Reporte zur Charge UJ674AB

Symptomtext

ACTHIB was administered to 6 patients and the diluent supplied was expired with no reported adverse event; Initial information received on 12-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 patients who were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired 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 patients received a dose of 0.5 ml once of suspect HIB (PRP/T) VACCINE (Powder and solvent for solution for injection) (LYOPHILIZED POWDER LOT: UJ674AB, EXP: 04-Jun-2023; DILUENT LOT # U7261AA, EXP: 07-Apr-2023; strength: standard) via unknown route in unknown administration site for immunization. On an unknown date 6 patients were administered HIB (PRP/T) VACCINE [ACT-HIB] and the diluent supplied was expired with no reported adverse event (expired product administered) (latency: same day). It was reported, "They are declining to provided any patient information citing possible HEPA violations. Caller is upset stating that Sanofi supplied these vaccines but the expiration dates are different. Caller is asking if the vaccines can be replaced. Caller is questioning the use of alternative diluents with the product and ask is this a contamination issue with the expired diluent. Caller is requesting a case summary to be emailed. Caller was attempting to justify the use of the diluent and states, "it is bad on you all" for supplying the product with different expiration dates on the diluent. Caller asks, "Am I going to get in trouble?" Action taken was not applicable. At time of reporting, the outcome was Unknown for the event. 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.