Received May 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
heart failure; Safety information originally reported under manufacturer case PV202500058845 has been nullified and re-entered under this new manufacturer report number 202500104046. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) 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. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (16May2025): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. Updated information: Reporter and patient's name updated. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (19May2025): This is a follow-up report to notify that the cases PV202500058845 and 202500104046 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500104046. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.