Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK0938B | OT |
administered with ACT-HIB/Instead of using the diluent, sterile water was used with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB]/instead of using the diluent, sterile water was used 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 (Rotavirus vaccine); 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 21-Jan-2025, the patient received HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml 1x(once) lot UK0938B expiry 31-Aug-2025 via intramuscular route in vastus lateralis (strength standard) for Immunization/instead of using the diluent, sterile water was used with no reported adverse event (product preparation error) (latency same day). 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.
Rotavirus vaccine; Pediarix; Prevnar 20