Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / LA |
Temperature excursion/temperature reached: 8.5 °C to 8.8 °C for 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to master case US-SA-2025SA112035. This case involves a 19 years old female patient who was administered Influenza Usp Trival A-B Subvirion Vaccine [Fluzone] after temperature excursion/temperature reached: 8.5 °c (Degree Celsius) to 8.8 °c for 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Nurse called to report a temperature excursion that occurred on 04-Apr-2025. On 14-Apr-2025, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion Vaccine Suspension for injection (lot U8442BA, Expiry: 20-Jun-2025) (Strength: Standard) via intramuscular route in the left deltoid as Influenza immunization that had temperature excursion/temperature reached: 8.5 °c to 8.8 °c for 30 minutes with no reported adverse event (product storage error). Human error: yes Reportedly, No adverse events were noted. There was no previous excursion and extended stability data does not cover the excursion. 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.; Sender's Comments: US-SA-2025SA112035:Master case