Received Dec 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
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)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset 2024, outcome "recovered" (2024), described as "coughing"; LETHARGY (non-serious) with onset 2024, outcome "recovered" (2024), described as "severe lethargic (wife slept through most days of the week)". Additional information: Reported as, He and his wife had severe reaction 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.