Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Ocular hyperaemia, Pain, Urinary tract infection
Clinical narrative: started losing her appetite; UTI; nausea; bloodshot eyes; spontaneous nose bleed; Wegener's disease. It has attacked her sinuses, lungs and kidneys; passed out; pain on her left side and shoulder; blood clot in her leg with a piece breaking off and traveling to her lung.; patient was tired; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (bloodshot eyes), EPISTAXIS (spontaneous nose bleed), DECREASED APPETITE (started losing her appetite), NAUSEA (nausea), URINARY TRACT INFECTION (UTI), LOSS OF CONSCIOUSNESS (passed out), GRANULOMATOSIS WITH POLYANGIITIS (Wegener's disease. It has attacked her sinuses, lungs and kidneys), PAIN (pain on her left side and shoulder), DEEP VEIN THROMBOSIS (blood clot in her leg with a piece breaking off and traveling to her lung.) and FATIGUE (patient was tired) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Glioma (she were diagnosed at the age of six with a tectal glioma.). Family history included Autoimmune disorder. Concurrent medical conditions included Autoimmune disorder.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced OCULAR HYPERAEMIA (bloodshot eyes) (seriousness criterion hospitalization), EPISTAXIS (spontaneous nose bleed) (seriousness criterion hospitalization) and NAUSEA (nausea) (seriousness criterion hospitalization). On 18-Jul-2021, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criterion hospitalization). On 23-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DECREASED APPETITE (started losing her appetite) (seriousness criterion hospitalization), GRANULOMATOSIS WITH POLYANGIITIS (Wegener's disease. It has attacked her sinuses, lungs and kidneys) (seriousness criteria hospitalization and medically significant), PAIN (pain on her left side and shoulder) (seriousness criterion hospitalization), DEEP VEIN THROMBOSIS (blood clot in her leg with a piece breaking off and traveling to her lung.) (seriousness criteria hospitalization and medically significant) and FATIGUE (patient was tired) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Jul-2021 to 09-Aug-2021 due to GRANULOMATOSIS WITH POLYANGIITIS and LOSS OF CONSCIOUSNESS, then from 14-Aug-2021 to 27-Aug-2021 due to DEEP VEIN THROMBOSIS, FATIGUE and PAIN. The patient was treated with RITUXIMAB (RITUXAN) for Red blood cell abnormality NOS, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Red blood cell abnormality NOS, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (bloodshot eyes), EPISTAXIS (spontaneous nose bleed), DECREASED APPETITE (started losing her appetite), NAUSEA (nausea), URINARY TRACT INFECTION (UTI), LOSS OF CONSCIOUSNESS (passed out), GRANULOMATOSIS WITH POLYANGIITIS (Wegener's disease. It has attacked her sinuses, lungs and kidneys), PAIN (pain on her left side and shoulder), DEEP VEIN THROMBOSIS (blood clot in her leg with a piece breaking off and traveling to her lung.) and FATIGUE (patient was tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, Urine cytology: blood and bacteria. (abnormal) blood and bacteria, probably an UTI..         No concomitant medical information reported. She were done with 5 plasmapheresis  treatment while in the hospital. now on steroids and has had 4 doses of Rituxan as well as Eliquis and other medication to help her produce red blood cells.  The patient was regularly monitored with seeing the neurosurgeon every year and MRIs every other year.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.