Received Dec 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | 00069-2432-10 | OT |
she felt extremly letargic; completly out of it; [WITHHELD] TARGETED IMMUNIZATION ENGAGEMENT (TIE) This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. An 80-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Oct2024 at 08:41 as dose 1, single (Lot number: 00069-2432-10) at the age of 80 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (hospitalization) with onset 02Oct2024 at 11:00, outcome "unknown", described as "completly out of it"; LETHARGY (hospitalization) with onset 02Oct2024 at 11:00, outcome "unknown", described as "she felt extremly letargic". The patient was hospitalized for lethargy, confusional state (start date: 02Oct2024, discharge date: 23Oct2024, hospitalization duration: 21 day(s)). The events "she felt extremly letargic" and "completly out of it" required physician office visit and emergency room visit. The reporter's assessment of the causal relationship of "she felt extremly letargic" and "completly out of it" with the suspect product(s) BNT162b2 omicron (kp.2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Clinical course: Pt stated that she felt extremely lethargic and completely out of it couple of hours after receiving her COVID shot. Her husband called ambulance and she was taken to the hospital. She ended up on the psychiatric ward for 3 weeks.; Sender's Comments: Based on a close drug-event temporal relationship, a contributory role of BNT162b2 omicron (kp.2) to the occurrence of the reported serious events Lethargic and Confusional state cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.