Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8515CA | OT / RA |
FLUZONE HD given post temperature excursion not covered by extended stability with no reported adverse event; Initial information received on 19-Feb-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case linked to other case US-SA-2025SA053939 This case involves 67 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone high dose] post temperature excursion not covered by extended stability with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 14-Feb-2025, the patient received 0.5 ml of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength once with lot U8515CA and expiry date 30-JUN-2025 via intramuscular route in right Arm for immunization post temperature excursion not covered by extended stability with no reported adverse event (poor quality product administered) (Latency same day) Reportedly, there were no previous excursion, human error not involved. 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-2025SA053939:FLUZONE HD Patient #1: US-SA-2025SA054381: US-SA-2025SA054097:Fluzone