Received Jun 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
relapsed AL amyloidosis; relapsed AL amyloidosis; Falls; Steroid-induced myopathy (during dexamethasone treatment); unintentional weight loss of 25 pound; Crescentic glomerulonephritis; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic glomerulonephritis), PRIMARY AMYLOIDOSIS (relapsed AL amyloidosis) and DISEASE RECURRENCE (relapsed AL amyloidosis) in a 73-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: The patient's past medical history included Fatigue (mild) in 2019, Chest discomfort in 2019, AL amyloidosis (AL amyloid (lambda subtype) involving the kidneys and heart) in January 2020 and COVID-19 from September 2020 to 2020. Previously administered products included for AL amyloidosis: Cyclophosphamide from January 2020 to 2020. Past adverse reactions to the above products included No adverse effect with Cyclophosphamide. Concurrent medical conditions included Hypertension and Atrial fibrillation. Concomitant products included Ixazomib from January 2020 to an unknown date and Dexamethasone from January 2020 to 2023 for AL amyloidosis. In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic glomerulonephritis) (seriousness criterion medically significant). In December 2022, the patient experienced ABNORMAL LOSS OF WEIGHT (unintentional weight loss of 25 pound). In 2023, the patient experienced FALL (Falls) and MYOPATHY (Steroid-induced myopathy (during dexamethasone treatment)). In February 2026, the patient experienced PRIMARY AMYLOIDOSIS (relapsed AL amyloidosis) (seriousness criterion medically significant) and DISEASE RECURRENCE (relapsed AL amyloidosis) (seriousness criterion medically significant). At the time of the report, GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic glomerulonephritis) and ABNORMAL LOSS OF WEIGHT (unintentional weight loss of 25 pound) had resolved, PRIMARY AMYLOIDOSIS (relapsed AL amyloidosis) and DISEASE RECURRENCE (relapsed AL amyloidosis) had not resolved and FALL (Falls) and MYOPATHY (Steroid-induced myopathy (during dexamethasone treatment)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2019, Blood immunoglobulin G: 1200 mg/dl with immunoparesis. In 2019, Light chain analysis: A significantly reduced kappa-to-lambda FLC ratio of 0.07, 11.2 mg/dl Reference range: not provided and 0.83 mg/dl serum kappa free light chains (FLC). In 2019, Urine analysis: monoclonal immunoglobulin G lambda fragment was detected in the urine. In January 2020, Biopsy bone marrow: Amyloid deposition, identified as AL amyloid (lambda subtype) based on mass spectrometry, was detected on bone marrow and fat biopsies. In January 2020, Blood creatinine: 1.04 mg/dl Reference range: not provided and 0.9 mg/dl Reference range: not provided. In January 2020, Echocardiogram: revealed an ejection fraction of 74%, a global averaged left ventricular longitudinal peak systolic strain of -16%, and an N-terminal pro-B-type natriuretic peptide level of 538 pg/mL. In January 2020, Ejection fraction: 74 % Reference range: not provided. In January 2020, Haemoglobin: 14.7 mg/dl Reference range: not provided. In January 2020, Light chain analysis: kappa-to-lambda ratio 0.074. In January 2020, N-terminal prohormone brain natriuretic peptide: 538 pg/ml. In January 2020, Protein urine: 3.1 gram per 24 hour (proteinuria). In 2020, Blood creatinine: remained stable. In 2020, Light chain analysis: FLC ratio of 0.46 and a difference between involved and uninvolved FLC of 0.89 and 1.52 mg/dl Lambda FLC decreased. In 2020, Protein urine: Proteinuria remained stable which stayed between 3 and 4 g/d. In September 2020, Blood creatinine: 1.43 mg/dl transient increase in creatinine. In September 2020, Light chain analysis: kappa-to-lambda ratio 0.43. In October 2020, Blood creatinine: 1.1 mg/dl transient increase in creatinine resolved quickly and returned to a baseline the next month. In 2021, Light chain analysis: 0.88 mg/dl rapidly reducing lambda FLC. In June 2021, SARS-CoV-2 antibody test: postinfection assessment of his immune response found a COVID-19 spike protein antibody titer of greater than 250 U/mL. In August 2021, Blood creatinine: 1.0 mg/dl Reference range: not provided. In August 2021, Light chain analysis: kappa-to-lambda ratio 0.43. In September 2021, Blood creatinine: 1.0 mg/dl Reference range: not provided. In September 2021, Light chain analysis: actual increase in the kappa to-lambda ratio