Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Oedema peripheral, Proteinuria, SARS-CoV-2 test, Sepsis
Clinical narrative: generalized muscle weakness,I couldn't get out of bed; confusion; proteinuria; urinary incontinence; Sepsis; I had A-fib while in the hospital.; My ankles are with edema.; This spontaneous case was reported by a physician and describes the occurrence of MUSCULAR WEAKNESS (generalized muscle weakness,I couldn't get out of bed), CONFUSIONAL STATE (confusion), PROTEINURIA (proteinuria), URINARY INCONTINENCE (urinary incontinence), SEPSIS (Sepsis) and ATRIAL FIBRILLATION (I had A-fib while in the hospital.) 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.     The patient's past medical history included Post streptococcal glomerulonephritis (40 yr history of kidney transplant, due to Post streptococcal nephritis) and Kidney transplant (40 yr history of kidney transplant, due to Post streptococcal nephritis). Concurrent medical conditions included Autoimmune disorder (autoimmune disease).   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ATRIAL FIBRILLATION (I had A-fib while in the hospital.) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (generalized muscle weakness,I couldn't get out of bed) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization), PROTEINURIA (proteinuria) (seriousness criterion hospitalization), URINARY INCONTINENCE (urinary incontinence) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant) and OEDEMA PERIPHERAL (My ankles are with edema.). The patient was hospitalized from 14-Feb-2021 to 21-Feb-2021 due to ATRIAL FIBRILLATION, CONFUSIONAL STATE, MUSCULAR WEAKNESS, PROTEINURIA, SEPSIS and URINARY INCONTINENCE. At the time of the report, MUSCULAR WEAKNESS (generalized muscle weakness,I couldn't get out of bed) had not resolved, CONFUSIONAL STATE (confusion), PROTEINURIA (proteinuria) and URINARY INCONTINENCE (urinary incontinence) had resolved and SEPSIS (Sepsis), ATRIAL FIBRILLATION (I had A-fib while in the hospital.) and OEDEMA PERIPHERAL (My ankles are with edema.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood albumin: albumin levels kept dropping (Low) albumin levels kept dropping. In February 2021, Haemoglobin: hemoglobin levels kept dropping (Low) hemoglobin levels kept dropping. In February 2021, SARS-CoV-2 test: result not provided result not provided (tested for Covid-19 4 times, while hospitalized). On 21-Feb-2021, C-reactive protein: high (145) (High) high (145). In March 2022, C-reactive protein: 100. my crp elevates, periodically (High) 100. My CRP elevates, periodically.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. All systemic diseases were excluded. The patient was started on steroids. Things seemed to respond well to to high-dose steroids. A month after his discharge, his CRP was 100. My CRP elevates, periodically. He knew that MIS-C can happen post vaccination with Pfizer.  It was unknown that the patient experienced a similar event in the past.  Company Comment: This spontaneous case concerns a 73-year-old male patient with past medical history of Post streptococcal glomerulonephritis and Kidney transplant, who experienced the unexpected serious (hospitalization and medically significant) AESI of Atrial fibrillation, unexpected serious (hospitalization and medically significant) event of Sepsis and unexpected serious (hospitalization) events of Muscular weakness, Confusional state, Proteinuria and Urinary incontinence on an unknown date in Feb-2021 while the second dose of mRNA-1273 vaccine administered on 25-Jan-2021. Patient experienced generalized muscle weakness and couldn't get out of bed. He had confusion, proteinuria, urinary incontinence, and A-fib while in the hospital, patient was hospitalized for 7 days from 14-Feb-2021 to 21-Feb-2021 and was treated setroids. On the last day of my admission his CRP was high (145). After discharge, his hemoglobin & albumin levels were dropping along with ankle edema. Patients medical history of Post streptococcal glomerulonephritis and Kidney transplant could be confounding for the events Sepsis, Proteinuria and Urinary incontinence. Patients elderly age could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Live-Follow-up  No New Information accepted; Sender's Comments: This spontaneous case concerns a 73-year-old male patient with past medical history of Post streptococcal glomerulonephritis and Kidney transplant and Concurrent medical condition of Autoimmune disorder, who experienced the unexpected serious (hospitalization and medically significant) AESI of Atrial fibrillation, unexpected serious (hospitalization and medically significant) event of Sepsis and unexpected serious (hospitalization) events of Muscular weakness, Confusional state, Proteinuria and Urinary incontinence on an unknown date in Feb-2021 while the second dose of mRNA-1273 vaccine administered on 25-Jan-2021. Patient experienced generalized muscle weakness and couldn't get out of bed. He had confusion, proteinuria, urinary incontinence, and A-fib while in the hospital, patient was hospitalized for 7 days from 14-Feb-2021 to 21-Feb-2021 and was treated setroids.  On the last day of my admission his CRP was high (145). After discharge, his hemoglobin & albumin levels were dropping along with ankle edema. Patients medical history of Post streptococcal glomerulonephritis and Kidney transplant could be confounding for the events Sepsis, Proteinuria and Urinary incontinence. Patients elderly age could be a risk factor for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.