Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Magnetic resonance imaging, Paraesthesia, Platelet count, Tinnitus
Clinical narrative: Essential Thrombocytosis; Two strokes; Tingling in fingers and toes; Intermittent swooshing sound in both ears; Vision problems in both eyes; Lightheadedness/Dizziness; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) and CEREBROVASCULAR ACCIDENT (Two strokes) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included HYDROXYCARBAMIDE (HYDREA), PREDNISONE and APIXABAN (ELIQUIS) for an unknown indication.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Two strokes) (seriousness criterion medically significant), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). At the time of the report, ESSENTIAL THROMBOCYTHAEMIA (Essential Thrombocytosis), CEREBROVASCULAR ACCIDENT (Two strokes), PARAESTHESIA (Tingling in fingers and toes), TINNITUS (Intermittent swooshing sound in both ears), VISUAL IMPAIRMENT (Vision problems in both eyes), DIZZINESS (Lightheadedness/Dizziness), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cytokine test: increase (High) Increase. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Abnormal MRI showed two strokes.. On an unknown date, Platelet count: 1.1 million to 1.8million (High) High.         Concomitant medication mentioned as Cholesterol pill ,Thyroid pill. Treatment information was not provided. On an unknown date the patient Cat Scan, blood work, bone marrow biopsy done , results were not reported.  Patient reported that she had four children with a 50 percent chance of passing on in particular the Essential Thrombocytosis.  The caller was advised not to get the vaccine, by her physician. When her mother tested for ET, Essential Thrombocytosis and said could have triggered this.  Company Comment: 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.; 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.