Reporte zur Charge UJ8778AA

Symptomtext

given pentacel to a patient using only the liquid component, without the hib component with no reported adverse event; Initial information received on 19-Jul-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who was given only the liquid component of diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)], without the HIB component with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitants: None On 19-Jul-2023, the patient received 0.5 mL dose 2 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard) (Batch number: UJ8778AA; Expiry date: 22-Mar-2024) via intramuscular route in the left thigh for Immunization only the liquid component was given, without the hib component with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event product preparation error. 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.