Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
patient received 2 doses of ACT-HIB with no reported adverse event; Initial information received on 31-Jan-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who experienced patient received 2 doses of ACT-HIB with no reported adverse event after receiving HIB (PRP/T) Vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Nov-2024, the patient received 2DF (dosage form) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested corresponding to the one at time of event occurrence. On 18-Nov-2024, the patient developed patient received 2 doses of ACT-HIB with no reported adverse event (latency same day) following the administration of HIB (PRP/T) Vaccine. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. 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.