Received Feb 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
anaphylactic reaction to a flu vaccine 5 years ago; Initial information received on 23-Jan-2026 regarding an unsolicited valid serious case received from a patient. This case involves Elderly female patient who had anaphylactic reaction to a flu vaccine 5 years ago after receiving influenza vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Polymyalgia rheumatica and Ehlers-Danlos syndrome. On an unknown date, the patient received unknown dose of suspect influenza vaccine (Unknown strength, formulation, lot and expiry date) produced by unknown manufacturer via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On an unknown date the patient developed anaphylactic reaction to a flu vaccine 5 years ago (anaphylactic reaction) (unknown latency) following the administration of influenza vaccine. Reportedly, The patient had an anaphylactic reaction to a flu vaccine given five years ago Action taken: Not applicable. corrective treatment: Not reported Outcome: Recovered / Resolved on an unknown date for the event. Seriousness criteria: This event was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 26-Jan-2026: This case involves Elderly female patient who had anaphylactic reaction to a flu vaccine 5 years ago after receiving influenza vaccine. Further information regarding event details, latency, past medical history, previous vaccination, allergic history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Ehlers-Danlos syndrome; Polymyalgia rheumatica