Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
excessive urination; Chills; headache; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 16:15 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering"; POLYURIA (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering", described as "excessive urination"; HEADACHE (non-serious) with onset 13Sep2025 at 08:00, outcome "recovering". Therapeutic measures were not taken as a result of polyuria, chills, headache. 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 didn't took any other medications within 2 weeks of the event started. No known drug allergy. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None