Reporte zur Charge U7172AB

Symptomtext

3 doses of acthib administered to patients, but the diluent was expired (10/29/2022),with no reported adverse event; Initial information received on 10-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender of patients who had 3 doses of HIB (PRP/T) VACCINE [ACT-HIB] administered, but the diluent was expired (10/29/2022),with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE (lot U7172AB and expiry date: 29-Oct-2022, lot: UJ604AA and expiry date: 29-Oct-2022, lot:UJ604AA expiry date: 29-Oct-2022) via unknown route in unknown administration site for immunization. On an unknown date the patient developed a non-serious event of 3 doses of acthib administered to patients, but the diluent was expired (10/29/2022),with no reported adverse event (expired product administered) (latency: same day) following the administration of HIB (PRP/T) VACCINE. Nurse was asking if there was any information to why the diluent's expiration date was sooner than the actual medication and she said it was a waste to discard the powder component if it was not expired. It was used first time. Action taken : not applicable. Outcome: Unknown 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.