Received May 28, 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 ae; Initial information received on 18-May-2026 regarding an unsolicited valid non-serious case received from healthcare professional (HCP). This case involves a 4-month-old male patient who was administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine-520 (Pentacel) post excursion with no 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 conjugate (Pneumococcal Conjugate vaccine) and rotavirus vaccine (Rotavirus vaccine). On 10-Mar-2026, the patient received a 0.5 mL dose 2 of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], (powder and suspension for suspension for injection) (batch/lot number: UK332AA, expiration date: 31-Aug-2026) (strength: standard) via intramuscular route in right thigh for immunization. The patient was administered post excursion with no adverse event (poor quality product administered, onset: 10-Mar-2026, latency: same day). The event was related to a temperature excursion of 48.9 degrees Fahrenheit (9.38 degrees Celsius) that occurred from 05-Mar-2026 to 01-Apr-2026 (712 hours duration) due to refrigerator malfunction and human error was not involved. The vaccine was determined to be unsuitable for use post excursion; however, it was administered to the patient. No adverse events were reported following the administration. 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; Rotavirus vaccine