Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8770KA | OT |
product used sent to PV as unsuitable product administered with no reported adverse event; Lowest of 1 Celsius and the highest of 45.2 Celsius Duration: Over the course of 13 days but it was a total duration of 94 minutes with no reported adverse event; Initial information received on 30-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Infant and unknown gender patient who had Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which went under temperature excursion: negative disposition: lowest of 1 celsius and the highest of 45.2 celsius duration: over the course of 13 days but it was a total duration of 94 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Sep-2025, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8770KA, expiry date and strength not reported) via unknown route in unknown administration site for Influenza and sent to pv as unsuitable product administered with no reported adverse event (poor quality product administered), lowest of 1 celsius and the highest of 45.2 celsius duration: over the course of 13 days but it was a total duration of 94 minutes (product storage error) (latency same day). Reportedly, the data reader is broken. The extended stability data did not cover the excursion. 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.