Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | 3 | — | OT |
patient's 4th dose was administered earlier than scheduled with no reported ae; Initial information received on 07-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 year old female patient who was administered with 4th dose of Rabies (HDC) vaccine [Imovax rabies] earlier than scheduled with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Mar-2025 the patient received an unknown dose (dose 1) of suspect Rabies (HDC) vaccine Powder and solvent for suspension for injection, On 27-Mar-2025 she also received an unknown dose (dose 2), On 31-Mar-2025 received an unknown dose (dose 3) and On 04-Apr-2025, the patient received an unknown dose (dose 4) all with standard strength, frequency-once, batch number, expiry date-unknown for post exposure vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On 04-Apr-2025 the patient was administered with 4th earlier than scheduled with no reported AE (inappropriate schedule of product administration) (latency-same day). Reportedly-Patient has been previously vaccinated and the current dose was for post exposure. 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.