Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Lymph node pain, Lymphadenopathy, Muscle fatigue
Clinical narrative: Chest discomfort, Constriction chest; Muscle weakness; Shortness of breath; Muscle fatigue; Appetite lost; Difficulty sleeping; Skin looked yellow; Shoulder discomfort; Splenomegaly; Fever; Headache; Diagnosed with non-Hodgkin's lymphoma; Right leg DVT; Night sweats; Unexplained weight loss; Excruciating pain in left arm from lymph node; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) and DEEP VEIN THROMBOSIS (Right leg DVT) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included RIVAROXABAN from July 2021 to an unknown date for DVT of legs, GABAPENTIN (NEURONTIN) and TRAMADOL for Pain, LEVOTHYROXINE for an unknown indication.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node) and FATIGUE (Fatigue). On 13-Jul-2021, the patient experienced DEEP VEIN THROMBOSIS (Right leg DVT) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest discomfort, Constriction chest), MUSCULAR WEAKNESS (Muscle weakness), DYSPNOEA (Shortness of breath), MUSCLE FATIGUE (Muscle fatigue), DECREASED APPETITE (Appetite lost), INSOMNIA (Difficulty sleeping), SKIN DISCOLOURATION (Skin looked yellow), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), SPLENOMEGALY (Splenomegaly), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NON-HODGKIN'S LYMPHOMA (Diagnosed with non-Hodgkin's lymphoma), DEEP VEIN THROMBOSIS (Right leg DVT), NIGHT SWEATS (Night sweats), WEIGHT DECREASED (Unexplained weight loss), CHEST DISCOMFORT (Chest discomfort, Constriction chest), MUSCULAR WEAKNESS (Muscle weakness), DYSPNOEA (Shortness of breath), MUSCLE FATIGUE (Muscle fatigue), DECREASED APPETITE (Appetite lost), INSOMNIA (Difficulty sleeping), SKIN DISCOLOURATION (Skin looked yellow), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), SPLENOMEGALY (Splenomegaly), LYMPH NODE PAIN (Excruciating pain in left arm from lymph node), FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, White blood cell count: 32000 (abnormal) White blood cells: 32000.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was not provided. Patient had lab test that included BP 110/82, Pulse as 102, temperature as 100.8 degree farheneit, oxygen saturation as 96 percent, body mass index as 19.66 kg/m2 and respiratory as 18. Patient had biopsy of right inguinal lymph node in 30-Jun-2021. Flow cytometry showed small lymphocytic lymphoma/CLL. PET-CT scan showed  splenomegaly with minimal bilateral axillary and inguinal adenopathy. Generalized weakness improved significantly. Patient had a medical history of thyroid disease. Had left knee cartilage surgery on 2014 and had colonoscopy.  Company comment: This case concerns a 61-year-old male patient with a history of thyroid disease, who experienced serious unexpected event of Non Hodgkin's lymphoma and deep vein thrombosis.  The event deep vein thrombosis occurred approximately 36 days after the second dose of mRNA-1273, and Non Hodgkin's lymphoma occurred approximately three months after second dose. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-245684 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Events added, reporter added-HCP and concomitant medications were added. On 22-Sep-2021: Non-Significant follow up received on 22-sep-2021. No new information was added. On 04-Oct-2021: Non Significant Follow up On 04-Oct-2021: Non Significant follow up; Sender's Comments: This case concerns a 61-year-old male patient with a history of thyroid disease, who experienced serious unexpected event of Non Hodgkin's lymphoma and deep vein thrombosis. The event deep vein thrombosis occurred approximately 36 days after the second dose of mRNA-1273, and Non Hodgkin's lymphoma occurred approximately three months after second dose. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.