Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK174AB | OT |
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. This case is linked to US-SA-2025SA054065 (Master case). This case involves a 7 months old male patient to whom had inappropriate use of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] and 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 Hepatitis B Vaccine; Rotavirus Vaccine Live Reassort Oral 5v (Rotateq); And Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) for Immunisation. On 17-Feb-2025, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength: standard, frequency: once, expiry date: Mar-2026 and lot UK174AB via intramuscular route in the left leg as immunization and inappropriate use of suspect given post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (latency: same day). Reportedly: "Max/low temperature reached: Negative 0.3 degrees C, Duration: 1 hour, Previous Excursion: no Human error: NO, Administered post-excursion: Yes, 2-Fluzone HD doses, 1-ADACEL dose, and 3-PENTACEL doses. the extended stability data cover the excursion for BEYFORTUS but no for all other products." 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.; Sender's Comments: US-SA-2025SA054065:Fluzone
HEPATITIS B VACCINE; ROTATEQ; PREVNAR 20