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.

Department of Oral and Maxillofacial Surgery Justus Liebig University Giessen Germany

Department of Pediatric Dentistry Justus Liebig University Giessen Germany

Department of Public Health Faculty of Medicine Masaryk University Brno Czech Republic

Department of Restorative Dentistry with Endodontics Medical University of Silesia Katowice Poland

Zobrazit více v PubMed

Amorim dos Santos J, Normando AGC, Carvalho da Silva RL, et al. Oral manifestations in patients with COVID-19: a 6-month update. J Dent Res. 2021;100:1321-1329. doi:10.1177/00220345211029637

Biadsee A, Biadsee A, Kassem F, Dagan O, Masarwa S, Ormianer Z. Olfactory and oral manifestations of COVID-19: sex-related symptoms-a potential pathway to early diagnosis. Otolaryngol Head Neck Surg. 2020;163:194599820934380. doi:10.1177/0194599820934380

Dziedzic A, Wojtyczka R. The impact of coronavirus infectious disease 19 (COVID-19) on oral health. Oral Dis. Published online May 6 2020;27:703-706. doi:10.1111/odi.13359

Al-Khanati NM, Riad A, Sahloul ME, Klugar M. Aphthous-like stomatitis of COVID-19 patients. Braz J Oral Sci. 2020;19:e201354. doi:10.20396/bjos.v19i0.8661354

Riad A, Kassem I, Badrah M, Klugar M. The manifestation of oral mucositis in COVID-19 patients: a case-series. Dermatol Ther. 2020;33(6):e14479. doi:10.1111/dth.14479

Hocková B, Riad A, Valky J, et al. Oral complications of ICU patients with COVID-19: case-series and review of two hundred ten cases. J Clin Med. 2021;10(4):581. doi:10.3390/jcm10040581

Lechien JR, Chetrit A, Chekkoury-Idrissi Y, et al. Parotitis-like symptoms associated with COVID-19, France, March-April 2020. Emerging Infect Dis. 2020;26(9):2270-2271. doi:10.3201/eid2609.202059

Riad A, Kassem I, Issa J, Badrah M, Klugar M. Angular cheilitis of COVID-19 patients: a case-series and literature review. Oral Dis. 2020;odi.13675. doi:10.1111/odi.13675

World Health Organization (WHO). A Brief History of Vaccination. History of Vaccination. Accessed November 5 2022. https://www.who.int/news-room/spotlight/history-of-vaccination/a-brief-history-of-vaccination

World Health Organization (WHO). COVID-19 vaccines. Accessed July 3 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines

MacDonald NE, SAGE Working Group on Vaccine Hesitancy. Vaccine hesitancy: definition, scope and determinants. Vaccine. 2015;33(34):4161-4164. doi:10.1016/j.vaccine.2015.04.036

Azarpanah H, Farhadloo M, Vahidov R, Pilote L. Vaccine hesitancy: evidence from an adverse events following immunization database, and the role of cognitive biases. BMC Public Health. 2021;21(1):1686. doi:10.1186/S12889-021-11745-1/FIGURES/2

di Spirito F, Amato A, di Palo MP, et al. Oral lesions following anti-SARS-CoV-2 vaccination: a systematic review. Int J Environ Res Public Health. 2022;19(16):10228. doi:10.3390/IJERPH191610228/S1

Riad A, Põld A, Kateeb E, Attia S. Oral adverse events following COVID-19 vaccination: analysis of VAERS reports. Front Public Health. 2022;10:2230. doi:10.3389/FPUBH.2022.952781/BIBTEX

Riad A, Pokorná A, Attia S, Klugarová J, Koščík M, Klugar M. Prevalence of COVID-19 vaccine side effects among healthcare workers in the Czech Republic. J Clin Med. 2021;10(7):1428. doi:10.3390/jcm10071428

Klugar M, Riad A, Mekhemar M, et al. Side effects of mRNA-based and viral vector-based COVID-19 vaccines among German healthcare workers. Biology. 2021;10(8):752. doi:10.3390/biology10080752.

Riad A, Hocková B, Kantorová L, et al. Side effects of mRNA-Based COVID-19 vaccine: nationwide phase IV study among healthcare workers in Slovakia. Pharmaceuticals. 2021;14(9):873. doi:10.3390/PH14090873

Chun Y, Jang J, Jo JH, Park JW. Various painful oral adverse reactions following COVID-19 vaccination: a case series. BMC Oral Health. 2022;22(1):64. doi:10.1186/S12903-022-02100-W/FIGURES/2

Troeltzsch M, Gogl M, Berndt R, Troeltzsch M. Oral lichen planus following the administration of vector-based COVID-19 vaccine (Ad26.COV2.S). Oral Dis. 2021;28:1-2. doi:10.1111/ODI.14025

Caggiano M, Amato M, di Spirito F, Galdi M, Sisalli L. mRNA COVID-19 vaccine and oral lichen planus: a case report. Oral Dis. Published online. 2022;28:2624-2626. doi:10.1111/ODI.14184

