Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / LA |
Max/low temperature reached: 8.5 °C to 8.8 °CDuration: 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 was linked to US-SA-2025SA112035 [master case] This case involves a 24 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone], Suspension for injection (strength- standard, expiry date- 20-JUN-2025 and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error)(latency: same day). On 11-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the left arm. Reportedly, Human error was involved. Previous Excursion: No. Human was present; Product was administered post excursion. The extended stability data Doesn't 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.; Sender's Comments: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA114290: US-SA-2025SA112035: