Received Dec 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
severe rxn/ coughing; severe lethargic; wife slept through most days of the week; This is a spontaneous report received from an Other HCP and a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Sep2024 at 13:15 as dose 1, single (Batch/Lot number: unknown) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LETHARGY (non-serious) with onset 25Sep2024 at 17:00, outcome "recovered" (Oct2025), described as "severe lethargic"; COUGH (non-serious) with onset 25Sep2024 at 17:00, outcome "recovered" (Oct2025), described as "severe rxn/ coughing"; SOMNOLENCE (non-serious) with onset 25Sep2024 at 17:00, outcome "recovered" (Oct2025), described as "wife slept through most days of the week". The events "severe rxn/ coughing", "severe lethargic" and "wife slept through most days of the week" required physician office visit. Clinical course: Reporter declined as he and his wife had severe rxn with last year pfizer vaccine, it took them a whole week to get recover from coughing and severe lethargic (wife slept through most days of the week). The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500142679 Same reporter and suspect drug, different patients and events;