Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: On 16-July, the patient was supposed to receive the second dose of the postexposure regimen but it came to a mixup and the patient mistakenly received Hyperrab immunoglobulin instead of RabAvert vaccine; Case reference number US-BN-2023-001277 is a spontaneous case report initially received from a pharmacist via Bavarian Nordic (reference number: BN_2023_02370) on 18-Jul-2023 and concerns a male patient of unknown age.  The patient's relevant medical history and concomitant medication details were not provided.  On 13-Jul-2023, the patient was bitten by a bat and received first dose of RabAvert (batch number not provided) at an unknown dose, route or site of administration for rabies post-exposure prophylaxis for vaccine-naive patients. As reported, the patient had no previous rabies vaccinations.   On 16-Jul-2023, three days after the first dose of RabAvert, the patient was supposed to receive the second dose of the postexposure regimen, but it came to a mixup an the patient mistakenly received co-suspect Hyperrab (immunoglobulin human anti-rabies, batch number not provided) administered intramuscularly at a dose of 1 mL at an unknown site of administration, instead of RabAvert vaccine (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.   Additional information received from agency on 18-Jul-2023 included an additional reference.   Additional information received from Bavarian Nordic on 19-Jul-2023 included BN local case ID.; Reporter's Comments: A male patient of unknown age was bitten by a bat and received first dose of RabAvert for rabies post-exposure prophylaxis for vaccine-naive patients. On the day 3 after the first dose, the patient was supposed to receive the second dose of the postexposure regimen, but it came to a mixup and the patient mistakenly received co-suspect Hyperrab instead of RabAvert vaccine, 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 relevant medical history and concomitant medication details were not provided. 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 male patient of unknown age was bitten by a bat and received first dose of RabAvert for rabies post-exposure prophylaxis for vaccine-naive patients. On the day 3 after the first dose, the patient was supposed to receive the second dose of the postexposure regimen, but it came to a mixup and the patient mistakenly received co-suspect Hyperrab instead of RabAvert vaccine, 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 relevant medical history and concomitant medication details were not provided. 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.