Received Apr 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | — |
Only the DTAP/IPV component was administered, without mixing the dry component which is the Hib with no AE; Initial information received on 13-Mar-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a patient of unknown age and unknown gender to whom only the (DTaP/IPV) component of PENTACEL (VERO) was administered, without mixing the dry component which is the (Hib) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. The patient received only the (DTaP/IPV) component of PENTACEL (VERO) without mixing the dry component which is the (Hib) with no adverse event (Single component of a two-component product administered, onset: unknown, latency: same day) (suspension for suspension for injection) (batch number and expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. A pediatric doctor informed that there was a misuse of a vaccine and it was reported that they forgot to give the Hib component of PENTACEL. 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