Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
unintentionally administered FLUZONE HIGHDOSE twice in a season- September 2025 and March 2026 with no AE; Initial information received on 04-Jun-2026 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74-year-old male patient who unintentionally administered Influenza Usp Trival A-B High Dose Subvirion Vaccine (Fluzone Hd) twice in a season- September 2025 and March 2026 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. Concomitant medication(s) included Pfizer BioNTech COVID-19 vaccine. On 16-Mar-2026, the patient received a 0.5 mL once dose of Influenza Usp Trival A-B High Dose Subvirion Vaccine suspension for injection (batch/lot number: unknown; expiry date: unknown) (strength: unknown) via intramuscular route in an unknown administration site for immunization [Immunisation]. In Sep-2025, the patient received the same vaccine influenza usp trival a-b high dose subvirion vaccine with no adverse event (extra dose administered) (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 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.
Comments: NONE
Pfizer BioNTech COVID-19 vaccine