Symptomtext
expired pentacel was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient to whom expired pentacel was administered with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Sep-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection lot UJ752AAA, expiry date: 09-Sep-2023 via unknown route in unknown administration site for prophylactic vaccination (strength and dose: unknown), expired pentacel was administered to a patient with no reported adverse event (expired product administered) (latency same day). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired product administered 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.