Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial enlargement, Blood pressure measurement, COVID-19, Cough, Drug ineffective
Clinical narrative: he has normal blood pressure, maybe a bit low; nasal congestion; cough; Mild thickening of the left ventricular wall/heart thickening.; his left atrium was a little large; had COVID in August; first dose29 dec2020 and second dose 26jan2021 and COVID in August.; This spontaneous case was reported by a consumer and describes the occurrence of LEFT VENTRICULAR HYPERTROPHY (Mild thickening of the left ventricular wall/heart thickening.), ATRIAL ENLARGEMENT (his left atrium was a little large), HYPOTENSION (he has normal blood pressure, maybe a bit low), COVID-19 (had COVID in August) and DRUG INEFFECTIVE (first dose29 dec2020 and second dose 26jan2021 and COVID in August.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chemotherapy (Routine cardiology evaluation prior to cardiotoxic chemotherapy) in 2011.   On 29-Dec-2020 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, the patient experienced COVID-19 (had COVID in August) and DRUG INEFFECTIVE (first dose29 dec2020 and second dose 26jan2021 and COVID in August.). On 01-Nov-2021, the patient experienced LEFT VENTRICULAR HYPERTROPHY (Mild thickening of the left ventricular wall/heart thickening.) and ATRIAL ENLARGEMENT (his left atrium was a little large). On an unknown date, the patient experienced HYPOTENSION (he has normal blood pressure, maybe a bit low), NASAL CONGESTION (nasal congestion) and COUGH (cough). At the time of the report, LEFT VENTRICULAR HYPERTROPHY (Mild thickening of the left ventricular wall/heart thickening.) and ATRIAL ENLARGEMENT (his left atrium was a little large) had not resolved, HYPOTENSION (he has normal blood pressure, maybe a bit low), COVID-19 (had COVID in August) and DRUG INEFFECTIVE (first dose29 dec2020 and second dose 26jan2021 and COVID in August.) outcome was unknown and NASAL CONGESTION (nasal congestion) and COUGH (cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 01-Nov-2021, Echocardiogram: abnormal (abnormal) Mild thickening of left ventricle of heart and enlargement of left atrium. On 24-Nov-2021, Magnetic resonance imaging: normal (normal) exclude amyloidosis as a potential etiology but no suggestive findings of amyloidosis on MRI scan, but show LVEF of 47%. On an unknown date, Blood pressure measurement: normal (normal) normal blood pressure, maybe a bit low. On an unknown date, Ejection fraction: 47 (Low) 47 percentage.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient height reported 72 Inches. No concomitant medications reported by reporter No treatment medications provided by the reporter.  Patient had a heart thickening and he is kind of shy of having the booster because of that. Patient was not sure if they could be related to the Moderna vaccine  Company Comment: This is a spontaneous case concerning a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine. Drug ineffective was also noted in the case (patient received the two doses in the correct interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up document attached contained No New Information. On 14-Dec-2021: Added: Reporters, Patient Identifier updated,suspect dose details added, events added. On 03-Jan-2022: Updated Reporter details, patient demographics, medical history, lab data, suspect drug details, event start date and outcome for left ventricular hypertrophy and Atrial enlargement and deleted event Amyloidosis and dose 3 details of suspect product; Sender's Comments: This is a spontaneous case concerning a 69-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI COVID-19. The event occurred approximately 9 months after the second dose of mRNA-1273 vaccine. Drug ineffective was also noted in the case (patient received the two doses in the correct interval). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.