Unexpected vaginal bleeding and COVID-19 vaccination

 RESEARCH ARTICLE

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Unexpected vaginal bleeding and COVID-19 vaccination in nonmenstruating women

KRISTINE BLIX HTTPS://ORCID.ORG/0009-0007-7838-0161 , IDA LAAKE HTTPS://ORCID.ORG/0000-0002-0546-896X, LENE JUVET HTTPS://ORCID.ORG/0000-0003-3317-8203, ANNA HAYMAN ROBERTSON HTTPS://ORCID.ORG/0000-0001-6295-0528, IDA HENRIETTE CASPERSEN HTTPS://ORCID.ORG/0000-0003-2591-8435, SIRI MJAALAND HTTPS://ORCID.ORG/0000-0002-3870-5861, SIRI N. SKODVIN HTTPS://ORCID.ORG/0000-0003-4545-2513, PER MAGNUS HTTPS://ORCID.ORG/0000-0002-6427-4735, BERIT FEIRING HTTPS://ORCID.ORG/0000-0003-1505-1671, AND LILL TROGSTAD HTTPS://ORCID.ORG/0000-0002-9557-5725Authors Info & Affiliations

SCIENCE ADVANCES

22 Sep 2023

Vol 9, Issue 38

DOI: 10.1126/sciadv.adg1391

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Abstract

The association between coronavirus disease 2019 (COVID-19) vaccination and vaginal bleeding among nonmenstruating women is not well studied. The Norwegian Institute of Public Health followed several cohorts throughout the pandemic and early performed a systematic data collection of self-reported unexpected vaginal bleeding in nonmenstruating women. Among 7725 postmenopausal women, 7148 perimenopausal women, and 7052 premenopausal women, 3.3, 14.1, and 13.1% experienced unexpected vaginal bleeding during a period of 8 to 9 months, respectively. In postmenopausal women, the risk of unexpected vaginal bleeding (i.e., postmenopausal bleeding) in the 4 weeks after COVID-19 vaccination was increased two- to threefold, compared to a prevaccination period. The corresponding risk of unexpected vaginal bleeding after vaccination was increased three- to fivefold in both nonmenstruating peri- and premenopausal women. In the premenopausal women, Spikevax was associated with at 32% increased risk as compared to Comirnaty. Our results must be confirmed in future studies.

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INTRODUCTION

After the coronavirus disease 2019 (COVID-19) vaccination rollout in December 2020, spontaneous reporting systems received reports of menstrual disturbances at frequencies not seen in previous vaccination campaigns (1, 2). Such events were not addressed in the preceding clinical vaccine trials (3, 4). The European Medicines Agency recently decided that the product information of the mRNA vaccines (i.e., Spikevax and Comirnaty) should be updated to include heavy menstrual bleeding as a potential side effect (5).

Spontaneous reporting systems have also received reports of vaginal bleeding after menopause [i.e., postmenopausal bleeding (PMB)] following COVID-19 vaccination (6, 7). PMB can be a symptom of endometrial carcinoma and precancerous lesions (8) and is considered an important medical event (9). According to clinical guidelines, women with PMB should be referred for specialized gynecological examination (10). A slightly increased risk of being diagnosed with PMB after COVID-19 vaccination has been described in a large U.S. cohort of women aged ≥55 years (11) and in a Swedish registry study (12). However, vaginal bleeding might be transient and experienced as nonsevere, and medical care is not always sought. Therefore, the excess risk of unexpected vaginal bleeding after vaccination may not be well described by diagnosis trends alone.

A substantial proportion of the female population does not menstruate because they use long-term hormonal contraception. 

https://www.science.org/doi/10.1126/sciadv.adg1391