Reporte zur Charge UJ973AA

Symptomtext

medication error/an inappropriate use due to the administration of an expired product with no reported adverse event; Initial information received on 20-Nov-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 1-year-old female patient and the reporter reported medication error/an inappropriate use due to the administration of an expired product HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 03-Nov-2023, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (strength: unknown) (lot: UJ973AA, expiry date: 07-Oct-2023) via intramuscular route in the thigh nos for Immunization and medication error/an inappropriate use due to the administration of an expired product with no reported adverse event (expired product administered) (latency: same day). 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 and Regulatory Authority 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.