Symptomtext
5th shot of acthib was administered with no reported adverse event; Initial information was received on 22-Nov-2023 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 4 years old female patient to whom 5th shot of HIB (PRP/T) vaccine [ACT-HIB] was administered 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 polio vaccine inact (IPV) for prophylactic vaccination; and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for prophylactic vaccination. On an unknown date, the patient received a 0.5 ml, once (dose 5) of suspect HIB (PRP/T) vaccine (Powder and suspension for suspension for injection) (lot UJ806AB, expiry date:18-Feb-2024, strength: standard) via intramuscular route in unknown administration site for Immunisation and 5th shot of act-hib was administered with no reported adverse event (extra dose administered) (latency: same day). 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.