WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Sweden.
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Sweden; New Zealand Pharmacovigilance Centre, Division of Health Sciences, University of Otago, New Zealand; Department of General Practice, University of Otago, Christchurch, New Zealand.
J Pediatr Adolesc Gynecol. 2023 Aug;36(4):383-392. doi: 10.1016/j.jpag.2023.03.006. Epub 2023 Mar 17.
To review and characterize reports of vulval aphthous ulcers (VAUs) following COVID-19 vaccination in VigiBase, the World Health Organization global database of reported potential adverse effects of medicinal products, to demonstrate the importance and power of case reports for rare suspected adverse reactions and to investigate whether they suggest a potential for COVID-19 vaccination to be a trigger METHODS: Cases reporting the Medical Dictionary for Regulatory Activities' (MedDRA) preferred term "Vulvovaginal ulceration" and related preferred terms in adolescent patients aged 12-17 years in association with any COVID-19 vaccine were extracted from VigiBase. The cases were clinically reviewed, and causality was assessed by applying the Bradford Hill criteria to the obtained case series.
As of June 30th, 2022, there were 444 reports for the selected Medical Dictionary for Regulatory Activities preferred terms following COVID-19 vaccination in VigiBase. Ninety-four de-duplicated reports concerned adolescent female patients. Thirty-seven cases were clinically consistent with the diagnosis of VAU. On causality assessment, the analyzed case series fulfilled 6 of the 9 Austen Bradford Hill criteria supporting a potential causal relationship.
VAUs can be perceived as a traumatic experience, especially in adolescent patients. There is, furthermore, a risk that the ulcers will be misdiagnosed, resulting in avoidable investigation and treatment burdens for patients. We communicate our findings to support the small number of published case reports and raise awareness of VAUs occurring in a temporal association with COVID-19 vaccination. Furthermore, our analysis supports observations about the value of case reports for the recognition and assessment of rare adverse events.
审查并描述世界卫生组织全球药品潜在不良反应报告数据库 VigiBase 中 COVID-19 疫苗接种后出现外阴口疮性溃疡（VAU）的报告，以证明病例报告对于罕见疑似不良反应的重要性和作用，并调查它们是否表明 COVID-19 疫苗接种可能成为一个触发因素。
从 VigiBase 中提取报告 MedDRA 首选术语“外阴阴道溃疡”和相关首选术语，并与任何 COVID-19 疫苗相关的年龄在 12-17 岁青少年患者的病例。对病例进行临床审查，并应用布拉德福·希尔标准对获得的病例系列进行因果关系评估。
截至 2022 年 6 月 30 日，VigiBase 中有 444 例与 COVID-19 疫苗接种相关的选定 MedDRA 首选术语报告。94 例重复报告涉及青春期女性患者。37 例临床诊断符合 VAU。在因果关系评估中，分析的病例系列符合支持潜在因果关系的 9 项奥斯汀·布拉德福·希尔标准中的 6 项。
VAU 可被视为一种创伤性体验，尤其是在青春期患者中。此外，溃疡可能会被误诊，从而给患者带来不必要的检查和治疗负担。我们报告这些发现是为了支持少数已发表的病例报告，并提高对 COVID-19 疫苗接种后发生 VAU 的认识。此外，我们的分析支持了病例报告对于识别和评估罕见不良事件的价值的观点。
