Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Saline infusion sonogram, Ultrasound scan
Clinical narrative: menorrhagia- gushing blood; Bleeding; Menstrual irregularities; spotting; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Lot number: Ff2593) at the age of 39-years as dose 3 (booster), single for covid-19 immunisation. No known allergies. No other relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. No other medications the patient received within 2 weeks of vaccination. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 013620a, Location of injection: Arm Left), administration date: 23Jan2021, when the patient was 38 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 026L20A, Location of injection: Arm Left), administration date: 29Dec2020, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 08Nov2021, outcome "recovered" (2021), described as "Bleeding"; MENSTRUATION IRREGULAR (non-serious) with onset 08Nov2021, outcome "recovering", described as "Menstrual irregularities"; INTERMENSTRUAL BLEEDING (non-serious) with onset 08Nov2021, outcome "recovering", described as "spotting"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset Dec2021, outcome "recovering", described as "menorrhagia- gushing blood". The events "bleeding", "menstrual irregularities", "spotting" and "menorrhagia- gushing blood" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: hysteroscopy: (Dec2021) negative; pathology test: (Dec2021) negative; saline infusion sonogram: (Dec2021) unknown results; sars-cov-2 test: (unspecified date) negative, notes: Blood test; (unspecified date) negative, notes: Nasal Swab; ultrasound scan: (Dec2021) unknown results. No hospitalization prolonged. Therapeutic measures were taken as a result of haemorrhage, menstruation irregular, intermenstrual bleeding, heavy menstrual bleeding. The detail clinical course was reported as menstrual irregularities- 2 weeks after vaccine started spotting and second week of Dec developed menorrhagia- gushing blood. Had ultrasound, started on birth control taper but not tolerated then had saline ultrasound and ended up with hysteroscopy, d&c with iud to stop bleeding. Bleeding lasted about 8 weeks. Pathology came back negative. No reason for this to occur but similar issue noted among others who also received Pfizer vaccine.; Sender's Comments: Based on compatible temporal association, the causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.