Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
heart valve replacement; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-791486 (Moderna). A patient (age and gender not provided) 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 included: "Diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEART VALVE REPLACEMENT (medically significant), outcome "unknown". Clinical course: The reporter was reaching out to obtain information on mNEXSPIKE. The reporter stated that the patient normally receives Pfizer COVID-19 vaccine, but when went to book an appointment at pharmacy noted that Moderna now has both mNEXSPIKE and Spikevax available. They wanted to get some additional information about the vaccine before goes to talk to doctor about which one should get. The reporter stated that both and are diabetic, and that recently had a heart valve replacement. The reporter also stated that the patient hasn't had a lot of side effects from the vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Diabetic