Received Jan 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | 6J3277 | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 5 | 6J3277 | — |
Liver hematomas/has had the last 2 years, just keeps getting more of them; brain farting; Cancer in her uterus; PATIENT SUPPORT PROGRAM This is a solicited report received from a Consumer or other non HCP, Program ID. A 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: 6J3277) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos Disease" (unspecified if ongoing), notes: Has had for 20 years; "Breast cancer", start date: 2021 (unspecified if ongoing), notes: diagnosed in 2021; "Diabetes" (unspecified if ongoing), notes: has had for maybe 10 years. Type 2 and is on Ozempic; "Polycystic kidneys" (unspecified if ongoing), notes: diagnosed 10 years ago. The patient's concomitant medications were not reported. Vaccination history included: COVID-19 (Dose 1, Lot no. EW0150), administration date: 01Apr2021, when the patient was 50-year-old, for COVID-19 immunization; COVID-19 (Dose 2, Lot no. ER8729), administration date: 22Apr2021, when the patient was 50-year-old, for COVID-19 immunization; COVID-19 (Dose 3, Lot no. FJN20), administration date: 01Dec2021, when the patient was 50-year-old, for COVID-19 immunization; COVID-19 (Dose 4, Lot no. FM7553), administration date: 28May2022, when the patient was 51-year-old, for COVID-19 immunization. The following information was reported: UTERINE CANCER (medically significant) with onset 2025, outcome "unknown", described as "Cancer in her uterus"; HEPATIC HAEMATOMA (medically significant), outcome "unknown", described as "Liver hematomas/has had the last 2 years, just keeps getting more of them"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "brain farting". Therapeutic measures were taken as a result of uterine cancer. The reporter's assessment of the causal relationship of "liver hematomas/has had the last 2 years, just keeps getting more of them", "cancer in her uterus" and "brain farting" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: There is no reasonable possibility that the events "liver hematomas/has had the last 2 years, just keeps getting more of them", "cancer in her uterus" and "brain farting" were related to BNT162B2, BNT162B2 OMI BA.4-5. These are more likely due to the history of breast cancer and other comorbid conditions or intercurrent conditions.,Linked Report(s) : US-PFIZER INC-202600004834 Same reporter/patient/suspect vaccine; different dose/event;
Medical History/Concurrent Conditions: Autoimmune thyroiditis (Has had for 20 years); Breast cancer female (diagnosed in 2021); Polycystic kidney (diagnosed 10 years ago); Type 2 diabetes mellitus (has had for maybe 10 years. Type 2 and is on Ozempic)