Received Jun 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK332AA | IM / RL |
products administered post excursion with no reported adverse event; Initial information received on 18-May-2026 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 25-month-old female patient who was administered with the suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (PENTACEL) post excursion with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included pneumococcal vaccine conj (PCV) and hepatitis a vaccine (HePA). On 17-Mar-2026, the patient received 0.5 ml dose 2 of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (PENTACEL) powder and suspension for injection, Strength = standard, frequency: once, batch UK332AA, expiry date:31-Aug-2026 via intramuscular route in the right thigh for immunization. It was reported ldquohuman error was not involved. Medical assistant reported a temperature excursion and asked for guidance about it. Product(s) involved: unopened IPOL# Reason of the excursion: Malfunction with refrigerator; Temperature reached (maximum/lowest): 48.9F (9.389C) for Duration of excursion: 05-Mar-2026 ndash 01-Apr-2026 (712 hours)rdquo. 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.
Comments: NONE
Pneumococcal conjugate vaccine; Hepa