Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK208AA | IM |
administration of the lyophilized component of ACTHIB reconstituted with an alternate diluent, with no reported adverse event; Initial information received on 30-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional. This case involves a 7-month-old male patient as there was administration of the lyophilized component of haemophilus type b (HIB) vaccine (ACT-HIB) reconstituted with an alternate diluent, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DAPTACEL). On 28-Apr-2026, the patient received haemophilus type b (HIB) vaccine Powder and solvent for solution for injection Dose 0.5 ml 1x(once) strength-standard in right leg via intramuscular route for immunization, administration of the lyophilized component of ACTHIB reconstituted with an alternate diluent, with no reported adverse event (Product preparation issue) (latency same day) (batch: UK208AA, expiry date: 30-Apr-2026). 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
Daptacel