Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
ACTHIB being given to children 6 to 7 weeks of age with no reported AE; Initial information received on 27-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Infant and unknown gender patient for whom HIB (PRP/T) vaccine [ACT-HIB] being given to children 6 to 7 weeks of age with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization; being given to children 6 to 7 weeks of age with no reported ae (product administered to patient of inappropriate age) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.