Reporte zur Charge UJ7948B

Symptomtext

expired pentacel has been administered to a patient with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient and reporter reported that patient has been administered expired diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] 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 Hepatitis A Vaccine (Hepa [Hepatitis A Vaccine]); Pneumococcal Vaccine Conj (Pneumococcal Conjugate Vaccine) And Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination. On 11-Oct-2023, the patient received a expired unknown (dose 2) dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: 08-Oct-2023 and lot UJ7948B) via intramuscular route in the right thigh as immunization (expired product administered) (same day latency). 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.