Reporte zur Charge U7171AA

Symptomtext

ACTHIB that was administered to a patient after the expiration date, however the patient supposed to receive Pentacel, with no reported adverse event; ACTHIB that was administered to a patient after the expiration date, however the patient supposed to receive Pentacel, with no reported adverse event; Initial information received on 13-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp). This case involves a 2-month-old female patient to whom HIB (PRP/T) VACCINE [ACT-HIB] that was administered after the expiration date, however the patient supposed to receive Pentacel, 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 patient was administered 0.5ml total dose of suspect HIB (PRP/T) VACCINE Strength: standard (formulation: unknown) (lot number: U7171AA expiry date: 26-Oct-2022) in unknown administration site for Immunization, after the expiration date (expired product administered), however the patient supposed to receive Pentacel (strength, formulation, route, dose, lot: unknown), with no reported adverse event (wrong product administered) (latency: unknown). It was reported, wanting to know next steps to take. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) and DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable. At time of reporting, the outcome was Unknown for both events. 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.