Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
administered an expired dose of Act-Hib vaccine to a 2-month-old baby, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old female patient who received an expired dose of Hib (Prp/T) vaccine [Act-Hib] 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 Apr-2025, the patient received an expired dose of suspect Hib (Prp/T) vaccine, Powder and solvent for solution for injection, (unknown strength), Expiry date 31-Mar-2025, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) with no reported adverse event (Expired product administered) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, medical assistant had administered an Act-Hib vaccine to a 2-month-old baby, noting that the vaccine expired in Mar-2025.She asked whether there is a grace period for using the vaccine past its expiration date. 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.