Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: Gotten my period again/ 2nd booster and now gotten my period again; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (Gotten my period again/ 2nd booster and now gotten my period again) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B22A) for COVID-19 prophylaxis.     The patient's past medical history included Tumor excision (Stomach cancer (cist) tumor removed) in 2020. Concurrent medical conditions included Drug allergy (Allergy to oxycodone), Food allergy, Allergy to molds, Stomach cancer (Stomach Cancer (Cist) tumor removed. Checkups ongoing.) since 2020, Eczema on 1958, Blood pressure high, Acid reflux (esophageal) and Restless leg syndrome. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), LOSARTAN and AMLODIPINE for Blood pressure high, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hypersensitivity.    On 22-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (Gotten my period again/ 2nd booster and now gotten my period again) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (Gotten my period again/ 2nd booster and now gotten my period again) outcome was unknown.            Patient received dose 4 (second booster).  Patient was taking an unknown concomitant medication for RLS.  Patient's menopause was before 7 years. Patient woke up to fi nd that got her period again. Patient had not had a period in over 9 years and now another year had gone by 2nd booster and now got period again. The last time this happened went to doctor, they did a uterine biopsy and it came back negative so doctor said it was possible it was from the shot, now this had happened a 2nd time.  Treatment information was not provided. Company comment-This spontaneous case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage on an unknown date after receiving fourth dose of mRNA-1273 vaccine in covid 19 vaccination series. Patient had her periods after vaccination, she had not had her periods for 9 years and in menopause. She had similar issues twice after vaccination previously, an uterine biopsy done at that time was normal. No further details on clinical course, lab reports and treatment received were reported. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-074721, MOD-2021-074747, MOD-2022-646237 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Postmenopausal haemorrhage on an unknown date after receiving fourth dose of mRNA-1273 vaccine in covid 19 vaccination series. Patient had her periods after vaccination, she had not had her periods for 9 years and in menopause. She had similar issues twice after vaccination previously, an uterine biopsy done at that time was normal. No further details on clinical course, lab reports and treatment received were reported. Outcome of the event was unknown at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.