Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle twitching, Tremor, Weight, Weight decreased
Clinical narrative: feels like has no energy/I have no energy; want to do is sleep / sleeping part doesn't seem to be stopping/tiredness / exhaustion; EKG showed atrial fibrillation; high cholesterol; not feel too good/not feeling well; couldn't eat; lost 10 lbs; light headed; lost taste; lost smell; shakiness; twitching; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (EKG showed atrial fibrillation) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Atrial fibrillation since an unknown date. Concurrent medical conditions included Thyroid disorder. Concomitant products included DULOXETINE HYDROCHLORIDE (DULOXETINE HCL), LAMOTRIGINE, CLONAZEPAM (CLOZEPAM [CLONAZEPAM]), LITHIUM CARBONATE, PANTOPRAZOLE, ROSUVASTATIN CALCIUM, QUETIAPINE FUMARATE (SEROQUEL) and LEVOTHYROXINE for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced MALAISE (not feel too good/not feeling well), DECREASED APPETITE (couldn't eat), WEIGHT DECREASED (lost 10 lbs), DIZZINESS (light headed), AGEUSIA (lost taste), ANOSMIA (lost smell), TREMOR (shakiness) and MUSCLE TWITCHING (twitching). In August 2021, the patient experienced ATRIAL FIBRILLATION (EKG showed atrial fibrillation) (seriousness criterion medically significant) and BLOOD CHOLESTEROL INCREASED (high cholesterol). On 18-Aug-2021, the patient experienced ASTHENIA (feels like has no energy/I have no energy) and FATIGUE (want to do is sleep / sleeping part doesn't seem to be stopping/tiredness / exhaustion). At the time of the report, ATRIAL FIBRILLATION (EKG showed atrial fibrillation), MALAISE (not feel too good/not feeling well), DECREASED APPETITE (couldn't eat), WEIGHT DECREASED (lost 10 lbs), DIZZINESS (light headed), AGEUSIA (lost taste), ANOSMIA (lost smell), BLOOD CHOLESTEROL INCREASED (high cholesterol), ASTHENIA (feels like has no energy/I have no energy), FATIGUE (want to do is sleep / sleeping part doesn't seem to be stopping/tiredness / exhaustion), TREMOR (shakiness) and MUSCLE TWITCHING (twitching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Weight: weight loss 10 lbs lost 10 lbs. In August 2021, Blood cholesterol: high cholesterol High. In August 2021, Electrocardiogram: abnormal finding of atrial fibrillation.         No treatment information was provided by the reporter.  The patient received 2nd dose of the Moderna COVID-19 vaccine on 21 May 2021, around 10:30 AM. She received the 2nd dose in the left (non-dominant) arm. She says that by 5 PM the same day, she started to feel not good. She told her boyfriend that she was going to lay down as she was not feeling well. She laid on her couch covered up. Her tiredness and exhaustion lasted for at least 4.5 weeks. She couldn't eat anything and lost 10 lbs because of that. The thought of food and drinks would just make her run to the bathroom. She would get light headed to the point where she had to watch herself when she would stand up from a sitting position. For 2 weeks, she did not even know what was going on. She also lost taste and smell of food. About 2 or 3 weeks ago, she was seen by a cardiologist who did an EKG. There was a new finding of atrial fibrillation in the EKG, which was not there before the vaccine. However, she did mention that the atrial fibrillation runs in her family. Her cholesterol was high according to her doctor, which was also a new finding. She felt like she had no energy. All she wanted to sleep. She did not want to do anything at her house, including laundry, dishes, or scrub the floor. She steps out to do groceries, which was not a lot of times, and gets back home exhausted. The sleeping part did not seem to be stopping, and that the exhaustion and being tired all the time was out of control. She had shakiness and twitching that she has been experiencing since she received the 2nd dose of the vaccine.  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.   This case was linked to MOD-2021-290976 (Patient Link).; Sender's Comments: 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.