Reporte zur Charge U774BA

Symptomtext

administered pentacel to an 18 month old patient, but it was seven days expired with no reported adverse event; Initial information received on 25-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves 18-months-old female patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)], but it was seven days expired 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 (Pneumococcal); and influenza vaccine (Flu Vaccine VII) for Immunisation. On 25-Sep-2023 at around 16:30 hours, the patient received 0.5 mL Dose 4 of suspect diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/ HIB (PRP/T) vaccine, suspension for injection (Strength: standard; Frequency: once ) (batch number: U774BA; expiry date: 18-Sep-2023) via intramuscular route in the left thigh for Immunization but it was seven days expired with no reported adverse event (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.