COVID-19 vaccine and menstrual conditions in female: data analysis of the Vaccine Adverse Event Reporting System (VAERS)

(2022) 22:403 Zhang et al. BMC Women’s Health https://doi.org/10.1186/s12905-022-01934-4 Open Access RESEARCH COVID‑19 vaccine and menstrual conditions in female: data analysis of the Vaccine Adverse Event Reporting System (VAERS) Bing Zhang1, Xiao Yu2, Jinxing Liu2, Jinbao Liu3* and Pengfei Liu4* Abstract Background: In reports of adverse reactions following vaccination with the coronavirus disease 2019(COVID-19) vaccines, there have been fewer reports of concern for menstrual disorders in female. Objective: Our study employed Vaccine Adverse Event Reporting System (VAERS) to investigate and analyze the relationship between COVID-19 Vaccines and menstrual disorders in female. Methods: We collected reports of menstrual disorders in VAERS from July 2, 1990 to November 12, 2021, and performed a stratified analysis. The potential relationship between COVID-19 vaccine and reports of menstrual disorders was evaluated using the Reporting Odds Ratio (ROR) method. Results: A total of 14,431 reports of menstrual disorders were included in the study, and 13,118 were associated with COVID-19 vaccine. The ROR was 7.83 (95% confidence interval [95%CI]: 7.39–8.28). The most commonly reported event was Menstruation irregular (4998 reports), and a higher percentage of female aged 30–49 years reported menstrual disorders (42.55%) after exposure to COVID-19 Vaccines. Both for all reports of menstrual disorders (ROR = 5.82; 95%CI: 4.93–6.95) and excluding reports of unknown age (ROR = 13.02; 95%CI: 10.89–15.56),suggest that female age may be associated with menstrual disorders after vaccination with the COVID-19 Vaccines. Conclusion: There is a potential safety signal when the COVID-19 vaccine is administered to young adult female (30–49 years old), resulting in menstrual disorders in. However, due to the well-known limitations of spontaneous reporting data, it is challenging to explicity classify menstrual disorders as an adverse event of the COVID-19 Vaccines, and reports of adverse reactions to COVID-19 Vaccines in this age group should continue to be tracked. Keywords: VAERS, COVID-19 vaccine, Menstrual disorders events, 30–49 years, Risk signals Impacts on practice *Correspondence: ; 3 Department of Orthopedics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250000, Shandong, China 4 Department of Reproduction and Genetics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250000, Shandong, China Full list of author information is available at the end of the article 1. After the launch of the COVID-2019 vaccine, consideration attention has been focused on special populations, such as elderly, children, pregnant women, and even congenital allergies, while less attention is paid to reports of adverse reactions in adults women after vaccination. 2. The proportion of women aged 30–49 years reporting menstrual disorders after vaccination has risen, © The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Zhang et al. BMC Women’s Health (2022) 22:403 and reports of adverse reactions in this age group in women should continue to be monitored. Background Coronavirus disease of 2019 [1] (COVID-19) is a highly pathogenic viral infection caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). COVID-19 infection remains a global concern since the end of 2019 to date. According to WHO, as of January 6, 2022, 293,750,692 cases of COVID-19 have been diagnosed worldwide, and 55,972,114 instances have been diagnosed in the United States. For epidemic control, the safe and effective vaccine is the long-term option for conquering the COVID-19 global pandemic [2]. Research studies [3] have shown that an average vaccination level of roughly 80 doses per 100 inhabitants between countries can sustain a reduction in the number of confirmed cases and deaths. The recent emergence of the Omicron variant further emphasizes the necessity of vaccination, and prevention efforts needed to protect against COVID-19. The U.S. Food and Drug Administration (FDA) approved three COVID-19 vaccines for emergency use in the United States in mid-December 2020 [4, 5] and late February 2021 [6], respectively. By the end of 2021, more than a dozen COVID-19 vaccines in six categories are approved for use worldwide. Local and systemic reactions were the predominant types of adverse events observed in pre-emergency authorization clinical trials of these vaccines. Because of the short development cycle of COVID-19 vaccines, there are continuing concerns regarding the post-marketing safety and efficacy of vaccines. Accordingly, in order to continue to monitor the post-marketing safety of vaccines, countries throughout the world have established different measures to gather information about vaccine recipients. The Centers for Disease Control and Prevention in the United States uses the Vaccine Adverse Reaction Reporting System (VAERS) for ongoing monitoring of the safety of the COVID-19 vaccine [7]. Since the launch of the COVID-19 vaccine, more research points have focused on special groups such as the elderly [8], adolescents [9, 10], and maternity [11, 12]. More attention is devoted to aspects such as rare allergic reactions [13] and cardiovascular system diseases [14] after vaccination, whereas less attention is paid to female’s menstrual circumstances. In a cohort study [15] that included 3959 individuals (2,403 vaccinated with COVID-19 vaccine; 1,556 unvaccinated): COVID-19 vaccination is associated with a slight change in cycle length but not menses length. In a questionnaire which included 164 women [16], it was suggested that temporary and Page 2 of 9 self-limiting menstrual cycle irregularities may occur in some vaccinated women, regardless of the type of COVID-19 vaccine. Henceforth, continuous attention to the effects of COVID-19 exposure on women’s health and adverse effects after vaccination (especially menstr (...truncated)