Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | 2 | U8881AA | OT / LL |
vaccine administration incident where a 10-month-old patient received their very first dose of FLUZONE NP on 17Sep2025 and received the second dose on 24Sep2025, with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a vaccine administration incident where a 10 months old female patient received their very first dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone) on 17sep2025 and received the second dose on 24sep2025, with no reported adverse event while receiving vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis B Vaccine. On 17-Sep-2025, the patient received a Dose 1 (0.5ml) suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine; Suspension for injection (lot U8881AA with expiry date 30-JUN-2026) with unknown (strength) via intramuscular route in the left thigh. On 24-Sep-2025 she also received a Dose 2 (0.5ml) of vaccine with an unknown (batch number and expiry date) via intramuscular route in the left thigh for Influenza; vaccine administration incident where a 10-month-old patient received their very first dose of fluzone np on 17sep2025 and received the second dose on 24sep2025, with no reported adverse event (inappropriate schedule of product administration) (latency: 7 days) Reportedly: Nurse mentioned that the doctors are wondering since the vaccines were only given a week apart from one another, does the patient need to have another dose and if so, when do they need to receive it. Regulatory Authority provided information from the attached SRD. 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.
HEPATITIS B [HEPATITIS B VACCINE]