Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / RA |
temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event; Fluzone was administered to patient post excursion 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 cases- US-SA-2025SA113850, US-SA-2025SA113376, US-SA-2025SA113846, US-SA-2025SA113257, US-SA-2025SA113835, US-SA-2025SA113170, US-SA-2025SA113172, US-SA-2025SA112035, US-SA-2025SA113179, US-SA-2025SA113850. This case involves a 36 years old female patient who was exposed to temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event and influenza usp trival a-b subvirion vaccine [Fluzone] was administered to patient post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received 0.5 ml dose of suspect influenza usp trival a-b subvirion vaccine Suspension for injection lstrength- standard) (lot U8442BA and expiry date- 20-JUN-2025) via intramuscular route in the right deltoid for Influenza (Influenza immunization) and temperature excursion: negative disposition with human error max/low temperature reached: 8.5 °c to 8.8, duration: 30 minutes with no reported adverse event (product storage error) and fluzone was administered to patient post excursion with no reported adverse event (poor quality product administered) (latency- same day). Treatment: None given. No adverse events were reported 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-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113850: US-SA-2025SA113376: US-SA-2025SA113846: US-SA-2025SA113257: US-SA-2025SA113835: US-SA-2025SA113170: US-SA-2025SA113172: US-SA-2025SA112035: US-SA-2025SA113257: