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Analysis of COVID-19 mRNA Vaccine-induced Mouth Ulcers Using the Japanese Adverse Drug Event Report Database
T Onoda1, H Tanaka2, H Matsuo3
1Department of Practical Pharmacy, Faculty of Pharmaceutical Sciences, Toho University, Chiba.
Abstract:
There are case reports of mouth ulcers caused by the coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine; however, the actual number and characteristics of cases are unknown. Therefore, we examined this issue using the Japanese Adverse Drug Event Report (JADER), a large Japanese database. We calculated the reported odds ratio (ROR) of drugs that may be specifically associated with mouth ulcers and assumed that a signal was present if the lower limit of the calculated ROR's 95% confidence interval (CI) was > 1. In addition, the time to symptom onset after administration of the COVID-19 mRNA and influenza HA vaccines was investigated. We found that the JADER database contained 4,661 mouth ulcer cases between April 2004 and March 2022. The COVID-19 mRNA vaccine was the eighth most common causative drug for mouth ulcers, with 204 reported cases. The ROR was 1.6 (95% CI, 1.4-1.9) and a signal was detected. There were 172 mouthulcer cases associated with the Pfizer-BioNTech's COVID-19 mRNA vaccine, 76.2% of which were female. The outcome was no unrecovered cases with the influenza HA vaccine, whereas the COVID-19 mRNA vaccine showed unrecovered cases (Pfizer-BioNTech: 12.2%, Moderna: 11.1%). The median time-to-onset of the mouth ulcers was two days for the COVID-19 mRNA vaccine and one day for the influenza HA vaccine, indicating that mouth ulcers caused by the COVID-19 mRNA vaccine were delayed adverse events. In this study, the COVID-19 mRNA vaccine was shown to cause mouth ulcers in a Japanese population.
Insights
The COVID-19 mRNA vaccine is linked to mouth ulcers, with delayed onset reported in a Japanese study. This finding highlights potential adverse events associated with the vaccine.
Area of Science:
- Pharmacovigilance
- Immunology
- Public Health
Background:
- Case reports suggest a link between COVID-19 mRNA vaccines and mouth ulcers.
- The incidence and characteristics of vaccine-associated mouth ulcers remain unclear.
- Understanding vaccine adverse events is crucial for public health confidence.
Purpose of the Study:
- To investigate the association between COVID-19 mRNA vaccines and mouth ulcers.
- To characterize the incidence, demographics, and timing of mouth ulcer onset post-vaccination.
- To compare adverse event profiles with influenza HA vaccines.
Main Methods:
- Analysis of the Japanese Adverse Drug Event Report (JADER) database (April 2004 - March 2022).
- Calculation of the Reported Odds Ratio (ROR) to identify drug-specific signals for mouth ulcers.
- Investigation of time-to-symptom onset following COVID-19 mRNA and influenza HA vaccine administration.
Main Results:
- COVID-19 mRNA vaccine identified as the eighth most common cause of mouth ulcers in JADER, with 204 reported cases.
- A significant signal for mouth ulcers was detected (ROR = 1.6; 95% CI, 1.4-1.9).
- Mouth ulcers following COVID-19 mRNA vaccination showed delayed onset (median 2 days) and a higher proportion of unrecovered cases compared to influenza HA vaccine.
Conclusions:
- The COVID-19 mRNA vaccine is associated with an increased risk of developing mouth ulcers in the Japanese population.
- Mouth ulcers represent a delayed adverse event following COVID-19 mRNA vaccination.
- Further investigation into the mechanisms and management of vaccine-associated stomatitis is warranted.
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