Symptomtext
expired PENTACEL vaccine was administered with no reported adverse event; Initial information was received on 28-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 an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) and rotavirus vaccine LIVE ORAL 1V (Rotarix) for Prophylactic vaccination. On 28-Sep-2023, the patient received a 0.5 ml, once (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ682AA, expiry date: 16-Sep-2023, strength: standard) via intramuscular route in Right thigh for Immunization and administered an expired vaccine 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. 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.