Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ascites, Bone scan, Brain natriuretic peptide, Bronchoalveolar lavage, Cardiac failure congestive
Clinical narrative: PULMONARY INTERSTITIAL EDEMA/DIFFICULTY BREATHING; CONGESTIVE HEART FAILURE/SWELLING IN FEET; RESPIRATORY FAILURE; VOCAL CORD POLYP; LEFT VENTRICULAR HYPERTROPHY; LEFT ATRIUM WAS MILDLY DILATED; OSTEOARTHRITIS; CHRONIC OBSTRUCTIVE PULMONARY DISEASE; LEGS FELT TIGHT; FLUID RETENTION; ASCITES IN STOMACH; This spontaneous report received from a patient concerned a 53 year old female of an unspecified race and ethnic origin. The patient's weight was 292 pounds, and height was 65 inches. The patient's past medical history included: hysterectomy, and concurrent conditions included: psoriatic arthritis, pain worsened, weight gain, rheumatoid arthritis, psoriasis, anemic, restless leg, anxiety, depression, hypertension, tachycardia, and high cholesterol. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, 1 total administered on 17-MAY-2021 for covid-19 vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Iron for anemic, Clonazepam for anxiety, Celexa (celecoxib) for depression, Zocor (simvastatin) for high cholesterol, Folic Acid for methotrexate supplement, Humira (adalimumab) for moderate to severe rheumatoid arthritis, Lyrica (pregabalin) for pain, Requip (ropinirole hydrochloride) for restless leg, and Metoprolol for tachycardia, and hypertension.  On 19-MAY-2021, the patient experienced ascites in stomach, her legs felt tight, and had fluid retention. On an unspecified date in JUN-2021, the patient experienced chronic obstructive pulmonary disease. On 17-JUN-2021, the patient experienced respiratory failure. The patient had brain natriuretic peptide test which revealed congestive heart failure. The patient had total body bone scan which revealed osteoarthritis in the knees, sacroiliac joints, ankles, and shoulders. The patient had echocardiogram which revealed that her left atrium was mildly dilated and had left ventricular hypertrophy. The patient had nasal swab test which came negative for COVID-19. On 21-JUN-2021, the patient had chest X-ray which revealed pulmonary interstitial edema. On an unspecified date, the patient had difficulty in breathing, swelling in feet, and vocal cord polyp. The patient had lung lavage with unspecified results and had body weight measure which revealed that she gained weight. The patient was hospitalized for an unspecified number of days. Treatment medications (dates unspecified) included: Prednisone, Mobic (meloxicam), Lasix (furosemide), Proair (salbutamol sulfate), Breo Ellipta (fluticasone furoate/vilanterol trifenatate), Ultrame (tramadol hydrochloride), and Methotrexate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from respiratory failure, osteoarthritis, left atrium was mildly dilated, left ventricular hypertrophy, fluid retention, pulmonary interstitial edema, legs felt tight, congestive heart failure, ascites in stomach, chronic obstructive pulmonary disease, and swelling in feet, had not recovered from vocal cord polyp. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210959296-COVID-19 VACCINE AD26.COV2.S-Congestive heart failure/ swelling in feet, Respiratory failure ,Pulmonary interstitial edema/difficulty breathing ,Ascites in stomach,. 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).