Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8875BA | OT / RA |
when she pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event; when she pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event; Initial information received on 27-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age male patient who was administered INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and when administering physician pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other immunizations. On 20-Oct-2025, the patient received a dose of 0.5 ml once of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) (lot: U8875BA; expiry date: 30-Jun-2026; strength: high dose) via intramuscular route in the right arm for Immunization and when administering physician pushed the retraction button, the retraction mechanism broke, the little bit that was left sprayed out, and got on the patient's skin with no adverse event (exposure via skin contact) (accidental exposure to product) (latency: same day). It was reported, "The patient is concerned that he did not get the full dose, though the administering technician believes she did. Caller states there is always a little bit left in the hub and needle, and believes that was all that had sprayed out, as the needle was fully in the patient's arm for the administration of the dose. The retraction button broke after the dose was given. 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.