Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1PS11M | OT |
patient received IPOL After excursion with no reported adverse events; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to US-SA-2025SA100789 (same reporter) This case involves an unknown age and unknown gender patient who received IPV (Vero) [IPol] (opened) after temperature excursion with no reported adverse events. 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 suspect IPV (Vero) (opened), Suspension for injection, lot W1PS11M, (Unknown Strength) and expiry date 08-Sep-2025 via unknown route in unknown administration site for immunisation, after being exposed to temperature excursion with no reported adverse events (poor quality product administered) (Latency Same day). Reportedly, Duration and temperature of excursion: 22-Jan-25: negative 13 F for 4 Hours; Previous Excursion: 31-Dec-24: 48 F for 30 minutes; Reason: Fridge malfunction; Was product administered: Yes, for opened IPol (opened); Was it related to a human error: No. 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-2025SA100789:FLUZONE