Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
Max/low temperature reached 46.7F for 8 days and vaccine was administered to patient with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked with US-SA-2025SA035137, US-SA-2025SA035116 and US-SA-2025SA035178. This case involves a 4 years old female patient where reporter reported max/low temperature reached 46.7f for 8 days and IPV (VERO) [IPOL] was administered to patient 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 a dose of suspect IPV (VERO) Suspension for injection at a strength (standard) lot W1C831M and expiry date- 21-NOV-2025 via unknown route in unknown administration site (dose, strength: not provided) for Immunization and max/low temperature reached 46.7f for 8 days and vaccine was administered to patient with no reported adverse event (poor quality product administered) (latency- same day). 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-2025SA035137: US-SA-2025SA035116: US-SA-2025SA035116: