Reporte zur Charge UJ807AAA

Symptomtext

due to product leaking and patient not receiving full dose with no adverse event reported; Initial information received on 13-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who due to product leaking and patient not receiving full dose with no adverse event reported while receiving diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)]. 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), rotavirus vaccine live reassort oral 5V (Rotateq) and hepatitis B vaccine (HEPATITIS B VACCINE) for Prophylactic vaccination. On 06-Mar-2023, the patient received a dose 1 at 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection, (lot number: UJ807AAA; expiry date: 08-Oct-2023) via intramuscular route in the left thigh for immunisation. On 06-Mar-2023, due to product leaking and patient not receiving full dose with no adverse event reported (incorrect dose administered) (latency: same day) following the administration of diphtheria/tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine. It was reported as there is a discrepancy between nurse and parent, nurse reports full administration but the parent reports product leaking and patient not receiving full dose. No details on amount or where the leaking occurred due to full administration reported from staff. No lab data was reported. 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 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.