Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Reticulocyte count, SARS-CoV-2 test, Smear test, Systemic lupus erythematosus
Clinical narrative: Evans Syndrome; Systemic Lupus Erythematosus (SLE); This literature-non-study case was reported in a literature article and describes the occurrence of EVANS SYNDROME (Evans Syndrome) and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic Lupus Erythematosus (SLE)) in a 24-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.    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 EVANS SYNDROME (Evans Syndrome) (seriousness criteria hospitalization and medically significant). an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic Lupus Erythematosus (SLE)) (seriousness criterion medically significant). The patient was treated with PREDNISONE (oral use) at a dose of 1 milligram/kilogram and IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous use) at an unspecified dose and frequency. At the time of the report, EVANS SYNDROME (Evans Syndrome) was resolving and SYSTEMIC LUPUS ERYTHEMATOSUS (Systemic Lupus Erythematosus (SLE)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time: (Positive) (warm agglutinin IgG) and normal. On an unknown date, Antibody test: Positive. On an unknown date, Antinuclear antibody: Positive. On an unknown date, Blood lactate dehydrogenase: 467. On an unknown date, Complement factor C3: low. On an unknown date, Complement factor C4: low. On an unknown date, Double stranded DNA antibody: elevated to 1506. On an unknown date, Haemoglobin: 11.5 with normal MCV (no urinary/GI bleeding per patient). On an unknown date, Haptoglobin: Less than 20. On an unknown date, Hepatitis viral test: Negative. On an unknown date, International normalised ratio: normal. On an unknown date, Liver function test: normal. On an unknown date, Physical examination: was otherwise unremarkable. On an unknown date, Platelet count: 8000, 69000 Upon discharge and increased to 247000 after 2 months. On an unknown date, Prothrombin time: normal. On an unknown date, Reticulocyte count: 1.2 %. On an unknown date, SARS-CoV-2 test: Negative. On an unknown date, Smear test: showed medium sized platelets with no schistocytes. On an unknown date, White blood cell count: 3.8.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient with no significant PMH presented to the ED with lower extremity petechiae and ecchymoses first noted 3 days after first dose of Moderna vaccine 3 weeks prior. Patient denied any recent infection, sick contact or use of any new medications and was hemodynamically stable.   Initial diagnosis of immune thrombocytopenic purpura and autoimmune hemolytic anemia was made. Patient improved remarkably and patient was discharged. Patient was subsequently diagnosed with Systemic Lupus Erythematosus (SLE).  Author highlighted an immune mediated response to the mRNA-1273 COVID-19 vaccine. It appears that the vaccine could serve as a trigger for autoimmunity in individuals who were genetically predisposed or had underlying autoimmune disease although the exact mechanism remains unclear.  Company comment: This literature non study case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant and hospitalization) events of Evans syndrome and systemic lupus erythematosus. The event of Evans syndrome was diagnosed approximately 3 weeks after first dose of mRNA-1273 with first symptoms occurring approximately 3 days after the first dose of mRNA-1273. Event of Systemic lupus erythematosus was diagnosed on an unknown date. As reported, the patient presented with lower extremity petechiae and ecchymoses first noted 3 days after her first dose of Moderna vaccine 3 weeks prior. Patient denied any recent infection, sick contact or use of any new medications and was hemodynamically stable. Physical exam was otherwise unremarkable. Patient's labs were significant for a Hb of 11.5 with normal MCV (no urinary/GI bleeding per patient), corrected reticulocyte count of 1.2%, platelets of 8,000 and WBC of 3.8. Further lab work showed lactate dehydrogenase (LDH) of 467, haptoglobin <20, positive Coombs test (warm agglutinin IgG) and normal LFTs/INR/PT and PTT. Peripheral smear showed medium sized platelets with no schistocytes. Hepatitis and Covid-19 PCR was negative. Initial diagnosis of immune thrombocytopenic purpura and autoimmune hemolytic anemia was made. She improved remarkably following the administration of oral prednisone (1mg/kg) and intravenous immunoglobulins. Upon discharge her platelets were 69,000 and increased to 247,000 after 2 months. Rheumatological workup revealed positive ANA, elevated dsDNA antibodies to 1506 and positive Chromatin antibody. C3 and C4 complements were also low. She was subsequently diagnosed with Systemic Lupus Erythematosus (SLE). No further information about the events was provided. Author highlighted an immune mediated response to the mRNA-1273 COVID-19 vaccine could serve as a trigger for autoimmunity in individuals who were genetically predisposed or had underlying autoimmune disease although the exact mechanism remains unclear. The benefit-risk relationship of mRNA-1273 is not affected by this report.