Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
IPOL max/low temperature reached: 46.7F/duration out of labelled range: 8 days/ Human error: Yes with no reported adverse event; vaccine administered after excursion 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 is linked to case- US-SA-2025SA035136, US-SA-2025SA035137, US-SA-2025SA035116, US-SA-2025SA035119, US-SA-2025SA035178 This case involves a 6 years old female patient to whom vaccine ( IPV (VERO) [IPOL]) was administered after excursion and max/low temperature reached: 46.7f/duration out of labelled range: 8 days/ human error: yes 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 was administered IPV (VERO) Suspension for injection (strength- standard) 1x(once) (dose unknown) lot W1C831M expiry date-21-Nov-2025 via unknown route in unknown administration site for immunization after excursion with no reported adverse event (poor quality product administered) (latency same day). On an unknown date ipol max/low temperature reached: 46.7f/duration out of labelled range: 8 days/ human error: yes with no reported adverse event (product storage error) (unknown latency). Reportedly, Reason: They thought it can be stored up to this maximum temperature. Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. 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-2025SA035136: US-SA-2025SA035137: US-SA-2025SA035116: US-SA-2025SA035119: US-SA-2025SA035178: US-SA-2025SA035116: US-SA-2025SA035119: US-SA-2025SA035178:Cluster case