Received Jan 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK363AA | OT / RL |
ACTHIB was reconstituted with the MMR diluent instead of the ACTHIB diluent with no reported adverse event; Initial information received on 30-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 month old female patient who received HIB (PRP/T) VACCINE [ACT-HIB] was reconstituted with the MMR diluent instead of the ACT-HIB 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 Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap) For Immunisation; Influenza Vaccine (Flu [Influenza Vaccine]) for Immunisation; and Pneumococcal vaccine (Pneumococcal vaccine) for Immunisation. On 24-Dec-2025, the patient received a dose of 0.5ml (dose 4) of suspect HIB (PRP/T) vaccine (lot UK363AA, frequency-once, and expiry date- 31-Dec-2026) via intramuscular route in the right thigh for Immunization and was reconstituted with the mmr diluent instead of the acthib diluent with no reported adverse event (product preparation error) (latency-same day). Reportedly-ACTHIB was reconstituted with the MMR diluent instead of the ACTHIB diluent, and was administered to 2 patients. 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.
TDAP; FLU [INFLUENZA VACCINE]; Pneumococcal vaccine