Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
had all the symptoms of flu; had runny nose; cough; Initial information received on 24-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case is linked to US-SA-2025SA355292 and US-SA-2025SA359058 This case involves 92 years old female patient who had all the symptoms of flu, runny nose and cough 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. List of concomitant or no other vaccines: No other vaccines On 21-Oct-2025, the patient received a standard dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (Frequency = Once) (lot number, expiry date- not reported) via unknown route in unknown administration site for Influenza (Influenza immunization). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. On 22-OCT-2025 the patient had all the symptoms of flu (influenza like illness); had runny nose (rhinorrhoea) and cough (latency- 1 day). It was reported, ''Caller was injected with a flu shot for seniors and her doctor only told her it's a Sanofi flu shot for seniors. She had the shot on 21Oct2025, and she got sick the next day. She did not have a fever but she felt terrible. Her nose run and she is still coughing and when she cough, her nose runs. Patient stated that she never had that problem so patient is curious if that is a normal thing after receiving the shot''. 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 Not Recovered / Not Resolved for the events.; Sender's Comments: US-SA-2025SA355292:patient's husband 02733319 US-SA-2025SA359058:for young girls 02733322