Reporte zur Charge 013L2UA

Symptomtext

arrhythmia; Coughing; lot of fat in my stomach; dizziness; leg pain; Disorientated; Feeling abnormal; malaise; Nausea; Joint pain; Myalgia; headache; sore throat; Allergy to vaccine; Difficulty sleeping; Difficulty breathing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (arrhythmia) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L2UA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Oxygen therapy. On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), HYPERSENSITIVITY (Allergy to vaccine), INSOMNIA (Difficulty sleeping), DYSPNOEA (Difficulty breathing) and HEADACHE (headache). On 23-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (leg pain), DISORIENTATION (Disorientated), FEELING ABNORMAL (Feeling abnormal), MALAISE (malaise), NAUSEA (Nausea), ARTHRALGIA (Joint pain) and MYALGIA (Myalgia). On 21-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia) (seriousness criteria hospitalization and medically significant). On 12-May-2021, the patient experienced ABDOMINAL DISCOMFORT (lot of fat in my stomach). On 13-May-2021, the patient experienced COUGH (Coughing). The patient was hospitalized on 21-Apr-2021 due to ARRHYTHMIA. At the time of the report, ARRHYTHMIA (arrhythmia), OROPHARYNGEAL PAIN (sore throat), HYPERSENSITIVITY (Allergy to vaccine), INSOMNIA (Difficulty sleeping), DYSPNOEA (Difficulty breathing), DIZZINESS (dizziness), PAIN IN EXTREMITY (leg pain), DISORIENTATION (Disorientated), ABDOMINAL DISCOMFORT (lot of fat in my stomach), COUGH (Coughing), FEELING ABNORMAL (Feeling abnormal), MALAISE (malaise), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Myalgia) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information provided was Nasal Spray Vicks Vapo Rub, Tylenol ,Prednisone 10mg PO BID , Fluticasone Spray BID A month later, the patient experienced "sore throat", "headache", "allergies", and thought it was his age, "I didn't sleep well", "with difficulty breathing". Patient consulted primary care on 16Mar2021. Patient had blood work done. Patient was using a nasal spray, Vicks VapoRub, and Tylenol. On 23Mar2021, the symptoms included "dizziness, leg pain, I could not sleep enough, felling nauseated, disoriented, I did not have control over myself, I felt horrible, malaise, lower left leg pain, pain in my left clavicle, knee pain, and left shoulder pain, the pain alternated sites in the body". These symptoms continued on and off until patient called the primary care, who sent patient to the Emergency Room and patient was hospitalized on 21Apr2021, for 3 days, had bloodwork done, and was told it was arrhythmia, by a student, they did all the possible testing for vesicle and stomach. They did a heart test, possibly an echocardiogram before I left the hospital. "They gave me oxygen to help me breath", patient was connected to monitors with wires, and stated "I felt the same and left hospital against medical advice. I went to see my primary, "he checked me out" and patient was referred to specialist 29Apr2021, who indicated medications. Patient consulted "heart doctor" on 12May2021. Patient stated is a smoker, has a "lot of fat in my stomach", and "I continue having difficulty breathing", and "I keep coughing". "You have an Arrhythmia", the cardiologist told the patient. He was advised by the specialist to stop smoking and get another unknown test that was not done in the hospital. 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.; 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.