Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK201AC | OT / RL |
partial dose of ACTHIB due to patient moving during injection with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 months old female patient who received partial dose of HIB (PRP/T) vaccine [ACT-HIB] due to patient moving during injection 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 20V (CRM197) (Pneumococcal 20) for Immunisation. On an unknown date, the patient received a partial dose 4 of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 30-APR-2026 and lot UK201AC) via intramuscular route in the right thigh for Immunization due to patient moving during injection with no reported adverse event (incorrect dose administered) (same day latency). Reportedly, the reporter asked what was appropriate follow up. What was the time she could take another Act-HIB. No side effect. 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.
PNEUMOCOCCAL VACCINE CONJ 20V (CRM197)