Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8820BA | OT / LA |
productive cough; body aches; rhinorrhea; experienced sore throat; chills; Initial information received on 21-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 68 years old male patient who experienced experienced sore throat, chills, rhinorrhea, productive cough and body aches after receiving Influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2025, the patient received 0.5 (unit unknown) of suspect Influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe (lot UT8820BA: strength, and expiry date Not reported) via intramuscular route in the left arm for influenza (Influenza immunization). On 18-Nov-2025 on same day the patient experienced sore throat (oropharyngeal pain) and chills. On 19-NOV-2025 the patient developed rhinorrhea (rhinorrhoea), productive cough and body aches (pain) (latency: 1 day). Action taken: Not applicable. The patient was treated with anti-inflammatories, acetaminophen and decongestant. At time of reporting, the outcome was Unknown for all the events.