Received Sep 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK231AA | OT / RL |
staff used sterile water to dilute ACT-HIB and administered it to a patient with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 14 months old female patient who was administered HIB (PRP/T) vaccine [ACT-HIB] and staff used sterile water to dilute it 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 Hepatitis a vaccine, Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr), Pneumococcal vaccine and Varicella zoster vaccine all for prophylactic vaccination (Immunisation). On 26-Aug-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot UK231AA and expiry date: 30-Jun-2026) (strength: standard and frequency: once) via intramuscular route in right vastus lateralis for immunisation and staff used sterile water to dilute it 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.
Hepatitis a vaccine; Mmr; Pneumococcal vaccine; Varicella vaccine