Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
whole arm is swollen, it was all swollen like a very bad reaction; had severe reaction in his arm, whole arm is hot and red; had severe reaction in his arm, whole arm is hot and red; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Healthcare Professional). This case involves a 4 years old male patient who had whole arm is swollen, it was all swollen like a very bad reaction and had severe reaction in his arm, whole arm is hot and red while receiving Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Sep-2025, the patient received a dose (0.5ml) of suspect Influenza USP Trival A-B Subvirion no Preservative Vaccine; Suspension for injection (lot number, strength, dose and expiry date not reported) via unknown route in the arm non (not otherwise specified) for Influenza. Information on the batch number was requested corresponding to the one at time of event occurrence. On 29-SEP-2025 the patient whole arm is swollen, it was all swollen like a very bad reaction (vaccination site swelling) and had severe reaction in his arm, whole arm is hot and red (vaccination site warmth) and (vaccination site erythema) (latency: same day) Action taken was not applicable. Received steroids as corrective treatment for all the events. At time of reporting, the outcome was Unknown for all the events.