Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK107AB | OT / LL |
medication error due to administration of incorrect reconstitution of ACTHIB with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 2 months old female patient who received HIB (PRP/T) vaccine [ACT-HIB] incorrectly reconstituted 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 rotavirus vaccine, pneumococcal vaccine CONJ 20V (CRM197) (prevnar 20) and diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (VERO), tetanus vaccine toxoid (pediarix), all for Immunisation. On 19-Mar-2025, the patient received 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength with lot UK107AB and expiry date 30-Sep-2025 via intramuscular route in the left thigh for Immunization that was incorrectly reconstituted with no reported adverse event (product preparation error) (Latency same day) Reportedly, Reporter stated that, administered ACTHIB that was reconstituted with sterile water 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.
ROTAVIRUS VACCINE; PREVNAR 20; PEDIARIX