Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Covid; Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Clinical course: During an inbound call to complete enrollment for financial assistance, the patient stated, that he was really sick and not feeling good, and wants to do everything over the phone because he was laying down. If he sit, headache like crazy. Patient stated" I can't go on the computer; I'm laying down talking." The agent advised they would need to play the consent recordings. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.