Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | UNK | — | OT |
this situation is pre-assessed as an off-label use as per local labelling due to product not administered immediately after reconstitution with no adverse event; the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14; Initial information received on 04-Aug-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves an unknown age male patient who was prescribed with Rabies (HDC) vaccine [Imovax Rabies] that should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 and the product was not administered immediately after reconstitution with no 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 received an unknown dose of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection (expiry date, lot number and strength-unknown) via unknown route in unknown administration site for Immunization was not administered immediately after reconstitution (wrong technique in product usage process) and the vaccine should be administered on day 0, 3, 7, 14 and 28 but their prescription was only for day 0,3 ,7 and 14 with no adverse event (product prescribing error). Reportedly- The vaccine must be administered immediately after reconstitution but on their day 7, their vaccine was already reconstituted on the desk. 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.