Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8800CA | — |
received FLUZONE-NP after being administered with Fluzone-HD the same day, with no reported adverse event; received FLUZONE-NP after being administered with Fluzone-HD the same day, with no reported adverse event; Initial information received on 14-May-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 73-year-old female patient who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone NP] after being administered with Fluzone-High dose the same day, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), and family history were not provided. At the time of the event, the patient had ongoing conditions of hypertension, chronic obstructive pulmonary disease (COPD), and kidney disease. Concomitant medication included Fluzone high dose. On 07-Oct-2025, the patient received an unknown dose of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (batch/lot number: U8800CA, expiration date: 30-Jun-2026) (strength: unknown) via unknown route in an unknown administration site for influenza immunization after being administered with Fluzone-High dose the same day, with no reported adverse event (Extra dose administered) (Product administered to patient of inappropriate age) (latency: same day). 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 medication 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.
COPD; Hypertension; Kidney disorder
INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE