Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | TFAA2429 | OT |
administration of FLUBLOK to a 7 month old patient (with no reported adverse event); Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8-month-old female patient who received Influenza trivalent recombinant vaccine [Flublok TIV] (with no reported adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Mar-2025, the patient received 0.5ml dose of suspect Influenza trivalent recombinant vaccine Solution for injection , once (strength-standard) (lot TFAA2429) (expiry date-30-Jun-2025) via intramuscular route in left leg for Immunization (with no reported adverse event) (product administered to patient of inappropriate age) (latency-same day). Action taken with 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.