Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menopause
Clinical narrative: POSTMENOPAUSAL BLEEDING; MENSTRUAL IRREGULARITIES/ MENSTRUAL CYCLE CHANGES/ RESUMPTION OF MENSES AFTER A PERIOD OF NO MENSES; VAGINAL BLEEDING; PERIMENOPAUSAL BLEEDING; HEAVY MENSTRUATION; MENSTRUATION PROLONGED ABOUT FOR CONTINUE 18 DAYS; MORE PERIOD PAIN/EXTREME MENSTRUAL CRAMPING; DELAYED MENSTRUAL CYCLE/ MISSED MY PERIOD (LATE BY 22 DAYS); EARLY MENSTRUAL PERIOD/ PERIOD STARTED EARLY; BREAST TENDERNESS; UTERINE SPOTTING/ INTERMENSTRUAL SPOTTING; EMOTIONAL AND MOODY / MOOD CHANGES/PMS (PREMENSTRUAL SYNDROME) SYMPTOMS; PULSATILE TINNITUS; This spontaneous report was received. Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to active surveillance, in December, 2020January, 2022: an observational Regulatory Authority. 2022 Aug 09. This report concerned multiple patients (female patients). The objective of this study was to identify and classify reports of menstrual irregularities and vaginal bleeding after COVID-19 vaccination. The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced sudden postmenopausal bleeding, menstrual irregularities, menstrual cycle changes, resumption of menses after a period of no menses, vaginal bleeding, perimenopausal bleeding, heavy menstruation, the patients had menstruation prolonged about for continue 18 days, and more period pain and had extreme menstrual cramping. It was stated that, the patients had menopause but still had light periods. Some patients reported of pulsatile tinnitus, breast tenderness, emotional and moody/mood changes, uterine spotting and PMS (premenstrual syndrome) symptoms. The patient had early menstrual period/period started early. It was reported that, the patients (63815) respondents reported on menstrual irregularities and vaginal bleeding, which included 62679 female respondents (1o0 percent of 5975363) aged greater than 18 years. The median age was 37 years. The patient respondents who submitted responses related to menstruation or vaginal bleeding were aged 65 years and older, which included female respondents (specificity) themes than for the theme of resuming menses (70o8 percent sensitivity, 99o3 percent specificity). The responses related to menstruation or vaginal bleeding, the most common theme was timing of menses (70981 [83o6 percent] responses). This theme included reports of menstruation starting earlier or later than expected, missed menstrual cycles, delayed menstrual cycle/missed my period (late by 22 days), and intermenstrual spotting. Severity of menstrual symptoms, such as heavy flow, more pain than usual, prolonged bleeding, or subjective descriptors, such as worse symptoms, was a theme for 56890 (67o0 percent) responses. 45942 (54o1 percent) responses met criteria for both timing and severity themes. About 3439 (4o0 percent) responses were related to menopausal bleeding and 2378 (2o8 percent) were related to resumption of menses after a period of no menses; 608 (0o7 percent) responses overlapped between these themes. Responses related to resumption of menses included those from people whose menstrual cycles were previously suppressed due to medication or breastfeeding. The median age of those reporting symptoms related to menopause (54 years [5062]) or resumption of menses (47 years [3753]) was higher than for timing (37 years [3043]), severity (37 years [3144]), and other (37 years [3044]).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the menstrual irregularities/ menstrual cycle changes/ resumption of menses after a period of no menses, vaginal bleeding, postmenopausal bleeding, perimenopausal bleeding, heavy menstruation, menstruation prolonged about for continue 18 days, more period pain/extreme menstrual cramping, delayed menstrual cycle/ missed my period (late by 22 days), early menstrual period/ period started early, pulsatile tinnitus, breast tenderness, uterine spotting/ intermenstrual spotting and emotional and moody / mood changes/pms (premenstrual syndrome) symptoms was not reported. The authors emphasized on that several types of menstrual symptoms were reported, with most being related to disruptions in menstrual timing (83o6 percent) or increased severity of menstrual symptoms (67o0 percent), such as bleeding or pain. Some respondents also described symptoms related to perimenopausal and postmenopausal bleeding (4o0 percent), and resumption of menses after a long period of no menses (2o8 percent). A link between COVID-19 vaccination and menstruation is biologically plausible. The clinical and long-term significance of the heterogeneous symptoms related to menstruation and vaginal bleeding after COVID-19 vaccination described in responses is unclear. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230336645-Postmenopausal bleeding. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.