Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Biopsy kidney, Blood creatinine, Cellulitis, Deep vein thrombosis
Clinical narrative: acute tubulointerstitial nephritis; immune complex GN; Lupus nephritis II; Acute kidney injury; Acute kidney injury; right leg deep vein thrombosis; cellulitis; Inappropriate schedule of vaccine administered; This literature-non-study case was reported in a literature article and describes the occurrence of the first episode of ACUTE KIDNEY INJURY (Acute kidney injury), the second episode of ACUTE KIDNEY INJURY (Acute kidney injury), TUBULOINTERSTITIAL NEPHRITIS (acute tubulointerstitial nephritis), GLOMERULONEPHRITIS (immune complex GN), LUPUS NEPHRITIS (Lupus nephritis II), DEEP VEIN THROMBOSIS (right leg deep vein thrombosis) and CELLULITIS (cellulitis) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.      Concurrent medical conditions included Systemic lupus erythematosus, Lupus nephritis, Hashimoto's thyroiditis, Renal tubular atrophy (maintained in complete remission on mycophenolate mofetil), Renal interstitial fibrosis (maintained in complete remission on mycophenolate mofetil) and Proteinuria. Concomitant products included MYCOPHENOLATE MOFETIL for Systemic lupus erythematosus, Lupus nephritis and Proteinuria.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced the first episode of ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (right leg deep vein thrombosis) (seriousness criteria hospitalization and medically significant) and CELLULITIS (cellulitis) (seriousness criteria hospitalization and medically significant). On 13-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (acute tubulointerstitial nephritis) (seriousness criteria hospitalization and medically significant), GLOMERULONEPHRITIS (immune complex GN) (seriousness criteria hospitalization and medically significant) and LUPUS NEPHRITIS (Lupus nephritis II) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-May-2021 due to ACUTE KIDNEY INJURY, CELLULITIS and DEEP VEIN THROMBOSIS, and then on 08-Jul-2021 due to ACUTE KIDNEY INJURY. The patient was treated with PREDNISONE for Adverse event, at a dose of 60 milligram, slow taper; CEFALEXIN for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at an unspecified dose and frequency and APIXABAN for Anticoagulant therapy, at an unspecified dose and frequency. At the time of the report, last episode of ACUTE KIDNEY INJURY (Acute kidney injury) had resolved and TUBULOINTERSTITIAL NEPHRITIS (acute tubulointerstitial nephritis), GLOMERULONEPHRITIS (immune complex GN), LUPUS NEPHRITIS (Lupus nephritis II), DEEP VEIN THROMBOSIS (right leg deep vein thrombosis), CELLULITIS (cellulitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2014, Biopsy kidney: ifta 10% IFTA 10% on kidney biopsy. On 20-Jul-2021, Biopsy kidney: abnormal Severe granulomatous ATIN and immune complex GN with class II lupus nephritis. Kidney biopsy revealed 4 out 0f 14 glomeruli to be globally sclerotic. The remaining glomeruli had focal, segmental mesangial hypercellularity. The tubules showed focal moderate tubulitis, associated with multifocal interstitial and mixed inflammatory infiltrate composed of mononuclear leukocyrtes and oesnophils. Two non-caseating granulomas were present. The biopsy findings were consistent with granulomatous ATIN, and mesangial proliferative lupus nephritis. On an unknown date, Blood creatinine: 0.9 - 1.1 mg/dl baseline serum creatinine had been  0.9 - 1.1 mg/dL with sub-nephrotic-range proteinuria on stable dose of MMF, 5.6 mg/dl During hospitalization, serum creatinine peaked at 5.6 mg/dL, 2.8 mg/dl Nadir serum  creatinine 2.8 mg/dL, 2.04 mg/dl On admission, serum creatinine of 2.04 mg/dL, 1.7 mg/dl Nine days later, her serum creatinine improved to 1.7 mg/dL, 4.4 mg/dl On re-admission, serum creatinine  of 4.4 mg/dL noted on outpatient tests. and 2.82 mg/dl Four weeks later, serum creatinine improved to 2.82 mg/dL.. On an unknown date, Microscopy: abnormal EM showed sparse mesangial electron-dense deposits and tubuloreticular  inclusions (TRI) and leukocyturia Urine microscopy showed leukocyturia with out hematuria. On an unknown date, Mycobacterium test: negative (Negative) Stains for fungi and acid-fast bacilli were negative.. On an unknown date, Urine protein/creatinine ratio: 0.6 mg/mg 0.6 mg/mg on  UPCR, 2,500 mg/g Peak  proteinuria 2,500 mg/g UPCR, 300 mg/g Nadir proteinuria 300 mg/g and 0.5 g/g UPCR of 0.5 g/g.