Sex: M
Vaccine: RAB
Symptoms: Immunoglobulin therapy, Inappropriate schedule of product administration, Injection site pain, Lack of vaccination site rotation
Clinical narrative: 27-May-2023 bitten by a dog, first RabAvert dose on 05-Jun-2023 for post-exposure  dog bite; On 05-Jun-2023 patient received one RabAvert dose for post-exposure  dog bite; RabAvert and HyperRab administered in left deltoid on the same day; Pain at the injection site; Case reference number US-BN-2023-000975 is a spontaneous case report initially received from a pharmacist via Company (reference number: USBAV23-0718) on 05-Jun-2023 and concerns a 14-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 27-May-2023, the patient was bitten by a dog in the thigh. As reported, the bite was treated.  On an unspecified date, the puncture wound had healed and closed.  On 05-Jun-2023, nine days after the dog bite, the patient was vaccinated with the first dose of RabAvert, (batch number: 0905, as reported), at 1 mL, intramuscularly, in the left deltoid for indication reported as post-exposure  dog bite (explicitly coded as 'inappropriate schedule of vaccine administered') and with co-suspect HyperRab (immunoglobulin human anti-rabies (IVIG)), at unknown dose and route of administration, split between arms, half and half to distribute the human rabies immune globulin (HRIG) evenly to lessen the pain, as reported, in the left deltoid, same muscle as RabAvert and in the other shoulder for indication reported as post-exposure  dog bite (explicitly coded as 'lack of vaccination site rotation'). As reported, vaccine was given in one arm, the healthcare professional that administered RabAvert and HyperRab was trained that way and that because the wound was closed HRIG could be put in patient's deltoid. *As also reported, error was made by a registered nurse (RN), improperly trained at hospital emergency room (ER) and that IG and RabAvert were not given correctly: IG was not given around the woud/given at different anatomical site than the wound. * On the same day the patient experienced pain at injection site. *  *As reported, the patient received one RabAvert dose (explicitly coded as 'incomplete course of vaccination'). *  *On 07-Jun-2023, event pain at injection site was considered as resolved. *  *The reporter assessed event pain at injection site as non-serious and causality assessment for the event pain at injection site was reported as possible. *  Additional information received on 06-Jun-2023 from Bavarian Nordic included local BN case ID.  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 pharmacist on 05-Jul-2023: New information included date of exposure, new non-serious AE pain at injection site, information on medication error and new special situations inappropriate schedule of vaccine administered and incomplete course of vaccination.  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 pharmacist on 04-Aug-2023: dose confirmation, seriousness criteria, causality assessment, start and stop date for event pain at injection site updated.; Reporter's Comments: A 14-year-old male patient was bitten by a dog in the thigh. As reported, the bite was treated and on unspecified date, the puncture wound had healed and closed. Reportedly, on the day 9 after the dog bite, the patient was vaccinated with the first dose of RabAvert, at 1 mL, intramuscularly, in the left deltoid for indication reported as post-exposure prophylaxis of dog bite, which is considered as inappropriate schedule of vaccine administered, and with co-suspect HyperRab, at unknown dose and route of administration, split between arms, half and half to distribute the human rabies immune globulin (HRIG) evenly to lessen the pain, as reported, in the left deltoid, same muscle as RabAvert and in the other shoulder for indication reported as post-exposure for dog bite, which is considered as lack of vaccination site rotation. The patient received one RabAvert dose, which is considered as incomplete course of vaccination. On the same day as the RabAvert vaccination, the patient experienced a non-serious event of pain at injection site. The event of injection site pain is listed for RabAvert according to the CCDS and PI. Lack of vaccination site rotation, inappropriate schedule of vaccine administered, and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Lack of vaccination site rotation, inappropriate schedule of vaccine administered, and incomplete course of vaccination have been considered as not related to the suspect vaccine, but to a human factor. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the event has been considered as related to RabAvert. This case is considered non-serious.; Sender's Comments: A 14-year-old male patient was bitten by a dog in the thigh. As reported, the bite was treated and on unspecified date, the puncture wound had healed and closed. Reportedly, on the day 9 after the dog bite, the patient was vaccinated with the first dose of RabAvert, at 1 mL, intramuscularly, in the left deltoid for indication reported as post-exposure prophylaxis of dog bite, which is considered as inappropriate schedule of vaccine administered, and with co-suspect HyperRab, at unknown dose and route of administration, split between arms, half and half to distribute the human rabies immune globulin (HRIG) evenly to lessen the pain, as reported, in the left deltoid, same muscle as RabAvert and in the other shoulder for indication reported as post-exposure for dog bite, which is considered as lack of vaccination site rotation. The patient received one RabAvert dose, which is considered as incomplete course of vaccination. On the same day as the RabAvert vaccination, the patient experienced a non-serious event of pain at injection site. The event of injection site pain is listed for RabAvert according to the CCDS and PI. Lack of vaccination site rotation, inappropriate schedule of vaccine administered, and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Lack of vaccination site rotation, inappropriate schedule of vaccine administered, and incomplete course of vaccination have been considered as not related to the suspect vaccine, but to a human factor. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the event has been considered as related to RabAvert. This case is considered non-serious.