Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
died of complications; Guillain Barre; Initial information received on 28-Oct-2025 regarding an unsolicited valid serious case received from a physician. This case involves Elderly male patient who had guillain barre and died of complications 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 unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation). On an unknown date the patient developed guillain barre (guillain-barre syndrome) and died of complications (death) (unknown latency) following the administration of influenza USP TRIVAL A-B high dose subvirion vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for the events (Guillain-Barre syndrome). At time of reporting, the outcome was Unknown for the event guillain barre and was Fatal for the event died of complications. It is unknown if an autopsy was done. The cause of death was reported as unknown. Seriousness criteria: These events were assessed as medically significant and the event death was leading to death.; Sender's Comments: Sanofi company comment dated 03-Nov-2025: This is an initial report of a serious listed event with fatal outcome. An elderly male patient (specific age unknown) developed Guillain-Barré syndrome (GBS) with unknown TTO after vaccination. The patient subsequently died of unknown complications. Temporal association cannot be assessed due to lack of vaccination and event onset dates. No medical history or concomitant medications were provided. No information regarding clinical course, diagnostic confirmation of GBS, or specific complications leading to death was reported. The cause of death was reported as unknown, and no death certificate or autopsy information was provided. The role of the suspect vaccine cannot be assessed due to lack of information. More complete information is needed regarding vaccination date, event onset, medical history, clinical course, diagnostic confirmation of GBS (per Brighton Collaboration Case Definition criteria), and specific cause of death. Based on the limited information provided, this case is classified as "Reported GBS with insufficient evidence to meet the case definition" according to the Brighton Collaboration Case Definition. Known potential risk of GBS is monitored by routine PV activities, SET meetings and PBRERs; Reported Cause(s) of Death: died of complications.