Authors
Makio Shozu, Shokichi Teramoto, Hisao Osada, Yasunori Sato, Keiichi Takahashi
Published in
Taiwanese journal of obstetrics & gynecology. Volume 65. Issue 6. Pages 1097-1105.
Abstract
Acute vulvar ulcers have been reported following gene-based COVID-19 vaccinations, though causality remains uncertain. This study aims to examine the association between vaccination and ulcer occurrence.
This observational study analyzed vulvar ulcer cases reported to the Vaccine Adverse Event Reporting System (VAERS) from January 2002 to February 2022. Risk was estimated by comparing VAERS-reported ulcer cases with vaccine recipient data from the COVID Data Tracker. Causality was assessed using the Bradford Hill criteria.
From 2021 to 2022, the proportion of vulvar ulcers among reported adverse events exceeded the upper control limits for the first time since 2002. Most cases (134/137, 97.8%) were linked to COVID-19 vaccines. Ad26.COV2.S had the highest relative risk (2.72 vs. BNT162b2; 95% CI: 1.17-6.30). For two-dose vaccines, the second dose posed a higher risk (dose 2 vs. dose 1: RR 3.52; 95% CI: 2.06-6.02 for BNT162b2; RR 2.40; 95% CI: 1.82-3.18 for mRNA-1273). Ulcers appeared a median of 2 days post-vaccination (IQR: 1.25-2.75) and resolved after a median of 12 days (IQR: 7-18). Adolescent females aged 12-17 years had the highest risk (RR vs. age 25-39: 4.01; 95% CI: 2.67-6.05), with a 46.0-fold increased risk (95% CI: 11.2-188.9) compared to age-matched females who received HPV vaccines.
Vulvar ulcers were closely associated with COVID-19 vaccination, especially in adolescent females. While findings suggest a potential link, further research is warranted to determine causality.
PMID:
42951458
Bibliographic data and abstract were imported from PubMed on 29 Oct 2026.
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