Reporte zur Charge UJ384ABA

Symptomtext

Expired dose of ACT-HIB was administered with no reported adverse event; Initial information received on 25-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via Media information (under the reference: 00826716). This case involved a 15-month-old and patient receiving HIB (PRP/T) VACCINE [ACT-HIB] 4 days after the expiration date of the vaccine (expired product administered). On an unknown date, the patient received dose of suspect HIB (PRP/T) VACCINE [lot UJ384ABA, expiration date: 15-Oct-2021] via an unknown route at the unknown administration site for prophylactic vaccination It was a case of actual medication error due to expired vaccine use. (latency: same day) It was reported "Caller states a dose of ACT-HIB was administered 4 days after the expiration date of the vaccine. Caller was looking for information in regard to possible adverse effects as well as if they need to re-vaccinate." At the time of report, no adverse event reported. This suspected adverse reaction report was 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 was 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.