Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands.
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands; Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Groningen, Netherlands.
Vaccine. 2024 Nov 14;42(25):126130. doi: 10.1016/j.vaccine.2024.07.031. Epub 2024 Aug 23.
Several studies described that COVID-19 vaccinations can cause menstrual disorders. Our study aimed to describe whether this also resulted in more general practitioner (GP) consultations for menstrual disorders after COVID-19 vaccination, based on a large cohort study.
A retrospective self-controlled cohort study was performed including vaccinated women in 2021 aged 12-49 years from two large, representative GP databases in the Netherlands. Incidence rates and incidence rate ratio's (IRR) were calculated using Poisson regression, adjusting for SARS-CoV-2 infection as time-varying confounder. The exposed period was set at maximum six months after each COVID-19 vaccination and the non-exposed period was defined as all-time outside the exposed period.
The cohort included 631,802 women, of which 18,986 (3 %) consulted the GP for a menstrual disorder during 2021. Increased GP consultations were observed among 12-14 year olds for amenorrhea/hypomenorrhea/oligomenorrhea (IRR: 1.85, 95 % CI: 1.30-2.65) and irregular/frequent menstruation (IRR: 1.33, 95 % CI: 1.06-1.69) after COVID-19 vaccination in general, and after Pfizer/BioNTech vaccination (IRR: 1.87, 95 % CI: 1.31-2.67 for amenorrhea/hypomenorrhea/oligomenorrhea and IRR: 1.35, 95 % CI: 1.06-1.70 for irregular/frequent menstruation). Persons from this age group were in general also vaccinated with Pfizer/BioNTech. No increase in the frequency of GP consultations were observed for older age groups, other vaccine brands, and potential risk groups.
For the majority of women, no increased GP consultations for menstrual disorders was found. Solely for the youngest age group (12-14 year olds) increased GP consultations for specific types of menstrual disorders was found after Pfizer/BioNTech vaccination.
几项研究表明,COVID-19 疫苗接种可能会导致月经紊乱。我们的研究旨在描述 COVID-19 疫苗接种后是否会导致更多的普通科医生(GP)咨询月经紊乱,这是基于一项大型队列研究。
这是一项回顾性自身对照队列研究,纳入了 2021 年荷兰两个大型代表性 GP 数据库中 12-49 岁的接种疫苗女性。使用泊松回归计算发病率和发病率比(IRR),调整 SARS-CoV-2 感染作为时变混杂因素。暴露期设定为每次 COVID-19 疫苗接种后最长六个月,非暴露期定义为暴露期之外的所有时间。
该队列包括 631,802 名女性,其中 2021 年有 18,986 名(3%)因月经紊乱咨询 GP。在普通科医生中,观察到 12-14 岁年龄组的闭经/月经过少/稀发排卵(IRR:1.85,95%CI:1.30-2.65)和不规则/频繁月经(IRR:1.33,95%CI:1.06-1.69)的就诊次数增加,接种 COVID-19 疫苗后普遍如此,且接种辉瑞/生物技术疫苗后更是如此(IRR:1.87,95%CI:1.31-2.67 闭经/月经过少/稀发排卵和 IRR:1.35,95%CI:1.06-1.70 不规则/频繁月经)。该年龄组的人一般也接种了辉瑞/生物技术疫苗。在年龄较大的人群、其他疫苗品牌和潜在的高危人群中,没有观察到 GP 咨询月经紊乱的频率增加。
对于大多数女性来说,没有发现月经紊乱的 GP 咨询增加。仅在最年轻的年龄组(12-14 岁)中,接种辉瑞/生物技术疫苗后,特定类型的月经紊乱 GP 咨询增加。