Received Aug 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764BB | OT |
Flu-like symptoms; had a fever sore muscle; had a fever sore muscle; still have a bad cough; felt very weak and they could not function; sore throat; Initial information received on 22-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case involves a 72 years old female patient who had Flu-like symptoms, sore throat, felt very weak and they could not function, had a fever sore muscle, had a fever sore muscle and still have a bad cough after receiving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Aug-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8764BB, expiry date 30-Jun-2026, strength not reported) via unknown route in unknown administration site for Influenza. On 19-Aug-2025, the patient developed sore throat (oropharyngeal pain) (latency 11 days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. On 20-Aug-2025, the patient developed felt very weak and they could not function (asthenia) (latency 12 days) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. On an unknown date, the patient developed had a fever sore muscle (pyrexia), had a fever sore muscle (myalgia) and still have a bad cough (cough) and Flu-like symptoms (latency unknown) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. 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 Unknown for the event (Oropharyngeal pain), (Asthenia), (Myalgia), (Flu-like symptoms) was Not Recovered / Not Resolved for the event (cough) and was Recovered / Resolved on an unknown date for the event (Pyrexia).