Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F23%3A00130739" target="_blank" >RIV/00216224:14110/23:00130739 - isvavai.cz</a>
Result on the web
<a href="https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.28771" target="_blank" >https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.28771</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1002/jmv.28771" target="_blank" >10.1002/jmv.28771</a>
Alternative languages
Result language
angličtina
Original language name
Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports
Original language description
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. < 0.001) a higher prevalence of all most common (top 20) oral SEs, except for salivary hypersecretion, which was equally prevalent among females and males. The present study revealed a low prevalence of oral SEs, with taste-related, other sensory and anaphylactic SEs being the most common SEs 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 SEs to verify whether they are causally linked to COVID-19 vaccines.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30304 - Public and environmental health
Result continuities
Project
<a href="/en/project/LX22NPO5101" target="_blank" >LX22NPO5101: The National Institute for Research on the Socioeconomic Impact of Diseases and Systemic Risks</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Journal of Medical Virology
ISSN
0146-6615
e-ISSN
1096-9071
Volume of the periodical
95
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
20
Pages from-to
1-20
UT code for WoS article
000996236800020
EID of the result in the Scopus database
2-s2.0-85159761079