Received Feb 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
received Comirnaty/get COVID, symptomatic COVID; received Comirnaty/get COVID, symptomatic COVID; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 04Sep2024 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: Comirnaty (primary immunization series completed), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2025, outcome "unknown" and all described as "received Comirnaty/get COVID, symptomatic COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Feb2025) Positive; (20Feb2025) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient reported two adverse events that basically count as a vaccine failure and as a drug failure. There are three people (one of which is the patient). They all received Comirnaty and religiously got it each year. He has a disabled son, his wife, and him (the patient) managed for the first time to get COVID, symptomatic COVID at the beginning of this month (Feb2025) and they were put on Paxlovid and all of them have had rebound. All of them after coming off Paxlovid got even sicker. The patient became sick in 12Feb when he started taking the Paxlovid and then completed the five days course. He received the vaccine on 04Sep2024. He was positive by BinaxNOW test. When confirmed if all three to them were COVID positive on same date 12Feb2025, the patient confirmed Yes but they all differ a little bit. 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-202500042863 same reporter/drug/event, different patient;US-PFIZER INC-202500042895 same reporter/drug/event, different patient;US-PFIZER INC-202500042863 Same reporter and vaccine and event, different patients.;
Test Date: 20250212; Test Name: BinaxNOW test; Test Result: Positive ; Test Date: 20250220; Test Name: BinaxNOW test; Test Result: Positive