Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of RabAvert on 29-Aug-2023, second on 01-Sep-2023, and third dose on 06-Sep-2023; Case reference number US-BN-2023-001512 is a spontaneous case report initially received from a pharmacist via Agency (reference number: EUBAV23-1447) on 11-Sep-2023 and concerns a 23-year-old female patient.  The patient's relevant medical history and concomitant medication details were not provided.  At the time of vaccination patient was not pregnant.  On 29-Aug-2023, the patient was vaccinated with the first dose of RabAvert vaccine (batch number not provided) at an unknown dose, route or site of administration for indication reported as pre-exposure prophylaxis.   On 01-Sep-2023, three days after the first dose, the patient was vaccinated with the second dose of RabAvert vaccine (batch number not provided) at an unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  On 06-Sep-2023, eight days after the first dose, the patient was vaccinated with the third dose of RabAvert vaccine (batch number not provided) at an unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received on 12-Sep-2023 from Agency included local Agency case ID.; Reporter's Comments: A 23-year-old female patient was vaccinated with the second dose of RabAvert vaccine for indication reported as pre-exposure prophylaxis on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 8 after the first dose, the patient was vaccinated with the third dose of RabAvert vaccine, which is also considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. At the time of vaccination patient was not pregnant. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 23-year-old female patient was vaccinated with the second dose of RabAvert vaccine for indication reported as pre-exposure prophylaxis on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 8 after the first dose, the patient was vaccinated with the third dose of RabAvert vaccine, which is also considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. At the time of vaccination patient was not pregnant. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.