Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8804AA | OT |
FLUZONE HD was administered which had temperature excursion Negative 0.9 Celsius Duration: 9 hours and 23 minutes negative disposition and product used with no Adverse Event; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a physician. This case is linked to US-SA-2025SA349954. This case involves a 85 years old female patient to whom influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] whwas administered which had temperature excursion negative 0.9 celsius duration: 9 hours and 23 minutes negative disposition and product used with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Nov-2025, the patient received 0.5 ml dose of suspect influenza USP trival A-B high dose subvirion vaccine , Suspension for injection in pre-filled syringe (strength not reported) (lot UT8804AA; Expiration date: 30Jun2026) via intramuscular route in the deltoid nos (not otherwise specified) for Immunization which had temperature excursion negative 0.9 celsius duration: 9 hours and 23 minutes negative disposition and product used with no adverse event (poor quality product administered) (latency: unknown). Human error: No ; Administered: Yes; Does extended stability data cover the excursion: No It was reported that "Patient has not been made aware yet. No problem was 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-2025SA349954: