Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | U8837BA | OT / LA |
patient was "moving their arm" during administration/vaccine administered at less than the approved dose with no AE; Initial information received on 24-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who moved his arm during administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone HD] and less than the approved dose was administered at with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Oct-2025, the patient while receiving 0.5ml dose 1 of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8837BA and expiry date 30-Jun-2026 via intramuscular route in the left deltoid for Immunization moved his arm and less than the approved dose was administered at with no reported adverse event (incorrect dose administered) (latency Same day). Reportedly, the patient was "moving their arm" during administration and confirmed that the prefilled syringe was not damaged. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.