Received Feb 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | GH9702 | OT / LA |
endometrial cancer; vaccine was administered subcutaneous; heavy and abnormal vagina bleeding; This is a spontaneous report received from an Other HCP. A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 42 years subcutaneous, in left arm for covid-19 immunisation. The facility where the vaccine was administered was in a Public Health Department and not at a facility. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, batch/lot number EW0150), administration date: 03Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; BNT162b2 (dose 2, batch/lot number EW0170), administration date: 24Apr2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding"; BNT162b2 (dose 3, batch/lot number FH8028), administration date: 21Nov2021, when the patient was 41-year-old, for Covid-19 Immunization, reaction(s): "heavy and abnormal vagina bleeding". The patient did not receive any other vaccine on the same date as the Pfizer vaccine, was not taking any other medications within 2 weeks prior to the event onset, and did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The following information was reported: VAGINAL HAEMORRHAGE (disability, life threatening) with onset Nov2022, outcome "recovered" (Nov2022), described as "heavy and abnormal vagina bleeding"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Nov2022, outcome "unknown", described as "vaccine was administered subcutaneous"; ENDOMETRIAL CANCER (disability, life threatening, medically significant) with onset Mar2024, outcome "unknown". The events "endometrial cancer" and "heavy and abnormal vagina bleeding" required physician office visit. Therapeutic measures were taken as a result of endometrial cancer. Clinical course: The patient experienced heavy and abnormal vagina bleeding within 2-5 days of each dosing and lasted 1-2 days and went away. The patient was diagnosed endometrial cancer in Mar2024. The patient visited an OBGYN. The events were reported as life threatening illness (immediate risk of death from the event) and disability or permanent damage.; Sender's Comments: The events endometrial cancer, and vaginal haemorrhage are conservatively assessed as related to the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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-202500000306 same reporter/patient, different dose;US-PFIZER INC-202500000311 same reporter/patient, different dose;US-PFIZER INC-202500000312 same reporter/patient, different dose;