Received May 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK378AA | LL |
administered the liquid portion only of Pentacel/powder portion was not administered with no AE; Initial information received on 01-May-2026 regarding an unsolicited valid non-serious case received from other healthcare professional This case involves a 6-month-old female patient who was administered the liquid portion only of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and the powder portion was not administered with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included hepatitis b vaccine r (hepatitis B vaccine) and pneumococcal vaccine conj 20v (CRM197) (Prevnar 20). On 24-Apr-2026, the patient received a 0.5 mL of dose 2 of diphtheria/tetanus/5 hybrid AC pertussis/IPV (VERO)/HIB(PRP/T) vaccine powder and suspension for suspension for injection (batch number: UK378AA, expiration date: 31-Mar-2027) (strength: unknown) via unknown route in the left thigh for immunization without the powder component and only administered the liquid portion only of Pentacel with no reported adverse event (Single component of a two-component product administered, 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.
Hepatitis B Vaccine recombinant; Prevnar 20