Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
pain is in her left hip; pain is in her both upper arms, and her fingers; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves 85 years old female patient who had pain in her left hip and pain in her both upper arms, and her fingers 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 02-Sep-2025, the patient received a dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (once) (lot number, strength, 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 03-SEP-2025 the patient developed pain in her left hip (arthralgia) and pain is in her both upper arms, and her fingers (pain in extremity) (latency- 1 day). It was reported, ''Caller is reporting that she received a FLUZONE HD last month, but she has been really sick, next to disabled, ever since she received the vaccine. We asked for her to describe her symptoms, and she stated it was "painful". She said it looks like arthritis all over, though she did not mention any physical appearance symptoms. She said it started with pain the day after her injection and it has continued since. Caller said the pain is in her both upper arms, her left hip, and her fingers. She thought it would go away after a few days but it has stayed with her. Caller stated she wished she had never gotten the shot. We asked if she had reached out to her doctor about it, and she said yes. The provider told her she would have to get started with physical therapy. She did not say the doctor gave her any other advice or treatment''. Action taken was not applicable. It was not reported if the patient received corrective treatment for both the events. At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.