Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
| DTP | DTP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
The product administered in error was PENTACEL and the PENTACEL dose should have been the ACT-HIB with no reported adverse event; an inappropriate use due to administration of an extra dose of DTaP from PENTACEL with no reported adverse event; Initial information received on 14-May-2025 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves Child and unknown gender patient where product administered in error was diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel] and the pentacel dose should have been the act-hib and an inappropriate use due to administration of an extra dose of diphtheria, tetanus and nos pertussis vaccine from pentacel with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (Strength- standard and frequency- once) lot number not reported via unknown route in unknown administration site (dose and expiration date: not provided) and received a dose of suspect diphtheria, tetanus and nos pertussis vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for prophylactic vaccination (immunization) and the product administered in error was pentacel and the pentacel dose should have been the act-hib with no reported adverse event (wrong product administered) and inappropriate use due to administration of an extra dose of dtap from pentacel with no reported adverse event (extra dose administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. Reportedly, no other vaccines had been used. Product used : Used. 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.