Received Dec 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK304AA | OT / RL |
administered the Hib vaccine incorrectly due to improper mixing of the diluent, with no reported adverse event; Initial information received on 15-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to these cases US-SA-2025SA379012 and US-SA-2025SA378836. This case involves an 1 years old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] incorrectly due to improper mixing of the diluent, 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, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Dtap) and Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) both for Immunisation. On 12-Dec-2025, the patient received 0.5 ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK304AA, expiry date:31-Aug-2026, Frequency :Once, strength: standard via intramuscular route in the right Outer Thigh for Immunization, incorrectly due to improper mixing of the diluent, with no reported adverse event (product preparation error) (latency: same day). It was reported "They identified three potentially affected patients and would like to know whether it is appropriate to revaccinate all three. Of the three, two appear to have received the vaccine correctly, and one received ACT-HIB that was mixed improperly. The Clinical Supervisor stated that a nurse noticed today that the number of diluent vials and powder vials did not matched. There was one extra diluent, indicating that an incorrect mix was used for one dose. They do not know which patient received the incorrectly mixed ACT-HIB. The Clinical Supervisor would like guidance on whether revaccination of all three patients is appropriate and the recommended interval before administering another dose of ACT-HIB". 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-2025SA379012:2nd patient US-SA-2025SA378836:
DTAP; Prevnar 13