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE KIDNEY INJURY (Acute kidney injury), TUBULOINTERSTITIAL NEPHRITIS (acute tubulointerstitial nephritis), GLOMERULONEPHRITIS (immune complex GN), LUPUS NEPHRITIS (Lupus nephritis II), DEEP VEIN THROMBOSIS (right leg deep vein thrombosis), CELLULITIS (cellulitis) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) to be related.    The patient had 21-year history of systemic lupus erythematosus and Lupus nephritis diagnosed 7 years ago was treated with MMF and achieved complete remission. Patient's baseline serum creatinine was found out with sub-nephrotic-range proteinuria on stable dose of mycophenolate mofetil.  On 19-May-2021, patient was admitted with right leg deep vein thrombosis and cellulitis and was noted to have AKI after first dose of Moderna vaccine.  On 08-Jul-2021 patient was re-admitted for AKI after she received the second dose of the vaccine.  Mycophenolate mofetil was continued, and high-dose prednisone was added with slow taper. Four  weeks later, serum creatinine improved. proteinuria remained stable in the low-sub-nephrotic range throughout the course of acute illness.  Company comment: This literature case concerns a 39-year-old female patient with relevant medical history of systemic lupus erythematosus for 21 years and lupus nephritis for 7 years who quickly achieved remission following mycophenolate mofetil (MMF) therapy, who experienced serious, unexpected events of Acute kidney injury, Tubulointerstitial nephritis, Glomerulonephritis, Lupus nephritis, Deep vein thrombosis and Cellulitis, which led to hospitalization. The events acute kidney injury, deep vein thrombosis and cellulitis occurred 17 days after the patient received the first dose of mRNA-1273. The patient was treated with cephalexin and doxycycline for cellulitis and was anticoagulated with apixaban. The second episode of acute kidney injury reoccurred 25 days after the second dose of mRNA-1273. In addition to concurrent MMF, the patient was also treated with prednisone and the patient's serum creatinine improved 4 weeks later. The patient's relevant medical history is a possible confounder for all of the reported events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-483213, MOD-2022-485479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2022: Follow up received by safety on 17-Feb-2022 has Email with FTA received from team and  contain significant information. Reporter information, literature information, patient information, relevant history, product tab and event tab were updated.; Sender's Comments: This literature case concerns a 39-year-old female patient with relevant medical history of systemic lupus erythematosus for 21 years and lupus nephritis for 7 years who quickly achieved remission following mycophenolate mofetil (MMF) therapy, who experienced serious, unexpected events of Acute kidney injury, Tubulointerstitial nephritis, Glomerulonephritis, Lupus nephritis, Deep vein thrombosis and Cellulitis, which led to hospitalization. The events acute kidney injury, deep vein thrombosis and cellulitis occurred 17 days after the patient received the first dose of mRNA-1273. The patient was treated with cephalexin and doxycycline for cellulitis and was anticoagulated with apixaban. The second episode of acute kidney injury reoccurred 25 days after the second dose of mRNA-1273. In addition to concurrent MMF, the patient was also treated with prednisone and the patient's serum creatinine improved 4 weeks later. The patient's relevant medical history is a possible confounder for all of the reported events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.