Received Mar 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8514A | OT |
The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; The serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves unknown age adult medical assistant female patient who was exposed to influenza USP trival A-B subvirion no preservative vaccine [Fluzone] after it fell on the table, where it got into contact with her wrist (skin) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, patient was exposed to an unknown dose of influenza USP trival A-B subvirion no preservative vaccine, Unknown strength, Suspension for injection, Expiry date 30-Jun-2025 and lot UT8514A via unknown route in unknown administration site for inlufenza due to serum fell on the table which is where it got into contact with her wrist (skin) later on with no reported adverse event (accidental exposure to product) (exposure via skin contact) (latency Same day) Reportedly, the vaccine serum leaked on the table during preparation, due to which it came in contact with medical assistant's wrist later on. This incident did not occurred with other vaccines when caps were opened, and she was advised to contact the manufacturer. Action taken was 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.