Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
administered the solution portion of the vaccine and not the powder with no reported adverse event; Initial information received on 26-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who experienced administered the solution portion of the vaccine and not the powder with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Aug-2025, the patient received an unknown dose of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunisation and administered the solution portion of the vaccine and not the powder with no reported adverse event (single component of a two-component product administered) (latency same day). Reportedly, she said that it was only the 0.4% sodium chloride diluent that was administered and the powder was not mixed with it and wanted to know if the solution will have adverse effects to the patient. 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.