Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | W1C831M | OT |
punctured IPOL was exposed to Highest/lowest temperature reached: lowest of 33.8°F Duration of excursion: 6 to 7 hours, with no reported adverse event; punctured IPOL was administered after excursion with no reported adverse event; Initial information received on 14-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient to whom had received punctured IPV (VERO) [IPOL] was exposed to highest/lowest temperature reached: lowest of 33.8°f duration of excursion: 6 to 7 hours and administered after excursion 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 unknown (dose 1) dose of suspect IPV (Vero) suspension for injection (strength: unknown, expiry date: 21-Apr-2025 and lot W1C831M) via unknown route in unknown administration site as prophylactic vaccination (immunization) (poor quality product administered) (same day latency) and was exposed to highest/lowest temperature reached: lowest of 33.8°f duration of excursion: 6 to 7 hours, with no reported adverse event (product storage error) (unknown latency). Reportedly: "She confirmed there was an excursion a few times a day and it happened a couple of months ago. They just downloaded the temperature log. She mentioned that when they set the temperature, it's always at 39°F to 40°F and because they're not open when the clinic is closed, the temperature may have gone down. She also said it may be the refrigerator cycle but she doesn't really know what caused it. Previous excursion: None, the extended stability data cover the excursion for the unopened vaccines. No for the opened Ipol. If negative advice, the products have been administered post excursion, 1 dose of Ipol, 2 doses of Tenivac, and 1 dose of Adacel. The punctured IPOL was administered to a patient post excursion; 1 dose was given. She said she only had the excursion of information and that she'd relay the stability data to their doctors." Action taken: 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.