Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
received an ACT-HIB vaccine that expired 28-Feb-2025 with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] that expired 28-Feb-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in Mar-2025, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (expiry date 28-Feb-2025) (lot number and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization) with no reported adverse event (expired product administered) (Latency: same day). There will be no information on batch number and expiration date 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.