Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | IM |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Fever; Chills; Sweats; Nausea; Vomiting; Severe headache; High Blood Pressure; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 11:00 as dose 1, single (left shoulder) (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Peg, reaction(s): "Allergy: PEG"; Iodine iv tracing dye, reaction(s): "Allergy: Iodine IV tracing dye". The following information was reported: CHILLS (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered"; PYREXIA (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered", described as "Fever"; HYPERTENSION (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered", described as "High Blood Pressure"; NAUSEA (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered"; HEADACHE (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered", described as "Severe headache"; HYPERHIDROSIS (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered", described as "Sweats"; VOMITING (non-serious) with onset 12Sep2025 at 14:00, outcome "not recovered". Therapeutic measures were not taken as a result of pyrexia, chills, hyperhidrosis, nausea, vomiting, headache, hypertension. Additional information: Patient didn't received any other vaccines on the same date as the vaccine. Patient didn't received any other vaccines within 4 weeks prior to the vaccine. Patient took any other medications within 2 weeks of the event started. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.