from 0.37 to 0.46 with a difference between involved and uninvolved FLC of 1.57, 2.92 mg/dl increased and 1.35 mg/dl kappa FLC increased. In September 2021, Protein urine: proteinuria worsened significantly to 8.5 g/24 hour. In January 2022, Blood creatinine: 1.36 mg/dl Despite therapy change, continued to increase. In May 2022, Blood creatinine: 1.42 mg/dl creatinine climbing. In May 2022, Light chain analysis: kappa-to-lambda ratio 0.84 and 2.07 mg/dl reference range: Not provided. In 2022, Light chain analysis: the kappa-to-lambda ratio increased to 0.87, 0.86 mg/dl lambda FLC dropped to a nadir and 0.74 mg/dl reference range: Not provided. In December 2022, Blood creatinine: 2.7 mg/dl Creatinine continued to increase. In December 2022, Light chain analysis: kappa-to-lambda ratio of 1.01, 2.10 mg/dl reference range: Not provided and 2.12 mg/dl reference range: Not provided. In December 2022, Protein urine: Proteinuria stabilized at 4 g/24 hours. In December 2022, Weight: unintentional weight loss of 25 pounds. In January 2023, Biopsy kidney: demonstrated extensive amyloid deposition in glomeruli, vessels, and interstitium, with 2 glomeruli exhibiting cellular crescents and fibrinoid necrosis. Congo red staining was positive within glomeruli, vessels, and focally in the interstitium, displaying characteristic apple green birefringence under polarized light. In January 2023, Histology: Features of crescentic glomerulonephritis in renal AL amyloidosis showed glomeruli with segmental cellular crescents, Mesangial areas were expanded by acellular amyloid deposits. In January 2023, Immunoassay: On immunofluorescence, amyloid deposits in glomeruli and vessels show bright smudgy staining for lambda light chain. Amyloid deposits were negative for kappa light chain, confirmed lambda light-chain restriction. In January 2023, Microscopy: A high-magnification electron microscopy image of vascular amyloid deposits showing randomly oriented straight fibrils. Staining of glomeruli showed negative for immunoglobulin kappa light chain. Electron microscopy showed widespread deposition of randomly oriented fibrils involving glomeruli, vessel walls, and interstitium, without punctate-powdery electron-dense deposits. A high-magnification light microscopic image showing a glomerulus with a segmental cellular crescent staining fibrinoid necrosis. There was mesangial and segmental glomerular capillary wall deposition of Congo red-positive amyloid material. Under dark polarized light, amyloid deposits exhibit apple green birefringence. In 2023, Anti-glomerular basement membrane antibody: (Negative) Reference range: not provided. In 2023, Antineutrophil cytoplasmic antibody: (Negative) Reference range: not provided. In 2023, Antinuclear antibody: (Negative) Reference range: not provided. In 2023, Blood creatinine: 3.3 mg/dl serum creatinine further increased 3 months later, 2.8 mg/dl Reference range: not provided and 2.3 mg/dl Dexamethasone initially reduced creatinine. In 2023, Light chain analysis: kappa-to-lambda ratio 0.93 and kappa-to-lambda ratio 0.93. In February 2026, Biopsy kidney: showed AL amyloidosis without crescents indicating the new worsening in kidney function and proteinuria was due to relapsed AL amyloidosis rather than the crescentic glomerulonephritis. In February 2026, Blood creatinine: 2.11 mg/dl while on mycophenolate mofetil, the creatinine which nadired at 1.86 mg/dl rose to 2.11 mg/ dL. In February 2026, Light chain analysis: 2.45 mg/dl Lambda FLC also increased from 1.14 mg/dL to 2.45 mg/dL. In February 2026, Protein urine: increase in proteinuria from 1.6 g/day to 4.1 g/day. On an unknown date, Blood creatinine: Approximately 2.4 mg/dL, 1.9 mg/dl Over the following years, creatinine steadily improved and 1.86 mg/dl Reference range: not provided. On an unknown date, Light chain analysis: kappa to-lambda ratio 0.37, 2.53 mg/dl Reference range: not provided, 1.14 mg/dl Reference range: not provided, lambda FLC levels remained stable without further reduction. and 0.93 mg/dl kappa FLC. On an unknown date, Protein urine: 2.7 gram per 24 hour (proteinuria decreased) and 1.6 g/day. On an unknown date, Weight: regained weight despite resolution of edema. