Reporte zur Charge UJ7578A

Symptomtext

administration of PENTACEL which had expired 5 days prior to use with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4-years-old female patient who was administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] which had expired 5 days prior to use 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 measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination. On 14-Sep-2023, the patient received 0.5 mL Booster dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (Strength: standard; Frequency: once) (batch number: UJ7578A; expiry date: 09-Sep-2023) via intramuscular route in the left thigh for immunization which had expired 5 days prior to use with no reported adverse event (expired product administered) (same day latency). Reportedly, Medical assistant called to know if the administered PENTACEL would still count as a valid dose even though it had expired 5 days prior to use. Caller mentioned that no adverse reaction was experienced by the patient. (Treatment : Immunization) 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.