Received Jan 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK227AC | OT / LL |
diluted the vaccine, but the powder did not dissolve and only the diluent was administered, with no reported adverse event; Initial information received on 14-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered to only the diluent of HIB (PRP/T) Vaccine [ACT-HIB] as it was diluted, but the powder did not dissolve, 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 Hepatitis a vaccine (Hepatitis A) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation. On 14-Jan-2026, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK227AC, expiry date 30-Jun-2026, frequency once and strength standard) via intramuscular route in the left thigh for Immunization and diluted the vaccine, but the powder did not dissolve and only the diluent was administered, with no reported adverse event (product preparation error) (latency same day). It was reported "Caller requested guidance regarding a timeframe of when the patient can be re-vaccinated. She confirmed that they did dilute the ACT-HIB powder with the supplied diluent. However, the powder did not dissolve, it was still stuck to the vial. She didn't know why, the temperatures in their refrigerator are within range. Because the powder did not dissolve upon diluting, they feel like the patient did not get a proper dose of ACTHIB. They askes if the patient can receive another dose of ACT-HIB and when the patient can receive another dose." 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.
Hepatitis A; Dtap