Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK363AA | OT |
administration of ACTHIB reconstituted with a diluent different than what comes in the box with no reported adverse event; Initial information received on 20-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administrated of HIB (PRP/T) Vaccine [ACT-HIB] which was reconstituted with a diluent different than what comes in the box 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 (Pneumococcal vaccine) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) for Immunisation. On 14-Jan-2026, the patient received 0.5mL of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK363AA, expiry date 31-Dec-2026, frequency once and strength standard) via intramuscular route in unknown administration site for Immunization and reconstituted with a diluent different than what comes in the box with no reported adverse event (product preparation error) (latency same day). It was reported "They asked whether the patient should be revaccinated and which side effects should they look out for." 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; Daptacel