Received Apr 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 78-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 included: "COVID-19", start date: 2022 (unspecified if ongoing), notes: He wound up in the hospital three times three years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID-19". The clinical course was reported as follows: The patient's wife reported that her husband was recently diagnosed with COVID-19. He contracted it again, and his doctor prescribed nirmatrelvir;ritonavir (PAXLOVID) to him on the morning of 01Apr2025. He has not been sleeping well and was quite sick. The reporter mentioned that they got all those COVID-19 shots; he must have had seven of them; they were all Pfizer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: COVID-19 (He wound up in the hospital three times three years ago.)