Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
couple of inches above her husband's knee caps were swelling; administration of a double dose to an immunocompromised patient.; Initial information received on 14-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp(non-healthcare professional). This case involves a 71 years old male patient who was administered to double dose to an immunocompromised patient and couple of inches above knee caps were swelling 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. At the time of the event, the patient had ongoing Immunodeficiency. On 04-Nov-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date not reported) (frequency twice and strength High Dose) via unknown route in unknown administration site for Influenza(influenza immunization), administration of a double dose to an immunocompromised patient. (off label use)(latency same day). On 05-Nov-2025, the patient developed couple of inches above her husband's knee caps were swelling (joint swelling) (latency 1 day) following the administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine. It was reported- Caregiver said a couple of inches above her husband's knee caps were swelling, it did not hurt but it was swollen for a few days. She did not specify where the dose was administered. Caregiver was told by the pharmacist that people commented about experiencing swelling above the knees. Caregiver wanted to know if there have been any report of people who experienced swelling around the knee area for her to find out if it's a problem with her husband's body or if it's a side effect. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event(joint swelling). At time of reporting, the outcome was Unknown for the event (joint swelling).; Sender's Comments: US-SA-2025SA347004:
Immunocompromised