Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
Addition of nausea the next morning; Within 8 hours chills, body aches and fatigue; Within 8 hours chills, body aches and fatigue; Within 8 hours chills, body aches and fatigue; Elevated heart rate and temp at night; Elevated heart rate and temp at night; This is a spontaneous report received from a Consumer or other non HCP. A 51-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 13Oct2025 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 13Oct2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "anal cancer" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN topical; PROGESTERONE; ESTRADIOL. The following information was reported: HEART RATE INCREASED (non-serious), BODY TEMPERATURE INCREASED (non-serious) all with onset 13Oct2025 at 18:00, outcome "not recovered" and all described as "Elevated heart rate and temp at night"; CHILLS (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 13Oct2025 at 18:00, outcome "not recovered" and all described as "Within 8 hours chills, body aches and fatigue"; NAUSEA (non-serious) with onset 14Oct2025, outcome "not recovered", described as "Addition of nausea the next morning". Therapeutic measures were taken as a result of chills, pain, fatigue, heart rate increased, body temperature increased, nausea. Additional information: The patient received Advil as treatment for the events. 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: Anal cancer; Penicillin allergy; Ulcerative colitis
ESTROGEN; PROGESTERONE; ESTRADIOL