Reporte zur Charge UJ8418A

Symptomtext

reporting that a dose of pentacel was inadvertently administered to a patient who was not age appropriate with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 40 years old male patient who took dose of diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] inadvertently and who was not age appropriate with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Aug-2023, the 40 years old male patient received a 0.5 mL dose of suspect diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot UJ8418A, Expiry date: 09-Feb-2024, Strength: standard, Frequency: once) via intramuscular route in the left deltoid as Immunization and (product administered to patient of inappropriate age) (Latency: same day). First time product used : No Still using product : Yes Action taken was not applicable. At time of reporting, the outcome was 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 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.