Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK169AC | OT / RL |
administered 2 doses of ACTHIB on the same day on one patient, with no reported adverse event; 2 doses of ACTHIB was administered to a patient that were both incorrectly reconstituted with sterile water, with no reported adverse event; Initial information received on 05-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old male patient who incorrectly administered 2 doses of Hib (PRP/T) vaccine [Act-Hib] on the same day with no reported adverse event and these 2 doses were incorrectly reconstituted with sterile water, 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 diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix) and rotavirus vaccine live reassort oral 5v (Rotateq) both for Immunisation.. On 30-Apr-2025, the patient received a (dose 2) of 1 ml dose of suspect Hib (PRP/T) vaccine, Powder and solvent for solution for injection, lot UK169AC, expiry date:28-Feb-2026,unknown strength, frequency: once, via intramuscular route in the right thigh for Immunization which was incorrectly administered to one patient on same day twice (extra dose administered) and both doses were incorrectly reconstituted with sterile water, with no reported adverse event (product preparation error) (latency: same day) . 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.
PEDIARIX; ROTATEQ