Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Hives all over my body; Feet were so swollen; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25Sep2025, outcome "not recovered", described as "Feet were so swollen"; URTICARIA (non-serious) with onset 25Sep2025, outcome "not recovered", described as "Hives all over my body". Therapeutic measures were taken as a result of urticaria, peripheral swelling. Additional information: the patient got the Covid vaccine on Wednesday, September 24, 2025. On Thursday the 25th, the patient developed hives all over the body and the feet were so swollen that the patient had to go to the hospital. The patient thought it's a reaction to the vaccine since it's a live virus. The patient was prescribed Prednisone, but on Saturday, September 27, 2025, the patient was still the same. The patient reported she/he can send photos. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.