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

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.