Symptomtext
Sterile Water for Injection as the diluent of ACT-HIB instead of the 0.4% Sodium Chloride with no adverse event; Initial information received on 07-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2-months-old male patient who had sterile water for injection as the diluent of HIB (PRP/T) vaccine [ACT-HIB] instead of the 0.4% sodium chloride with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included polio vaccine inact 3V (vero) (IPOL) for Immunisation. On 29-Aug-2023, the patient received 0.5 mL dose 1 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (Strength: Standard; Frequency: Once) (batch number: UJ837AA; expiry date: unknown) via intramuscular route in the left vastus lateralis for Immunization with sterile water for injection as the diluent instead of the 0.4% sodium chloride with no adverse event (product preparation error) (same day latency). 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.