Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | U881DA | OT / LA |
administration of 2 doses of fluzone np/received second administration by mistake with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old male patient who was administered with 2 doses of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] and second administration was by mistake with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2025, the patient was administered with 2 doses of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U881DA, Strength: standard, Frequency: once, expiry date:30-Jun-2026, via intramuscular route in the left deltoid for Influenza [Immunisation], and second administration was by mistake with no reported adverse event (extra dose administered) (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.