Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | Unknown | IM |
The patient received the second dose of RabAvert on day seven; Case reference number US-BN-2025-000965 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-1147) on 16-May-2025 and concerns a 5-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient touched bat. On an unspecified date, within 24 hours of touching a bat, the patient received 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 and site of administration intramuscularly for indication post-exposure prophylaxis along and the patient received Rabies immunoglobulin (brand name: unknown; batch number: unknown), at unknown dose, route or site of administration for indication post-exposure prophylaxis. On 16-May-2025, on day seven, the patient received the second dose of Rabavert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose and site of administration, intramuscularly (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, the patient had not experienced any adverse events due to Rabavert and the post-exposure series were not completed yet. No further information was provided.; Reporter's Comments: This case concerns a 5-year-old male child patient received first dose of RabAvert vaccine along with Rabies immunoglobulin for an indication of post-exposure prophylaxis. On day 7 after the first dose, patient had received the second dose, which is considered as inappropriate schedule of product administration. At the time of the initial report, the patient had not experienced any adverse events due to RabAvert and the post-exposure series were not completed yet. Inappropriate schedule of product administration is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 5-year-old male child patient received first dose of RabAvert vaccine along with Rabies immunoglobulin for an indication of post-exposure prophylaxis. On day 7 after the first dose, patient had received the second dose, which is considered as inappropriate schedule of product administration. At the time of the initial report, the patient had not experienced any adverse events due to RabAvert and the post-exposure series were not completed yet. Inappropriate schedule of product administration is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None
IMMUNGLOBULIN