Received Jan 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK363AA | OT / LL |
dose of ACTHIB was reconstituted with 0.7 mL of sterile water instead of the 0.4% sodium chloride ACTHIB diluent and administered to a patient with no AE; Initial information received on 06-Jan-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who received a dose of Hib (Prp/T) Vaccine [Act-Hib] which was reconstituted with 0.7 ml of sterile water instead of the 0.4% sodium chloride 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 Pneumococcal Vaccine [Pneumo]; Covid-19 Vaccine; And Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP) all for Immunisation. On 06-Jan-2026, the patient received 0.7ml (dose 3) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection (once), Strength standard, lot UK363AA via intramuscular route in the left vastus lateralis for immunisation which was reconstituted with 0.7 ml of sterile water instead of the 0.4% sodium chloride diluent diluent 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.
PNEUMOCOCCAL VACCINE; COVID-19 VACCINE; DTAP