Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Rabipur dose seven days and third Rabipur dose 28 days after dog bite; Case reference number US-BN-2023-000961 is a spontaneous case report initially received from a pharmacist via Company (reference number: USBAV23-0705) on 31-May-2023 and concerns a female patient of unknown age.  The patient had no medical history and concomitant medication.  On 03-May-2023 (to be confirmed), the patient had a dog bite. On the same day (to be confirmed), the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose, intramuscularly, at an unknown site of administration for post-exposure.  On 10-May-2023, seven days after the dog bite, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at unknown dose, intramuscularly, at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  On 31-May-2023, 28 days after the dog bite, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at unknown dose, intramuscularly, at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  As reported, the patient was accidently told the pre-exposure schedule and not the post-exposure schedule.  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccination.  Additional information received on 01-Jun-2023 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert (seven days after the dog bite), at unknown dose, intramuscularly, at an unknown site of administration which is considered as inappropriate schedule of vaccine administered. 28 days after the dog bite, the patient was vaccinated with the third dose of RabAvert, at unknown dose, intramuscularly, at an unknown site of administration which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. Reportedly, the patient was accidently told the pre-exposure schedule and not the post-exposure schedule. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccination. The patient had no medical history and concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert (seven days after the dog bite), at unknown dose, intramuscularly, at an unknown site of administration which is considered as inappropriate schedule of vaccine administered. 28 days after the dog bite, the patient was vaccinated with the third dose of RabAvert, at unknown dose, intramuscularly, at an unknown site of administration which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. Reportedly, the patient was accidently told the pre-exposure schedule and not the post-exposure schedule. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccination. The patient had no medical history and concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.