Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac failure congestive, Cardiomyopathy, Computerised tomogram, Echocardiogram
Clinical narrative: NON-ISCHEMIC CARDIOMYOPATHY; CONGESTIVE HEART FAILURE (TROUBLE BREATHING, FLUID RETENTION, SWOLLEN HANDS, ABDOMEN EXTREMELY DISTENDED, ACUTE SYSTOLIC HEART FAILURE, HEART WAS EXTREMELY ENLARGED); PREMATURE HEARTBEAT; BLOOD CLOT; KIDNEY STONES; SORENESS IN THE LEFT ARM; PAROXYSMAL ATRIAL FIBRILLATION (SYNCOPE, COLLAPSE); This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 240 pounds and height was 174 centimeters. The patient had no known allergies and no heart condition before the vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 42A21A and expiry: unknown) dose was not reported, 1 total administered on 06-APR-2021 around 11:30 on the left arm for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, right after the administration, the patient experienced soreness in the left arm, but nothing patient could not handle. Since 06-APR-2021, the patient experienced syncope/ collapse episode and was in detox several times, had to have a loop monitor inserted into her chest. Patient was diagnosed with paroxysmal atrial fibrillation. On 17-APR-2021, around 09:00 patient had trouble breathing, abdomen was getting distended, by 15:00 patient was looking like 9 months pregnant, patient's hands were very swollen, abdomen extremely distended. Patient was admitted to the emergency room (ER) and was made stabilized. Patient had a computerised tomogram (CAT) scan and all sort of testing and it was determined that patient had fluid retention. Patient was treated with Lasix (furosemide) to get the fluid off. On 19-APR-2021, patient underwent an echocardiogram and was diagnosed with congestive heart failure, non-ischemic cardiomyopathy, acute systolic heart failure (with ejection fraction= 25%). Patient was sent to another hospital with a cardiac center, where was told that arteries were clean but heart was extremely enlarged. Then patient was hospitalized for 4 more days and sent back home. Cardiac team put patient on high blood pressure medicine because they wanted patient's blood pressure to be around 90/60. Treatment medications were started which included metoprolol 25 mg 3 times a day, then lowered to 25 mg twice a day. Patient was also started with Xarelto (rivaroxaban) 20 mg once a day. On MAY-2021, the patient had kidney stones. On 28-JUN-2021, the patient had first blood clot under the blood thinner. Patient had shortness of breath (extremely painful, like someone was stabbing). From that patient was taking Lovenox 110 U twice a day and was told that would need to take that for the rest of her life. Patient had second blood clot six days after the first one, it was smaller than the first one but extremely painful too. On an unspecified date, the patient had premature heartbeat. Laboratory data showed elevated troponins. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness in the left arm, blood clot, paroxysmal atrial fibrillation (syncope, collapse), premature heartbeat, kidney stones, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged) and non-ischemic cardiomyopathy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210730842-covid-19 vaccine ad26.cov2.s-blood clot, congestive heart failure (trouble breathing, fluid retention, swollen hands, abdomen extremely distended, acute systolic heart failure, heart was extremely enlarged), non-ischemic cardiomyopathy, paroxysmal atrial fibrillation (syncope, collapse), kidney stones. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).