Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
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.; an account created in Jan2024 was located for her, x stated, " Okay, that's probably when we had COVID before.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An 81-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), 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: COVID-19 (medically significant), outcome "unknown", described as "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."; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "an account created in Jan2024 was located for her, x stated, " Okay, that's probably when we had COVID before.". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: During an inbound transfer from the Pfizer dedicated support team, the Pfizer agent, (name), stated, "I do have a patient on my back line, she has questions regarding Paxlovid. From what it sounds like she's already got her medication, and she already paid for it at the pharmacy." The patient was then transferred to [withheld] for reimbursement assistance. Once the call was transferred, the patient, (name), stated, " I am on Paxlovid My husband and I both have, we both have COVID, and he probably got it a couple of days before I did. So, I'm assuming I caught it from him. Then we didn't test, until it was Thursday of last week, I 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 my doctor called mine in. Well, he went to the pharmacy and got his Then it was several hours later, and the pharmacy called me, and they said that they were out of it when my doctor sent my prescription in ... So finally, they got it filled, and I went to pick it up and when I picked it up, they charged me dollar 47. When asked for the date her medication was purchased, (name) stated " Yes, it was on November the 6th." After advising that an enrollment would need to be completed, (name) stated," Does this mean, I would have to take more Paxlovid if I get sicker or don't get well?" After advising of the options for enrollment, (name) stated, " I don't really feel well enough to answer questions for 25 minutes." When assisting (name) locate the online enrollment form, (name) stated, " My brain's not working" After advising (name) that an account created in Jan2024 was located for her, (name) 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, my husband and I." When offered to be transferred to the Drug Safety Unit, (name) stated, " Well, I think it's working, we're better. Okay, I will. I'm about worn out now, though, but it won't be much longer." (name) continued to state,". I started out with a sore throat, but my husband, he didn't have a sore throat, and he doesn't have one now. But I've still got a terrible sore throat. My throat is very red." After transferring to the Drug safety Unit (name) stated, "just pray for us to get well and this Paxlovid to work."Note to DSU: This source document contains events for two patients (name) and her husband. During this source call only (name) full name, date of birth, phone number, gender and zip code were verbally confirmed. (name) demographic information as well as the prescriber information was obtained from a previous online enrollment created on 31Jan2024. However, it was not confirmed if the prescriber listed is the current prescribing doctor for (name). During this source call it was confirmed that both patients do not share the same doctor. The only information for the second patient verbally provided during this call was (name) husband's gender. It was not confirmed if both of the patient's share any of the same demographic information. This call was warm transferred to Pharmacist (name) with the Pfizer Drug Safety, reference number #. However, the reportable safety information provided to Pharmacist (name) was incorrect. Sending this source document to provide clarity on interaction: This is a two-person event for (name) 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.