Sex: M
Vaccine: RAB, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event, Wound treatment
Clinical narrative: First dose of RabAvert was administered approximately two weeks after a dog bite; second dose was administered on day two, third dose on day 12 and fourth dose on day 21; Case reference number BN-2022-000978 is a spontaneous case report initially received on 25-Apr-2022 from a pharmacist via Communications (reference number: USBAV22-0142) and concerns a 22-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported also as two weeks prior to 13-Apr-2022, the patient was bitten by a dog.  On 14-Apr-2022, approximately two weeks after the dog bite, the patient was vaccinated with the first dose of RabAvert (Inactivated rabies virus vaccine; batch number: YRBA831A) at a dose 1 mL, administered intramuscularly in the left deltoid region and received Kedrab (immunoglobulin human anti-rabies), both for post-exposure prophylaxis treatment of rabies due to a dog bite (explicitly coded as 'inappropriate schedule of vaccine administered').  On 16-Apr-2022, two days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: YRBA831A), at a dose 1 mL, administered intramuscularly in the right deltoid region (explicitly coded as 'inappropriate schedule of vaccine administered').  On 26-Apr-2022, 12 days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: YRBA831A), at a dose of 1 mL, administered intramuscularly in the left deltoid region (explicitly coded as 'inappropriate schedule of vaccine administered').  On 05-May-2022, 21 days after the first dose, the patient was vaccinated with the fourth dose of RabAvert (batch number: YRBA831A), at a dose of 1 mL, administered intramuscularly in the right deltoid region (explicitly coded as 'inappropriate schedule of vaccine administered'). The patient did not receive the fifth dose,* but received proper wound care*.  As reported, the patient did not experience any adverse event due to RabAvert.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information was received from the reporter on 11-May-2022: New information included patient's details, vaccination details for the four administered doses of RabAvert, brand name of the immune globulin administered and confirmation that the patient did not experience any adverse event. The event of 'Missed dose' was deleted as it was confirmed that the patient received additional doses of RabAvert and one additional non-event was captured.  Follow up information was received from the reporter on 17-May-2022: New information dog bite details and confirmation that the patient did not receive the fifth dose.  Follow up information was received from the reporter on 20-May-2022: New information included confirmation that the patient did not receive the fifth dose and that proper wound care was performed, which caused the event 'incomplete course of vaccination' to be deleted.; Reporter's Comments: A 22-year-old male patient was vaccinated with the first dose of RabAvert for post-exposure prophylaxis treatment and received Kedrab (immunoglobulin human anti-rabies), as reported, approximately two weeks after the dog bite, which is considered as inappropriate schedule of product administration. Reportedly, the patient received the second dose of RabAvert on the day 2 after the first dose, which is considered as inappropriate schedule of product administration. Reportedly, the patient was vaccinated with the third dose of RabAvert on the day 12 after the first dose, which is considered as inappropriate schedule of product administration. The patient was vaccinated with the fourth dose of RabAvert on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. The patient did not receive the fifth dose, but received proper wound care, as reported. No associated adverse events were reported. Inappropriate schedule of product administration is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 22-year-old male patient was vaccinated with the first dose of RabAvert for post-exposure prophylaxis treatment and received Kedrab (immunoglobulin human anti-rabies), as reported, approximately two weeks after the dog bite, which is considered as inappropriate schedule of product administration. Reportedly, the patient received the second dose of RabAvert on the day 2 after the first dose, which is considered as inappropriate schedule of product administration. Reportedly, the patient was vaccinated with the third dose of RabAvert on the day 12 after the first dose, which is considered as inappropriate schedule of product administration. The patient was vaccinated with the fourth dose of RabAvert on the day 21 after the first dose, which is considered as inappropriate schedule of product administration. The patient did not receive the fifth dose, but received proper wound care, as reported. No associated adverse events were reported. Inappropriate schedule of product administration is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to RabAvert, but to a human factor. The case is non-serious.