Reporte zur Charge UJ636AA

Symptomtext

extra dose of ACTHIB was inadvertently administered to a patient with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old and unknown gender patient to whom extra dose of HIB (PRP/T) VACCINE [ACT-HIB] was inadvertently administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Nov-2022 extra dose 0.25 ml (once) dose of suspect HIB (PRP/T) VACCINE (formulation: unknown) (lot UJ636AA , strength, standard) via unknown route in the thigh NOS (not otherwise specified) for immunization was inadvertently administered to a patient with no reported adverse event (extra dose administered) (latency: same day). Action taken: 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 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.