Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764BB | OT |
warm just below the injection site; had a red reaction just below the injection site; small, puffy, swollen just below the injection site; Initial information received on 13-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves an unknown age female patient who had a red reaction, small, puffy, swollen and warm just below the injection site 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 11-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 and expiry date: 30-Jun-2026) (strength not reported) via unknown route in unknown administration sit for influenza. On an unknown date in Aug-2025, the patient had a red reaction, small, puffy, swollen, warm just belowthe injection site (vaccination site erythema) (vaccination site swelling) (vaccination site warmth) (latency: Few days approximately). 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 all the events.