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General practitioner consultation for postmenopausal bleeding after COVID-19 vaccination-a self-controlled cohort
Rana Jajou1, Eugène P van Puijenbroek1,2, Renee Veldkamp3
1Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Postmenopausal bleeding (PMB) risk was not increased after COVID-19 vaccination in women aged 50 and older. This large study found no significant association between COVID-19 vaccines and PMB consultations in general practice.
Area of Science:
- Obstetrics and Gynecology
- Vaccinology
- Public Health
Background:
- Postmenopausal bleeding (PMB) incidence is rising globally.
- The association between COVID-19 vaccination and PMB remains largely uncharacterized.
- Understanding potential side effects of COVID-19 vaccines is crucial for public health.
Purpose of the Study:
- To investigate the risk of postmenopausal bleeding (PMB) following COVID-19 vaccination.
- To analyze PMB incidence in women aged 50 years and older after COVID-19 vaccination using primary care data.
- To assess potential associations across different vaccine types, brands, and doses.
Main Methods:
- A retrospective self-controlled cohort study design was employed.
- Inclusion criteria: Women aged ≥50 years vaccinated in 2021, registered in Dutch GP databases.
- Comparison of PMB consultations in the 28 days post-vaccination versus non-exposed periods, with adjustments for SARS-CoV-2 infection.
Main Results:
- A total of 692,760 vaccinated women aged ≥50 years were analyzed.
- No overall increase in GP consultations for PMB was detected across all COVID-19 vaccines.
- Specific vaccine brands (mRNA vs. vector) and doses (Moderna, Pfizer/BioNTech) did not show statistically significant associations with increased PMB risk.
Conclusions:
- COVID-19 vaccination in women aged 50 and older is not associated with an increased incidence of postmenopausal bleeding in primary care.
- Findings apply to all analyzed COVID-19 vaccine brands, doses, and potential risk groups.
- Routine general practitioner data confirms the safety profile of COVID-19 vaccines regarding PMB.
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