Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood culture, Body temperature, Complement factor C3, Condition aggravated
Clinical narrative: Lupus nephritis flare/ systemic lupus erythematosus flare; Lupus nephritis flare/ systemic lupus erythematosus flare; This literature-non-study case was reported in a literature article and describes the occurrence of LUPUS NEPHRITIS (Lupus nephritis flare/ systemic lupus erythematosus flare) in a 30-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:    The patient's past medical history included Hematoma (needing a blood transfusion with his initial kidney biopsy.) and COVID-19 (Six months prior which resolve within a week with symptomatic over the counter treatment.). Concurrent medical conditions included Lupus nephritis (WHO Class 2 and 5 in 2019) since 2019 and Pulmonary embolism (Due to recent history of pulmonary embolism, he was on coumadin.). Concomitant products included HYDROXYCHLOROQUINE for Lupus nephritis, WARFARIN SODIUM (COUMADIN) for Pulmonary embolism, HEPARIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced LUPUS NEPHRITIS (Lupus nephritis flare/ systemic lupus erythematosus flare) (seriousness criteria hospitalization and medically significant) and CONDITION AGGRAVATED (Lupus nephritis flare/ systemic lupus erythematosus flare). The patient was treated with MYCOPHENOLATE MOFETIL ongoing since an unknown date for Lupus nephritis, at a dose of 1500 milligram twice a day; PREDNISONE for Lupus nephritis, at a dose of 40 milligram; PREDNISONE for Lupus nephritis, at a dose of 60 milligram; PREDNISONE for Lupus nephritis, at a dose of 5 milligram and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous use) at a dose of 500 milligram, 3 days. At the time of the report, LUPUS NEPHRITIS (Lupus nephritis flare/ systemic lupus erythematosus flare) and CONDITION AGGRAVATED (Lupus nephritis flare/ systemic lupus erythematosus flare) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 3.19 g/dL, 2.81 mg/dl, 1.7 mg/dl, 1.1 mg/dl and 0.79 mg/dl Four days earlier. On an unknown date, Blood culture: Negative. On an unknown date, Body temperature: 103.3 Fahrenheit. On an unknown date, Complement factor C3 (90-200): 77, 86, within normal range and 101.7 (9months earlier). On an unknown date, Culture urine: Negative. On an unknown date, Double stranded DNA antibody: Positive and Negative. On an unknown date, International normalised ratio: normal. On an unknown date, Urine analysis: 12 g proteinuria and trace hematuria. and negative for proteinuria and hematuria. On an unknown date, White blood cell count: 3.3 k/mm3 and 7700/mm3.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered LUPUS NEPHRITIS (Lupus nephritis flare/ systemic lupus erythematosus flare) and CONDITION AGGRAVATED (Lupus nephritis flare/ systemic lupus erythematosus flare) to be related.    This is the report of Lupus nephritis flare post Moderna mRNA-1273 coronavirus vaccine.  Due to recent history of pulmonary embolism, the patient was on coumadin.  Patient experienced weakness and chills which began 24 hours post-vaccination. Patient had fevers 3 days after receiving one dose of mRNA-1273 vaccine. Symptoms also included generalized arthralgia and a headache.  The lab tests had shown normal electrolytes.   Patient was on maintenance therapy for lupus nephritis included mycophenolate mofetil 1500 mg bid, hydroxychloroquine and 5mg prednisone. Despite intravenous hydration, creatinine went up to 3.19 g/dl the next day. Pulse dose solumedrol (500 mg intravenously 3 days) was initiated and then switched to 60 mg prednisone. Five days later, creatinine was down to 1.7 mg/dl and fevers resolved.  Kidney biopsy was initially held due to a therapeutic INR and coumadin was held. Once INR was normal and while on a heparin bridge, he declined a kidney biopsy as renal function was improving with treatment. He had a history of a hematoma needing a blood transfusion with his initial kidney biopsy which also was a reason for him to decline a kidney biopsy.  AKI, low c3, symptoms, dsDNA positivity and negative infectious workup clinically correlate with a lupus nephritis flare. Prompt treatment helped improve parameters with C3 coming up to 86, five days after steroid initiation along with symptomatic improvement.   He was discharged on 60 mg oral prednisone with a plan to taper. Mycophenolate mofetil was continued as before.   One month later, creatinine was down to 1.1 mg/dl, C3 within normal range, WBC at 7700/mm3 and dsDNA negative. Prednisone was down to 40mg. Second dose of the COVID vaccine had not yet been administered per recommendations from rheumatology. Plan was to gradually taper prednisone.  Company Comment: This is a literature non-study case concerning a 30-year-old male patient with relevant medical history of Lupus nephritis (WHO Class 2 and 5 in 2019) since 2019, Pulmonary embolism and COVID-19 (Six months prior to admission) who experienced the serious (due to medically significant and hospitalization) unexpected event of Lupus nephritis (reported as Lupus nephritis flare so condition aggravated was added in the case). The event occurred the following day after a dose of mRNA-1273 vaccine. Weakness, chills, generalized arthralgia and a headache began 24 h post-vaccination. Initial labs showed a creatinine of 2.81 mg/dl, normal electrolytes, WBC count 3.3 k/mm3 , 12 g proteinuria and trace hematuria. C3 was low at 77 (normal is 90200) and dsDNA positive. Four days earlier in the office, creatinine was 0.79 mg/dl. C3 was 101.7, 9 months earlier. Maintenance therapy for lupus nephritis included mycophenolate mofetil 1500 mg bid, hydroxychloroquine and 5mg prednisone. Blood and urine culture was negative. Despite intravenous hydration, creatinine went up to 3.19 g/dl the next day. Pulse dose solumedrol (500 mg intravenously for 3 days) was initiated and then switched to 60 mg prednisone. Five days later, creatinine was down to 1.7 mg/dl and fevers resolved. Due to recent history of pulmonary embolism, he was on coumadin. Kidney biopsy was initially held due to a therapeutic INR and coumadin was held. Once INR was normal and while on a heparin bridge, he declined a kidney biopsy as renal function was improving with treatment. AKI, low c3, symptoms, dsDNA positivity and negative infectious workup clinically correlate with a lupus nephritis flare. Prompt treatment helped improve parameters with C3 coming up to 86, 5 days after steroid initiation along with symptomatic improvement. He was discharged on 60 mg oral prednisone with a plan to taper. Mycophenolate mofetil was continued as before. One month later, creatinine was down to 1.1 mg/dl, C3 within normal range, WBC at 7700/mm3 and dsDNA negative. Prednisone was down to 40mg. Urinalysis was negative for proteinuria and hematuria. Second dose of the COVID vaccine had not yet been administered per recommendations from rheumatology. Plan is to gradually taper prednisone. The outcome of the event was reported as recovering. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.