Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
stated her daughter's friend got flublok and she wasn't 18 yet with no reported adverse event; Initial information received on 07-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer. This case involves an unknown age female patient who had received Influenza Trivalent Recombinant Vaccine [Flublok TIV] and she wasn't 18 yet with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the less than 18 years old patient received a unknown dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly: "Caller refused to provide event information without her friend's approval." Action taken: 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.