Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
four patients received pentacel that was not suitable for use due to the excursion with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves 4 patients of unknown demographics who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] that was not suitable for use due to the excursion 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 in February 2025, the patients received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (expiry date, lot number not reported) via unknown route in unknown administration site for Immunization that was not suitable for use due to the excursion with no reported adverse event (poor quality product administered) (latency: on same day).Information regarding batch number corresponding to the one at time of event occurrence is requested. Action taken was not applicable. Reportedly, there was a power outage with the unknown result of a lowering of the temperature. It happened on 12Feb2025. Max/low temperature reached: 31.4°F (<0°C) Duration: 41 minutes. Previous Excursion: NO, Human error: NO, Administered post-excursion: YES for pentacel (4 patients). 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.