Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK093AB | OT |
91 days old baby got an Act-Hib vaccine that was expired with no adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 91 days old female got an HIB (PRP/T) Vaccine [ACT-HIB] that was expired with no 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 UK093AB with expiry date 30-SEP-2025) with unknown (strength and dosage) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation); old baby got an act-hib vaccine that was expired with no ae (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE. (latency: unknown) 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.