Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
patient's heart defibrillator shocked him; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. Other Case identifier(s): 2025SA279798 (Sanofi). A 74-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; sarilumab (KEVZARA), since Jul2025 at 150 mg (150 mg, every other week (qow) strength: 150mg/1.14ml), subcutaneous for polymyalgia rheumatica. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious) with onset 2025, outcome "unknown", described as "patient's heart defibrillator shocked him". The action taken for sarilumab was unknown. Additional information: In Jul2025, the patient started taking KEVZARA (SARILUMAB) Solution for injection (strength: 150mg/1.14ml) at dose 150 mg QOW subcutaneous for Polymyalgia rheumatica. On an unknown date, the patient received a dose of suspect COVID-19 VACCINE not produced by Sanofi Pasteur lot number not reported. On an unknown date in 2025 the patient developed a non-serious event "patient heart defibrillator shocked him" (unknown latency) following the first dose intake (unknown batch number and expiry date) of SARILUMAB. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "patient daughter reported that the patient heart defibrillator shocked him today at 5:30 am. The patient daughter stated that she will let his and know about that. They advised they had Kevzara on hold due to some adverse effects, but now believe it was due to reaction to covid booster. No additional information was provided." It was not reported if the patient received corrective treatment for the event (Patient's heart defibrillator shocked him). At time of reporting, the outcome was Unknown for the event patient's heart defibrillator shocked him. Additional information was received on 19-Sep-2025 from patient: New suspect COVID-19 VACCINE added. Text amended. Company causality for drug KEVZARA and event reported as not related. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
KEVZARA