Reporte zur Charge UJ646AA / U7251

Symptomtext

The HIB itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event; Initial information received on 26-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1-year-old male patient, the hib (HIB (PRP/T) VACCINE [ACT-HIB]) itself was ok with exp (expiry) date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event. The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 14-Mar-2023, the patient received a dose number: 3 of an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (expiry date: o4-Jan-2023) (lot: UJ646AA / U7251AA) via intramuscular route in unknown administration site for prophylactic vaccination. On 20-Mar-2023 the patient had an event of the hib itself was ok with exp date of 04/01/2023 but the diluent had an expiration date of 03/05/2023 with no reported adverse event (expired product administered) (latency: 6 days) following the administration of HIB (PRP/T) VACCINE. There were no lab data/results available. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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.