Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
administering pentacel but only the dtap-ipv dose was given with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age male patient who recieved Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] but only the dtap-ipv dose was given with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Apr-2025, the patient received an unknown dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine standard strength (lot number, formulation and expiry date-unknown) via unknown route in unknown administration site for Immunization but only the dtap-ipv dose was given with no reported ae (single component of a two-component product administered) (latency-same day). Reportedly- Only the liquid part of PENTACEL was administered. They further asked if they have to revaccinate or when can they give the Hib component. 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.; Sender's Comments: US-SA-2025SA135316:02514958, 02515969 and 02515973