Received Jul 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | IM |
IMOVAX RABIES prescribed 3 times, with no reported adverse event; Initial information received on 30-Jun-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 22-year-old patient who was prescribed Rabies (HDC) Vaccine [Imovax Rabies] at off label diagnosis of open bite, unspecified thigh, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On an unspecified date, the patient was prescribed 1 mL dose, (three times) of Rabies (HDC) Vaccine as powder and solvent for suspension for injection of unknown strength (batch/lot number and expiry date: unknown) via intramuscular route in an unknown administration site for off label diagnosis of open bite, unspecified thigh, with no reported adverse event. (off label use) (latency: 1 day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. 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