Report #2856090

Overview

Sex

Male

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

passed away; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): AE-020540 (BioNTech), 2025SA224373 (Sanofi). A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, hospitalization, medically significant), outcome "fatal", described as "passed away". The date and cause of death for the patient were unknown. No autopsy was performed. Additional information: Initial information received on 30Jul2025 regarding an unsolicited non-valid serious courtesy case received from a consumer/non-hcp (healthcare professional). This case involves an unknown age male patient who began experiencing issues; ended up in the hospital; could not return home immediately and passed away, after receiving Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone high dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza USP Trival A-B high dose Subvirion vaccine Suspension for injection in pre-filled syringe and also received an unknown dose of suspect COVID-19 vaccine not produced by (name withheld) formulation-unknown both with (lot number, strength and expiry date-unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient who began experiencing issues; ended up in the hospital; could not return home immediately (Adverse event NOS) and passed away (Death NOS) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was unknown for the event of adverse event NOS was Fatal for the event of Death NOS. Seriousness Criteria- This event was assessed as medically significant and was leading to death (death NOS). The patient was hospitalized for this event of (Adverse event NOS) and medically significant. Company Comment 04Aug2024: This case involves an unknown age male patient who reported to be began experiencing issues; ended up in the hospital; could not return home immediately and passed away, after receiving Influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone high dose]. Based on available information as no latency, cause of death, autopsy reports, medical history and concomitant medications provided, the event is not assessed to vaccine. Batch/lot number is not provided, and it cannot be obtained. BNT162B2 is under agreement with BIONTECH SE.; Reported Cause(s) of Death: Unknown cause of death