Received Mar 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
use of Tubersol instead of the intended flu vaccine with no reported adverse event; Initial information received on 24-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old female patient who experienced inappropriate use of Tubersol [Tuberculin test] instead of the intended flu vaccine with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Mar-2025, the patient received an 0.5 ml dose of tuberculin test [tubersol], Solution for injection 0.5 for Immunisation was exposed to tubersol instead of the intended flu vaccine via intramuscular route in the left deltoid for tuberculin skin test (tuberculin test) (wrong product administered) (latency: same day) (lot number:3CA48C1, unknown strength, expiry date:31-OCT-2031) List concomitant or no other vaccines no other vaccines. Reportedly, Nurse at a walk-in clinic at college called regarding TUBERSOL that was incorrectly administered. Should have administered 0.1 ml intradermal and instead was delivered at 0.5 intramuscular. 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. .
TUBERSOL