Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
could not sleep at night; husband also had a cough, was coughing so much; runny nose; Initial information received on 24-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case is linked to US-SA-2025SA355066 this case. This case involves a 85 years old male patient who could not sleep at night, also had a cough, was coughing so much and runny nose 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 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 on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date In 2025 the patient could not sleep at night (insomnia), ad a cough, was coughing so much (cough) and runny nose (rhinorrhoea) (latency: few days approximately). 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. Now patient also reported that her husband also got a flu shot which she also had on the same day and the husband also had a cough and runny nose. The patient's husband was not sick as she but the he was coughing so much night". Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.; Sender's Comments: US-SA-2025SA355066:patient's husband 02733319