Received Apr 15, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UT8873MA | IM / RA |
Patient has received two "flu shots." First administration was with a Sanofi product. Second administration was with a non Sanofi product with no reported adverse event; Initial information received on 20-Mar-2026 regarding an unsolicited valid non-serious case received from other healthcare professional via pharmaceutical company. This case involves a 53-year-old female patient who received a double dose of the flu shot first with the suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (Fluzone Np) and second with a non company suspect with no reported adverse event. The patient's past medical history, past medical treatment(s), past drugs, vaccination(s), family history, and concomitant medications were not provided. On 22-Dec-2025, the patient received first dose (0.5 ml) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine ,suspension for injection, Strength: standard, frequency: once, batch: UT8873MA, Expiration Date :30-Jun-2026 via intramuscularly route in right deltoid for immunization and then second dose was administered with a non company suspect with onset date 19-Mar-2026 with no reported adverse event (extra dose administered) (latency: same day). It was reported "Second administration was with a non-Sanofi product". 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