Received Aug 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK113AB | OT |
acthib vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 7 years old female patient (124.46 cm and 21.82 kg) who was vaccinated with HIB (PRP/T) Vaccine [ACT-HIB] which was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Jun-2025, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK113AB, expiry date and strength not reported) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) and vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging, with no reported adverse event (product preparation error) (latency same day). Reportedly, acthib vaccination was prepared with a merck sterile diluent, not the diluent provided in the packaging. Error was detected during monthly inventory of vaccines when 5 diluents were noted and only 4 vials of the powder. Action taken was not applicable. 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. Additional information was received on 30-Jul-2025 via Physician: Patient details has been added, lot number and dose of the suspect have been added. Narrative amended accordingly.