Report #2879271

Overview

Sex

Female

Age

65 yrs

State

FL

Recovered

Unknown

Vaccinated

Apr 7, 2021

Onset

—

Days to onset

—

Hospital days

5

Symptoms (1)

Symptom narrative

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; 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 07Apr2021 as dose 2, single (Lot number: ER8733) 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: comirnaty (Dose 1, intramuscular in left arm; lot: FM9992), administration date: 09Mar2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "mitral valve clip that did not stop the leaking in her heart". The following information was reported: MITRAL VALVE INCOMPETENCE (hospitalization, medically significant), outcome "unknown", described as "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 patient was hospitalized for mitral valve incompetence (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of mitral valve incompetence. Clinical course: Patient went to the bathroom on the evening of 27Jul2022 and could not breathe after walking out. She had to call an ambulance to set her up and get her to (redacted). She has COPD but no history of heart problems (did have a heart cath in Nov2021) 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. She had several prior COVID vaccinations to the one listed all from Pfizer: 1. 09Mar2021 at the (redacted) in Left arm, 2. 07Apr2021 Lot # ER8733 in left arm at the (redacted), 3. 13Oct2021 Lot FC3183 in left arm at (redacted). Result or outcome of adverse event(s): Hospitalization: Number of days (if known): 5. The reporter's assessment of the causal relationship of "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" 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-202500246133 Same patient and product; different dose and event;

Medical history

Medical History/Concurrent Conditions: COPD (but no history of heart problems)