Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8830BA | OT |
he received a FLUZONE HD vaccine and it didn't work/he has the flu now; he received a FLUZONE HD vaccine and it didn't work/he has the flu now; Initial information received on 17-Dec-2025 regarding an unsolicited valid serious case received from a Patient along with live follow up received on same date, both documents were processed together. This case involves a 83 years old male patient who received a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] and it didn't work/he has the flu now. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Oct-2025 or 09-Oct-2025 the patient received suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine dose 0.5 ml 1x(once) Suspension for injection in pre-filled syringe, expiry date:30-Jun-2026, strength not reported, lot U8830BA via unknown route in unknown administration site for prophylactic vaccination (Immunization). On an unknown date in 2025 he received a fluzone hd vaccine and it didn't work/he has the flu now (vaccination failure) (influenza) (unknown latency). Reportedly, Patient called to confirm that he believes the product did not work because he has flu symptoms now. He confirmed that he did not experience any technical issues during the injection process and everything seemed to function correctly. Based on the patient's confirmation, this case is classified as a No PTC as there was no malfunction or defect with the product itself. Action taken- not applicable. It was not reported if the patient received a corrective treatment for the events At time of reporting, the outcome was Not Recovered / Not Resolved for both the events. Seriousness criteria-Medically significant for vaccination failure Additional information was received on 18-Dec-2025 from Patient: suspect expiry date has been added and clinical course has been updated, text amended accordingly.; Sender's Comments: Sanofi Company Comment follow-up dated-18-Dec-2025:This case involves a 83 years old male patient who received a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] and it didn't work/he has the flu now. Further information regarding exact latency,concurrent condition during vaccination, previous vaccination history,past medical history, medical treatment(s), family history , concomitant medication and tolerance, underlying conditions,allergic history, laboratory investigations are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.