Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Complement factor C4, Glomerulonephritis rapidly progressive, Haemoglobin, Headache, Immunology test
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: Glomerulonephritis after Moderna COVID-19 Vaccination. Kidney Int. 2021;100 (2):473-4     Concurrent medical conditions included Hypertension (he was treated with amlodipine). Concomitant products included AMLODIPINE for Hypertension.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced ASTHENIA (Weakness) and HEADACHE (Headache). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) (seriousness criterion medically significant). The patient was treated with RITUXIMAB for Glomerulonephritis, at a dose of 375 mg/m2; PREDNISONE for Glomerulonephritis, at an unspecified dose and frequency and CYCLOPHOSPHAMIDE for Pauci-immune glomerulonephritis and Crescentic glomerulonephritis, at a dose of 7.5 mg/kg once. At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis), ASTHENIA (Weakness) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Anti-glomerular basement membrane antibody: negative (Negative) negative. In 2021, Antineutrophil cytoplasmic antibody: positive (Positive) positive and negative (Negative) negative. In 2021, Biopsy kidney: abnormal (abnormal) revealed cellular crescents and fibrinoid necrosis in 38 of 46 glomeruli, with some tubular injury. , a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made. In 2021, Blood bicarbonate: 21 meq/l (Low) 21 mEq/l. In 2021, Blood creatinine: 10.42 mg/dl (High) 10.42 mg/dl and 8.41 mg/dl (High) 8.41 mg/dl (baseline 1.11 mg/dl, 8 months prior. In 2021, Blood potassium: 5.0 meq/l (normal) 5.0 mEq/l. In 2021, Blood sodium: 129 meq/l (Low) 129 mEq/l. In 2021, Blood urea: 82 mg/dl (High) 82 mg/dl. In 2021, Complement factor C3: normal (normal) normal. In 2021, Complement factor C4: normal (normal) normal. In 2021, Haemoglobin: 14.6 g/dl (normal) 14.6 g/dl. In 2021, Immunology test: abnormal (abnormal) segmental fibrin staining the glomerular capillary loops, confirming fibrinoid necrosis. In 2021, Microscopy: abnormal (abnormal) No immune complexmediated deposits, interstitial fibrosis and tubular atrophy were mild. In 2021, Serology test: positive (Positive) positive cytoplasmic A NCA titers and antibodies to proteinase-3 (PR3). and abnormal (abnormal) a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made. In 2021, Toxicologic test: negative (Negative) negative. In 2021, Ultrasound kidney: no hydronephrosis (normal) no hydronephrosis. In 2021, Urine analysis: abnormal (abnormal) 'had 1+ proteinuria and microscopic hematuria with dysmorphic red blood cells.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Antineutrophil cytoplasmic antibody Glomerulonephritis) to be possibly related. No further causality assessments were provided for ASTHENIA (Weakness) and HEADACHE (Headache).    The patient was presented with headache and weakness 2 weeks after receiving his second dose of the Moderna (mRNA-1273) vaccine on 15-Apr-2021. Headache started the day after his second vaccination and was associated with weakness. Vitals were stable, and physical examination was unremarkable. Intravenous (IV) hydration was initiated. Interstitial fibrosis and tubular atrophy were mild. Rituximab was initiated at 375 mg/m2, but the patient developed severe dyspnea and declined further doses. One dose of cyclophosphamide 7.5 mg/kg (per CYCIDPS trial dosing) was given; however, hemodialysis was initiated for hyperkalemia and worsening renal function. Currently, he continues to require dialysis, while on prednisone, and with a plan to repeat cyclophosphamide 2 weeks after the first dose.  On the basis of serologic and biopsy findings, a diagnosis of pauci-immune necrotizing and crescentic glomerulonephritis was made.  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. Further information has been requested. Of note, the patient's medical history of Hypertension is a confounding factor that may play a possible contributory role.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow up received by safety 28-Jul-2021 included an email from the ? team with an abstract and no new information.; 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. Further information has been requested. Of note, the patient's medical history of Hypertension is a confounding factor that may play a possible contributory role.