Received Apr 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK354AA | RL |
received only the powder HIB portion that was mixed incorrectly with a separate sterile diluent,with no reported adverse event; Initial information received on 02-Apr-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional (HCP). This case involves a 15 months old female patient who had received only the powder haemophilus type B (HIB) portion that was mixed incorrectly with a separate sterile diluent, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Prevnar. On 27-Nov-2025, the patient received a 0.5 mL once dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch number: UK354AA, expiry date: 28-Feb-2027) (strength: unknown) via unknown route in right thigh for immunization. Pentacel was ordered for a patient. The patient received only the powder HIB portion that was mixed incorrectly with a separate sterile diluent (Product preparation error, latency: same day). The liquid portion of Pentacel was not administered. 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
Prevnar