Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK208AA | OT / RL |
reconstituted ACT-HIB with sterile saline instead of the accompanying sodium chloride, with no adverse event; Initial information received on 18-Dec-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old female patient who was administered to HIB (PRP/T) Vaccine [ACT-HIB] which was reconstituted with sterile saline instead of the accompanying sodium chloride, with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr), Immunoglobulin varicella-zoster (Varicella zoster immune globulin) for and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 11-Dec-2025, the patient received a dose of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK208AA, expiry date 30-Apr-2026, frequency once and strength standard) via intramuscular route in the right thigh for Immunization and reconstituted act-hib with sterile saline instead of the accompanying sodium chloride, with no adverse event (product preparation error) (latency same day). It was reported "reconstituted ACT-HIB with sterile saline. Pediatrician reports that they drew up ACT-HIB with sterile saline instead of the accompanying sodium chloride, and administered it to a patient. She asked how should they proceed, were there any safety risks and was the dose invalid?" 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.
Mmr; Varicella zoster immune globulin; Prevnar 20