Received Apr 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 1 | — | — |
Membranous Nephropathy; exposure to the Covid-19 virus; This spontaneous case was reported by a physician and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) in a 79-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hemoglobinopathy. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) (seriousness criterion medically significant) and EXPOSURE TO SARS-COV-2 (exposure to the Covid-19 virus). The patient was treated with Telmisartan at a dose of 1 dosage form; Nebivolol hydrochloride (Nebivolol) at a dose of 1 dosage form; Dapagliflozin propanediol monohydrate (Dapagliflozin) at a dose of 1 dosage form; Metformin hydrochloride (Metformin) at a dose of 1 dosage form; Glipizide at a dose of 1 dosage form; Evolocumab at a dose of 1 dosage form and Atorvastatin calcium (Atorvastatin) at a dose of 1 dosage form. At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous Nephropathy) had resolved and EXPOSURE TO SARS-COV-2 (exposure to the Covid-19 virus) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy kidney: showed membranous nephropathy, stage 2 of 4. On an unknown date, Blood creatinine: 1.01 to 1.40 mg/dl and 1.14 mg/dl. On an unknown date, Chest X-ray: not shown malignancy. On an unknown date, Colonoscopy: not shown malignancy. On an unknown date, Computerised tomogram abdomen: not shown malignancy. On an unknown date, Computerised tomogram pelvis: not shown malignancy. On an unknown date, Hepatitis B virus test: Negative. On an unknown date, Hepatitis C virus test: Negative. On an unknown date, Oesophagogastroduodenoscopy: not shown malignancy. On an unknown date, Prostatic specific antigen: not shown malignancy. On an unknown date, Proteinuria: 2888 milligram, 2112 milligram 21 days later after the final vaccine administration and 203 milligram nineteen months after the final vaccine administration. On an unknown date, Treponema test: Negative. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. The patient was presented with ankle edema and 2888 mg proteinuria after 5 doses of mRNA 1273. The mRNA 1273 vaccination for Covid-19 was given on 19, 18, 10, and 3 months before symptom onset. 5th dose was given one month prior. Patient's saliva was sent for Renasight panel. Homozygosity for HBB beta hemoglobinopathy was detected. Heterozygosity for HOGA1, ROBO2, BCS1L, C1QB, MAG12, INVS, and MEFV were detected-none of which had a definitive association with membranous nephropathy. Nineteen months after administration of his last Covid vaccine, repeated 24-hour urine measures and found that 203 mg proteinuria, and the serum creatinine was 1.14 mg/dl. Immunostaining for PLA2R, EXT2, NELL1, and THSD7A were performed at Clinic Laboratories and interpreted negative. Light microscopic, immunofluorescence staining for IgG, and electron microscopy specimens were shown. Antibody cross-reactivity to components of the glomerular basement membrane versus deposition of antigen antibody conjugated in the glomerular basement membrane were possible etiologies. Boosted with five doses of the vaccine and exposure to the Covid-19 virus might all had exacerbated that autoimmune response. The diminution of proteinuria from 2888 milligrams to 2112 milligrams 21 days later to 203 mg, nineteen months after the final vaccine administration suggested that the antigen antibody complexes deposited in the glomerular basement membrane cleared and that the biopsy documented membranous nephropathy at the time of the acute proteinuria resolved.; Reporter's Comments: Medical history of exposure to COVID-19 could be a confounding factor for the case. The benefit-risk relationship of product is not affected by this report.
Hemoglobinopathy
Test Name: Renal biopsy; Result Unstructured Data: showed membranous nephropathy, stage 2 of 4; Test Name: Creatinine; Result Unstructured Data: 1.01 to 1.40 mg/dl; Test Name: serum creatinine; Test Result: 1.14 mg/dL; Test Name: CXR; Result Unstructured Data: not shown malignancy; Test Name: colonoscopy; Result Unstructured Data: not shown malignancy; Test Name: CT abdomen; Result Unstructured Data: not shown malignancy; Test Name: CT pelvis; Result Unstructured Data: not shown malignancy; Test Name: Hepatitis B; Test Result: Negative ; Test Name: hepatitis C; Test Result: Negative ; Test Name: EGD; Result Unstructured Data: not shown malignancy; Test Name: PSA; Result Unstructured Data: not shown malignancy; Test Name: proteinuria; Test Result: 2888 mg; Test Name: proteinuria; Test Result: 2112 mg; Test Name: proteinuria; Test Result: 203 mg; Test Name: RPR; Test Result: Negative