Received Dec 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | OT |
Intentional Off Label Prescription by HCP: Imovax prescribed with off label diagnosis of Other injury of unspecified body region, initial encounter with no reported adverse event; Initial information received on 21-Dec-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 61 years old female patient who was prescribed RABIES (HDC) VACCINE [IMOVAX RABIES] with off label diagnosis of other injury of unspecified body region, initial encounter 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, the patient was prescribed, 1mL, dose of suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site, with off label diagnosis other injury of unspecified body region, initial encounter with no reported adverse event (product prescribing issue) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.