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS RAPIDLY PROGRESSIVE (Crescentic glomerulonephritis) to be related. No further causality assessments were provided for PRIMARY AMYLOIDOSIS (relapsed AL amyloidosis), DISEASE RECURRENCE (relapsed AL amyloidosis), ABNORMAL LOSS OF WEIGHT (unintentional weight loss of 25 pound), FALL (Falls) and MYOPATHY (Steroid-induced myopathy (during dexamethasone treatment)). The patient was diagnosed with amyloid light-chain (AL) amyloidosis (AL amyloidosis) involving the kidneys and heart in January 2020. He began therapy in January 2020 with ixazomib, cyclophosphamide, and dexamethasone, achieving a hematologic very good partial response after 3 months. In September 2020, he developed COVID-19 infection and cyclophosphamide was discontinued. There was a transient increase in creatinine, but this resolved quickly and creatinine returned to a baseline the next month. In June 2021, a postinfection assessment of his immune response found a COVID-19 spike protein antibody titer of greater than 250 U/mL. Approximately 11 months after recovering from COVID-19 infection, he received the Moderna mRNA 1273 COVID-19 vaccine (Moderna) in August 2021. The next month, the lambda FLC levels increased, but kappa FLC also increased, resulting in an actual increase in the kappa to-lambda ratio. However, proteinuria worsened significantly. Owing to worsening proteinuria, therapy was switched to daratumumab, rapidly reducing lambda FLC. Despite this change, creatinine continued to increase by January 2022. With ongoing renal deterioration, bortezomib was added in May 2022. With the addition of bortezomib, lambda FLC dropped to a nadir and the kappa-to-lambda ratio increased, but creatinine continued to increase until December 2022. At that time, proteinuria stabilized. The patient also noted an unintentional weight loss of 25 pounds. A kidney biopsy performed in January 2023. The patient was not receiving medications typically associated with crescentic glomerulonephritis. Dexamethasone initially reduced but was discontinued after 2 months because the patient experienced repeated falls attributed to steroid-induced myopathy. The therapy was switched to cyclophosphamide in 2023, but serum creatinine further increased 3 months later, accompanied by significant lower extremity edema. Daratumumab and bortezomib were discontinued and prednisone and mycophenolate mofetil were initiated in 2023. Edema resolved with diuretics, prednisone was tapered, and treatment continued with mycophenolate mofetil alone. Over the following years, creatinine steadily improved, proteinuria decreased, whereas lambda FLC levels remained stable without further reduction. He also regained weight despite resolution of edema. Renal outcome was reported as sustained renal improvement and stabilization with creatinine approximately 2.4 mg/dL . In Feburary 2026, while on mycophenolate mofetil, the creatinine rose along with an increase in proteinuria. Lambda FLC also increased. A repeat kidney biopsy was performed which showed AL amyloidosis without crescents indicating the new worsening in kidney function and proteinuria was due to relapsed AL amyloidosis rather than the crescentic glomerulonephritis. Patient would restart treatment for AL amyloidosis. Author concluded that this was a complicated case of crescentic glomerulonephritis that developed despite successful treatment of AL amyloidosis. The clue that another source of kidney injury might be present beside AL amyloidosis was the diversion between hematologic response and renal progression. This case illustrated the importance of kidney biopsy in cases in which the clinical course does not fit. Without kidney biopsy, crescentic glomerulonephritis would not have been diagnosed, and proper treatment would never had been administered. As kidney disease did not respond to clone-directed therapy for AL amyloidosis, it would have likely resulted in end-stage kidney disease. This case underscored the importance of kidney biopsy in patients whose kidney function declines unexpectedly during successful treatment of systemic diseases such as AL amyloidosis. Company comment: Crescentic glomerulonephritis (PT: Glomerulonephritis rapidly progressive) is confounded by underlying systemic AL amyloidosis with established renal involvement, as well as prior fluctuations in renal function and significant proteinuria indicating ongoing renal disease activity. Steroid-induced myopathy (PT: Myopathy) and associated falls are confounded by concomitant dexamethasone therapy; hence events are assessed as not related. The benefit-risk relationship of the product is not affected by this report.
