Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK109AA | OT |
temperature excursion for vaccine as temperature reached: max: 4.3°C, low: 0.0°C duration: 1 hour with no reported adverse event; Initial information received on 29-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 4 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that had temperature excursion as temperature reached: max: 4.3 degree celsius, low: 0.0 degree celsius duration: 1 hour with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Apr-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UK109AA and expiry date 30-Sep-2025) (frequency: once and strength standard) via intramuscular route in unknown administration site for immunization and that had temperature excursion as temperature reached: max: 4.3 degree Celsius, low: 0.0 degree Celsius, duration: 1 hour with no reported adverse event (poor quality product administered) (Latency same day). Reportedly, There was no previous excursion. Human error was unknown and vaccine was administered post-excursion. Extended stability data did not cover the excursion. 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.