Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Arthritis, Bone pain, Gait inability
Clinical narrative: pain in hands; pain in bones; pain in joints; patient has been experiencing allergy; arrhythmia,heart rhythm; arthritis; doesn't walk too much; everything hurts; stuffed nose; something stuck in my throat, like phlegm; having a cold; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia,heart rhythm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 30M20A and 032620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atrial fibrillation (patient had atrial fibrillation because of stress as her husband died) in 2019, Vomiting on 01-Nov-2021 and Diarrhea on 01-Nov-2021. Concurrent medical conditions included Allergy (March/April 2021 She said is because she moved to another place where allergies are common) since 2021. Concomitant products included APIXABAN (ELIQUIS), SOTALOL, ATORVASTATIN and CLONAZEPAM for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (pain in hands), BONE PAIN (pain in bones) and ARTHRALGIA (pain in joints). In 2021, the patient experienced ARRHYTHMIA (arrhythmia,heart rhythm) (seriousness criterion medically significant), ARTHRITIS (arthritis), GAIT INABILITY (doesn't walk too much), PAIN (everything hurts), NASAL CONGESTION (stuffed nose), OROPHARYNGEAL DISCOMFORT (something stuck in my throat, like phlegm), NASOPHARYNGITIS (having a cold) and HYPERSENSITIVITY (patient has been experiencing allergy). At the time of the report, ARRHYTHMIA (arrhythmia,heart rhythm), PAIN IN EXTREMITY (pain in hands), BONE PAIN (pain in bones), ARTHRITIS (arthritis), GAIT INABILITY (doesn't walk too much), PAIN (everything hurts), NASAL CONGESTION (stuffed nose), OROPHARYNGEAL DISCOMFORT (something stuck in my throat, like phlegm), NASOPHARYNGITIS (having a cold), ARTHRALGIA (pain in joints) and HYPERSENSITIVITY (patient has been experiencing allergy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Oxygen saturation: normal (normal) Normal. On 01-Dec-2021, SARS-CoV-2 test: high (High) high level of antigens.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication reported as sotalol 80 and atorvastatin 20 and other concomitant medication include diarrhea med Treatment including Humidifier, cream on the hands, arms, shoulders and legs. She couldn't find her blood thinner and stomach medication, also reported diarrhea medication NOS. Events also includes that she feels older. She said that before she was very active. Patient mentioned she had an endoscopy done and also patient mentions she will have a heart ablation on 06Jan2022 to prevent any switching of the rhythm.  This case concerns a 71-year-old female patient with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Arrhythmia. The events of occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the first dose was given. The medical condition of Atrial Fibrillation remains a confounder. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 71-year-old female patient with relevant medical history of Atrial Fibrillation, who experienced the unexpected serious adverse event of special interest, Arrhythmia. The events of occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since no information about the first dose was given. The medical condition of Atrial Fibrillation remains a confounder. No clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.