Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK3048A | OT |
acthib was administered without reconstitution with no reported ae; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] without reconstitution with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose (dose 1) (dose 2) (dose 3) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot, strength and expiry date not reported) via unknown route in unknown administration site for immunization. On 17-Jul-2025, the patient received an unknown dose (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK3048A, strength: standard and frequency: once) via unknown route in the thigh nos (not otherwise specified) for immunization without reconstitution with no reported adverse event (product preparation error) (Latency: same day). 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.