LAUSR

AIM During the COVID-19 vaccination campaigns, the number of reports of menstrual abnormalities increased rapidly. Here we describe the nature and potential risk factors associated with menstrual abnormalities based on spontaneously reporting data as well as data from a prospective cohort event monitoring (CEM) study as these are poorly studied. METHODS Reports of menstrual abnormalities received by the Netherlands Pharmacovigilance Centre Lareb in the spontaneous reporting system between February 2021 and April 2022 were summarized. In addition, logistic regression analysis was performed on the reported menstrual abnormalities in the CEM study to assess the association between person characteristics, prior SARS-CoV-2 infection and use of hormonal contraceptives and the occurrence of menstrual abnormalities after vaccination RESULTS: We analysed over 24,000 spontaneous reports of menstrual abnormalities and over 500 episodes (among 16,929 included women) of menstrual abnormalities in the CEM study. The CEM study showed an incidence of 41.4 per 1.000 women aged ≤54 years. Amenorrhea/oligomenorrhea and heavy menstrual bleeding collectively accounted for about half of all abnormalities reported. Significant associations were observed for the age group 25-34 years (OR 2.18; 95%CI 1.45-3.41) and the Pfizer vaccine (OR 3.04; 95%CI 2.36-3.93). No association was observed for body mass index and presence of most comorbidities assessed CONCLUSION: The cohort study showed a high incidence of menstrual disorders among women aged ≤54 years, and this observation was supported by the analysis of spontaneous reports. This suggests that a relation between COVID-19 vaccination and menstrual abnormalities is plausible and should be further investigated.