Received Mar 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 1 | — | OT |
2nd dose given before 4 week mark with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old and unknown gender patient who received 2nd dose of influenza quadrival A-B multidose vaccine preserved [Fluzone] before 4 week mark with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Jan-2025, the patient received an unknown dose 1 of influenza quadrival A-B multidose vaccine preserved Suspension for injection (strength, expiry date and lot number not reported) via intramuscular route in unknown administration site for influenza protection (Influenza immunisation). On 31-Jan-2025 patient also received an unknown dose 2 of same vaccine with an unknown batch number via intramuscular route in unknown administration site for Influenza immunization before 4-week mark with no reported adverse event (inappropriate schedule of product administration) (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.