Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | U8875AA | IM / RA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U875AA | OT / RA |
administration of fluzone hd to a patient younger than 65 with no reported ae; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 47 years old female patient who administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U875AA, expiry date: 30-Jun-2026, strength: high, frequency: once, via intramuscular route in the right arm for Influenza with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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.