Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
I have COVID; I have COVID; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 IMMUNISATION, reaction(s): "COVID-19", "DRUG INEFFECTIVE"; Bnt162b2 (6 BOOSTER DOSES), for COVID-19 IMMUNISATION. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have COVID". The event "i have covid" required physician office visit. Clinical Course: The patient stated, "I just went to senior medical center, and I have COVID, and she prescribed Paxcovid. I used Pfizer for all of my booster shots. When asked to repeat herself, stated, "No, no, I just said I had Pfizer for all of my booster shots." When asked if they had Pfizer booster shots before, (withheld) stated, "Oh, yes." When asked if they had COVID previously, (withheld) stated, "I had COVID I didn't have it during the epidemic time in 2021 and all that, but I had it later. I went somewhere and I got it, and I only had what you called a mild case, and I took Paxcovid then, and they gave it to me. "After asking if she remembers when she last took Paxlovid, stated, "Uh, no, I don't know when I got it, but I have, I have a shot book that tells me all my medication-boosters and everything that I got from Pfizer." When confirming if she had the booter shots, stated, "Six of them. "When asked to clarify if she had the 6 boosters, (withheld) stated, "I think so, I had every time I was supposed to get one, I got it." When asked if she got the booster shots but not COVID, stated, "I never got COVID except for the one time that I said back a couple of years ago. Not during the big time or anything, but I have had COVID the one time." The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.