Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | — |
The patient received the second dose of RabAvert, 18 days after the first dose; Case reference number US-BN-2025-000372 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0585) on 14-Mar-2025 and concerns a 26-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 20-Feb-2025, the patient took the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication pre-exposure prophylaxis. On 10-Mar-2025, 18 days after the patient took first dose, the patient took second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due to RabAvert. Additional information received from pharmacist via Med Communication (reference number: USBAV25-0586) on 14-Mar-2025: New information included patient information, new reporter information.; Reporter's Comments: A 26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related.; Sender's Comments: A 26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related.
Comments: NONE