Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
temperature excursion for open ipol max/low temperature reached: 46.7F Duration out of labelled range: 8 days with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked to US-SA-2025SA035116 (cluster case). This case involves a 5 years old male patient who received (opened) poliomyelitis vaccine (INACTIVATED) [IPOL] which was exposed to temperature excursion max/low temperature reached: 46.7f duration out of labelled range: 8 days with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of IPV (VERO) Suspension for injection with standard strength (expiry date- 21-NOV-2025 and lot W1C831M) once via unknown route in unknown administration site as Immunization and was exposed to temperature excursion, max/low temperature reached: 46.7f duration out of labelled range: 8 days with no reported adverse event (product storage error) (latency- same day). Action taken was not applicable. Reportedly, they thought vaccines could be stored up to this maximum temperature. There was no previous excursion. Human error was involved. 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-2025SA035116:Cluster case US-SA-2025SA035116: