Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID-19; COVID; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old female 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE NUMBER UNKNOWN, SINGLE), for Covid 19 immunization; Covid 19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Manufacturer unknown), for Covid 19 immunization. The following information was reported: COVID-19 (medically significant) with onset 08Sep2025, outcome "unknown", described as "COVID"; DRUG INEFFECTIVE (medically significant) with onset 08Sep2025, outcome "unknown", described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caller would like to know if Paxlovid would still do anything for the patient if they've been diagnosed with COVID and it's past 5 days. Caller provided a brief history: both she and her husband were diagnosed with COVID yesterday. Her husband has been sick since thursday, and she just really developed symptoms on sunday. Neither one of them has a temperature (fever). Caller said they were prescribed Paxlovid and she is under the impression from everything she's read and heard. She is aware that the medication should be started within the 5-day period of symptom onset. Caller said that her husband is already past that since he had it since thursday, so she would like to know if it would help him at all or not. They haven't started taking the medication. Caller mentioned that they have no fever and are outside of the symptom window. Both she and her husband have been fully vaccinated, including some shots from Pfizer. She is asking if they might have developed some immunity to COVID-19. PMI offered DSU transfer, caller declined. DSU: e-transmitting potential AE; Caller declined DSU transfer. Question: Caller mentioned that they have no fever and are outside of the symptom window. Both she and her husband have been fully vaccinated, including some shots from Pfizer. She is asking if they might have developed some immunity to COVID-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500179020 Same reporter/product/event, different patient;