Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / LA |
Mitral valve clip that did not stop the leaking in her heart; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from a healthcare professional and a consumer, Program ID. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: But no history of heart problems. The patient's concomitant medications were not reported. The patient had the first dose of COVID-19 vaccine on 09Mar2021 (lot number reported as FM9992; pending clarification). The following information was reported: MITRAL VALVE INCOMPETENCE (hospitalization), outcome "unknown", described as "Mitral valve clip that did not stop the leaking in her heart". The patient was hospitalized for 4 to 5 days and eventually had to have a mitral valve clip that did not stop the leaking in her heart and is now contemplating a mitral valve repair. The reporter's assessment of the causal relationship of "mitral valve clip that did not stop the leaking in her heart" with the suspect product(s) BNT162b2 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. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on known disease pathophysiology, the event mitral valve incompetence is assessed as not related to BNT162B2, and more likely due to degenerative mitral valve disease brought about by old age.,Linked Report(s) : US-PFIZER INC-PV202500145857 Same patient and product; different dose and event;US-PFIZER INC-202500246134 Same patient and product; different dose and event;US-PFIZER INC-202500246135 Same patient and product; different dose and event;
Medical History/Concurrent Conditions: COPD (But no history of heart problems)