Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK193AA | OT / RL |
nurse instead of grabbing the sterile water that is in the box with the powder, she grabbed the sterile diluent with no reported adverse event; Initial information received on 18-Dec-2025 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 12 months old female patient who had administered HIB (PRP/T) Vaccine [Act-Hib] and nurse instead of grabbing the sterile water that is in the box with the powder, she grabbed the sterile 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, Mumps vaccine, Rubella vaccine (Mmr) for Immunisation. On 12-Dec-2025, the patient received a 0.5 ml 1x (once) dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, expiry date: 30-Mar-2026 and lot UK193AA via intramuscular route in the right thigh as immunization and nurse instead of grabbing the sterile water that is in the box with the powder, she grabbed the sterile diluent with no reported adverse event (product preparation error) (latency: same day) . Action taken: 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