Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8804CA | OT / RA |
FLUZONE HD was accidentally given to a 21-year-old, with no reported adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old female patient who was accidentally given to 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. Concomitant medications included Elasomeran (Spikevax) for Immunisation. On 28-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot UT8804CA, expiry date 30-Jun-2026, frequency once and strength Fluzone High Dose) via intramuscular route in the right deltoid for Immunisation and was accidentally given to a 21-year-old, 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.
Spikevax