Received Aug 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP. A 45-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 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2025, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2025) Positive. Additional Information: During an inbound call for financial assistance, the patient stated, she actually tested positive today for COVID, her doctor sent in a prescription for Paxlovid for her because she had a lot of other medical conditions and she just got out the hospital for one of them. Her insurance wasn't approving Paxlovid. She guesses that's stopped or something How do she could get help getting the antibodies, the Paxlovid, because she means, she had been vaccinated. She got the Pfizer vaccines. She was getting sick" Additionally she stated, "she's antigen...she has got two dogs that she need to make sure survive, so she guessed she should probably survive too." Toward the end of the call, she stated, This is the first time she had ever gotten COVID, and she didn't even leave her house. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Test Date: 20250811; Test Name: Covid 19 Test; Test Result: Positive