Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, High density lipoprotein, Icterus index, Immature granulocyte count, Influenza A virus test
Clinical narrative: Not making sense; Left pontine ischemic stroke without hemorrhagic stroke; Double Vision; Slurred speech; Unsteady Gait; This spontaneous case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke), DIPLOPIA (Double Vision), DYSARTHRIA (Slurred speech), GAIT DISTURBANCE (Unsteady Gait) and FEELING ABNORMAL (Not making sense) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia, Cardiomegaly, Pulmonary embolism, Smoker, Ventricular tachycardia, DVT, Implantable cardioverter defibrillator insertion, Cough, Vasectomy in 1982, Pacemaker insertion (cardiac) (2005,2009,2015) in July 2002 and Colonoscopy (2015) in January 2005. Family history included Congestive cardiac failure (Mother had CHF). Concurrent medical conditions included Drug allergy (From Bactrim), Drug allergy (trimethoprim), Hypertension, Diabetes mellitus (Diabetes mellitus type 2), Peripheral neuropathy, Chronic back pain, Morbid obesity, Left bundle branch block, Ischemic cardiomyopathy, GERD, Hyperhidrosis, Insomnia and Chronic thrombocytopenia. Concomitant products included CODEINE PHOSPHATE, GUAIFENESIN (VIRTUSSIN AC) for Cough, ASCORBIC ACID, ACETYLSALICYLIC ACID (ECOTRIN), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), CARVEDILOL (COREG), FLUTICASONE PROPIONATE (FLOVENT HFA), FUROSEMIDE (LASIX P), LISINOPRIL (ZESTRIL), MULTIVITAMIN WITH MINERALS, OMEPRAZOLE, LORATADINE, APIXABAN from an unknown date to 07-Jun-2021, VITAMIN D3, TRIAMCINOLONE ACETONIDE, CANAGLIFLOZIN, METFORMIN, PREGABALIN, PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRAMADOL + ACETAMINOFEN), TRAZODONE, UBIDECARENONE (COQ10 [UBIDECARENONE]), ZOLPIDEM, NIACIN, CLOPIDOGREL, APIXABAN (ELIQUIS), LISINOPRIL and SALBUTAMOL SULFATE (PROAIR RESPICLICK) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke) (seriousness criteria hospitalization and medically significant), DIPLOPIA (Double Vision) (seriousness criterion hospitalization), DYSARTHRIA (Slurred speech) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Unsteady Gait) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Not making sense) (seriousness criterion hospitalization). The patient was hospitalized from 07-Jun-2021 to 08-Jun-2021 due to DIPLOPIA, DYSARTHRIA, FEELING ABNORMAL, GAIT DISTURBANCE and ISCHAEMIC STROKE. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) (oral) on 07-Jun-2021 for Adverse event, at a dose of 75 mg once a day and NICOTINIC ACID (NIASPAN) (oral) on 07-Jun-2021 for Adverse event, at a dose of 500 mg once a day. At the time of the report, ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke) had resolved and DIPLOPIA (Double Vision), DYSARTHRIA (Slurred speech), GAIT DISTURBANCE (Unsteady Gait) and FEELING ABNORMAL (Not making sense) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive Covid-19 virus test. On 07-Jun-2021, Activated partial thromboplastin time (24-36): 36.3 (High) high. On 07-Jun-2021, Alanine aminotransferase (1-50): 29 (normal) 29 u/L. On 07-Jun-2021, Albumin globulin ratio (1.1-2.2): 1.6 (normal) normal. On 07-Jun-2021, Anion gap (5-15): 6 (normal) 6. On 07-Jun-2021, Aspartate aminotransferase (17-59): 32 (normal) 32 u/L. On 07-Jun-2021, Basophil count (0-0.2): 0.0 (normal) 0.0. On 07-Jun-2021, Basophil percentage (0-2): 0.6 (normal) 0.6 %. On 07-Jun-2021, Blood albumin (3.5-5.0): 4.0 (normal) 4.0 g/dL. On 07-Jun-2021, Blood alkaline phosphatase (38-126): 70 (normal) 70 u/L. On 07-Jun-2021, Blood bilirubin (0.2-1.3): 0.8 (normal) 0.8 mg/dL. On 07-Jun-2021, Blood calcium (8.4-10.2): 9.0 (normal) 9.0 mg/dL. On 07-Jun-2021, Blood chloride (98-107): 108 (High) 108. On 07-Jun-2021, Blood creatinine (0.8-1.5): 1.1 (normal) 1.1 mg/dL. On 07-Jun-2021, Blood glucose (75-110): 147 (High) 147 mg/dL. On 07-Jun-2021, Blood lactate dehydrogenase (0.6-2.2): 1.6 (normal) 1.6. On 07-Jun-2021, Blood osmolarity (261-280): 270 (normal) 270. On 07-Jun-2021, Blood potassium (3.6-5): 3.7 (normal) 3.7. On 07-Jun-2021, Blood pressure measurement: 162/76 (High) at 10:40, 162/76  at 11:46, 165/78  at 07:49, 127/74 and  at 09:48, 150/86 (High). On 07-Jun-2021, Blood sodium (136-146): 137 (normal) 137. On 07-Jun-2021, Blood urea (9-20): 20 (normal) 20 mg/dL. On 07-Jun-2021, Blood urea nitrogen/creatinine ratio (6-26): 18 (normal) 18 ratio. On 07-Jun-2021, Body temperature: 97.6 (normal) at 10:40, 97.6, at 07:49, 97.8 F,  at 09:48, 97.8 F. On 07-Jun-2021, Carbon dioxide (22-30): 23 (normal) 23. On 07-Jun-2021, Coagulation factor (0.84-1.14): 1.36 (High) 1.36. On 07-Jun-2021, Computerised tomogram: no acute intracanal finding (normal) No acute intracanal finding. On 07-Jun-2021, Eosinophil count (0-0.5): 0.3 (normal) 0.3. On 07-Jun-2021, Eosinophil percentage (0-4): 6.1 (High) 6.1 %. On 07-Jun-2021, Globulin (2.4-3.6): 2.6 (normal) 2.6 g/dL. On 07-Jun-2021, Glomerular filtration rate (60-Unknown): 67 (normal) 67 ml/mil. On 07-Jun-2021, Haematocrit (41-53): 45.0 (normal) 45.0%. On 07-Jun-2021, Haemoglobin (13.5-17.5): 15.5 (normal) 15.5 %. On 07-Jun-2021, Heart rate: 60 (Low) at 10:40, 60 at 11:46, 61 at 07:49, 64 and at 09:48, 61. On 07-Jun-2021, Icterus index (0-7): <2.0 (normal) <2.0. On 07-Jun-2021, Immature granulocyte count (0.0-0.3): 0.0 (normal) 0.0 and 0.0 (normal) 0.0 %. On 07-Jun-2021, Influenza A virus test: negative (Negative) Negative. On 07-Jun-2021, Influenza B virus test: negative (Negative) Negative. On 07-Jun-2021, International normalised ratio (0.84-1.14): 1.38 (High) 1.38. On 07-Jun-2021, Lymphocyte count (1-4.8): 1.2 (normal) 1.2. On 07-Jun-2021, Lymphocyte percentage (23-45): 23.6 (normal) 23.6 %. On 07-Jun-2021, Mean cell haemoglobin (26-34): 33.2 (normal) 33.2. On 07-Jun-2021, Mean cell haemoglobin concentration (31-37): 34.4 (normal) 34.4. On 07-Jun-2021, Mean cell volume (80-100): 96.4 (normal) 96.4. On 07-Jun-2021, Mean platelet volume (9.4-12.4): 10.9 (normal) 10.9. On 07-Jun-2021, Monocyte count (0-0.8): 0.4 (normal) 0.4. On 07-Jun-2021, Monocyte percentage (0-9.0): 6.8 (normal) 6.8 %. On 07-Jun-2021, NIH stroke scale: 0 (normal) NIH Stroke scale score of 0. On 07-Jun-2021, Neutrophil count (1.8-7.7): 3.2 (normal) 3.2. On 07-Jun-2021, Neutrophil percentage (33-66): 62.9 (normal) 62.9%. On 07-Jun-2021, Oxygen saturation: 96 (Low) at 10:40, 96%, 97 (Low) at 11:46, 97% and 98 (normal) at 07:49, 98. On 07-Jun-2021, Platelet count (130-400): 93 (Low) 93. On 07-Jun-2021, Protein total normal (6.3-8.2): 6.6 (normal) 6.6 g/dL. On 07-Jun-2021, Red blood cell count (4.5-5.9): 4.67 (normal) 4.67. On 07-Jun-2021, Red cell distribution width (36.9-50.2): 44.9 (normal) 44.9. On 07-Jun-2021, Respiratory rate: 18 (Inconclusive) at 10:40, 18, at 11:46, 21, at 07:49, 20 and at 09:48, 16. On 07-Jun-2021, Respiratory syncytial virus test: negative (Negative) negative. On 07-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. On 07-Jun-2021, Troponin I (0.0-0.12): <0.012 (normal) <0.012 ng/mL. On 07-Jun-2021, White blood cell count (4.5-11): 5.1 (normal) 5.1. On 07-Jun-2021, X-ray: no acute pulmnory finding. (normal) No acute pulmnory finding.. On 08-Jun-2021, Alanine aminotransferase (1-50): 31 (normal) 31 u/L. On 08-Jun-2021, Anion gap (5-15): 4 (Low) 4. On 08-Jun-2021, Aspartate aminotransferase (17-59): 23 (normal) 23 u/L. On 08-Jun-2021, Basophil count (0-0.2): 0.0 (normal) 0.0. On 08-Jun-2021, Basophil percentage (0-2): 0.7 (normal) 0.7 %. On 08-Jun-2021, Blood albumin (3.5-5.0): 3.2 (Low) 3.2 g/dL. On 08-Jun-2021, Blood alkaline phosphatase (38-126): 65 (normal) 65 u/L. On 08-Jun-2021, Blood bilirubin (0.2-1.3): 0.9 (normal) 0.9 mg/dL. On 08-Jun-2021, Blood calcium (8.4-10.2): 8.4 (normal) 8.4 mg/dL. On 08-Jun-2021, Blood chloride (98-107): 109 (High) 109. On 08-Jun-2021, Blood cholesterol (Unknown-200): 94 (normal) 94. On 08-Jun-2021, Blood creatinine (0.8-1.5): 1.0 (normal) 1.0 mg/dL. On 08-Jun-2021, Blood culture: no growth (normal) No growth after 5 days. On 08-Jun-2021, Blood glucose (75-110): 109 (normal) 109 mg/dL, 162 (High) 162 mg/dL and 157 (High) 157 mg/dL. On 08-Jun-2021, Blood potassium (3.6-5): 3.7 (normal) 3.7. On 08-Jun-2021, Blood sodium (136-146): 140 (normal) normal. On 08-Jun-2021, Blood triglycerides (Unknown-150): 186 (High) 186 mg/dL. On 08-Jun-2021, Blood urea (9-20): 18 (normal) 18 mg/dL. On 08-Jun-2021, Carbon dioxide (22-30): 27 (normal) 27. On 08-Jun-2021, Echocardiogram: 50-55 (abnormal) Left ventricle ejection fraction estimated to be 50-55%.  Not well visualized. On 08-Jun-2021, Eosinophil count (0-0.5): 0.4 (normal) 0.4. On 08-Jun-2021, Eosinophil percentage (0-4): 7.9 (High) 7.9%. On 08-Jun-2021, Glomerular filtration rate (60-Unknown): >60 (normal) >60 ml/min. On 08-Jun-2021, Glycosylated haemoglobin (Unknown-5.7): 6.2 (High) 6.2 %. On 08-Jun-2021, Haematocrit (41-53): 43.6 (normal) 43.6 %. On 08-Jun-2021, Haemoglobin (13.5-17.5): 15.2 (normal) 15.2 %. On 08-Jun-2021, High density lipoprotein (39-Unknown mg/dl): 26 mg/dl (Low) 26. On 08-Jun-2021, Immature granulocyte count (0.0-0.3): 0.01 (normal) 0.01. On 08-Jun-2021, Low density lipoprotein (Unknown-100): 31 (normal) 31 mg/dL. On 08-Jun-2021, Lymphocyte count (1-4.8): 1.6 (normal) 1.6. On 08-Jun-2021, Lymphocyte percentage (23-45): 28.7 (normal) 28.7 %. On 08-Jun-2021, Mean cell haemoglobin (26-34): 33.6 (normal) 33.6. On 08-Jun-2021, Mean cell haemoglobin concentration (31-37): 34.9 (normal) 34.9. On 08-Jun-2021, Mean cell volume (80-100): 96.5 (normal) 96.5. On 08-Jun-2021, Mean platelet volume (9.4-12.4): 11.8 (normal) 11.8. On 08-Jun-2021, Monocyte count (0-0.8): 0.6 (normal) 0.6. On 08-Jun-2021, Monocyte percentage (0-9.0): 10.7 (High) 10.7 %. On 08-Jun-2021, Neutrophil count (1.8-7.7): 2.9 (normal) 2.9. On 08-Jun-2021, Neutrophil percentage (33-66): 51.9 (normal) 51.9%. On 08-Jun-2021, Platelet count (130-400): 84 (Low) 84. On 08-Jun-2021, Protein total normal (6.3-8.2): 5.5 (Low) 5.5 g/dL. On 08-Jun-2021, Red blood cell count (4.5-5.9): 4.52 (normal) 4.52. On 08-Jun-2021, Very low density lipoprotein (Unknown-30): 37 (High) 37. On 08-Jun-2021, White blood cell count (4.5-11): 5.6 (normal) 5.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was admitted for further stroke workup. He could not undergo MRI evaluation due to his pacemaker. He was evaluated by Neurology who reviewed the outside hospital imaging and noted an acute ischemia in the pons. He additionally noted mild bilateral carotid atherosclerosis and bilateral PCA  atherosclerotic stenosis. While admitted, the patient underwent an echocardiogram with bubble study. The results of the echo were limited dues to poor acoustic window availability and morbid obesity of the patient- Ejection fraction was 50% to 55%. Neurology advised dual-anti platelet therapy with aspirin 81 mg and plavix 75 mg daily for 3 months, then can resume monotherapy with aspirin 81 mg daily. Recommended continuing Lipitor 20 mg every evening and adding Niacin 500 mg daily due to elevated triglycerides. Neurology advised stopping Eliguis as the previous DVT and PE were provoked by long drive/ immobility and anticoagulation would not be needed from a stroke standpoint. His stroke is  not suspected to, be cardioembolic. Speech Therapy evaluated the patient and advised no further treatment. physical Therapy evaluated the patient and advised no further services were necessary upon discharge. The patient was comfortable with discharge. The remainder of his conditions were managed with his chronic medical therapy.  Company Comment: Very limited information regarding these events  have  been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding these events  have  been provided at this time.  Further information has been requested