European Medicines Agency (EMA). EudraVigilance. Human regulatory. Accessed October 23 2022. https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance

European Medicines Agency (EMA). European database of suspected adverse drug reaction reports. EudraVigilance. Accessed October 23 2022. https://www.adrreports.eu/en/eudravigilance.html

European Centre for Disease Prevention and Control (ECDC). COVID-19 Vaccine Tracker. Accessed October 23 2022. https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#uptake-tab

ICH IC for H of TR for P for HU. MedDRA Hierarchy. Medical Dictionary for Regulatory Activities. Published 2022. https://www.meddra.org/how-to-use/basics/hierarchy

Cirillo N. Reported orofacial adverse effects of COVID-19 vaccines: the knowns and the unknowns. J Oral Pathol Med. 2021;50(4):424-427. doi:10.1111/JOP.13165

Wan EYF, Chui CSL, Lai FTT, et al. Bell's palsy following vaccination with mRNA (BNT162b2) and inactivated (CoronaVac) SARS-CoV-2 vaccines: a case series and nested case-control study. Lancet Infect Dis. 2022;22(1):64-72. doi:10.1016/S1473-3099(21)00451-5

Riad A, Sağıroğlu D, Üstün B, et al. Prevalence and risk factors of CoronaVac side effects: an independent cross-sectional study among healthcare workers in Turkey. J Clin Med. 2021;10(12):2629. doi:10.3390/jcm10122629

Dziedzic A, Tanasiewicz M. Vaccination side effects. Br Dent J. 2021;230(4):184. doi:10.1038/S41415-021-2746-0

Riad A. Oral side effects of COVID-19 vaccine. Br Dent J. 2021;230(2):59. doi:10.1038/s41415-021-2615-x

di Spirito F, Contaldo M, Amato A, di Palo MP, Pantaleo G, Amato M. COVID-19 vaccine and oral lesions: putative pathogenic mechanisms. Oral Dis. 2022;28:2639. doi:10.1111/ODI.14361

Agrawal S, Verma K, Verma I, Gandhi J. Reactivation of Herpes Zoster virus after COVID-19 vaccination: is there any association. Cureus. 2022;14(5):25195. doi:10.7759/CUREUS.25195

Gringeri M, Battini V, Cammarata G, et al. Herpes zoster and simplex reactivation following COVID-19 vaccination: new insights from a vaccine adverse event reporting system (VAERS) database analysis. Expert Rev Vaccines. 2022;21(5):675-684. doi:10.1080/14760584.2022.2044799

Richardson-May J, Rothwell A, Rashid M. Reactivation of herpes simplex keratitis following vaccination for COVID-19. BMJ Case Rep. 2021;14(9):e245792. doi:10.1136/BCR-2021-245792

Naoum C, Hartmann M. Herpes zoster reactivation after COVID-19 vaccination-a retrospective case series of 22 patients. Int J Dermatol. 2022;61(5):628-629. doi:10.1111/IJD.16116

Jacobsen H, Klein SL. Sex differences in immunity to viral infections. Front Immunol. 2021;12:3483. doi:10.3389/FIMMU.2021.720952/XML/NLM

Green MS, Peer V, Magid A, Hagani N, Anis E, Nitzan D. Gender differences in adverse events following the Pfizer-BioNTech COVID-19 vaccine. Vaccines. 2022;10(2):233. doi:10.3390/VACCINES10020233

Klein SL, Jedlicka A, Pekosz A. The Xs and Y of immune responses to viral vaccines. Lancet Infect Dis. 2010;10(5):338-349. doi:10.1016/S1473-3099(10)70049-9

Sa S, Lee CW, Shim SR, et al. The safety of mRNA-1273, BNT162b2 and JNJ-78436735 COVID-19 vaccines: safety monitoring for adverse events using real-world data. Vaccines. 2022;10(2):320. doi:10.3390/VACCINES10020320/S1

Alhaidari F, Almuhaideb A, Alsunaidi S, et al. E-Triage systems for COVID-19 outbreak: review and recommendations. Sensors. 2021;21(8):2845. doi:10.3390/S21082845

Aldrees T, Almatrafi S, Aldriweesh T, Mokhatrish M, Salamh A, Alkholaiwi F. Medical students' awareness of smell loss as a predictor for coronavirus disease 2019. Front Public Health. 2020;8:863. doi:10.3389/FPUBH.2020.597897/BIBTEX

Srinivasan M. Taste dysfunction and long COVID-19. Front Cell Infect Microbiol. 2021;11:647. doi:10.3389/FCIMB.2021.716563/BIBTEX

Hertel M, Schmidt-Westhausen AM, Wendy S, et al. Onset of oral lichenoid lesions and oral lichen planus following COVID-19 vaccination: a retrospective analysis of about 300,000 vaccinated patients. Vaccines. 2022;10(3):480. doi:10.3390/VACCINES10030480

National Pharmacovigilance Assessment of Oral Adverse Events Following COVID-19 Vaccination in Germany (2020-2023)

Oral adverse events following COVID-19 and influenza vaccination in Australia