Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK377AA | IM / RL |
administration Acthib reconstituted with a different diluent, with no reported adverse event; Initial information received on 04-Mar-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6-month-old male patient who experienced administration ACT-HIB reconstituted with a different diluent, with no reported adverse event while being treated with haemophilus type b (HIB) vaccine (ACT-HIB). The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Pediarix, Prevnar 20 and Rotavirus oral. On 02-Mar-2026, the patient started taking haemophilus type b (HIB) vaccine powder and solvent for solution for injection (strength: standard) at a dose of 0.5 mL, 1X (cycle/series: dose 3, batch: UK377AA, expiry: 31-Dec-2026) intramuscular in right vastus lateralis for immunization and received ACT-HIB that was reconstituted with the diluent for measles, mumps and rubella (MMR) and Varicella, instead of the ACT-HIB diluent that comes in the box. The LPN wanted to check if that ACT-HIB dose was valid. Additional information was provided from the attached standard operating procedure (SRD). The patient experienced administration ACT-HIB reconstituted with a different diluent, with no reported adverse event (Product preparation error, onset: 02-Mar-2026 at 12:00 and latency: same day). 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
Pediarix; Prevnar 20; Rotavirus vaccine