Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK174AB | OT |
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 healthcare professional. This case was linked to other cases US-SA-2025SA054065, US-SA-2025SA054013, US-SA-2025SA054381, US-SA-2025SA054097, US-SA-2025SA054040. This case involves a 5 months old female patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] 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) and pneumococcal vaccine CONJ 20V (CRM197) (Prevnar 20), both for Immunisation. On 14-Feb-2025, the patient received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength once with lot UK174AB and expiry date 31-Mar-2026 via intramuscular route in right leg for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day) 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-2025SA054065:FLUZONE HD Patient 1 US-SA-2025SA054013:FLUZONE HD Patient 2 US-SA-2025SA054381:ADACEL US-SA-2025SA054097:PENTACEL Patient 1 US-SA-2025SA054040:PENTACEL Patient 3
ROTATEQ; PREVNAR 20