British journal of clinical pharmacology · 2025
General practitioner consultation for postmenopausal bleeding after COVID-19 vaccination-a self-controlled cohort study.
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Jajou Rana, van Puijenbroek Eugène P, Veldkamp Renee, Overbeek Jetty A, van Hunsel Florence P A M, Kant Agnes C
Аннотация
AIMS: The incidence of postmenopausal bleeding (PMB) has been increasing over the past years. Little is known about the risk of PMB after COVID-19 vaccination. Our study aimed to investigate this based on routine general practitioner (GP) healthcare data from the Netherlands.
METHODS: A retrospective self-controlled cohort study was performed, which included women aged ≥50 years who received at least 1 COVID-19 vaccination in 2021 and were registered in the GP databases of Nivel (the Nivel Primary Care Database, Nivel-PCD) or PHARMO by 1 January 2021. GP consultations for PMB in the exposed period (28 days after each COVID-19 vaccination) were compared with the nonexposed period (all-time outside the exposed period). Incidence rate ratios (IRRs) were calculated using Poisson regression, adjusting for SARS-CoV-2 infection during the study follow-up period.
RESULTS: A total of 692 760 COVID-19 vaccinated women aged ≥50 years were included. No increased GP consultations for PMB was observed for all COVID-19 vaccines together, as well as when stratifying the results by vaccine type (mRNA vs. vector) and vaccine brand (Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson). After the second Moderna dose an adjusted IRR of 1.47 (95% confidence interval: 0.93-2.32) was observed and after the third Pfizer/BioNTech dose an adjusted IRR of 1.33 (95% confidence interval: 0.92-1.93); however, these results were not statistically significant.
CONCLUSION: No increased number of GP consultations for PMB in primary care was observed after COVID-19 vaccination in general, nor for any of the COVID-19 vaccine brands, vaccine doses or potential risk groups.
METHODS: A retrospective self-controlled cohort study was performed, which included women aged ≥50 years who received at least 1 COVID-19 vaccination in 2021 and were registered in the GP databases of Nivel (the Nivel Primary Care Database, Nivel-PCD) or PHARMO by 1 January 2021. GP consultations for PMB in the exposed period (28 days after each COVID-19 vaccination) were compared with the nonexposed period (all-time outside the exposed period). Incidence rate ratios (IRRs) were calculated using Poisson regression, adjusting for SARS-CoV-2 infection during the study follow-up period.
RESULTS: A total of 692 760 COVID-19 vaccinated women aged ≥50 years were included. No increased GP consultations for PMB was observed for all COVID-19 vaccines together, as well as when stratifying the results by vaccine type (mRNA vs. vector) and vaccine brand (Pfizer/BioNTech, Moderna, AstraZeneca, Johnson & Johnson). After the second Moderna dose an adjusted IRR of 1.47 (95% confidence interval: 0.93-2.32) was observed and after the third Pfizer/BioNTech dose an adjusted IRR of 1.33 (95% confidence interval: 0.92-1.93); however, these results were not statistically significant.
CONCLUSION: No increased number of GP consultations for PMB in primary care was observed after COVID-19 vaccination in general, nor for any of the COVID-19 vaccine brands, vaccine doses or potential risk groups.