Sex: F
Vaccine: RAB
Symptoms: Immunoglobulin therapy, Product administered at inappropriate site, Product administration error
Clinical narrative: The patient was vaccinated with RabAvert in right outer thigh; RabAvert and HRIG were administered on the same leg; Case reference number US-BN-2022-002010 is a spontaneous case report initially received on 22-Aug-2022 from pharmacist (reference number: USBAV22-1110) and concerns a 12-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with RabAvert (rabies virus (inactivated, strain flury LEP); batch number: unknown) vaccine at dose reported as 1.0 ml, intramuscularly, in right outer high, for post-exposure immunisation (post-exposure rabies treatment) and with co-suspect HRIG (immunoglobulin human anti-rabies) at an unknown dose, reported also as half, route at the same leg, for unknown indication (explicitly coded as 'vaccine administered at inappropriate site' and 'product administration error').  At the time of this report, it was unknown which dose this was or if patient experienced adverse events.  Additional information received on 22-Aug-2022 included local case ID.; Reporter's Comments: A 12-year-old female patient was vaccinated with RabAvert, 1 ml, intramuscularly, in the right outer thigh (which is considered product administered at inappropriate site), for post-exposure rabies treatment. It was unknown if it was first dose or successive dose. Co-suspect medication was HRIG (human anti-rabies immunoglobulin), and it was administered as a half dose via unknown route at the same leg as RabAvert (which is considered product administration error due to the requirement to administer the two products at distant injection sites). No associated adverse events have been reported with the reported medication errors. Product administered at inappropriate site and product administration error are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Product administered at inappropriate site and product administration error are assessed as not related to RabAvert, but to human factor. The case is non-serious.; Sender's Comments: A 12-year-old female patient was vaccinated with RabAvert, 1 ml, intramuscularly, in the right outer thigh (which is considered product administered at inappropriate site), for post-exposure rabies treatment. It was unknown if it was first dose or successive dose. Co-suspect medication was HRIG (human anti-rabies immunoglobulin), and it was administered as a half dose via unknown route at the same leg as RabAvert (which is considered product administration error due to the requirement to administer the two products at distant injection sites). No associated adverse events have been reported with the reported medication errors. Product administered at inappropriate site and product administration error are considered listed per company convention. The patient's medical history and concomitant medications were not reported. Product administered at inappropriate site and product administration error are assessed as not related to RabAvert, but to human factor. The case is non-serious.