Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | 1 | W1C431M | OT |
The patient received the first dose on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 years old male patient who received the first dose of rabies (HDC) vaccine [Imovax Rabies] on 02-Apr-2025 and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Apr-2025, the patient received an unknown dose 1 of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength- standard, expiry date- 31-OCT-2025 and lot W1C431M) via unknown route in unknown administration site and was trying to receive the second dose on 11-Apr-2025 with no reported adverse event (routine immunisation schedule not administered). 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.