Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Hyperhidrosis, Hypertension, Peripheral coldness, Vaccination complication
Clinical narrative: Arterial regurgitation; Cardiac changes/EKG changes were observed in heart; Sweating profusely; Hands went cold; Felt dizzy; Chest pain; blood pressure elevated 180s over 110s/hypertensive; doesn't feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AORTIC VALVE INCOMPETENCE (Arterial regurgitation) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced AORTIC VALVE INCOMPETENCE (Arterial regurgitation) (seriousness criterion medically significant), CARDIAC DISORDER (Cardiac changes/EKG changes were observed in heart) and VACCINATION COMPLICATION (doesn't feel well). 16-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), PERIPHERAL COLDNESS (Hands went cold), DIZZINESS (Felt dizzy), CHEST PAIN (Chest pain) and HYPERTENSION (blood pressure elevated 180s over 110s/hypertensive). At the time of the report, AORTIC VALVE INCOMPETENCE (Arterial regurgitation) and CARDIAC DISORDER (Cardiac changes/EKG changes were observed in heart) had not resolved and HYPERHIDROSIS (Sweating profusely), PERIPHERAL COLDNESS (Hands went cold), DIZZINESS (Felt dizzy), CHEST PAIN (Chest pain), HYPERTENSION (blood pressure elevated 180s over 110s/hypertensive) and VACCINATION COMPLICATION (doesn't feel well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood pressure measurement: 180/110 (High) 180/110. On 16-Jan-2021, Electrocardiogram: abnormal (abnormal) EKG changes were observed in the heart.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. The patient went to the emergency room due to sweating profusely, blood pressure elevated 180s over 110s/hypertensive, hands went cold, felt dizzy, and chest pain.  She reported she will have to follow-up with a cardiologist because electrocardiogram (EKG) changed were observed in her heart.  The patient was not receiving treatment at the time of the initial report.  The patient called back on 13 Apr 2021 and noted continual, ongoing cardiac changes and "arterial regurgitation."   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient reported continual, ongoing cardiac changes and arterial regurgitation.  Outcomes of initially reported events changed from not resolved to unknown.  Narrative updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding these events has been provided at this time. Further information has been requested.