{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T13:06:33Z","timestamp":1787317593243,"version":"build-2736575974"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T00:00:00Z","timestamp":1742256000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002999","name":"Ministerie van Volksgezondheid, Welzijn en Sport","doi-asserted-by":"publisher","award":["SP332956"],"award-info":[{"award-number":["SP332956"]}],"id":[{"id":"10.13039\/501100002999","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The incidence of postmenopausal bleeding (PMB) has been increasing over the past years. Little is known about the risk of PMB after COVID\u201019 vaccination. Our study aimed to investigate this based on routine general practitioner (GP) healthcare data from the Netherlands.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A retrospective self\u2010controlled cohort study was performed, which included women aged \u226550\u2009years who received at least 1 COVID\u201019 vaccination in 2021 and were registered in the GP databases of Nivel (the Nivel Primary Care Database, Nivel\u2010PCD) or PHARMO by 1 January 2021. GP consultations for PMB in the exposed period (28\u2009days after each COVID\u201019 vaccination) were compared with the nonexposed period (all\u2010time outside the exposed period). Incidence rate ratios (IRRs) were calculated using Poisson regression, adjusting for SARS\u2010CoV\u20102 infection during the study follow\u2010up period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 692\u2009760 COVID\u201019 vaccinated women aged \u226550\u2009years were included. No increased GP consultations for PMB was observed for all COVID\u201019 vaccines together, as well as when stratifying the results by vaccine type (mRNA\n                      <jats:italic>vs<\/jats:italic>\n                      . vector) and vaccine brand (Pfizer\/BioNTech, Moderna, AstraZeneca, Johnson &amp; Johnson). After the second Moderna dose an adjusted IRR of 1.47 (95% confidence interval: 0.93\u20132.32) was observed and after the third Pfizer\/BioNTech dose an adjusted IRR of 1.33 (95% confidence interval: 0.92\u20131.93); however, these results were not statistically significant.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>No increased number of GP consultations for PMB in primary care was observed after COVID\u201019 vaccination in general, nor for any of the COVID\u201019 vaccine brands, vaccine doses or potential risk groups.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70045","type":"journal-article","created":{"date-parts":[[2025,3,18]],"date-time":"2025-03-18T08:49:48Z","timestamp":1742287788000},"page":"2352-2362","source":"Crossref","is-referenced-by-count":3,"title":["General practitioner consultation for postmenopausal bleeding after COVID\u201019 vaccination\u2014a self\u2010controlled cohort study"],"prefix":"10.1002","volume":"91","author":[{"given":"Rana","family":"Jajou","sequence":"first","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eug\u00e8ne P.","family":"van Puijenbroek","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"},{"name":"Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP) University of Groningen  Groningen Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renee","family":"Veldkamp","sequence":"additional","affiliation":[{"name":"Nivel (Netherlands Institute for Health Services Research)  Utrecht Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jetty A.","family":"Overbeek","sequence":"additional","affiliation":[{"name":"PHARMO Institute for Drug Outcomes Research  Utrecht Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Florence P. A. M.","family":"van Hunsel","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"},{"name":"Department of PharmacoTherapy, Epidemiology and Economics, Groningen Research Institute of Pharmacy (GRIP) University of Groningen  Groningen Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3767-110X","authenticated-orcid":false,"given":"Agnes C.","family":"Kant","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"},{"name":"Department of Clinical Pharmacy and Toxicology Leiden University Medical Center  Leiden Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,3,18]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Nederlands Huisartsen Genootschap.Vaginaal bloedverlies. Accessed July 5 