Received Jan 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
patient received 3 fluzone hd vaccines this season with no reported adverse event; Initial information received on 08-Jan-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 90 years old male patient who received 3 influenza USP trival A-B high dose subvirion vaccine [Fluzone hd] this season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Nov-2025, the patient received received 3 influenza USP trival A-B high dose subvirion vaccine [Fluzone hd] this season with no reported adverse event (extra dose administered) (Latency same day). It was reported, "patient received the FLUZONE HD: 08-Oct-2025; 04-Nov-2025; 24-Dec-2025. The patient has had no ill effects." 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 Pharmacovigi lance 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.