Reporte zur Charge UJ739AAA

Symptomtext

acthib that was administered a week after the expiration date with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 1 years old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] that was administered a week 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 diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination. On 17-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ739AAA; expiry date: 10-Aug-2023) via intramuscular route in the right thigh for Immunization a week after the expiration date 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 acthib that was administered a week after the expiration date with no reported adverse 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.