Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.; Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 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. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "Okay, that's probably when we had COVID before. We had all the vaccines except for the very last one... And it was Pfizer.". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was on Paxlovid. Her husband and patient both have, they both have COVID, and he probably got it a couple of days before patient did. So patient was assuming she caught it from him. Then they didn't test, until it was Thursday of last week, she believe, and when we tested, we both tested positive. So, then we called our doctor and told them, you know, that we had COVID, and they called in a prescription. We go to different doctors. So, his doctor called his in and her doctor called in. Well, he went to the pharmacy and got his. Then it was several hours later, and the pharmacy called her, and they said that they were out of it when her doctor sent her prescription in. So finally, they got it filled, and she went to pick it up and when she picked it up, they charged her dollar 47. When asked for the date her medication was purchased, stated Yes, it was on 06Nov. After advising that an enrollment would need to be completed, (withheld) stated, Does this mean, she would have to take more Paxlovid if she get sicker or don't get well. After advising of the options for enrollment, (withheld) stated, she don't really feel well enough to answer questions for 25 minutes. When assisting (withheld) locate the online enrollment form, (withheld) stated, "her brain's not working" After advising (withheld) that an account created in Jan2024 was located for her, (withheld) stated, " Okay, that's probably when we had COVID before. This is our second COVID, and we had all the vaccines except for the very last one. And it was Pfizer. You probably have information on me because we've we had the Pfizer vaccine, she and her husband. When offered to be transferred to the Drug Safety Unit, (withheld) stated, " Well, she thought it's working, we're better. Okay, she will. She was about worn out now, though, but it won't be much longer." (withheld) continued to state," she started out with a sore throat, but her husband, he didn't have a sore throat, and he doesn't have one now. But she had still got a terrible sore throat. This is a two-person event for (withheld) and her husband. Both patients have COVID again, taken Paxlovid previously, also mentioned taking the Pfizer vaccines but missed one of the vaccines. The information on the batch/lot number for (BNT162B2 OMI XBB.1.5) will be requested and submitted if and when received.