Received May 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK318AB | — |
ACTHIB was administered with the wrong diluent, diluent used was for MMR Varicella, with no reported adverse event; Initial information received on 08-May-2026 regarding an unsolicited valid non-serious case received from an other or unknown healthcare professional (HCP). This case involves a 15-month-old female patient to whom HIB (PRP/T) VACCINE [ACT-HIB] (ACT-HIB) was administered with the wrong diluent, diluent used was for MMR Varicella, 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 pneumococcal vaccine (pneumonia vaccine) and diphtheria vaccine toxoid/pertussis vaccine acellular/tetanus vaccine toxoid (DTAP vaccine). On 07-May-2026, the patient received a 0.5 mL once daily dose of HIB (PRP/T) VACCINE [ACT-HIB] powder and solvent for solution for injection (batch number: UK318AB, expiration date: 31-Mar-2027) (strength: standard) via left lateralis route in an unknown vaccination facility for immunization. A caller from a provider's office reported that the ACT-HIB was administered with the wrong diluent (Product preparation issue, onset date: 07-May-2026 and latency: same day). The diluent used was for MMR Varicella. A medical assistant (MIA) wanted to know if they should repeat the dose and what reactions should they expect. Medical information specialist (MIS) provided information from the ACT-HIB prescribing information. No further details were collected. 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 medication 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
Pneumococcal vaccine; DTaP vaccine