Reporte zur Charge UJ328AF

Symptomtext

The patient was given expired ACTHIB, with no reported adverse event; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case from a physician. This case involves a 15-month-old female patient who was given expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product used). The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination. On 26-Jul-2021, the patient received fourth dose of suspect HIB (PRP/T) VACCINE (lot UJ328AF and which was expired on 29-Jun-2021) via intramuscular route at an unknown administration site for prophylactic vaccination (expired product used). It was reported that, "caller reports patient was given expired ACTHIB; caller would like instruction on how to proceed." It was a case of an actual medication error due to expired vaccine used (same day). At time of reporting no adverse event was reported. 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.