Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphocyte percentage, Lymphoma, Mammogram, Mean cell haemoglobin, Mean cell haemoglobin concentration
Clinical narrative: tests confirmed early slow moving lymphoma, she was diagnosed with lymphoma; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (tests confirmed early slow moving lymphoma, she was diagnosed with lymphoma) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051E21A, 028L20A and 016M20A) for COVID-19 vaccination.     Patient had no allergies. Patient had not COVID positive test or diagnosis ever.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ROSUVASTATIN CALCIUM (CRESTOR), LATANOPROST and VITAMINS NOS for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 14-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHOMA (tests confirmed early slow moving lymphoma, she was diagnosed with lymphoma) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (tests confirmed early slow moving lymphoma, she was diagnosed with lymphoma) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2022, Mammogram: swollen lymph node showed up on her left breast (abnormal) swollen lymph node showed up on her left breast. On 13-Jan-2022, Ultrasound breast: enlarged lymph node (abnormal) enlarged lymph node. On 14-Mar-2022, Ultrasound breast: lymph node had enlarged even (abnormal) lymph node had enlarged even more. On 14-Apr-2022, Biopsy breast: she was diagnosed with lymphoma She was diagnosed with lymphoma. She currently has early slow moving lymphoma. On 21-Apr-2022, Alanine aminotransferase (0-55): 25 (normal) 25 IU/L. On 21-Apr-2022, Aspartate aminotransferase (6-50): 19 (normal) 19 IU/L. On 21-Apr-2022, Basophil count (0.0-0.2): 0.0 (normal) 0.0 K/UL. On 21-Apr-2022, Basophil percentage (0.0-2.0): 0.9 (normal) 0.9 percent. On 21-Apr-2022, Blood albumin (3.0-5.5): 4.1 (normal) 4.1 g/dL. On 21-Apr-2022, Blood alkaline phosphatase (30-120): 65 (normal) 65 IU/L. On 21-Apr-2022, Blood bicarbonate (21.0-31.0): 25.0 (normal) 25.0 mmol/L. On 21-Apr-2022, Blood bilirubin (0.1-1.4): 0.9 (normal) 0.9 mg/dL. On 21-Apr-2022, Blood calcium (8.5-10.5): 9.8 (normal) 9.8 mg/dL. On 21-Apr-2022, Blood chloride (96-109): 104 (normal) 104 mmol/L. On 21-Apr-2022, Blood creatinine (0.5-1.3): 0.7 (normal) 0.7 mg/dL. On 21-Apr-2022, Blood glucose (70-99): 89 (normal) 89 mg/dL. On 21-Apr-2022, Blood lactate dehydrogenase (125-220): 160 (normal) 160 IU/L. On 21-Apr-2022, Blood potassium (3.5-5.3): 4.6 (normal) 4.6 mmol/L. On 21-Apr-2022, Blood sodium (135-152): 142 (normal) 142 mmol/L. On 21-Apr-2022, Blood test: she was diagnosed with lymphoma She was diagnosed with lymphoma. She currently has early slow moving lymphoma.. On 21-Apr-2022, Blood urea (7-24): 15 (normal) 15 mg/dL. On 21-Apr-2022, Blood urea nitrogen/creatinine ratio (10-22): 21.4 (normal) 21.4. On 21-Apr-2022, Eosinophil count (0.0-0.7): 0.1 (normal) 0.1 K/UL. On 21-Apr-2022, Eosinophil percentage (0.0-6.0): 3.2 (normal) 3.2 percent. On 21-Apr-2022, Glomerular filtration rate (Unknown-less than 60): less than 60 (normal) less than 60 ml/min/1.73m2.. On 21-Apr-2022, Haematocrit (36-49): 44 (normal) 44 percent. On 21-Apr-2022, Haemoglobin (11.8-16.8): 14.4 (normal) 14.4 g/dL. On 21-Apr-2022, Immature granulocyte count (0.00-0.10): 0.01 (normal) 0.01 K/UL and 0.30 (normal) 0.30 percent. On 21-Apr-2022, Lymphocyte count (1.0-4.0): 0.9 (Low) 0.9 K/UL. On 21-Apr-2022, Lymphocyte percentage (10.0-50.0): 25.1 (normal) 25.1 percent. On 21-Apr-2022, Mean cell haemoglobin (27.0-35.0): 31.8 (normal) 31.8 pg. On 21-Apr-2022, Mean cell haemoglobin concentration (32.0-36.0): 32.8 (normal) 32.8 g/dL. On 21-Apr-2022, Mean cell volume (82-103): 97 (normal) 97 n. On 21-Apr-2022, Mean platelet volume (0.0-99.0): 9.7 (normal) 9.7 fl. On 21-Apr-2022, Monocyte count (0.2-1.0): 0.4 (normal) 0.4 K/UL. On 21-Apr-2022, Monocyte percentage (0.0-10.0): 11.8 (High) 11.8 percent. On 21-Apr-2022, Neutrophil count (2.0-7.0): 2.0 (normal) 2.0 K/UL. On 21-Apr-2022, Neutrophil percentage (40.0-75.0): 58.7 (normal) 58.7 percent. On 21-Apr-2022, Platelet count (130-400): 219 (normal) 219 K/UL. On 21-Apr-2022, Protein total (6.0-8.5): 6.7 (normal) 6.7 g/dL. On 21-Apr-2022, Red blood cell count (3.7-5.5): 4.5 (normal) 4.5 M/UL. On 21-Apr-2022, Red cell distribution width (0.0-16.0): 12.5 (normal) 12.5 percent. On 21-Apr-2022, White blood cell count (3.8-10.8): 3.5 (Low) 3.5 K/UL. On 17-May-2022, Bone scan: abnormal (abnormal) FDG-avid bony lesions, including bilateral acetabulum, sternum, ribs, thoracic and lumbar spines. 