Received Nov 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK175AB | OT |
vaccine was given 3 days after the expiration date with no reported adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 1 years old male patient who received HIB (PRP/T) vaccine [ACT-HIB] 3 days after the expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2025, the patient received unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (unknown strength) with lot UK175AB and expiry date 31-Oct-2025 via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) 3 days after the expiration date with no reported adverse event (expired product administered) (Latency same day). 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.