Vaccine hesitancy, spurred by misinterpretation of Adverse Events (AEs), threatens public health. Despite sporadic reports of oral AEs post-COVID-19 vaccination, systematic analysis is scarce. This study evaluates these AEs using the Australian Database of Adverse Event Notifications (DAEN). A secondary analysis of DAEN data was conducted, with the analysis period commencing from the start of the COVID-19 vaccination rollout in February 2021 and the inception of the influenza vaccine database in 1971, both through until December 2022. The focus of the analysis was on oral AEs related to COVID-19 and influenza vaccines. Reports were extracted according to a predefined schema and then stratified by vaccine type, sex, and age. Oral paresthesia was the most common oral AE after COVID-19 vaccination (75.28 per 10,000 reports), followed by dysgeusia (73.96), swollen tongue (51.55), lip swelling (49.43), taste disorder (27.32), ageusia (25.85), dry mouth (24.75), mouth ulceration (18.97), oral hypoaesthesia (15.60), and oral herpes (12.74). While COVID-19 and influenza vaccines shared most oral AEs, taste-related AEs, dry mouth, and oral herpes were significantly more common after COVID-19 vaccination. mRNA vaccines yielded more oral AEs than other types. Females had higher oral AE incidence. Most oral AEs did not differ significantly between COVID-19 and influenza vaccination. However, specific oral AEs, particularly taste-related, dry mouth, and oral herpes, were more prevalent after COVID-19 vaccination compared with seasonal influenza, especially in females and mRNA vaccine recipients.

• MeSH
• chřipka lidská * epidemiologie   prevence a kontrola   MeSH
• COVID-19 * prevence a kontrola   MeSH
• lidé MeSH
• vakcinace škodlivé účinky   MeSH
• vakcíny proti chřipce * škodlivé účinky   MeSH
• vakcíny proti COVID-19 * škodlivé účinky   MeSH
• xerostomie * MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Austrálie MeSH

• MeSH
• lidé MeSH
• opičí neštovice * MeSH
• zubní lékaři MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• dopisy MeSH
• práce podpořená grantem MeSH

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.

• MeSH
• anafylaxe * MeSH
• COVID-19 * epidemiologie   prevence a kontrola   MeSH
• lidé MeSH
• nežádoucí účinky léčiv MeSH
• systémy pro sběr zpráv o nežádoucích účincích léků MeSH
• vakcíny proti COVID-19 * škodlivé účinky   MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Evropa MeSH

Background: Oral adverse events (AEs) following COVID-19 vaccination have been sporadically reported during the previous months, warranting further investigation for their prevalence and suspected relationship with vaccine-elicited immune response. Methods: A retrospective analysis using the Vaccine Adverse Event Reporting System (VAERS) data was conducted to evaluate AEs within the oral cavity (mucosa, tongue, lips, palate, dentition, salivary glands) and AEs involving taste and other sensations. Oral AEs reported after receiving COVID-19 vaccination (test group) and seasonal influenza vaccination (control group) were extracted and cross-tabulated to assess their relative prevalence. Results: Among the 128 solicited (suspected) oral AEs, oral paresthesia (0.872%) was most reported after receiving COVID-19 vaccines, followed by the swelling of lips (0.844%), ageusia (0.722%), oral hypoesthesia (0.648%), swollen tongue (0.628%), and dysgeusia (0.617%). The reported prevalence of oral AEs was higher in the COVID-19 vaccine group than in the seasonal influenza group. The distribution pattern of the most reported oral AEs was similar for both COVID-19 and seasonal influenza vaccines. Female sex, older age (>39 years old), primer doses, and mRNA-based COVID-19 vaccines exhibited a higher reported prevalence of oral AEs. Conclusion: Within the limitations of this study, COVID-19 vaccines were found to be associated with rare oral AEs that are predominantly similar to those emerging following seasonal influenza vaccines. The most commonly reported oral AEs were oral paraesthesia (mouth-tingling), lip swelling, and ageusia, representing various pathophysiologic pathways that remain unclear. Taste-related AEs should be acknowledged in the context of the COVID-19 pandemic and the public should be adequately informed about a potential taste dysfunction after receiving the COVID-19 vaccination. Dentists and dental teams need to be aware of the prevalence, severity, and prognosis of oral AEs to inform their patients and increase public confidence in vaccines.

• MeSH
• ageuzie * chemicky indukované   MeSH
• chřipka lidská * MeSH
• COVID-19 * epidemiologie   prevence a kontrola   MeSH
• dospělí MeSH
• lidé MeSH
• pandemie MeSH
• retrospektivní studie MeSH
• systémy pro sběr zpráv o nežádoucích účincích léků MeSH
• vakcinace MeSH
• vakcíny proti chřipce * škodlivé účinky   MeSH
• vakcíny proti COVID-19 * škodlivé účinky   MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH