Reporte zur Charge UJ569AAA

Symptomtext

have administered expired PENTACEL to a patient with no reported AE; Initial information received on 11-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient of unknown demographics who received vaccine DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE [PENTACEL] and it was reported that have administered expired pentacel to a patient with no reported ae (adverse event) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2022, the patient received an unknown dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (formulation, strength: unknown) lot UJ569AAA, expiration date: 02-Oct-2022 in unknown administration site as Immunization. On 10-OCT-2022 the patient was administered expired pentacel with no reported ae (expired product administered) same day following the administration of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (have administered expired PENTACEL to a patient with no reported AE). 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.