Sex: F
Vaccine: RAB
Symptoms: Henoch-Schonlein purpura, Petechiae, Purpura, Vasculitis
Clinical narrative: Henoch-Schonlein Purpura (HSP) reported as vasculitis, consisting of petechiae and purpura in patient's legs mostly, and worse on ankles and feet; Case reference number US-BN-2023-001406 is a spontaneous case report initially received from consumer via agency (reference number: USBAV23-1393) on 05-Sep-2023 and concerns an 18-year-old female patient.  The patient's relevant medical history was not provided.   The patient's concomitant medication included metamizole (brand name unknown).  On 12-Aug-2023, the patient was vaccinated with the first dose of RabAvert, also reported as booster, (batch number not provided) at unknown dose, route and site of administration, for rabies prophylaxis. As reported, the patient had no known exposure, however a bat was present at patient's home.  On 15-Aug-2023, three days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert, also reported as booster, (batch number not provided) at unknown dose, route and site of administration.  On 20-Aug-2023, five days after the second dose of RabAvert, the patient experienced Henoch-Schonlein Purpura (HSP). The patient's mother reported that disease was 'vasculitis, consisting of petechiae and purpura in patient's legs mostly, and worse on ankles and feet'. The patient was in emergency room twice now, as reported, after the start of the symptoms and was monitored by dermatologist and endocrinologist with no treatment started yet. As reported, the patient was having urine and blood tests.  At the time of initial report, the outcome of the event Henoch-Schonlein purpura was unknown.  The reporter did not provide seriousness and causality assessment for the event of Henoch-Schonlein purpura, however the event Henoch-Schonlein purpura was assessed as serious due to the seriousness criteria of medical significance.  Additional information received from Bavarian Nordic on 06-Sep-2023 included local BN case ID.; Reporter's Comments: An 18-year-old female patient experienced serious event of Henoch-Schonlein Purpura, five days after she was vaccinated with the second dose (three days after the first dose) of RabAvert, also reported as booster, at unknown dose, route and site of administration. Henoch-Schonlein Purpura is unlisted according to CCDS v1 and USPI for RabAvert. The outcome was unknown. The patient's relevant medical history and concomitant medication included metamizole. Causality is assessed as related due to plausible temporal relationship and since contributory role of suspect product cannot be fully excluded at this point. The case is serious due to criteria of medical significance.; Sender's Comments: An 18-year-old female patient experienced serious event of Henoch-Schonlein Purpura, five days after she was vaccinated with the second dose (three days after the first dose) of RabAvert, also reported as booster, at unknown dose, route and site of administration. Henoch-Schonlein Purpura is unlisted according to CCDS v1 and USPI for RabAvert. The outcome was unknown. The patient's relevant medical history and concomitant medication included metamizole. Causality is assessed as related due to plausible temporal relationship and since contributory role of suspect product cannot be fully excluded at this point. The case is serious due to criteria of medical significance.