Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Intracardiac thrombus, Pyrexia
Clinical narrative: blood clots/He had blood clots in his heart; shortness of breath; cough; fever of 104°F; heart rate increased; This spontaneous case was reported by a patient and describes the occurrence of INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In July 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), COUGH (cough), PYREXIA (fever of 104°F) and HEART RATE INCREASED (heart rate increased). At the time of the report, INTRACARDIAC THROMBUS (blood clots/He had blood clots in his heart), DYSPNOEA (shortness of breath) and COUGH (cough) had not resolved, PYREXIA (fever of 104°F) had resolved and HEART RATE INCREASED (heart rate increased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fernite. On an unknown date, Heart rate: 192 beats a minute, fast.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. It has been reported that after first Moderna vaccine patient was sent to bed for 3-4 days with a fever of 104-degree Fahrenheit and then he got well. After 30 days of 1st vaccination, patient received the second shot of Moderna Covid-19 vaccine. After receiving the second shot, patient was unable to breathe. He called the physician and physician gave him treatment medication. Patient also received blood thinners as treatment medication. He was currently being monitored with a heart monitor. Patient had an appointment with cardiologist. He never experienced something like this in the past. Patient did not receive a diagnosis of myocarditis or pericarditis.  Company Comment This spontaneous case concerns a 73-year-old male patient with no medical history reported who experienced the unexpected medically significant AESI of intracardiac thrombus;  the unexpected events of heart rate increased, dyspnoea, cough and other expected event in the context of 2nd. dose of mRNA-1273 vaccine. The unexpected events occurred after the mentioned dose. At the time of the report, only Pyrexia event had resolved. The age is a contributor for the events. The benefit-risk relationship of mRNA-1273.815  vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-753415 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Dec-2023: Live significant information has been appended which included Reporter details, patent age, gender), Vaccination and event details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753415:Same Reporter other patient