Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK328AA | OT / RL |
reconstitution of ACTHIB with an alternate diluent and subsequent administration to a patient, with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1-year 5months old male patient who received HIB (PRP/T) vaccine [ACT-HIB] with an alternate diluent (sterile water) instead of ACTHIB 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 Measles Vaccine Live (Enders-Edmonston), Mumps Vaccine Live (Jeryl Lynn), Rubella Vaccine Live (Wistar Ra 27/3), Varicella Zoster Vaccine Live (Oka/Merck) (Proquad) For Immunisation; Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) For Immunisation; And Hepatitis A Vaccine Inact (Havrix) for Immunisation. On 16-Sep-2025, a 1 year 5months old patient received a 0.5ml dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK328AA) (expiry date-31-May-2026) via intramuscular route in the right thigh for Immunization was constituted with an alternate diluent (sterile water) instead of ACTHIB diluent, with no reported adverse event (single component of a two-component product administered). 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.
PROQUAD; VAXNEUVANCE; HAVRIX