Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Septic shock, Unresponsive to stimuli
Clinical narrative: Encephalopathy/progressive encephalopathy; respiratory failure; acute respiratory distress syndrome; aspiration pneumonia; septic shock; unresponsive; Recurrent fevers; This literature-non-study case was reported in a literature article and describes the occurrence of ENCEPHALOPATHY (Encephalopathy/progressive encephalopathy), RESPIRATORY FAILURE (respiratory failure), ACUTE RESPIRATORY DISTRESS SYNDROME (acute respiratory distress syndrome), PNEUMONIA ASPIRATION (aspiration pneumonia), SEPTIC SHOCK (septic shock) and UNRESPONSIVE TO STIMULI (unresponsive) in a 67-year-old female 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 COVID-19 (resolved with immunosuppression). Concurrent medical conditions included Rheumatoid arthritis, Sjogren's syndrome and Chronic obstructive pulmonary disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ENCEPHALOPATHY (Encephalopathy/progressive encephalopathy) (seriousness criteria hospitalization, medically significant and life threatening), RESPIRATORY FAILURE (respiratory failure) (seriousness criteria hospitalization, medically significant and life threatening), ACUTE RESPIRATORY DISTRESS SYNDROME (acute respiratory distress syndrome) (seriousness criteria hospitalization, medically significant and life threatening), PNEUMONIA ASPIRATION (aspiration pneumonia) (seriousness criteria hospitalization, medically significant and life threatening), SEPTIC SHOCK (septic shock) (seriousness criteria hospitalization, medically significant and life threatening), UNRESPONSIVE TO STIMULI (unresponsive) (seriousness criterion medically significant) and PYREXIA (Recurrent fevers). The patient was treated with LEVETIRACETAM for Encephalopathy, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at a dose of 1 gram and Hospice care (transition to hospice) for Encephalopathy. At the time of the report, ENCEPHALOPATHY (Encephalopathy/progressive encephalopathy) had resolved and RESPIRATORY FAILURE (respiratory failure), ACUTE RESPIRATORY DISTRESS SYNDROME (acute respiratory distress syndrome), PNEUMONIA ASPIRATION (aspiration pneumonia), SEPTIC SHOCK (septic shock), UNRESPONSIVE TO STIMULI (unresponsive) and PYREXIA (Recurrent fevers) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, CSF test: negative (Negative) Negative. On an unknown date, Coma scale: 3 Patient was liberated from the ventilator after four days of antibiotics but remained encephalopathic with a Glasgow Coma Scale (GCS) of 3.. On an unknown date, Electroencephalogram: negative (Negative) Negative. On an unknown date, Inflammatory marker test: elevated elevated inflammatory markers. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ENCEPHALOPATHY (Encephalopathy/progressive encephalopathy), RESPIRATORY FAILURE (respiratory failure), ACUTE RESPIRATORY DISTRESS SYNDROME (acute respiratory distress syndrome), PNEUMONIA ASPIRATION (aspiration pneumonia), SEPTIC SHOCK (septic shock), UNRESPONSIVE TO STIMULI (unresponsive) and PYREXIA (Recurrent fevers) to be related.    Concomitant product use was not provided by the reporter.    The patient was liberated from the ventilator after four days of antibiotics.  Laboratory tests also included negative findings on repeat infectious, autoimmune, and paraneoplastic testing.  The patient was unresponsive for 32 days and was transitioned to hospice. The patient had a dramatic improvement in the mental status within 24 hours and was subsequently discharged to an acute rehabilitation facility with resolution of encephalopathy.  Author notes that without a definitive diagnosis, the striking association of symptom onset following both vaccine doses and the response to steroids suggest a potential inflammatory encephalopathy in response to mRNA-1273-SARS-CoV-2 vaccine in this patient with underlying autoimmune disease.  Company comment:  This literature case concerns a 67-year-old female patient with relevant medical history of Rheumatoid arthritis, Sjogren's syndrome, COVID 19 and Chronic obstructive pulmonary disease who experienced the unexpected serious (life threatening, hospitalization & medically significant) events of Encephalopathy, Respiratory failure, Acute respiratory distress syndrome, Pneumonia aspiration, Septic shock And Unresponsive to stimuli. The event encephalopathy occurred both the times a day after the patient received the two doses of mRNA-1273. Events Respiratory failure, Acute respiratory distress syndrome, Pneumonia aspiration, Septic shock And Unresponsive to stimuli started a day after the patient received a second dose of mRNA-1273. History of autoimmune diseases (Rheumatoid arthritis and Sjogren's syndrome) and elderly age could be confounding for the event encephalopathy. History of chronic obstructive pulmonary disease, covid 19 and elderly age could be confounding for the events respiratory failure, acute respiratory distress syndrome. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This literature case concerns a 67-year-old female patient with relevant medical history of Rheumatoid arthritis, Sjogren's syndrome, COVID 19 and Chronic obstructive pulmonary disease who experienced the unexpected serious (life threatening, hospitalization & medically significant) events of Encephalopathy, Respiratory failure, Acute respiratory distress syndrome, Pneumonia aspiration, Septic shock And Unresponsive to stimuli. The event encephalopathy occurred both the times a day after the patient received the two doses of mRNA-1273. Events Respiratory failure, Acute respiratory distress syndrome, Pneumonia aspiration, Septic shock And Unresponsive to stimuli started a day after the patient received a second dose of mRNA-1273. History of autoimmune diseases (Rheumatoid arthritis and Sjogren's syndrome) and elderly age could be confounding for the event encephalopathy. History of chronic obstructive pulmonary disease, covid 19 and elderly age could be confounding for the events respiratory failure, acute respiratory distress syndrome. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.