Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Endometrial cancer, Vaginal haemorrhage
Clinical narrative: diagnosis of endometrial cancer in Mar2024; heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before; heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before; This is a spontaneous report received from an Other HCP.  A female patient in her 40's (not pregnant) received BNT162b2 (BNT162B2 NOS), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 5 decade for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; Bnt162b2 (DOSE 2, SINGLE, one month apart previous dose), administration date: 2021, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding". The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening), DISEASE RECURRENCE (disability, life threatening) all with onset 2023, latency 2 days after the suspect product(s) administration, outcome "recovering" and all described as "heavy and abnormal vagina bleeding 2 days post dosing for all three doses which she never experienced before"; ENDOMETRIAL CANCER (disability, life threatening) with onset Mar2024, outcome "recovering", described as "diagnosis of endometrial cancer in Mar2024". Therapeutic measures were taken as a result of endometrial cancer including surgery, chemo and radiation.  The information on the batch/lot number for BNT162B2 NOS will be requested and submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events VAGINAL HAEMORRHAGE, DISEASE RECURRENCE and the suspect drug Based on available information on the safety profile of Comirnaty so far, the product does not seem to be carcinogenic. There is limited information in the case regarding relevant risk factors including tobacco and alcohol use, human papilloma virus infection, family history of cancer, etc. Considering these factors, the reported ENDOMETRIAL CANCER is considered unlikely related to Comirnaty in this case report. However, as a cautionary measure, a relationship cannot be completely excluded since the patient received the vaccine before the event.  The case will be reassessed once additional information is available. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-202500000311 same reporter/patient, partial same event, different dose;US-PFIZER INC-202500000312 same reporter/patient, partial same event, different dose;