Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK368AB | IM / LL |
accidentally gave an ACTHIB vaccine with sterile water diluent instead of the diluent that comes in the package with no AE; Initial information received on 30-Apr-2026 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 2-year-old male patient who accidentally gave an HIB (PRP/T) VACCINE [ACT-HIB] with sterile water diluent instead of the diluent that comes in the package with no adverse event (AE). The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication(s) included DTaP and hepatitis A vaccine. On 25-Mar-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: UK368AB, expiration date: 31-Jan-2027) (strength: unknown) via intramuscular route in the left thigh for immunization [Immunisation]. The clinic manager mentioned that one of their medical assistants accidentally gave an ACT-HIB vaccine with sterile water diluent instead of the diluent that comes in the package (Product preparation issue, onset: 25-Mar-2026, latency: same day). They wanted to see if there was any information on anything they should expect regarding this event. No reaction and no treatment were reported. 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
Dtap; Hepatitis a vaccine