Received Oct 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Headache; chilis; nausea; brain fog; This is a spontaneous report received from a Consumer or other non HCP. A 56-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Oct2025 at 11:45 as dose 1, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE. The following information was reported: HEADACHE (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering"; BRAIN FOG (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering"; CHILLS (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering", described as "chilis"; NAUSEA (non-serious) with onset 22Oct2025 at 21:00, outcome "recovering". Therapeutic measures were not taken as a result of headache, chills, nausea, brain fog. Additional information: Patient didn't received any other vaccines on the same date of the vaccination. Patient didn't received any other vaccines within 4 weeks prior to the vaccination. Patient took other medications within 2 weeks of the event started. Patient mentioned that no allergy to drug. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Ulcerative colitis
MESALAMINE