Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK359AA | RL |
dose was incorrectly reconstituted with the diluent for the live MMR vaccine, with no reported adverse event; Initial information received on 03-Apr-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 6-month-old male patient who received HIB (Prp/T) Vaccine [Act-Hib] which was incorrectly reconstituted with the diluent for the live MMR vaccine, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included Rotavirus Vaccine Live Reassort Oral 5v [RotaTeq]. On 03-Mar-2026, the patient received 0.5 mL dose (dose 3) of HIB (Prp/T) Vaccine, Powder and solvent for solution for injection of unknown strength (batch: UK359AA, expiration date: 31-Aug-2026) via unknown route in right thigh for immunization [Immunisation], which was incorrectly reconstituted with the diluent for the live MMR vaccine, with no reported adverse event (Product preparation error) (latency: same day). The nurse administered the vaccine with the incorrect diluent. The office theory as to the cause was a medical assistant who was not well-trained. Action taken: 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.
Comments: NONE
Rotateq