Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK112AA | OT |
an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. The case is linked to US-SA-2025SA054097 (Master case). This case involves a 5 months old female patient who had an inappropriate use due to dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] given post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Immunisation; and Pneumococcal Vaccine Conj 20V (CRM197) (PREVNAR 20) for Immunisation. On 14-Feb-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 UK112AA, Expiry date: 30-Sep-2025, strength was unknown via intramuscular route in the right leg for Immunization and an inappropriate use due to dose of pentacel given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency : same day). Reportedly "Reason: Refrigerator Malfunction Max/low temperature reached: Negative 0.3 degrees c Duration: 1 hour. Previous Excursion? no. Human error? NO. Administered post excursion? YES." 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.; Sender's Comments: US-SA-2025SA053939:PENTACEL Patient 3 US-SA-2025SA054097:Master case
ROTATEQ; PREVNAR 20