Reporte zur Charge UJ887A

Symptomtext

flublok quad was accidentally given to 2 patients under the age of 18, with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2022SA418789(CLUSTER). This case involves a 16 years old female patient to whom influenza quadrivalent recombinant vaccine [flublok] was accidentally given under the age of 18 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2022, the patient under the age of 18 received a dose of 1 DF (dosage form) total of standard suspect influenza quadrivalent recombinant vaccine with no reported adverse event (product administered to patient of inappropriate age) with an unknown formulation (lot UJ 887AA, expiry date- 09-Jun-2023) via intramuscular route in the left deltoid for immunization. (latency: same day) Action taken: not applicable. Outcome Unknown 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.