Atrial fibrillation; Hypertension
Medical History/Concurrent Conditions: AL amyloidosis (AL amyloid (lambda subtype) involving the kidneys and heart); Chest discomfort; COVID-19; Fatigue (mild)
Ixazomib; Dexamethasone
Test Date: 2023; Test Name: antiglomerular basement membrane antibodies; Test Result: Negative ; Test Date: 2023; Test Name: antineutrophil cytoplasmic antibodies; Test Result: Negative ; Test Date: 2023; Test Name: antinuclear antibodies; Test Result: Negative ; Test Date: 202001; Test Name: bone marrow; Result Unstructured Data: Amyloid deposition, identified as AL amyloid (lambda subtype) based on mass spectrometry, was detected on bone marrow and fat biopsies; Test Date: 202301; Test Name: kidney biopsy; Result Unstructured Data: demonstrated extensive amyloid deposition in glomeruli, vessels, and interstitium, with 2 glomeruli exhibiting cellular crescents and fibrinoid necrosis. Congo red staining was positive within glomeruli, vessels, and focally in the interstitium, displaying characteristic apple green birefringence under polarized light; Test Date: 202602; Test Name: kidney biopsy; Result Unstructured Data: showed AL amyloidosis without crescents indicating the new worsening in kidney function and proteinuria was due to relapsed AL amyloidosis rather than the crescentic glomerulonephritis; Test Name: Creatinine; Result Unstructured Data: Approximately 2.4 mg/dL; Test Date: 2020; Test Name: Creatinine; Result Unstructured Data: remained stable; Test Name: serum creatinine; Test Result: 1.9 mg/dL; Test Name: serum creatinine; Test Result: 1.86 mg/dL; Test Date: 202001; Test Name: serum creatinine; Test Result: 1.04 mg/dL; Test Date: 202001; Test Name: serum creatinine; Test Result: 0.9 mg/dL; Test Date: 202009; Test Name: serum creatinine; Test Result: 1.43 mg/dL; Test Date: 202010; Test Name: serum creatinine; Test Result: 1.1 mg/dL; Test Date: 202108; Test Name: serum creatinine; Test Result: 1.0 mg/dL; Test Date: 202109; Test Name: serum creatinine; Test Result: 1.0 mg/dL; Test Date: 202201; Test Name: serum creatinine; Test Result: 1.36 mg/dL; Test Date: 202205; Test Name: serum creatinine; Test Result: 1.42 mg/dL; Test Date: 202212; Test Name: serum creatinine; Test Result: 2.7 mg/dL; Test Date: 2023; Test Name: serum creatinine; Test Result: 3.3 mg/dL; Test Date: 2023; Test Name: serum creatinine; Test Result: 2.8 mg/dL; Test Date: 2023; Test Name: serum creatinine; Test Result: 2.3 mg/dL; Test Date: 202602; Test Name: serum creatinine; Test Result: 2.11 mg/dL; Test Date: 2019; Test Name: immunoglobulin G; Test Result: 1200 mg/dL; Test Date: 202001; Test Name: Echocardiography; Result Unstructured Data: revealed an ejection fraction of 74%, a global averaged left ventricular longitudinal peak systolic strain of -16%, and an N-terminal pro-B-type natriuretic peptide level of 538 pg/mL; Test Date: 202001; Test Name: ejection fraction; Test Result: 74 %; Test Date: 202001; Test Name: hemoglobin; Test Result: 14.7 mg/dL; Test Date: 202301; Test Name: Histopathologic; Result Unstructured Data: Features of crescentic glomerulonephritis in renal AL amyloidosis showed glomeruli with segmental cellular crescents, Mesangial areas were expanded by acellular amyloid deposits; Test Date: 202301; Test Name: immunofluorescence; Result Unstructured Data: On immunofluorescence, amyloid deposits in glomeruli and vessels show bright smudgy staining for lambda light chain. Amyloid deposits were negative for kappa light chain, confirmed lambda light-chain restriction; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa to-lambda ratio 0.37; Test Date: 2019; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: A significantly reduced kappa-to-lambda FLC ratio of 0.07; Test Date: 202001; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.074; Test Date: 2020; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: FLC ratio of 0.46 and a difference between involved and uninvolved FLC of 0.89; Test Date: 202009; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.43; Test Date: 