Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0738 | OT / LA |
Headache; chills; hot flashes; low-grade temp; very weak; couldn't stand w/o feeling dizzy; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 10Nov2025, this case now contains all required information to be considered valid. This is a spontaneous report and received from Consumer or other non HCPs, Program ID: . An 82-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 23Oct2025 as dose 1, 0.3 ml single (Lot number: NA0738, Expiration Date: 19Jun2026) at the age of 82 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "asthma", start date: 1981 (ongoing); "Cholesterol", start date: 2010 (ongoing); "TIA", start date: Jun2025 (ongoing); "Allergies" (ongoing); "High blood pressure", start date: 2010 (ongoing); "Bladder problems" (ongoing); "bladder infection", start date: Jul2025 (ongoing); "Gastroesophageal reflux disease", start date: 2021 (ongoing); "Breast cancer", start date: 2017, stop date: 2021; "Breast cancer", start date: 2025 (ongoing). Concomitant medication(s) included: ENCORE [BETAMETHASONE DIPROPIONATE] taken for asthma; ATORVASTATIN taken for blood cholesterol; CLOPIDOGREL taken for transient ischaemic attack; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for multiple allergies; ANASTROZOLE taken for breast cancer; VERAPAMIL taken for hypertension; LOSARTAN taken for hypertension; TOLTERODINE taken for bladder disorder; PANTOPRAZOLE SODIUM taken for gastrooesophageal reflux disease; CEFPROZIL taken for cystitis. The following information was reported: CHILLS (non-serious) with onset 23Oct2025, outcome "recovering"; DIZZINESS POSTURAL (non-serious) with onset 23Oct2025, outcome "recovering", described as "couldn't stand w/o feeling dizzy"; HOT FLUSH (non-serious) with onset 23Oct2025, outcome "recovering", described as "hot flashes"; PYREXIA (non-serious) with onset 23Oct2025, outcome "recovering", described as "low-grade temp"; ASTHENIA (non-serious) with onset 23Oct2025, outcome "recovering", described as "very weak"; HEADACHE (non-serious), outcome "recovering". Therapeutic measures were taken as a result of chills, hot flush, pyrexia, asthenia, dizziness postural, headache.
Asthma; Bladder disorder NOS; Bladder infection; Blood pressure high; Breast cancer; Cholesterol; Gastroesophageal reflux disease; Multiple allergies; TIA
Medical History/Concurrent Conditions: Breast cancer
ENCORE [BETAMETHASONE DIPROPIONATE]; ATORVASTATIN; CLOPIDOGREL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ANASTROZOLE; VERAPAMIL; LOSARTAN; TOLTERODINE; PANTOPRAZOLE SODIUM; CEFPROZIL