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

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 used 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%CI4.93-6.95) and excluding reports of unknown age (ROR=13.02;95%CI10.89-15.56), suggest that female age may be associated with menstrual disorders after vaccination with the COVID-19 Vaccines. Conclusion: Our study suggests a potential safety signal among female who received the COVID-19 vaccine, which may cause menstrual disorders in young adult female (30-49 years old). However, due to the well-known limitations of spontaneous reporting data, it is challenging to directly define 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.