Received Apr 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK420AA | IM / RL |
act-hib was recently given with the wrong diluent to a patient with no reported adverse event; Initial information received on 02-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involved a 4-month-old female patient as haemophilus type b (HIB) vaccine (ACT-HIB) was recently given with the wrong diluent to a patient with no reported adverse event while being treated with The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Pediarix, Prevnar 20 and Rotateq for immunization. On 23-Feb-2026, the patient received dose 1 of haemophilus type b (HIB) vaccine powder and solvent for solution for injection (strength: standard) as 0.5 mL 1X intramuscular in right thigh for immunization with the wrong diluent to a patient with no reported adverse event (product preparation error, latency: same day) (batch: UK420AA, expiry: 31-Jan-2027). 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; Rotateq