Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK148AA | OT |
administered a dose of Act-HIB that was reconstituted with a different diluent than the one provided with the product with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered a dose of HIB (PRP/T) VACCINE [ACT-HIB] that was reconstituted with a different diluent than the one provided with the product 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 Pneumococcal vaccine conj 7v (CRM197), Pneumococcal vaccine conj 7v (CRM197) (Prevnar) and Hepatitis a vaccine, Hepatitis a vaccine (Hepatitis A) for Immunisation. On 30-Apr-2025, the patient received a dose 4 dose of suspect HIB (PRP/T) VACCINE dose 0.5 ml 1x(once) Powder and solvent for solution for injection lot UK148AA expiry date- 30-Sep-2025 via unknown route in unknown administration site for immunization (strength unknown) that was reconstituted with a different diluent than the one provided with the product 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.
Prevnar; Hepatitis A