Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | Y1A201M | OT |
administration of IPOL instead of the intended TUBERSOL with no reported adverse event; Initial information received on 27-Apr-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24-year-old male patient to whom administered POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] instead of the intended TUBERSOL 5TU [TUBERSOL] with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On 27-Apr-2026, the patient received a 0.1 mL once dose of POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] suspension for injection (batch: Y1A201M, expiry: 31-Jan-2027) (strength: standard) via subdermal route in left forearm for immunization (Immunisation) instead of TUBERSOL 5TU solution for injection for TB skin test (Tuberculin test) with no reported adverse event (Wrong product administered, latency: same day). The caller was not aware of any adverse reactions at the time of the call. Action taken: not applicable for both the suspects. 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
TUBERSOL