Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | — | OT |
vaccine administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from Nurse. This case involves an unknown age and unknown gender patient where IPV (VERO) [IPOL] vaccine was administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) 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, vaccine was administered to patient with 0.5 ml 1x (once) dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for immunization after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae (poor quality product administered) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested. 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.