Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
came down with COVID two weeks ago; came down with COVID two weeks ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jan2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Paxlovid for COVID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2025, outcome "unknown" and all described as "came down with COVID two weeks ago". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient's wife stated "My husband came down with COVID two weeks ago and the doctor provided or prescribed Paxlovid because he's got an upcoming surgery. When asked when the medication was picked up, patient's wife stated, "29May, just last month, so just over 2 weeks ago." "we were in such shock, but it was like 'Oh, we have to do this so he can have his surgery'." "When it's COVID you're just in a hurry to get the medication on the Paxlovid cause he had a upcoming heart procedure"...and we're spoiled, cause we all got it, my family, like a year or so ago (that was like almost 2 years ago), and the Paxlovid was free...it's kind of like a fast reaction, well we got to get this." When asked if Paxlovid was previously taken for COVID, patient's wife replied, "Yes, yes, and then we've had all our vacc-Pfizer, we get the Pfizer vaccinations regularly. We got it in Jan, just this year..." Later she said, "Thankfully I didn't get it I kept testing". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.