Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Fluid overload, Fluid retention, Gait disturbance, Haematoma
Clinical narrative: blood vessels are bursting; respiratory lung disease; myocarditis; Inflammation marker was extremely high; oxygen was saturated; blood cells seems to be clotting; aspiration; loss of appetite; pulmonary edema; Chron's Disease; Fluid overload; Retaining fluid; shortness of breath; prolong severely debilitating vasculitis; swelling; Could not walk; abdominal pain; dizziness; eyes burning; anemic; Cough; Weakness/ chronic weakness/ Debiliated; could no longer work; Could not sit up; Brain fog; Diarrhea; Pain/achiness; rash/rash on entire body; fatigue/chronic fatigue; joint pain; hypoxia; cardiogenic shock,; Cirrhosis; distorted heart function; ARDS; cardiac arrest; multiorgan failure; acute kidney injury; chest pain; diagnosis of lupus; hematoma; This spontaneous case was reported by a consumer and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosis of lupus), HYPOXIA (hypoxia), CARDIOGENIC SHOCK (cardiogenic shock,), HEPATIC CIRRHOSIS (Cirrhosis), CARDIAC DISORDER (distorted heart function), ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), CARDIAC ARREST (cardiac arrest), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), ACUTE KIDNEY INJURY (acute kidney injury), CHEST PAIN (chest pain), HAEMATOMA (hematoma), PURPURA (blood vessels are bursting), LUNG DISORDER (respiratory lung disease), MYOCARDITIS (myocarditis), INFLAMMATION (Inflammation marker was extremely high), OXYGEN SATURATION (oxygen was saturated), THROMBOSIS (blood cells seems to be clotting), ASPIRATION (aspiration), DECREASED APPETITE (loss of appetite), PULMONARY OEDEMA (pulmonary edema), CROHN'S DISEASE (Chron's Disease), FLUID OVERLOAD (Fluid overload), FLUID RETENTION (Retaining fluid), DYSPNOEA (shortness of breath), VASCULITIS (prolong severely debilitating vasculitis), SWELLING (swelling), GAIT DISTURBANCE (Could not walk), ABDOMINAL PAIN (abdominal pain), DIZZINESS (dizziness), EYE IRRITATION (eyes burning), ANAEMIA (anemic), COUGH (Cough), ASTHENIA (Weakness/ chronic weakness/ Debiliated), IMPAIRED WORK ABILITY (could no longer work), SITTING DISABILITY (Could not sit up), FEELING ABNORMAL (Brain fog), DIARRHOEA (Diarrhea), PAIN (Pain/achiness), RASH (rash/rash on entire body), FATIGUE (fatigue/chronic fatigue) and ARTHRALGIA (joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Atrial fibrillation and Urinary retention.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosis of lupus) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPOXIA (hypoxia) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOGENIC SHOCK (cardiogenic shock,) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEPATIC CIRRHOSIS (Cirrhosis) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC DISORDER (distorted heart function) (seriousness criteria hospitalization and life threatening), ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure) (seriousness criteria hospitalization, medically significant and life threatening), ACUTE KIDNEY INJURY (acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization and life threatening), HAEMATOMA (hematoma) (seriousness criteria hospitalization prolonged and life threatening), PURPURA (blood vessels are bursting) (seriousness criteria hospitalization, disability and life threatening), LUNG DISORDER (respiratory lung disease) (seriousness criteria hospitalization and life threatening), MYOCARDITIS (myocarditis) (seriousness criteria hospitalization, medically significant and life threatening), INFLAMMATION (Inflammation marker was extremely high) (seriousness criterion hospitalization), OXYGEN SATURATION (oxygen was saturated) (seriousness criterion hospitalization), THROMBOSIS (blood cells seems to be clotting) (seriousness criteria hospitalization, disability and medically significant), ASPIRATION (aspiration) (seriousness criteria hospitalization and medically significant), DECREASED APPETITE (loss of appetite) (seriousness criterion hospitalization), PULMONARY OEDEMA (pulmonary edema) (seriousness