Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK198AB | OT |
ACTHIB that was reconstituted with a sterile diluent with no reported adverse event; Initial information received on 11-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that was reconstituted with a sterile 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 CONJ 7V (CRM197) (PREVNAR) for Immunisation. On 10-Dec-2025, the patient received 0.5 ml of dose 4 of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 31-MAR-2026 and lot UK198AB) once via intramuscular route in unknown administration site for Immunization that was reconstituted with a sterile diluent with no reported adverse event (product preparation error) (latency- same day). It was reported that, "Treatment: none." 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.
PREVNAR