Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8792MA | IM / LL |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8792MA | OT / LL |
a 2-month-old patient that was given the full dose of FLUZONE NP with no adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who was given the full dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 29-Oct-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8792MA, expiry date 01-Jun-2026, frequency once and strength standard) via intramuscular route in the left thigh for Influenza (Influenza immunization) and 2-month-old patient that was given the full dose of fluzone np with no 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.