Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK151AA | OT / LL |
ACTHIB that expired in September 2025 was administered to an infant, with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves 6 months old male patient who was administered HIB (PRP/T) vaccine [ACT-HIB] that expired in september 2025, 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 Diphtheria vaccine toxoid, Hepatitis b vaccine rHBsAg (yeast), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix); Pneumococcal vaccine conj 7v (CRM197) (Prevnar); and Rotavirus vaccine live reassort oral 5v (Rotateq) for Prophylactic vaccination (Immunisation). On 17-Oct-2025, the patient received a Dose 3 (0.5 ml) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Frequency: once; Strength: standard) (lot UK151AA, expiry date-30-SEP-2025) via intramuscular route in the left thigh for Immunization; that expired in september 2025, 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.
Pediarix; Prevnar; Rotateq