Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Postmenopausal haemorrhage
Clinical narrative: Received her booster dose with Pfizer Covid vaccine on 12JAN2022; Got her period after being on full blown menopause and period again, Since January she has had her period each month/Past month the flow was heavier; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Got her period after being on full blown menopause and period again, Since January she has had her period each month/Past month the flow was heavier) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 203A21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Menopause (Was on full blown menopause. Prior to receiving the booster shot, she was menopause for 13 months). Concurrent medical conditions included Depression and Anxiety. Concomitant products included DULOXETINE for Depression and Anxiety.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received her booster dose with Pfizer Covid vaccine on 12JAN2022). In January 2022, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Got her period after being on full blown menopause and period again, Since January she has had her period each month/Past month the flow was heavier) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Got her period after being on full blown menopause and period again, Since January she has had her period each month/Past month the flow was heavier) and INTERCHANGE OF VACCINE PRODUCTS (Received her booster dose with Pfizer Covid vaccine on 12JAN2022) outcome was unknown.            It was reported that around 15 days after receiving the booster dose, started getting period again. Patient was very concerned because did not expected to get periods again. Patient had no other period symptoms of bloating or cramps.  Since Jan-2022 she has had her period each month and the past month the flow was heavier.  Patient used Duloxetine for long time.  No treatment details were reported.  Patient was never tested positive for COVID-19.  Company Comment: This spontaneous case concerns a 55-year-old, menopausal patient with vaccination of Tozinameran COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of Postmenopausal haemorrhage. The event started approximately 8 months after receiving mRNA-1273 as primary COVID-19 vaccine series. The patient reported to have been on menopause for 13 months prior to event and noted resumption of menses post-vaccination of Tozinameran, without other symptoms of bloating or cramps. There has also been increase in menstrual volume 3 months after onset. Information on whether the patient sought gynecologic consult and if there have been diagnostic procedures conducted were not provided in the case. Interchange of vaccine products also occurred wherein the patient received the co-suspect Tozinameran as booster dose approximately 8 months prior to mRNA-1273, and remains a confounder in the case. The patient The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Follow-up information received included an event heavy menstrual bleeding which is coded under Postmenopausal haemorrhage.; Sender's Comments: This spontaneous case concerns a 55-year-old, menopausal patient with vaccination of Tozinameran COVID-19 vaccine, who experienced the unexpected, serious (medically significant) event of Postmenopausal haemorrhage. The event started approximately 8 months after receiving mRNA-1273 as primary COVID-19 vaccine series. The patient reported to have been on menopause for 13 months prior to event and noted resumption of menses post-vaccination of Tozinameran, without other symptoms of bloating or cramps. There has also been increase in menstrual volume 3 months after onset. Information on whether the patient sought gynecologic consult and if there have been diagnostic procedures conducted were not provided in the case. Interchange of vaccine products also occurred wherein the patient received the co-suspect Tozinameran as booster dose approximately 8 months prior to mRNA-1273, and remains a confounder in the case. The patient The benefit-risk relationship of mRNA-1273 is not affected by this report.