports of oral side effects (SEs) following COVID‐19 vaccination warrant further investigation into their prevalence, severity, and aetiology. This study was conducted to synthesize 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 SEs 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 SE (0.381 case 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. 
ISSN:0146-6615
1096-9071
DOI:10.1002/jmv.28771