Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | UT8770JA | OT / RL |
gave a 3-and-a-half-month-old patient a FLUZONE NP with no adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves 3 and a half months old female patient who received a 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 08-Oct-2025, the patient received dose 1 of 0.5 ml of suspect influenza USP trival A-B subvirion NO preservative vaccine Suspension for injection of standard strength with lot UT8770JA and expiry date 30-Jun-2026 via intramuscular route in the right thigh for Influenza (Influenza immunisation) with no adverse event (product administered to patient of inappropriate age) (Latency same day). Reportedly, reporter mentioned that she gave a 3-and-a-half-month-old patient a fluzone NP, which they are not supposed to get until 6 months 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.