Age: 86.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Fluid overload, Lymphadenopathy, Weight
Clinical narrative: fluid overload; fatigue; Swollen lymph nodes; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FLUID OVERLOAD (fluid overload) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for Chronic lymphocytic leukaemia.    Concurrent medical conditions included Allergic reaction to drug, Chronic lymphocytic leukemia, Blood pressure high, Swollen lymph nodes, Swelling, Fatigue, Allergy to chemicals and Fruit allergy (Cantaloupes). Concomitant products included ATENOLOL for Blood pressure high, COENZYME Q10 [UBIDECARENONE], TURMERIC [CURCUMA LONGA RHIZOME], SELENIUM, VITAMIN D3, VITAMIN B COMPLEX, CALCIUM and FISH OIL for Supplementation therapy.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On 03-Apr-2021, the patient experienced FLUID OVERLOAD (fluid overload) (seriousness criterion hospitalization). The patient was hospitalized from 03-Apr-2021 to 05-Apr-2021 due to FLUID OVERLOAD. At the time of the report, FLUID OVERLOAD (fluid overload) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: 182 pounds 182 Pounds. On an unknown date, Weight: 194 pounds 194 Pounds.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter stated, the patient had been taking Imbruvica for the treatment of chronic lymphocytic leukemia for almost one month, but he complained that the drug had not helped to reduce the swelling, which might be caused by swollen lymph nodes. The swelling started before he started to take Imbruvica. The patient also said that the Imbruvica had not helped with his fatigue. He emphasized that he had no side effects from Imbruvica. On 03-Apr-2021, the patient was hospitalized for fluid overload, and 4.9 liters of fluid was removed from his body. He was discharged on 05-Apr-2021 to go home with a prescription of furosemide, to be taken orally daily, for the treatment of fluid overload. When he was admitted to the hospital, he weighed 194 pounds. When he was discharged from the hospital, he weighed 182 pounds. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The chronic lymphocytic leukemia is a cofounder