Received Mar 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | — | OT |
administration of the second dose of FLUZONE NP one week earlier than the minimum interval, with no reported advrse event; Initial information received on 11-Mar-2025 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 had administration of the second dose of Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] one week earlier than the minimum interval, 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 (dose 1) and on 31-Jan-2025, (dose 2) of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine (unknown strength, dosage, expiry date, formulation, batch number and route) via unknown administration site for prophylactic vaccination was administration of the second dose of fluzone np one week earlier than the minimum interval, with no reported adverse event (inappropriate schedule of product administration) (latency-22 days). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly, Medical assistant wanted to know if the patient was going to be okay and if they need an additional dose if the second dose was one week too early. They also asked what to do if the patient was not able to receive the second dose of FLUZONE NP four weeks from the invalid dose.They said that they still have patients to attend to and disconnected from the call. 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.