Received Jun 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8209CB | OT / LL |
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
11-month old patient received quadracel instead of pentacel with no reported adverse event; Initial information received on 03-Jun-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 11 months old male patient who received diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine [Quadracel] instead of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-May-2025, the patient received 0.5 ml dose of suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (vero) vaccine Solution for injection lot U8209CB and expiry date- 31-MAY-2026 via intramuscular route in the left vastus lateralis instead of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection lot number not reported with no reported adverse event (wrong product administered) (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.