Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK331AA | OT / LL |
This situation is pre-assessed as a medication error/an inappropriate use due to ACTHIB reconstitution with a different diluent and was administered with no adverse event; Initial information received on 17-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 10 months old female patient who inappropriately administered HIB (PRP/T) Vaccine [ACT-HIB] which was reconstituted with a different diluent with no 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 20v (CRM197) (Prevnar 20) for Immunisation. On 16-Sep-2025, the patient inappropriately received 0.5 ml (dose 3) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK331AA, expiry date:31-Jul-2026, strength:Strength = Vaccine was reconstituted with sterile water, via intramuscular route in the left vastus lateralis for immunization which was reconstituted with a different diluent with no adverse event (product preparation error) (latency: same day). Reportedly,Medical Assistant called to ask if the ACTHIB vaccination was valid when it was reconstituted with sterile water instead of the 0.4% sodium chloride diluent. 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 20