Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874BA | OT |
pain underneath her shoulder blade, down her arm especially the triceps, and under her armpit on the side where the vaccine was administered; pain in back; Initial information received on 05-Dec-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 66 years old female patient who experienced pain underneath her shoulder blade, down her arm especially the triceps, and under her armpit on the side where the vaccine was administered and pain in back 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 20-Nov-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: U8874BA; expiry date: 30-Jun-2026) via unknown route in unknown administration site for Influenza Immunisation. On 22-NOV-2025 the patient had pain underneath her shoulder blade, down her arm especially the triceps, and under her armpit on the side where the vaccine was administered (pain in extremity) (latency: 2 days). On an unknown date in NOV-2025 the patient had pain in back (back pain) (latency: few days). It was reported, "Patient is already 67 years old at the time of call." Action taken was not applicable. The patient was treated with Ibuprofen (Motrin) and Paracetamol (Tylenol) for both events. At time of reporting, the outcome was Not Recovered / Not Resolved for both events.