Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Anti-platelet factor 4 antibody test, Aspartate aminotransferase, Blood calcium
Clinical narrative: Bilateral Thalamic Stroke; COVID-19 vaccine induced immune thrombotic thrombocytopenia; This is a literature report.  A 62-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (ongoing); "ESRD" (ongoing), notes: for seven years; "low back pain" (unspecified if ongoing); "dialysis" (ongoing), notes: on Mondays, Wednesdays, and Fridays; "denied alcohol, drug, or tobacco use" (unspecified if ongoing); "denied alcohol, drug, or tobacco use" (unspecified if ongoing); "denied alcohol, drug, or tobacco use" (unspecified if ongoing). The patient's medical history, reported also as family history included: "HTN" (ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydrochlorothiazide for Elevated blood pressure, notes: 50 mg; Norvasc for Elevated blood pressure, notes: 10 mg; Losartan for Elevated blood pressure, notes: 25 mg. The following information was reported: THALAMIC STROKE (hospitalization, medically significant, life threatening), 1 day after the suspect product(s) administration, outcome "recovering", described as "Bilateral Thalamic Stroke"; THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (hospitalization, medically significant, life threatening), 1 day after the suspect product(s) administration, outcome "recovering", described as "COVID-19 vaccine induced immune thrombotic thrombocytopenia". The patient was hospitalized for thalamic stroke, thrombosis with thrombocytopenia syndrome (hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time: within normal limits; Alanine aminotransferase: 16 IU/l; Anti-platelet factor 4 antibody test: negative; Aspartate aminotransferase: 23 IU/l; Blood calcium: 8.2 mg/dl; Blood chloride: 100 mmol/L; Blood cholesterol: 292 mg/dl; Blood creatinine: 7.90 mg/dl, notes: elevated; Blood fibrinogen: 458; 458; Blood glucose: 111 mg/dl; Blood potassium: 4.4 mmol/L; Blood pressure measurement: 180/90; remained elevated after 24 hrs; stabilized; Blood sodium: 138 mmol/L; Blood triglycerides: 198 mg/dl; Blood urea: 42 mg/dl, notes: elevated; Body temperature: 98.7 Fahrenheit; Carbon dioxide: 27 mmol/L; Cardiac function test: revealed an S1S2 without, notes: any murmur, lungs were clear bilaterally; Chest X-ray: which showed a large cardiac silhouette; however,, notes: there were no other acute findings; Coma scale: 13; Computerised tomogram head: without contrast did not show any ischemic or, notes: hemorrhagic stroke; Echocardiogram: showed an ejection fraction (EF) of 60% with, notes: mild left ventricular hypertrophy but otherwise no anatomical issues; Ejection fraction: 60 %; Fibrin D dimer: normal; Fibrin D dimer: 150 ng/ml; 150 ng/ml; Full blood count: unremarkable; Glomerular filtration rate: 9 mL; Haematocrit: 35.6 %; Haemoglobin: 11.8 g/dl; Heart rate: 92; High density lipoprotein: 35 mg/dl; Imaging procedure: bilateral thalamic infarction; International normalised ratio: within normal limits; abdominal exam: unremarkable; A1C: 6.5; Low density lipoprotein: 217 mg/dl; Magnetic resonance imaging: bilateral acute ischemic changes involving both, notes: thalami with right larger than left; Mean cell volume: 89, notes: Units: fL; Metabolic function test: showed an elevated blood urea nitrogen, notes: and creatinine; Neurological examination: Preserved; Left facial droop, able to wrinkle his forehead, notes: Right side preserved; Preserved bilaterally; Preserved bilaterally; he did have a left facial droop with dysarthria;, notes: however, he did not have anomic aphasia; Right and leg strength were 5/5, with preserved, notes: sensation and DTR 2. Left-sided arm strength was 1/5 with preservation of sensation and DTR 2. Left leg noted to have hemiballismus with preserved sensation; his left upper and lower extremity strength, notes: did not improve hospital Day 3; his left lower extremity strength improved to 3/5;, notes: however, left upper extremity strength remained 1/5; strength in both extremities remained the same; Clinical presentation: left facial paralysis,, notes: dysarthria, slurred speech, anisocoria, left lower limb hemiballismus, left upper limb paralysis, horizontal nystagmus; the patient had a Glasgow coma scale of 13., notes: His cardiac exam revealed an S1S2 without any murmur, lungs were clear bilaterally, and the abdominal exam was unremarkable; Platelet count: thrombocytopenia; Platelet count: 116 x10 3/mm3; 154 x10 3/mm3; Prothrombin time ratio: within normal limits; Pupillary light reflex tests: Preserved bilaterally; Red blood cell count: 4.02, notes: Units 10 6/uL; Respiratory rate: 16; SARS-CoV-2 test: Negative; Tongue movement disturbance: Tongue slightly deviated to the right; Very low density lipoprotein: 39 mg/dl; Visual acuity tests: Anisocoria with the left being bigger than the, notes: right. Horizontal nystagmus bilaterally. Therapeutic measures were taken as a result of thalamic stroke, thrombosis with thrombocytopenia syndrome.  Clinical course: Patient had acute ischemic stroke following COVID-19 vaccination with mRNA vaccine. Clinical presentation: left facial paralysis, dysarthria, slurred speech, anisocoria, left lower limb hemiballismus, left upper limb paralysis, horizontal nystagmus. Imaging findings: bilateral thalamic infarction. Lab findings were thrombocytopenia, normal level of D-dimer, anti-PF4 antibodies: negative. Therapeutic measures were taken as a result of ischaemic stroke. Patient received treatment for the event acute ischemic stroke which included ASA, Clopidogrel. Outcome of the event was unknown; but reported that patient was alive. As of 21Jul2023, there has been a recent hesitancy in the public toward vaccination due to an overemphasis within the media of extremely rare side effects from the COVID-19 vaccine. VITT is a rare, life threatening condition that occurs within five to 10 days post-vaccination. It presents with thrombosis, thrombocytopenia, and coagulation abnormalities and should be ruled out in patients presenting with these symptoms in the setting of recent COVID-19 vaccination. Although the incidence is low and has only been observed in adenovirus-based vaccines, a systemic review of VITT is encouraged, when enough cases are available in the future, to identify risk factors, morbidity, and the occurrence of VITT in other COVID-19 vaccine types. Regardless of the low risk of VITT, clinicians should emphasize encouragement toward vaccination in all individuals who are able to do so.  Follow-up (21Jul2023): This is a literature report. This is a follow-up report based on the receipt of the publication; the case has been updated to include additional information identified in the publication. Updated information included: Reporter and literature information, RMH, Labs, Event tab (Event, outcome of the event, treatment received) updated.; Sender's Comments: Based on the temporal association, the causal association between BNT162B2 vaccine and the events Thalamic stroke and Thrombosis with Thrombocytopenia Syndrome cannot be completely excluded. The patient's advanced age, medical history of hypertension, diabetes mellitus, hyperlipidemia, and end-stage renal disease are confounding factors in this case. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics, Committees, and Investigators, as appropriate.