Reporte zur Charge UJ797AA/ /UJ801

Symptomtext

2 patients received ACT-HIB vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) with no reported adverse event; Initial information received on 23-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves unknown age and unknown gender patient's and reporter reported 2 patients received Hib (Prp/T) Vaccine [Act-Hib] vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) 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's received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot number: UJ797AA/ /UJ801AA; Expiry date: 09-Oct-2023) via unknown route in unknown administration site for immunization. On an unknown date, the reporter reported 2 patients received Hib (Prp/T) vaccine that was mixed incorrectly with a different diluent percentage (0.9% sodium chloride) with no reported adverse event (product preparation error) (latency: same day). It was reported, nurse who asked if 0.9% NaCl diluent can be used to mix ActHIB. She has already reported two patients who received ActHIB mixed with 0.9% sodium chloride to VAERS. Additional Description of event Adverse events :Nurse reported 0.9% NaCl diluent was used to mix ActHIB. She has already reported two patients who received ActHIB mixed with 0.9% sodium chloride diluent to VAERS. 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.