COVID-19 vaccination is not associated with an increase in incident postmenopausal bleeding (PMB) diagnoses, according to a recent study published in the American Journal of Obstetrics & Gynecology.
Takeaways
- The study found that COVID-19 vaccination is not associated with an increase in incident postmenopausal bleeding (PMB) diagnoses, providing reassurance in this regard.
- The absence of uterine bleeding evaluation during COVID-19 vaccine clinical trials led to concerns about PMB after vaccination. This study specifically addressed these concerns through a comprehensive analysis.
- The study utilized data from Kaiser Permanente Northwest (KPNW) and included incidents of PMB diagnoses from January 2018 to December 2021. Criteria for eligibility and exclusion were applied, focusing on female individuals aged 45 or older.
- The study was divided into 3 periods: pre-COVID, COVID-19 pre-vaccine availability, and COVID-19 vaccine availability. This allowed for a comprehensive examination of PMB incidents over time, particularly after the introduction of the COVID-19 vaccine.
- The results indicated that COVID-19 vaccination is not associated with PMB. The study's conclusion emphasizes that these findings can reassure both healthcare providers and patients who may have concerns about PMB caused by the COVID-19 vaccine.
Approximately 10% of menopausal individuals experience PMB, which is a key indicator of endometrial carcinoma. Uterine bleeding was not evaluated during the COVID-19 vaccine clinical trials, leading to concerns about PMB after vaccination.
Data has indicated a potential association between COVID-19 vaccination and menstruation, but there is little evidence about this association based on chart-reviewed medical record data. Investigators conducted a study to evaluate the impact of COVID-19 vaccination on PMB.
Kaiser Permanente Northwest (KPNW), an integrated health care delivery system in Oregon and Southwest Washington, was consulted for data. Incidents of PMB diagnoses from January 2018 to December 2021 were included in the analysis.
Eligibility criteria included female sex, age of 45 years or older, and active health plan membership during analysis. Exclusion criteria included preexisting PMB or abnormal uterine bleeding.International Classification of Diseases, Tenth Revision codes were used to determine PMB, calculated as monthly rates per 100,000 person-days.
The study was divided into 3 periods. The pre-COVID period was from January 2018 to January 2020, the COVID-19 and before COVID-19 vaccine availability period from February 2020 to November 2020, and the COVID-19 vaccine availability period from December 2020 to December 2021. These were referred to as period 1, period 2, and period 3, respectively.
Participants in the chart review population had documented COVID-19 vaccination from December 14, 2020,to August 14, 2021, a PMB diagnosis within 60 days following a COVID-19 vaccine dose, and KPW health system enrollment for 2 years before and 90 days after their first medical encounter for PMB.
For patients with a PMB code, the index date was determined by the bleeding diagnosis in the 60-day window. The chart review form was developed by the VSD Menstrual Irregularities Workgroup, which included epidemiologists, obstetrician-gynecologists, and public health researchers.
Factors measured in the chart review form included clinical history, bleeding onset, hormone therapy use, bleeding episode details, clinical evaluation, bleeding-related treatment, COVID-19 vaccination discussed at bleeding-related encounters, and bleeding etiology.
Data extracted included COVID-19 infection history in the past 60 days, patient demographics, and bleeding medical encounter settings. Bleeding severity was determined using anemia receipts data and receipts for intravenous (IV) fluids and IV iron.
There were 75,530 to 82,693 participants per month, 30 to 66 per month of whom presented with incident PMB diagnoses. A rate of 1.3 to 2.9 cases of PMB incidence per 100,000 person-days was reported across the full study period, with no significant changes across the 3 periods nor across age groups.
A diagnosis code for postvaccination PMB was reported in 104 individuals, 25 of whom were excluded following chart review. Of the remaining 79 cases, 76% were non-Hispanic White and the mean age was 59.6 years. Moderate anemia was reported in 1 case, which was identified as irrelevant to PMB after chart review. IV fluids or IV iron related to PMB were not observed.
A documented history of fibroids or uterine polyps was reported in 14 patients and the use of menopausal hormone therapy in the 60 days before the index date in 24. Confirmed COVID-19 infection in the 60 days before the index date was not seen in any patient.
There were 6 cases of a discussion about the potential association between COVID-19 vaccination and PMD between a patient and provider. Non-vaccine-related bleeding causes were identified as the source of PMD in 5 of these cases, and nongynecologic cancer was diagnosed shortly after the index date in the sixth.
These results indicated COVID-19 vaccination is not associated with PMB. Investigators concluded these findings can reassure providers and patients concerned about PMB caused by the COVID-19 vaccine.
Reference
Kauffman TL, Irving SA, Brooks N, et al. Postmenopausal bleeding after COVID-19 vaccination. Am J Obstet Gynecol. 2024;230:71.e1-14. doi:10.1016/j.ajog.2023.09.007
