Menstrual abnormalities after COVID-19 vaccination in the Netherlands: A description of spontaneous and longitudinal patient-reported data.
Br J Clin Pharmacol
; 89(10): 3126-3138, 2023 10.
Article
em En
| MEDLINE
| ID: mdl-37222170
ABSTRACT
AIMS:
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 1000 women aged ≤54 years. Amenorrhoea/oligomenorrhoea and heavy menstrual bleeding collectively accounted for about half of all abnormalities reported. Significant associations were observed for the age group 25-34 years (odds ratio 2.18; 95% confidence interval 1.45-3.41) and the Pfizer vaccine (odds ratio 3.04; 95% confidence interval 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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas contra COVID-19
/
COVID-19
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Distúrbios Menstruais
Tipo de estudo:
Etiology_studies
/
Incidence_studies
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Observational_studies
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Risk_factors_studies
Limite:
Adult
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Female
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Humans
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Middle aged
País/Região como assunto:
Europa
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article