1.3 cm focal FDG uptake at left acetabulum, SUV up to 6.6. 1.2 cm focal FDG activity at L2 spinous process, SUV up to 3.6. Focal FDG activity at right posterior ilium, SUV up to 2.7.. On 17-May-2022, Chest scan: abnormal (abnormal) physiologic FDG activity was seen in the mediastinal blood pool and myocardium. and fdg-avid left axillary nodes, measuring upto 2.2 c (abnormal) FDG-avid left axillary nodes, measuring upto 2.2 cm, SUV up to 7.7.. On 17-May-2022, Computerised tomogram neck: abnormal (abnormal) physiologic FDG uptake was seen in the neck muscles. On 17-May-2022, Hepatobiliary scan: no abnormal uptake (normal) no abnormal uptake. Liver background SUV mean, as a reference for comparison FDG studies was 2.5.. On 17-May-2022, Positron emission tomogram: no abnormal uptake (normal) No abnormal uptake, no abnormal uptake (normal) No abnormal uptake, no abnormal uptake (normal) No abnormal uptake, abnormal (abnormal) physiologic FDG uptake was seen in the visualized regions of the brain, extraocular muscles, large salivary gland and oropharynx, excreted activity was seen (abnormal) Excreted activity was seen, no abnormal uptake (normal) No abnormal uptake, no abnormal uptake (normal) No abnormal uptake and no abnormal uptake (normal) no abnormal uptake. Mild to moderate pericardial effusion, below background FDG uptake, SUV up to 0.9.. On 17-May-2022, Scan spleen: no abnormal uptake (normal) no abnormal uptake. On 17-May-2022, Ventilation/perfusion scan: no abnormal uptake (normal) no abnormal uptake.         Company Comment: This spontaneous case concerns a 77-year-old, female patient with no medical history reported who experienced the unexpected, serious (medically significant) event of Lymphoma which occurred 164 days after administration of first booster dose of mRNA-1273 vaccine. Patient has also received mRNA-1273 for the primary series of COVID-19 immunization taken within the recommended dosing interval and completed approximately 9 months prior to the first booster dose. Patient has no subjective complaints until 2 months after vaccination when she was incidentally found to have swollen lymph node on the left breast during a routine mammogram examination. Additional clinical investigations were performed which included blood tests, breast ultrasound, positron emission tomogram and ultrasound guided biopsy leading to a diagnosis of Lymphoma. The clinical course, biopsy findings and treatment details were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Added lab data.; Sender's Comments: This spontaneous case concerns a 77-year-old, female patient with no medical history reported who experienced the unexpected, serious (medically significant) event of Lymphoma which occurred 164 days after administration of first booster dose of mRNA-1273 vaccine. Patient has also received mRNA-1273 for the primary series of COVID-19 immunization taken within the recommended dosing interval and completed approximately 9 months prior to the first booster dose. Patient has no subjective complaints until 2 months after vaccination when she was incidentally found to have swollen lymph node on the left breast during a routine mammogram examination. Additional clinical investigations were performed which included blood tests, breast ultrasound, positron emission tomogram and ultrasound guided biopsy leading to a diagnosis of Lymphoma. The clinical course, biopsy findings and treatment details were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.