Reporte zur Charge UJ4168A

Symptomtext

given expired PENTACEL vaccine to a child with no reported adverse event; Initial information received on 23-Mar-2022 regarding an unsolicited valid non-serious case received by a health professional via call center. This case involves a child of unknown demographics who was given expired Pentacel with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (form, strength: unknown; lot UJ4168A and expiry date: 12-Mar-2022) via unknown route in unknown administration site as prophylaxis. On an unknown date (Latency: unknown), Nurse had given expired Pentacel vaccine to a child with no reported adverse event (expired product administered). Action taken: Not applicable. Event 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 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.