Received Jan 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (IMOVAX) | SANOFI PASTEUR | 2 | Y1C96T1 | OT / LA |
the prepared vaccine was stored in their fridge with no reported adverse event; Initial information received on 24-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old male patient who received rabies (HDC) vaccine [Imovax Rabies] and the prepared vaccine was stored in their fridge with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Dec-2025 at 09:28 hours, the patient received 1 ml of dose 2 of rabies (HDC) vaccine Powder and solvent for suspension for injection (strength- standard, expiry date- 31-AUG-2027 and lot Y1C96T1) once via intramuscular route in the left deltoid for Immunization and the prepared vaccine was stored in their fridge with no reported adverse event (product storage error). It was reported that, "their patient went to the clinic to get his dose, which was a day earlier than his scheduled vaccination. Due to this, the nurse had to reconstitute and prepare the IMOVAX for administration. However, due to the patient's correct vaccination schedule of 24DEC2025, the prepared vaccine was stored in their fridge yesterday, with an expiration date labeled as 24DEC2025." 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.