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

J 2023

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

RIAD, Abanoub; Nelly SCHULZ-WEIDNER; Arkadiusz DZIEDZIC; Hans-Peter HOWALDT; Sameh ATTIA et al.

Základní údaje

Originální název

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

Autoři

RIAD, Abanoub; Nelly SCHULZ-WEIDNER; Arkadiusz DZIEDZIC; Hans-Peter HOWALDT a Sameh ATTIA

Vydání

Journal of Medical Virology, Hoboken, Wiley, 2023, 0146-6615

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30304 Public and environmental health

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 6.800

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/23:00130739

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

anaphylaxis; COVID-19 vaccines; drug-related side effects and adverse reactions; oral manifestations; pharmacovigilance

Štítky

14110525, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 30. 10. 2023 15:15, Mgr. Tereza Miškechová

Anotace

V originále

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.

Návaznosti

LX22NPO5101, projekt VaV

Název: Národní institut pro výzkum socioekonomických dopadů nemocí a systémových rizik (Akronym: SYRI)

Investor: Ministerstvo školství, mládeže a tělovýchovy ČR, Národní institut pro výzkum socioekonomických dopadů nemocí a systémových rizik, 5.1 EXCELES

Přiložené soubory

Oral_side_effects_of_COVID-19_vaccines_in_32_European_countries_Analysis_of_EudraVigilance_reports.pdf

Citovat

RIAD, Abanoub; Nelly SCHULZ-WEIDNER; Arkadiusz DZIEDZIC; Hans-Peter HOWALDT a Sameh ATTIA. Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports. Journal of Medical Virology. Hoboken: Wiley, 2023, roč. 95, č. 5, s. 1-20. ISSN 0146-6615. Dostupné z: https://doi.org/10.1002/jmv.28771.

@article{2281317,
   author = {Riad, Abanoub and SchulzandWeidner, Nelly and Dziedzic, Arkadiusz and Howaldt, HansandPeter and Attia, Sameh},
   article_location = {Hoboken},
   article_number = {5},
   doi = {https://doi.org/10.1002/jmv.28771},
   keywords = {anaphylaxis; COVID-19 vaccines; drug-related side effects and adverse reactions; oral manifestations; pharmacovigilance},
   language = {eng},
   issn = {0146-6615},
   journal = {Journal of Medical Virology},
   title = {Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports},
   url = {https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.28771},
   volume = {95},
   year = {2023}
}

TY  - JOUR
ID  - 2281317
AU  - Riad, Abanoub - Schulz-Weidner, Nelly - Dziedzic, Arkadiusz - Howaldt, Hans-Peter - Attia, Sameh
PY  - 2023
TI  - Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports
JF  - Journal of Medical Virology
VL  - 95
IS  - 5
SP  - 1-20
EP  - 1-20
PB  - Wiley
SN  - 01466615
KW  - anaphylaxis
KW  - COVID-19 vaccines
KW  - drug-related side effects and adverse reactions
KW  - oral manifestations
KW  - pharmacovigilance
UR  - https://onlinelibrary.wiley.com/doi/full/10.1002/jmv.28771
N2  - 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.
ER  -

RIAD, Abanoub; Nelly SCHULZ-WEIDNER; Arkadiusz DZIEDZIC; Hans-Peter HOWALDT a Sameh ATTIA. Oral side effects of COVID-19 vaccines in 32 European countries: Analysis of EudraVigilance reports. \textit{Journal of Medical Virology}. Hoboken: Wiley, 2023, roč.~95, č.~5, s.~1-20. ISSN~0146-6615. Dostupné z: https://doi.org/10.1002/jmv.28771.

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