Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | FM9992 | IM / LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | FM9992 | LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | FM9992 | OT / LA |
could not breathe; 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 received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 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, lot number: FM9992, intramuscular, Left arm), administration date: 09Mar2021, when the patient was 65-year-old, for COVID-19 immunisation; BNT162b2 (dose 2, lot number: ER8733, intramuscular, Left arm), administration date: 07Apr2021, when the patient was 65-year-old, for COVID-19 immunisation; BNT162b2 (dose 3 (booster), lot number: FC3183, intramuscular, Left arm), administration date: 13Oct2021, when the patient was 65-year-old, for COVID-19 immunisation, reaction(s): "mitral valve leaking in her heart". On the evening of 27Jul2022, the patient went to the bathroom and experienced difficulty breathing after walking out. She called an ambulance for assistance and was transported to [withheld] Hospital. The patient has a history of chronic obstructive pulmonary disease (COPD) but no known history of heart problems, although she underwent a heart catheterization in Nov2021. She was hospitalized for approximately four to five days. During the hospitalization, a mitral valve clip procedure was performed; however, the intervention did not resolve the mitral valve leakage. The patient is currently considering undergoing a mitral valve repair. Outcome of the event was unknown. The reporter's assessment of the causal relationship of "mitral valve leakage" 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 plausible temporal relationships and current known available information, a possible contributory role of BNT162b2 cannot be excluded for the reported event dyspnea but consider also possible contributory effects from patient's medical history. 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-202500246133 Same patient and product; different dose and event;
Medical History/Concurrent Conditions: COPD (but no history of heart problems)