criteria hospitalization, disability and medically significant), CROHN'S DISEASE (Chron's Disease) (seriousness criteria hospitalization and medically significant), FLUID OVERLOAD (Fluid overload) (seriousness criterion hospitalization), FLUID RETENTION (Retaining fluid) (seriousness criterion hospitalization), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), VASCULITIS (prolong severely debilitating vasculitis) (seriousness criterion hospitalization), SWELLING (swelling) (seriousness criterion hospitalization), GAIT DISTURBANCE (Could not walk) (seriousness criteria hospitalization and disability), ABDOMINAL PAIN (abdominal pain) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization), EYE IRRITATION (eyes burning) (seriousness criterion hospitalization), ANAEMIA (anemic) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), ASTHENIA (Weakness/ chronic weakness/ Debiliated) (seriousness criterion hospitalization), IMPAIRED WORK ABILITY (could no longer work) (seriousness criteria hospitalization and disability), SITTING DISABILITY (Could not sit up) (seriousness criteria hospitalization and disability), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), PAIN (Pain/achiness) (seriousness criterion hospitalization), RASH (rash/rash on entire body) (seriousness criterion hospitalization), FATIGUE (fatigue/chronic fatigue) (seriousness criterion hospitalization) and ARTHRALGIA (joint pain) (seriousness criterion hospitalization). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (diagnosis of lupus), HYPOXIA (hypoxia), CARDIOGENIC SHOCK (cardiogenic shock,), HEPATIC CIRRHOSIS (Cirrhosis), CARDIAC DISORDER (distorted heart function), ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), CARDIAC ARREST (cardiac arrest), MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), ACUTE KIDNEY INJURY (acute kidney injury), CHEST PAIN (chest pain), HAEMATOMA (hematoma), PURPURA (blood vessels are bursting), LUNG DISORDER (respiratory lung disease), MYOCARDITIS (myocarditis), INFLAMMATION (Inflammation marker was extremely high), OXYGEN SATURATION (oxygen was saturated), THROMBOSIS (blood cells seems to be clotting), ASPIRATION (aspiration), DECREASED APPETITE (loss of appetite), PULMONARY OEDEMA (pulmonary edema), CROHN'S DISEASE (Chron's Disease), FLUID OVERLOAD (Fluid overload), FLUID RETENTION (Retaining fluid), DYSPNOEA (shortness of breath), VASCULITIS (prolong severely debilitating vasculitis), SWELLING (swelling), GAIT DISTURBANCE (Could not walk), ABDOMINAL PAIN (abdominal pain), DIZZINESS (dizziness), EYE IRRITATION (eyes burning), ANAEMIA (anemic), COUGH (Cough), ASTHENIA (Weakness/ chronic weakness/ Debiliated), IMPAIRED WORK ABILITY (could no longer work), SITTING DISABILITY (Could not sit up), FEELING ABNORMAL (Brain fog), DIARRHOEA (Diarrhea), PAIN (Pain/achiness), RASH (rash/rash on entire body), FATIGUE (fatigue/chronic fatigue) and ARTHRALGIA (joint pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: chron's disease (abnormal) Chron's Disease. In 2021, Inflammatory marker test: high (High) Extremely high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. Treatment included Chemotherapy, CPR, PEA, ECMO Machine.  Patient was reported as dead and later was revived after 6 minutes of CPR.  Company Comment: This case concerns a 66 -year-old patient who was diagnosed with Lupus and Crohn´s disease after the second dose of Moderna vaccine. Very limited information regarding these events has been provided at this time.  Additionally, other events have been reported, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.   This case was linked to MOD-2021-293826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23-AUG-2021, contains No New information.; Sender's Comments: This case concerns a 66 -year-old patient who was diagnosed with Lupus and Crohn´s disease after the second dose of Moderna vaccine. Very limited information regarding these events has been provided at this time.  Additionally, other events have been reported, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information is not expected.