Symptomtext
mixed ACT-HIB with the wrong diluent on the patients 4th dose with no reported adverse event; Initial information received on 06-Apr-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 18 months old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] mixed with the wrong 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation. On 04-Apr-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) VACCINE (lot UJ787AAA, strength - standard, frequency - once, expiry date - 11 Aug-2023) via intramuscular route in the left thigh for prophylactic vaccination (immunization). On 04-Apr-2023 the patient received act-hib mixed with the wrong diluent with no reported adverse event (product preparation error) (latency: same day). 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.