Received Jun 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 2 | FDP0052 | IM / LA |
The two patients were vaccinated with second dose of Rabavert, 21 days (first patient) and 24 days (second patient) after the first dose.; Case reference number US-BN-2024-002637 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-2681) on 10-Oct-2024 and concerns two male patients with *29-year-old (first patient) and 37-year-old (second patient) *. The patients relevant medical history and concomitant medications were not provided. On 17-Sep-2024, the *second patient* was vaccinated with first dose of RabAvert vaccine *(batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid* for pre-exposure prophylaxis. On 19-Sep-2024, the *first patient* was vaccinated with first dose of RabAvert vaccine *(batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid* for pre-exposure prophylaxis. The first patient was due for second dose of RabAvert vaccine on 24-Sep-2024, and second patient was due for second dose of RabAvert on 26-Sep-2024 and as reported, were unable to come on that week due to the tropical storm. *On 10-Oct-2024, 21 days after the first dose, the first patient was vaccinated with second dose of RabAvert vaccine (batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered') * *On 11-Oct-2024, 24 days after the first dose, the second patient was vaccinated with second dose of Rabavert vaccine (batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered') * *At the time of this follow-up report, the patients did not experience* any adverse events due to RabAvert vaccine. Additional information received from a nurse via Med Communications on 10-Oct-2024 included additional reference numbers. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 23-Oct-2024: New information included reporter details, patients age, RabAvert dosing details were added, previously coded event of Incomplete course of vaccination was deleted and new event of Inappropriate schedule of vaccine administered was added, and confirmation that patient did not experience any adverse event due to RabAvert.; Reporter's Comments: Two male patients, a 29-year-old (the first patient) and a 37-year-old (the second patient) were vaccinated with second dose of RabAvert vaccine for pre-exposure prophylaxis, on the days 21 and 24 after the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered as listed per company convention. The patients did not experience any adverse events due to RabAvert vaccine. The patients' relevant medical history and concomitant medications 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: Two male patients, a 29-year-old (the first patient) and a 37-year-old (the second patient) were vaccinated with second dose of RabAvert vaccine for pre-exposure prophylaxis, on the days 21 and 24 after the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered as listed per company convention. The patients did not experience any adverse events due to RabAvert vaccine. The patients' relevant medical history and concomitant medications 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