Reporte zur Charge UJ527AAA

Symptomtext

PENTACEL was administered to a patient after the expiration date with no reported adverse event; Initial information received on 26-Jul-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 6 months old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] after the expiration date 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 B Vaccine (Hepatitis B [Hepatitis B Vaccine)]; Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) and Rotavirus Vaccine (Rotavirus Vaccine) for Immunisation. On 25-Jul-2022, the patient received a 0.5 ml dose once total (dose 3) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine (lot: UJ527AAA; expiry date: 22-Jul-2022) via intramuscular route in the left thigh for Immunisation. On 25-JUL-2022 the patient was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/Ipv(Vero)/HIB(PRP/T) Vaccine after the expiration date with no reported adverse event (expired product administered) (latency: same day). It was unknown if there were lab data/results available. Action taken: Not applicable. Outcome: Unknown. 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.