Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / RA |
started having dry cough on 11Sep2024 and it lasted thru 28Sep2024. She went to urgent care on 29Sep2024 and was sent to ER, where she was diagnosed with Heart Failure; This is a spontaneous report received from a Pharmacist, Program ID. A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 11Sep2024 at 15:40 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant) with onset 11Sep2024 at 18:00, outcome "unknown", described as "started having dry cough on 11Sep2024 and it lasted thru 28Sep2024. She went to urgent care on 29Sep2024 and was sent to ER, where she was diagnosed with Heart Failure". The events "started having dry cough on 11sep2024 and it lasted thru 28sep2024. she went to urgent care on 29sep2024 and was sent to er, where she was diagnosed with heart failure" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of cardiac failure. Clinical Course: Date and time of vaccination(mm/dd/yyyy): 11Sep2024; Time: 03:40 PM; Date and time adverse event started: (mm/dd/yyyy): 11Sep2024; Time: 06:00; Age at vaccination: 70 Years 6 Months. Vaccine (type and brand name): COVID19 (Pfizer-BioNTech): Dose number in series: 3. Per pt, she started having dry cough on 11Sep2024 and it lasted thru 28Sep2024. She went to urgent care on 29Sep2024 and was sent to ER, where she was diagnosed with Heart Failure. Pt ended up having heart transplant in Apr2025. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported event CARDIAC FAILURE and the suspect drug The impact of this report on the benefit/risk profile of the Pfizer drug 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.