2024.https:\/\/richtlijnen.nhg.org\/standaarden\/vaginaal-bloedverlies#volledige-tekst"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525\u20131438.2007.00925.x"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471\u20130528.1995.tb09066.x"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41416\u2010019\u20100668\u20102"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2018.2820"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/0029\u20137844(95)00450\u20135"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/0002\u20139378(95)90571\u20135"},{"key":"e_1_2_12_9_1","unstructured":"Nederlandse Vereniging voor Obstetrie & Gynaecologie (NVOG).Richtlijn Postmenopauzaal bloedverlies Versie november 2015. Accessed July 5 2024.https:\/\/www.nvog.nl\/wp-content\/uploads\/2018\/02\/Postmenopauzaal-bloedverlies-1.0-12-11-2015.pdf"},{"key":"e_1_2_12_10_1","unstructured":"Nederlands Instituut voor Onderzoek van de Gezondheidszorg (Nivel).Methoden vaststellen Nivel\u2010cijfers ziekten en zorg \u2010Nivel Zorgregistraties Eerste Lijn. Accessed July 5 2024.https:\/\/www.nivel.nl\/nl\/panels-en-registraties\/nivel-zorgregistraties-eerste-lijn\/methoden\/vaststellen-cijfers-zorgverlening"},{"key":"e_1_2_12_11_1","unstructured":"Pharmacovigilance center Lareb.Postmenopausal bleeding after administration of COVID\u201019 vaccines. Accessed July 5 2024.https:\/\/www.lareb.nl\/media\/uc4hen1c\/signals_2022_postmenopausal\u2010bleeding_covid\u201019\u2010vaccines.pdf"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1126\/sciadv.adg1391"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1126\/sciadv.abm7201"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/ijgo.14809"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2023.09.007"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj\u20102023\u2013074778"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2022.07.006"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2589\u20107500(22)00125\u2010X"},{"key":"e_1_2_12_19_1","unstructured":"Nederlands Instituut voor Onderzoek van de Gezondheidszorg (Nivel).Zorg door de huisarts: jaarcijfers 2022 en trendcijfers 2018\u20132022. Accessed August 21 2024.https:\/\/www.nivel.nl\/sites\/default\/files\/bestanden\/1004432.pdf"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S247575"},{"key":"e_1_2_12_21_1","unstructured":"National Institute for Public Health and the Environment (RIVM).COVID\u201019. Accessed July 24 2024.https:\/\/www.rivm.nl\/en\/coronavirus-covid-19"},{"key":"e_1_2_12_22_1","unstructured":"HuismanC.Percentage gevaccineerden dat data wil delen met RIVM daalt onder de kritische grens van 95 procent. Accessed July 24 2024.https:\/\/www.volkskrant.nl\/nieuws-achtergrond\/percentage-gevaccineerden-dat-data-wil-delen-met-rivm-daalt-onder-de-kritische-grens-van-95-procent~bbe45557\/"},{"key":"e_1_2_12_23_1","unstructured":"European Medicines Agency (EMA).Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4\u20137 March 2024. Accessed July 24 2024.https:\/\/www.ema.europa.eu\/en\/news\/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-march-2024"},{"key":"e_1_2_12_24_1","unstructured":"Mayo Clinic.Menopause hormone therapy: Does it cause vaginal bleeding?Accessed August 21 2024.https:\/\/www.mayoclinic.org\/diseases-conditions\/menopause\/expert-answers\/hormone-replacement-therapy\/faq-20058499"},{"key":"e_1_2_12_25_1","unstructured":"National Health Services (NHS).Side effects of hormone replacement therapy (HRT). Accessed August 21 2024.https:\/\/www.nhs.uk\/medicines\/hormone-replacement-therapy-hrt\/side-effects-of-hormone-replacement-therapy-hrt\/#:~:text=Vaginal%20bleeding%20and%20HRT a%20sign%20of%20anything%20serious"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S389598"},{"key":"e_1_2_12_27_1","unstructured":"BlomJW De VriesCJ EekhofH et al.NHG\u2010Standaard M73 June 2022.https:\/\/richtlijnen.nhg.org\/standaarden\/de-overgang(Accessed 03\u201002\u20102025)"}],"container-title":["British Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/bcp.70045","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,29]],"date-time":"2025-07-29T07:15:30Z","timestamp":1753773330000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/bcp.70045"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3,18]]},"references-count":26,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1002\/bcp.70045"],"URL":"https:\/\/doi.org\/10.1002\/bcp.70045","archive":["Portico"],"relation":{},"ISSN":["0306-5251","1365-2125"],"issn-type":[{"value":"0306-5251","type":"print"},{"value":"1365-2125","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3,18]]}}}