Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | Unknown | — |
The patient was unable to receive the second dose of RabAvert on day seven; Case reference number US-BN-2025-000164 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0177) on 23-Jan-2025 and concerns a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient received first dose of RabAvert vaccine 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 pre-exposure. As reported, reported as on day seven was unable to receive second dose of RabAvert vaccine (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE