Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA18C1 | OT |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK30TAB | OT |
PENTACEL was administered due to the PENTACEL box looks like the ACTHIB box; that the PENTACEL box has changed; that the boxes are more similar than they used to be with no reported adverse event; DAPTACEL and PENTACEL were given to the same patient, with no reported adverse event; Initial information received on 29-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old female patient and it was reported DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] were given to the same patient and pentacel was administered due to the pentacel box looks like the acthib box; that the pentacel box has changed; that the boxes are more similar than they used to be with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal vaccine conj (Pneumococcal conjugate vaccine); COVID-19 vaccine; and Influenza vaccine (Flu) all for Immunisation. On 28-OCT-2025 a dose of 0.5 ml once of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot: 4CA18C1; expiry date: Feb-2027; strength: standard) and a dose of 0.5 ml once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Powder and suspension for suspension for injection) (lot: UK30TAB; expiry date: 30-Sep-2026; strength: standard) were given to the same patient, with no reported adverse event (extra dose administered) (latency: same day) both via unknown route in unknown administration site for Immunization and pentacel was administered due to the pentacel box looks like the acthib box; that the pentacel box has changed; that the boxes are more similar than they used to be with no reported adverse event (product packaging confusion) (unknown latency). It was reported, "the consumer was to have a DTAP and a standalone ACTHIB dose. It is easy to mistake the boxes due to the white on the top half of the box leads to coloring on the bottom half; that they are close together in their storage due to frequent use of the products" Action taken was 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.
Pneumococcal conjugate vaccine; COVID-19 vaccine; Flu