Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP00535 | IM / LA |
Patient received first dose of RabAvert on 03-Oct-2025 and patient will receive second dose on 07-Oct-2025; Case reference number US-BN-2025-001654 is a spontaneous case initially received from pharmacist via Bavarian-Nordic (reference number: CASE-000128) on 07-Oct-2025 and concerns 61-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 03-Oct-2025, the patient received Immunoglobulin and the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (*batch number: FDP00535 and expiration date 31-Aug-2027), at a dose of 1 ml, intramuscularly in left deltoid*, for post exposure to a bat as an indication. The second dose was scheduled for 06-Oct-2025, but the patient *received the second dose on 07-Oct-2025 of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00532 and expiration date 31-Aug-2027), at dose of 1 ml, intramuscularly in right deltoid*, for post exposure to a bat as an indication.(explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of *follow-up* report, it was unknown if the patient experienced any adverse event due to RabAvert, *as repoted no known reactions* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information received from the pharmacist on 25-Nov-2025 included patients initials, volumes, site and route of administration, batch and expiration date for both doses.; Reporter's Comments: A 61-year-old female patient received the first dose of RabAvert for post exposure to a bat as an indication. The second dose was received on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed 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: A 61-year-old female patient received the first dose of RabAvert for post exposure to a bat as an indication. The second dose was received on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed 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.