Received Jul 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | HH7595 | LA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 68-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient informed that the vaccine facility type was pharmacy. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing), notes: Prediabetes. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1, batch/lot number: HH7595), administration date: 03Oct2023, when the patient was 66-year-old, for Covid-19 immunization; Bnt162b2 (Primary Immunization series complete), for Covid-19 immunization; Bnt162b2 (dose number unknown (booster)), for Covid-19 immunization; Flu vaccine (about a month prior to that or 6 weeks prior COVID-19 vaccination), administration date: 2024, when the patient was 66 years old, for immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19. Her treatment included Paxlovid. Her prescription was filled on 04Jun. She was diagnosed with COVID on 04Jun and she started the five-day course of the medication that evening of the 4th. She took her last dose on the morning of 09Jun. The first time, she have had the body ache, same amount of fever. She did not run a high fever, it was right at a 100. The information on the batch/lot number for BNT162B2 OMICRON (KP.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Prediabetes