Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8442BA | OT / LA |
product administered after excursion with no adverse event; Temperature excursion/temperature reached: 8.5 °C to 8.8 °C with 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 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 This case involves a 22 years old female patient to whom INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] product administered after excursion with no adverse event and temperature excursion/temperature reached: 8.5 °c to 8.8 °c with 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 temperature excursion/temperature reached: 8.5 °c to 8.8 °c with 30 minutes with no reported adverse event (product storage error). On 15-Apr-2025, the patient received INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE dose 0.5 ml 1x(once) Suspension for injection (strength standard) lot U8442BA Expiry date-20-Jun-2025 via intramuscular route in the left deltoid for Influenza immunization, product administered after excursion with no adverse event (poor quality product administered) (latency same day). Cause of excursion-Human error (Reason: Monthly cycle count, inventory checking) 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: US-SA-2025SA113170: US-SA-2025SA113835: US-SA-2025SA113257: US-SA-2025SA113846: US-SA-2025SA113850: US-SA-2025SA114290: