Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK303AB | — |
5th dose in the DTaP series, but was inadvertently administered Pentacel, which is DTaP-IPV/Hib, so the patient received an extra, unintended dose of the Hib vaccine with no ae; Initial information received on 22-May-2026 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 5-year-old male patient who received an extra, unintended 5th dose of the Hib vaccine as he was inadvertently administered Pentacel (Diphtheria, Tetanus, Acellular Pertussis, IPV and Hib Vaccine) instead of the DTaP-IPV dose. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 18-May-2026, the patient received dose 5 of Diphtheria, Tetanus, Acellular Pertussis, IPV and Hib Vaccine Powder and suspension for suspension for injection (strength: unknown) 0.5 mL intramuscularly into the left deltoid for immunisation. The patient was due for his DTaP-IPV dose, the 5th dose in the DTaP series, but was inadvertently administered Pentacel, which is DTaP-IPV/Hib, so the patient received an extra, unintended dose of the Hib vaccine [(Extra dose administered, onset: 18-May-2026, latency: same day) (batch: UK303AB, expiry: 31-Aug-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