Reporte zur Charge UJ289AA

Symptomtext

inadvertently vaccinated with an expired dose of ACT-HIB with no reported adverse event; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender 9 patients who were inadvertently vaccinated with an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In 2017, the 9 patients were inadvertently vaccinated with an expired dose of dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ289AA, expiry date- 05-SEP-2016) (with an unknown dosage and strength) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Reportedly, Caller requested guidance on how to proceed. Caller declined to provide an e-mail address and would not give any further patient information. 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.