General practitioner consultation for postmenopausal bleeding after COVID‐19 vaccination—a self‐controlled cohort study
British Journal of Clinical Pharmacology, vol. 91, pp. 2352–2362
Abstract
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.
Authors 5
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Netherlands Pharmacovigilance Centre Lareb
Affiliation as printed
Netherlands Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands
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University of Groningen · Netherlands Pharmacovigilance Centre Lareb
Affiliation as printed
Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP) University of Groningen Groningen Netherlands
Netherlands Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands
Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Groningen, Netherlands
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands
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Affiliation as printed
PHARMO Institute for Drug Outcomes Research Utrecht Netherlands
PHARMO Institute for Drug Outcomes Research, Utrecht, Netherlands
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University of Groningen · Netherlands Pharmacovigilance Centre Lareb
Affiliation as printed
Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP) University of Groningen Groningen Netherlands
Netherlands Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands
Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP), University of Groningen, Groningen, Netherlands
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands
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Agnes C Kant corresponding Aachen Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden Netherlands Department of Clinical Pharmacy and Toxicology
Leiden University Medical Center · Netherlands Pharmacovigilance Centre Lareb
Affiliation as printed
Department of Clinical Pharmacy and Toxicology Leiden University Medical Center Leiden Netherlands
Netherlands Pharmacovigilance Centre Lareb 's‐Hertogenbosch The Netherlands
Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, Netherlands
Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands
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