Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK175AA | OT / RL |
report that a medical assistant administered ACTHIB two weeks past the expiration date with no adverse event; Initial information received on 17-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 9 months old male patient who received Hib (Prp/T) Vaccine[ACT-HIB] two weeks past the expiration date with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 17-Nov-2025, the patient received 0.5 ml (dose 1) of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection lot UK175AA, expiry date:31-Oct-2025, strength not reported, via intramuscular route in the right thigh, frequency:once for Immunization two weeks past the expiration date with no adverse event (expired product administered) (latency: same day). Reportedly, "It was reported "Nurse/Clinical Coordinator called to report that a medical assistant administered ACTHIB two weeks past the expiration date. Nurse mentioned that she does not have the NDC number of the vaccine but confirmed that the brand is ACTHIB" 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.
Prevnar 20