Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT / LL |
inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event; Initial information received on 10-Jun-2025 (with live follow up process together with CSD: 10-Jun-2025) regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old male patient for whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-May-2025, the patient received an unknown dose (0.5ml) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine; Suspension for injection (lot number, strength and expiry date not reported) via intramuscular route in the left thigh for Immunization; inappropriate use due to only the DTaP/IPV portion of the product being administered/ The patient only received the liquid part of the vaccine, it was not mixed with no reported adverse event (single component of a two-component product administered) (latency: same day). 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.