Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Electrocardiogram, Fatigue, Feeling abnormal
Clinical narrative: Tested positive or ANA (autoimmune disease); Spinal stenosis; Restless legs; Brain fog; Feeling off balance; Short-term memory loss; Lost a lot of weight (8 pounds),weight fell off quickly, and she is not able to gain it back; Dizziness; Joint pain,shoulder pain than runs down to the fingers; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (Tested positive or ANA (autoimmune disease)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included TRAZODONE for Sleep disorder NOS, CLONAZEPAM (KLONOPIN) for Sleep disorder NOS and Anxiety, LEVOMILNACIPRAN HYDROCHLORIDE (FETZIMA) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, 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 AUTOIMMUNE DISORDER (Tested positive or ANA (autoimmune disease)) (seriousness criterion medically significant), SPINAL STENOSIS (Spinal stenosis), RESTLESS LEGS SYNDROME (Restless legs), FEELING ABNORMAL (Brain fog), BALANCE DISORDER (Feeling off balance), AMNESIA (Short-term memory loss), ABNORMAL LOSS OF WEIGHT (Lost a lot of weight (8 pounds),weight fell off quickly, and she is not able to gain it back), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain,shoulder pain than runs down to the fingers) and FATIGUE (Extreme fatigue). At the time of the report, AUTOIMMUNE DISORDER (Tested positive or ANA (autoimmune disease)), SPINAL STENOSIS (Spinal stenosis), RESTLESS LEGS SYNDROME (Restless legs), FEELING ABNORMAL (Brain fog), BALANCE DISORDER (Feeling off balance), AMNESIA (Short-term memory loss), ABNORMAL LOSS OF WEIGHT (Lost a lot of weight (8 pounds),weight fell off quickly, and she is not able to gain it back), DIZZINESS (Dizziness), ARTHRALGIA (Joint pain,shoulder pain than runs down to the fingers) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Autoantibody test: positive (Positive) ANA (autoimmune disease). In 2021, Electrocardiogram: abnormal (abnormal) abnormal EKG.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug reported. Patient reported - She was prescribed meloxicam but didn't  take. Now she is changing her diet (now gluten free) and tomorrow starts on plant based. They did cognitive test. Rheumatologist and cardiologist, think her symptoms could be related to the vaccine.  Company Comment: This case concerns a 37 year-old female with no relevant concurrent medical condition who experienced the unexpected event of Austominnume disease(medically significant), along with other non serious events. The patient received her second dose of mRNA-1273 (Moderna COVID-19 Vaccine on 15-Feb-2021. On an unknown date she started to experience Autoimmune disorder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 37 year-old female with no relevant concurrent medical condition who experienced the unexpected event of Austominnume disease(medically significant), along with other non serious events. The patient received her second dose of mRNA-1273 (Moderna COVID-19 Vaccine on 15-Feb-2021. On an unknown date she started to experience Autoimmune disorder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine is not affected by this report.