Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK169AC | OT |
a six month-old boy received the diluent only, instead of the intended ACT- HIB vaccine and not the powder portion of the vaccine with no reported adverse event; Initial information received on regarding an unsolicited valid non-serious case received from a other health professional along with live follow up both are processed together on 25-Feb-2025. This case involves a 6 months old male patient to whom had received the diluent only, instead of the intended HIB (PRP/T) Vaccine [ACT-HIB] and not the powder portion of the vaccine 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 20-Feb-2025, the patient received a 0.5 ml dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, lot UK169AC and expiry date: 28-Feb-2026) via intramuscular route in unknown administration site as prophylactic vaccination (immunization) and received the diluent only, instead of the intended act-hib vaccine and not the powder portion of the vaccine with no reported adverse event (product preparation error) (latency: same day). Reportedly: "She states that they are in the practice of removing the little tiny square label which used to have both the lot number and expiration date printed on it, and putting it on a piece of paper for documentation/ record keeping. But now the vaccine label has a tiny piece of paper which doesn't include the expiration date, so they have to take the whole label off and when that is done, the two vials for the vaccine look basically the same, aside from some red writing. So the new labels do not work with their tracking protocol. She feels that there should be some better safeguards. She states that ACT-HIB is the only vaccine that they still use that utilizes this kind of system for 2-component vaccines. She mentions one manufacturer that uses an elastic-tab that keeps the two components hooked together, which she states is a really great feature. She reports that Merck now puts their diluent in a pre-filled syringe, packaged with the vaccine needing reconstitution." 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.
Pediarix; Prevnar 20