Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | IM |
product was reconstituted with sterile water from another vaccine, instead of the intended ACTHIB specific diluent with no AE; Initial information received on 19-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (health care professional). This case involves a 1-year-old male patient who had received product which was reconstituted with sterile water from another vaccine, instead of the intended HIB (PRP/T) VACCINE [ACT-HIB] specific diluent with no AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included varivax and hepatitis A. On 13-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/lot number: unknown, expiry date: unknown) (strength: STANDARD) via intramuscular route in an unknown administration site for immunization [Immunisation]. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested A licensed practical nurse (LPN) reported that the patient received a dose of ACTHIB that had been reconstituted with an alternate diluent. The product was reconstituted with sterile water from another vaccine, instead of the intended ACTHIB specific diluent with no AE (Product preparation issue, onset: 13-May-2026, latency: same day). The caller was not aware of any adverse reactions at the time of the call. The caller requested information on whether the dose administered was considered a valid dose or whether it should be repeated. The caller accepted follow-up from pharmacovigilance (PV) for lot number, expiration date and national drug code (NDC) number as this information was not available at the time of the call. 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
Varivax; Hepatitis A