Received Sep 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
not cognitively aware- not using right words when trying to talk; high fever; disoriented; agitated; Threw up; This is a spontaneous report received from a Consumer or other non HCP. A 37-year-old patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 12Sep2025 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Pleomorphic xanthroastrocytoma" (unspecified if ongoing) and no known allergies. Concomitant medication(s) included: INFLUENZA taken for immunisation, on 04Sep2025 as dose number unknown, single; ATORVASTATIN; KEPPRA [LEVETIRACETAM]; METOPROLOL; AVASTIN [BEVACIZUMAB]; KEYTRUDA. The following information was reported: VOMITING (hospitalization) with onset 13Sep2025 at 07:00, outcome "recovering", described as "Threw up"; AGITATION (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "agitated"; DISORIENTATION (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "disoriented"; PYREXIA (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "high fever"; COGNITIVE DISORDER (hospitalization) with onset 13Sep2025 at 09:00, outcome "recovering", described as "not cognitively aware- not using right words when trying to talk". The patient was hospitalized for vomiting, cognitive disorder, pyrexia, disorientation, agitation (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of vomiting, cognitive disorder, pyrexia, disorientation, agitation. Additional information: Patient received covid shot COMIRNATY (2025-2026 FORMULA) at 4P on 12Sep2025 - cognitively aware. Patient threw up at 7A the next morning 13Sep2025 and still cognitively aware. Patient then threwup at 9A but not cognitively aware, not using right words when trying to talk, had high fever, disoriented and agitated. As the result of these events, patient was hospitalized for 2 days. Treatment received for events included: Tylenol, antibiotics, anti-virals, morphine. The outcomes of events were reported as "recovering". 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: Pleomorphic xanthoastrocytoma
ATORVASTATIN; KEPPRA [LEVETIRACETAM]; METOPROLOL; AVASTIN [BEVACIZUMAB]; KEYTRUDA