Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8837CA | OT |
during administration, and the patient had exposure to the vaccine dripping down their arm when the syringe malfunctioned with no reported adverse event; during administration, and the patient had exposure to the vaccine dripping down their arm when the syringe malfunctioned with no reported adverse event; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this case US-SA-2025SA346520. This case involves an unknown age and unknown gender patient who was exposed with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose]while administration, vaccine dripping down their arm when the syringe malfunctioned with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date In Oct-2025, the patient was exposed with an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8837CA, expiry date:30-Jun-2026, strength not reported via unknown route in unknown administration site for Influenza, vaccine dripping down their arm when the syringe malfunctioned with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency: same day). It was reported "The liquid came out the base instead of the needle tip. Caller asked about credit/reimbursement for these vaccines" 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.; Sender's Comments: US-SA-2025SA346520: