Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
she has insulin-dependent type-2 diabetes and is fragile; she has insulin-dependent type-2 diabetes and is fragile; took Pfizer covid-19 vaccine and she is immunocompromised; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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 (Primary Immunization series completed.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS (medically significant), DIABETES MELLITUS INADEQUATE CONTROL (medically significant), outcome "unknown" and all described as "she has insulin-dependent type-2 diabetes and is fragile"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "took Pfizer covid-19 vaccine and she is immunocompromised". Clinical information: The patient was interested in information regarding whether Comirnaty (2025-2026 formula) was a combination vaccine (either COVID-19 and influenza or COVID-19 and RSV). Caller did mention that, to her understanding, there was a combination vaccine that passed one clinical phase and failed another (Phase 2 or Phase 3) and expressed interest in this information because she has an appointment with her PCP today and wants information regarding the vaccines she needs and the required timing between these before she goes to the appointment, as she wants to be best informed. Caller also stated that she has insulin-dependent type-2 diabetes and is fragile and has also had all the [Pfizer] COVID-19 vaccines, because it is the only company she trusts. caller took Pfizer covid-19 vaccine and she is immunocompromised. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.