Received Dec 6, 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, Program ID. An 82-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 27Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The clinical course was reported as follows: The patient had received the Pfizer booster on and he was generally a reasonably healthy individual for his age. However, he was surprised by how strongly that round of COVID knocked him. He had needed nirmatrelvir, ritonavir (PAXLOVID) basically on an emergency basis Friday evening. His doctor had said that he might need a follow-up when he saw her that morning and could require a second prescription. Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.