202108; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.43; Test Date: 202109; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: actual increase in the kappa to-lambda ratio from 0.37 to 0.46 with a difference between involved and uninvolved FLC of 1.57; Test Date: 202205; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.84; Test Date: 2022; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: the kappa-to-lambda ratio increased to 0.87; Test Date: 202212; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio of 1.01; Test Date: 2023; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.93; Test Date: 2023; Test Name: kappa-to-lambda FLC ratio; Result Unstructured Data: kappa-to-lambda ratio 0.93; Test Name: lambda FLC; Test Result: 2.53 mg/dL; Test Name: lambda FLC; Test Result: 1.14 mg/dL; Test Date: 2019; Test Name: lambda FLC; Test Result: 11.2 mg/dL; Test Date: 2020; Test Name: lambda FLC; Test Result: 1.52 mg/dL; Test Date: 2021; Test Name: lambda FLC; Test Result: 0.88 mg/dL; Test Date: 202109; Test Name: lambda FLC; Test Result: 2.92 mg/dL; Test Date: 202205; Test Name: lambda FLC; Test Result: 2.07 mg/dL; Test Date: 2022; Test Name: lambda FLC; Test Result: 0.86 mg/dL; Test Date: 202212; Test Name: lambda FLC; Test Result: 2.10 mg/dL; Test Date: 202602; Test Name: lambda FLC; Test Result: 2.45 mg/dL; Test Name: lambda FLC levels; Result Unstructured Data: lambda FLC levels remained stable without further reduction.; Test Name: serum kappa free light chains (FLC); Test Result: 0.93 mg/dL; Test Date: 2019; Test Name: serum kappa free light chains (FLC); Test Result: 0.83 mg/dL; Test Date: 202109; Test Name: serum kappa free light chains (FLC); Test Result: 1.35 mg/dL; Test Date: 2022; Test Name: serum kappa free light chains (FLC); Test Result: 0.74 mg/dL; Test Date: 202212; Test Name: serum kappa free light chains (FLC); Test Result: 2.12 mg/dL; Test Date: 202301; Test Name: electron microscopy; Result Unstructured Data: A high-magnification electron microscopy image of vascular amyloid deposits showing randomly oriented straight fibrils. Staining of glomeruli showed negative for immunoglobulin kappa light chain. Electron microscopy showed widespread deposition of randomly oriented fibrils involving glomeruli, vessel walls, and interstitium, without punctate-powdery electron-dense deposits. A high-magnification light microscopic image showing a glomerulus with a segmental cellular crescent staining fibrinoid necrosis. There was mesangial and segmental glomerular capillary wall deposition of Congo red-positive amyloid material. Under dark polarized light, amyloid deposits exhibit apple green birefringence; Test Date: 202001; Test Name: N-terminal proB-type natriuretic peptide level; Result Unstructured Data: 538 pg/ml; Test Name: Protein urine; Result Unstructured Data: 2.7 gram per 24 hour (proteinuria decreased); Test Name: Protein urine; Result Unstructured Data: 1.6 g/day; Test Date: 202001; Test Name: Protein urine; Result Unstructured Data: 3.1 gram per 24 hour (proteinuria); Test Date: 2020; Test Name: Protein urine; Result Unstructured Data: Proteinuria remained stable which stayed between 3 and 4 g/d; Test Date: 202109; Test Name: Protein urine; Result Unstructured Data: proteinuria worsened significantly to 8.5 g/24 hour; Test Date: 202212; Test Name: Protein urine; Result Unstructured Data: Proteinuria stabilized at 4 g/24 hours; Test Date: 202602; Test Name: Protein urine; Result Unstructured Data: increase in proteinuria from 1.6 g/day to 4.1 g/day; Test Date: 202106; Test Name: COVID-19 spike protein antibody; Result Unstructured Data: postinfection assessment of his immune response found a COVID-19 spike protein antibody titer of greater than 250 U/mL; Test Date: 2019; Test Name: urine test; Result Unstructured Data: monoclonal immunoglobulin G lambda fragment was detected in the urine; Test Name: weight loss; Result Unstructured Data: regained weight despite resolution of edema; Test Date: 202212; Test Name: weight loss; Result Unstructured Data: unintentional weight loss of 25 pounds