Reporte zur Charge UJ653AAB

Symptomtext

patient administered acthib with expired diluent with no reported adverse events; Initial information received on 11-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional). This case involves a patient of an unknown age and gender who was administered HIB (PRP/T) VACCINE [ACT-HIB] with expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (Vaccine-lot number: UJ653AAB; Expiry date: 24-Apr-2023) (Diluent: Lot number- U7261AD, expiration date: 07-Apr-2023) (with an unknown strength) via unknown route in unknown administration site for Immunization. On 10-Apr-2023, the patient developed a non-serious patient was administered HIB (PRP/T) VACCINE with expired diluent with no reported adverse event (poor quality product administered) (Latency: same day). It was reported, Caller states the expiration on the diluent and vaccine have different expiration dates. Caller states a physician was looking at the expiration date on the vaccine (24APR2023) and gave the vaccine to a patient not realizing that the diluent expired on (7APR2023). Wanting to know next steps to take and any harm to patient. Caller does not have patients information at time of call.This situation is reported as a medication error due to ACTHIB being administered to a patient that was reconstituted with expired diluent 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 guidelines. 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.