Reporte zur Charge UJ651AA

Symptomtext

expired dose of PENTACEL being administered with no adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old female patient who had been administered with expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and Rotavirus vaccine live reassort oral 5V (Rotateq). On 01-Mar-2023, the patient being administered with an expired dose 2 of 0.5 ml once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection with no adverse event (expired product administered) (lot: UJ651AA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh with standard strength for immunization. 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.