Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Heart Failure; lymphatic system failed; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 16Jul2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP. An elderly patient 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: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "Heart Failure"; LYMPHATIC DISORDER (non-serious), outcome "unknown", described as "lymphatic system failed". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.