Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Severe chills; severe 103 fever; This is a spontaneous report received from a Consumer or other non HCP. A 77-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Nov2025 at 02:30 as dose 1, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "variant angina" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "low thyroid" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Allergy: bactrim" (unspecified if ongoing); "Allergy: iodine dyes" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE MONONITRATE; RANEXA [RIVAROXABAN]; VERAPAMIL; PLAVIX; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]. The following information was reported: CHILLS (non-serious) with onset 10Nov2025 at 21:00, outcome "recovered" (Nov2025), described as "Severe chills"; PYREXIA (non-serious) with onset 10Nov2025 at 21:00, outcome "recovered" (12Nov2025 at 21:00), described as "severe 103 fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia. Additional information: The patient didn't received any other vaccines on the same date as the vaccine(s) for which reporting and patient didn't received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which reporting. The Patient taking any other medications within 2 weeks of the event starting. Reported Event: Severe chills and 103 fever. Chills resolved within 24 hours, fever in 48 hours. Symptoms started a full 4 days after receiving vaccination. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Allergic reaction to antibiotics; Anemia; Diabetes; Iodine contrast media allergy; Peripheral neuropathy; Thyroid function decreased; Variant angina
ISOSORBIDE MONONITRATE; RANEXA [RIVAROXABAN]; VERAPAMIL; PLAVIX; SYNTHROID; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]
Test Date: 20251010; Test Name: Fever; Result Unstructured Data: Test Result:103