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 adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age male patient who was administered with 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 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 diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of PENTACEL was administered. She further asked if they had to revaccinate or when can they give the Hib component. Information on the batch number was requested corresponding to the one at time of event occurrence. 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-2025SA135329: