Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood albumin, Blood creatinine, Glomerulonephritis membranous, Protein urine
Clinical narrative: Membranous nephropathy relapse/Nephrotic syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy relapse/Nephrotic syndrome) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   Co-suspect product included non-company product AMLODIPINE for an unknown indication.    The patient's past medical history included Membranous nephropathy (ACE inhibitor was used and was resolved and diagnosed by kidney biopsy) in 1994 and Proteinuria. Previously administered products included for Membranous nephropathy: prednisone. Past adverse reactions to the above products included No adverse event with prednisone.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, 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 started AMLODIPINE (unknown route) at an unspecified dose. In 2021, the patient experienced GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy relapse/Nephrotic syndrome) (seriousness criterion medically significant). The patient was treated with RITUXIMAB at an unspecified dose and frequency. At the time of the report, GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy relapse/Nephrotic syndrome) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy kidney: showed recurrent membranous nephropathy (MN), EM stage 3-4, PLA2R positive. In 2021, Blood albumin: 2.7 milligram per decilitre. In 2021, Blood creatinine: 0.86 milligram per decilitre. In 2021, Protein urine: 5.73 g/d. In 2021, Urine protein/creatinine ratio: 8.00 two months later, nephrotic syndrome, 2.7 without intervention and 3.7 increased again latera month.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's historical product also included ACE inhibitor.  Concomitant product use was not provided by the reporter.  It was reported that between the two doses of Moderna that were taken on 03-Mar-2021 01-Apr-2021, the patient had onset of leg swelling, which was attributed to Amlodipine which was discontinued by his PCP. After the second dose of the vaccine, the edema progressed to anasarca. There was a reduction of anasarca after treatment. This was a case of MN that relapsed following vaccination after 26 years of remission.  The patient's laboratory data also included Anti-PLA2R positive (24 RU/ml, ref. > 19RU/mL). Due to regional surge of COVID-19 Omicron variant, immunosuppression was held to administer EvuSheld for COVID-19 prophylaxis. Proteinuria improved initially without intervention but increased again a month later. Rituximab is initiated three months after biopsy resulting in undetectable anti-PLR2 1 week after treatment and improvement of anasarca 2 weeks after treatment.  Onset or relapse of GN after vaccination historically has rarely been reported. There are numerous reports of de novo or relapsed GN after COVID-19 infection and increasing reports of GN after COVID- 19 vaccination with m RNA and traditional vaccine platforms.  Company comment: This is a literature non-study case concerning a 78 year old male  patient with relevant medical history of Membranous nephropathy (MN) and proteinuria in 1994  and treated with Prednisone and in complete remission, who experienced the serious (medically significant) unexpected, event of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy relapse/Nephrotic syndrome)  on an unspecified date after receiving the 2 dose of mRNA1273 vaccine. It was reported that between the two doses of Moderna taken on 03-Mar-2021 and 01-Apr-2021 respectively, the patient had onset of leg swelling, which was attributed to Amlodipine and hence was discontinued. After the second dose of the vaccine, the edema progressed to anasarca. Biopsy kidney: showed recurrent membranous nephropathy (MN), EM stage 3-4, PLA2R positive, patient's laboratory data included Protein urine: 5.73 g/d, Blood albumin: 2.7 milligram per decilitre, Blood creatinine: 0.86 milligram per decilitre, Urine protein/creatinine ratio: 8.00. The patient's historical product also included ACE inhibitor. Proteinuria improved initially without intervention but increased again a month later.  It was reported that due to regional surge of COVID-19 Omicron variant, immunosuppression was held to administer the COVID-19 vaccine, which could be a confounder for the relapse. Rituximab was initiated three months after biopsy, resulting in undetectable anti-PLR2, 1 week after treatment and improvement of anasarca 2 weeks after treatment with a reduction of anasarca after treatment. The event was resolving. This was a case of MN that relapsed following vaccination, after 26 years of remission. The author concluded that there are numerous reports of de novo or relapsed GN after COVID-19 infection and increasing reports of GN after COVID- 19 vaccination with m RNA and traditional vaccine platforms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a literature non-study case concerning a 78 year old male  patient with relevant medical history of Membranous nephropathy (MN) and proteinuria in 1994  and treated with Prednisone and in complete remission, who experienced the serious (medically significant) unexpected, event of GLOMERULONEPHRITIS MEMBRANOUS (Membranous nephropathy relapse/Nephrotic syndrome)  on an unspecified date after receiving the 2 dose of mRNA1273 vaccine. It was reported that between the two doses of Moderna taken on 03-Mar-2021 and 01-Apr-2021 respectively, the patient had onset of leg swelling, which was attributed to Amlodipine and hence was discontinued. After the second dose of the vaccine, the edema progressed to anasarca. Biopsy kidney: showed recurrent membranous nephropathy (MN), EM stage 3-4, PLA2R positive, patient's laboratory data included Protein urine: 5.73 g/d, Blood albumin: 2.7 milligram per decilitre, Blood creatinine: 0.86 milligram per decilitre, Urine protein/creatinine ratio: 8.00. The patient's historical product also included ACE inhibitor. Proteinuria improved initially without intervention but increased again a month later.  It was reported that due to regional surge of COVID-19 Omicron variant, immunosuppression was held to administer the COVID-19 vaccine, which could be a confounder for the relapse. Rituximab was initiated three months after biopsy, resulting in undetectable anti-PLR2, 1 week after treatment and improvement of anasarca 2 weeks after treatment with a reduction of anasarca after treatment. The event was resolving. This was a case of MN that relapsed following vaccination, after 26 years of remission. The author concluded that there are numerous reports of de novo or relapsed GN after COVID-19 infection and increasing reports of GN after COVID- 19 vaccination with m RNA and traditional vaccine platforms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.