Received May 28, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | Z9S4D | IM / RL |
patient receiving the second dose of act-hib at a later time and the dose was reconstituted with sterile water with no adverse event; Initial information received on 18-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a male patient of unknown age who received the second dose of ACT-HIB at a later time and the dose was reconstituted with sterile water with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 15-May-2026, the patient received a 0.5 mL dose 2 of HIB (PRP/T) Vaccine [ACT-HIB], Powder and solvent for solution for injection (batch: Z9S4D, expiration date: 04-Jun-2027) (strength: unknown) via intramuscular route in right vastus lateralis for immunization [Immunisation]. The patient received the second dose of ACT-HIB at a later time, and the dose was reconstituted with sterile water [Product preparation issue, onset: 15-May-2026, latency: same day]. A clinical supervisor reported that the patient received a dose of ACT-HIB that had been reconstituted with an incorrect diluent. The ACT-HIB had been reconstituted with sterile water (sterile diluent for mixing with live vaccines) instead of the correct diluent. No adverse event was 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 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