Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK148AA | OT / RL |
gave an expired dose of act-hib with no reported adverse event; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3 months old male 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 10-Oct-2025, the patient received 0.5 ml (dose 1) of expired suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK148AA, expiry date: 30-Sep-2025, strength: standard, frequency: once, via intramuscular route in the right thigh for Immunization, with no reported adverse event (expired product administered) (latency: same day). Reportedly, Caller stated that she needs to know if the patient is going to die, how long they should wait for another dose and what she should tell the parents. Caller asked if the patient would be harmed and is confirming that the patient would not die. 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.