Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Product administration error
Clinical narrative: RabAvert administered on 18-Feb-2022 and on 21-Feb-2022 was not valid; Patient received the post exposure series and had only four RabAvert doses and not five doses; About a year ago patient was bit by a dog, first RabAvert dose on 14-Feb-2022, second on 18-Feb-2022; Case reference number US-BN-2023-001155 is a spontaneous case report initially received from a consumer via Communications (reference number: USBAV23-0859) on 03-Jul-2023 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as about a year ago, the patient was bitten by a dog. As reported, the patient was not sure if she had an exposure, that there was a possibility but was not sure really.  On 14-Feb-2022, an unknown time after the animal exposure, the patient was vaccinated with the first dose of RabAvert (batch number not provided) at unknown dose, route and site of administration, for post exposure to rabies in the emergency room (ER).  On 18-Feb-2022, an unknown time after the animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number not provided) at unknown dose, route and site of administration in the ER (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, RabAvert administered on 18-Feb-2022 was not valid (explicitly coded as 'product administration error') (to be clarified).  On 21-Feb-2022, an unknown time after the animal exposure, the patient was vaccinated with the third dose of RabAvert (batch number not provided) at unknown dose, route and site of administration in the ER. As reported, RabAvert administered on 21-Feb-2022 was not valid (explicitly coded as 'product administration error') (to be clarified).  On 28-Feb-2022, an unknown time after the animal exposure, the patient was vaccinated with the fourth dose of RabAvert (batch number not provided) at unknown dose, route and site of administration in the ER. As reported, the patient only had four RabAvert doses, and not five (explicitly coded as 'incomplete course of vaccination').  On unspecified dates, an unknown time after the animal exposure, the patient had like four or five more of unspecified product in the actual bite mark, as reported (to be clarified).  At the time of initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccination.  Additional information received from Bavarian Nordic on 04-Jul-2023 included local BN case ID.; Reporter's Comments: A female patient of unknown age was bitten by a dog on an unspecified date. As reported, the patient was not sure if she had an exposure, that there was a possibility but was not sure really. Reportedly, the patient was vaccinated with the first and the second dose of RabAvert, four days apart, at unknown dose, route and site of administration, for post exposure to rabies in the ER, which is considered as inappropriate schedule of vaccine administered. As reported, the second RabAvert dose, administered on 18-Feb-2022 was not valid, which is considered as product administration error. The patient was vaccinated with the third dose of RabAvert, at unknown dose, route and site of administration in the ER. As reported, RabAvert administered on 21-Feb-2022 was not valid, which is considered as product administration error. Reportedly, the patient was vaccinated with the fourth dose of RabAvert, at unknown dose, route and site of administration in the ER. As reported, the patient only had four RabAvert doses, and not five, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccination. Product administration error, incomplete course of vaccination and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, incomplete course of vaccination and inappropriate schedule of product administration have 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 female patient of unknown age was bitten by a dog on an unspecified date. As reported, the patient was not sure if she had an exposure, that there was a possibility but was not sure really. Reportedly, the patient was vaccinated with the first and the second dose of RabAvert, four days apart, at unknown dose, route and site of administration, for post exposure to rabies in the ER, which is considered as inappropriate schedule of vaccine administered. As reported, the second RabAvert dose, administered on 18-Feb-2022 was not valid, which is considered as product administration error. The patient was vaccinated with the third dose of RabAvert, at unknown dose, route and site of administration in the ER. As reported, RabAvert administered on 21-Feb-2022 was not valid, which is considered as product administration error. Reportedly, the patient was vaccinated with the fourth dose of RabAvert, at unknown dose, route and site of administration in the ER. As reported, the patient only had four RabAvert doses, and not five, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccination. Product administration error, incomplete course of vaccination and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error, incomplete course of vaccination and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.