Symptomtext
ACTHIB vial with an expired diluent twas given to a patient; Initial information received on 14-Apr-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 23 months old female patient who received ACTHIB vial with an expired diluent twas. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP). On 13-Apr-2023, the patient received suspect HIB (PRP/T) VACCINE Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml (lot UJ671ABA, Expiry date: 27-May-2023) via intramuscular route in the right vastus lateralis for prophylactic vaccination (immunization). On 13-Apr-2023 the patient diagnosed with a non-serious acthib vial with an expired diluent twas given to a patient (expired product administered) (same day latency) following the administration of HIB (PRP/T) VACCINE. Action taken was not applicable. At time of reporting, the outcome was 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.