Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
receiving a 0.5 ml higher dose of tubersol intramuscularly with no reported adverse event; patient receiving a higher dose of tubersol intramuscularly with no reported adverse event; Tubersol given as I'M Injection when IPV ordered with no reported adverse event; Initial information received on 27-Jan-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old male patient who received 0.5 ml higher dose of Tuberculin Test [Tubersol] intramuscularly while IPV (VERO) ordered, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jan-2026, the patient received 0.5ml higher dose, Tubersol (Tuberculin Test), Solution for injection (once), Strength Standard (lot 4CA26C1 and expiry date 30-Apr-2028) via intramuscular in Deltoid NOS (not otherwise specified) for TB Skin Test [Tuberculin test], with no reported adverse event (incorrect dose administered) (incorrect route of product administration) while IPV (VERO) (Suspension for injection, strength: unknown) ordered, with no reported adverse event (wrong product administered) (Latency Same day). It was reported, tubersol given as im injection when IPV ordered, reason: packaging being extremely similar to IPV. 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. Additional information was received on 16-Feb-2026 via other health professional: Batch number and expiry date for the suspect has been added. Narrative amended accordingly. Additional information was received on 16-Feb-2026 via other healthcare professional, new event of "wrong product administered" added, new suspect IPV added, text amended accordingly.
TUBERSOL