Received Jul 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK303AB | OT |
Temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. Therefrigerator went too cold and did not alarm. Vaccines were given from the refrigerator with no reported adverse event; Initial information received on 15-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this US-SA-2025SA181088 [Master case]. This case involves a 18 months old male patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] in which temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. The refrigerator went too cold and did not alarm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Jun-2025, the patient received 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, lot UK303AB, expiry date: 31-Aug-2026, frequency:once, via intramuscular route in unknown administration site for prophylactic vaccination (immunisation) in which temptrak alarm was not cleared when a refrigerator returned to the clinic after repairs. therefrigerator went too cold and did not alarm. vaccines were given from the refrigerator with no reported adverse event (poor quality product administered) (latency:same day). Reportedly,no adverse event occurred.Sanofi was contacted by clinic who advised to revaccinate. 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-2025SA181088:master case