Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 3 | FC3183 | OT / LA |
mitral valve leaking in her heart; TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID: . A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Lot number: FC3183) 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. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: FM992, Intramuscular, Left Arm), administration date: 09Mar2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "mitral valve incompetence"; BNT162b2 (DOSE 2, SINGLE, Lot number: ER8733, Intramuscular, Left Arm), administration date: 07Apr2021, when the patient was 65-year-old, for Covid-19 Immunization, reaction(s): "mitral valve incompetence". The following information was reported: MITRAL VALVE INCOMPETENCE (hospitalization) with onset 2021, outcome "unknown", described as "mitral valve leaking in her heart". She 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. Therapeutic measures were taken as a result of mitral valve incompetence and did have a heart cath in Nov2021. The reporter's assessment of the causal relationship of "mitral valve 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.; 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-202500246134 Same patient and product; different dose and event;US-PFIZER INC-PV202500145857 Same patient and product; different dose and event;US-PFIZER INC-202500246133 Same patient and product; different dose and event;
Medical History/Concurrent Conditions: COPD (but no history of heart problems)