Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / RA |
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 31 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] which 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 (once) (strength- standard, expiry date- 20-Jun-2025and 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). On 10-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the right deltoid for immunization. Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post 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-2025SA113170: US-SA-2025SA112035:master case
Medical History/Concurrent Conditions: Abortion