Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) | SANOFI PASTEUR | UNK | — | OT |
caused more injection-site reactions than standard-dose influenza vaccines; Initial information received on 28-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who had injection-site reactions than standard-dose influenza vaccines after receiving influenza quadrival A-B high dose HV vaccine [fluzone high-dose quadrivalent]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received Unknown dose of suspect influenza quadrival A-B HIGh dose HV vaccine (Unknown strength, formulation, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) On an unknown date the patient developed injection-site reactions than standard-dose influenza vaccines (vaccination site reaction) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine. Information on the batch number was requested corresponding to the one at time of event occurrence Action taken was not applicable. It was not reported if the patient received corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.