Symptomtext
ACTHIB was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride ACTHIB diluent, with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1-year-old male patient, HIB (PRP/T) VACCINE [ACT-HIB] was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, 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, RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMR II); PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) and HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination. On 20-Jul-2023, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (strength: unknown) (lot: UJ735AA, expiry date: 07-Aug-2023) via intramuscular route in unknown administration site for immunization. On 20-Jul-2023 the patient had an event of acthib was reconstituted with 0.9% sodium chloride instead of using the 0.4% sodium chloride acthib diluent, with no reported adverse event (product preparation error) (latency: same day) following the administration of HIB (PRP/T) VACCINE. It was unknown if any lab data/tests available. Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was 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.