Received Dec 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK368AB | OT |
reconstituted using sterile water, not the diluent that came in its package with no adverse event; Initial information received on 04-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional via call center. This case involves a 15 months old male patient who experienced an event HIB (PRP/T) Vaccine [ACT-HIB] was reconstituted using sterile water, not the diluent that came in its package with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Varicella Zoster Vaccine (Varicella Vaccine); Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); and Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) all for Immunisation. On 03-Dec-2025, the patient received a 0.5 ml 1x dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength and expiry date: unknown) (lot :UK368AB) via unknown route in unknown administration site for immunization. On 03-DEC-2025 the patient developed an event reconstituted using sterile water, not the diluent that came in its package with no 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.
VARICELLA VACCINE; DTAP; MMR