Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK151AA | OT / RL |
expired ACT-HIB was administered with no reported adverse event; Initial information received on 20-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA313883 This case involves a 3 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. Concomitant medications included Rotavirus Vaccine (Rotavirus Vaccine); and Pneumococcal Vaccine Conj 15v (Crm197) (Vaxneuvance) both for Immunisation. On 08-Oct-2025, the patient received an expired 0.5ml (dose 2) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Strength Standard, Frequency Once, lot UK151AA and expiry date 30-Sep-2025 via intramuscular route in the right thigh for immunisation, 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.; Sender's Comments: US-SA-2025SA313883:
ROTAVIRUS VACCINE; VAXNEUVANCE