Sex: F
Vaccine: COVID19
Symptoms: Prothrombin time, Red blood cell count, Red blood cells urine, Red cell distribution width, Russell's viper venom time
Clinical narrative: Antiphospholipid syndrome (catastrophic); This is a literature report for the following literature source(s).  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "two prior miscarriages" (unspecified if ongoing), notes: one at 9 weeks of gestation and one at 13 weeks of gestation.; "outside hospital" (unspecified if ongoing); "weight gain" (unspecified if ongoing); "facial rash" (unspecified if ongoing), notes: consistent with acne; "Grade II/VI holosystolic murmur" (unspecified if ongoing), notes: at the apex; "crackles in bilateral lung bases" (unspecified if ongoing); "pitting edema" (unspecified if ongoing), notes: of the lower extremities bilaterally; "thrombocytopenia" (unspecified if ongoing); "acute kidney injury" (unspecified if ongoing); "normocytic anemia" (unspecified if ongoing); "leukocytosis" (unspecified if ongoing); "hematuria" (unspecified if ongoing); "proteinuria" (unspecified if ongoing), notes: without casts; "heart failure" (unspecified if ongoing), notes: with reduced ejection fraction and severe mitral and tricuspid regurgitation.; "Thoracentesis" (unspecified if ongoing), notes: drained 1800mL of transudative fluid; "confusion" (unspecified if ongoing); "memory loss" (unspecified if ongoing); "several seizure-like episodes" (unspecified if ongoing), notes: throughout the admission.; "5-pack-year smoking history" (unspecified if ongoing), notes: though she had quit one year prior to presentation; "joint arthralgias" (unspecified if ongoing); "myocardial infarction" (unspecified if ongoing), notes: without obstructive coronary arteries; "antiphospholipid syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANTIPHOSPHOLIPID SYNDROME (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovered", described as "Antiphospholipid syndrome (catastrophic)". The patient underwent the following laboratory tests and procedures: Activated partial thromboplastin time: elevated, notes: found in pre-operative labs; Activated partial thromboplastin time (25.0-38.0): 55.9 seconds; Alanine aminotransferase (8-37): 299 IU/l; Albumin globulin ratio: 0.9; Angiogram: showed no evidence of a large central, notes: pulmonary embolism, but did show a large right-sided pleural effusion and a small left-sided pleural effusion; showed no evidence of obstructive coronary artery, notes: disease; Anion gap (5-17): 19; Antibody test: Positive, notes: at 1:320; Antibody test (normal high range 1:80): 1:320, notes: homogeneous pattern; Antiphospholipid antibodies (30.3-43.2): 100.0 seconds; Arteriogram carotid: no evidence of large vessel arterial occlusion; Aspartate aminotransferase (normal high range 35): 315 IU/l; Atrial pressure: 32 mmHg; Bacterial test: 1 plus, notes: Ref Range & Units: Negative /hpf; Beta-2 glycoprotein antibody (normal high range 20): 21, notes: unit: SGU; Bilirubin urine: Negative, notes: Ref Range: Negative; Blood albumin (3.5-5.1): 2.8 g/dl; Blood alkaline phosphatase (33-120): 196 IU/l; Blood bilirubin (0.3-1.2): 1.0 mg/dl; Blood calcium (8.5-10.5): 8.9 mg/dl; Blood chloride (98-111): 94 mmol/L; Blood creatinine (0.50-1.10): 2.15 mg/dl; Blood culture: Negative, notes: throughout admission; Blood glucose (60-99): 111 mg/dl; Blood ketone body: Negative, notes: Ref Range: Negative; Blood potassium (3.5-5.2): 5.9 mmol/L; Blood pressure measurement: 107/63 mmHg; Blood sodium (135-145): 129 mmol/L; Blood urea (7-25): 44 mg/dl; Blood urine: 1 plus, notes: Ref Range: Negative; Body temperature: 36.7 Centigrade, notes: afebrile; Brain natriuretic peptide (0-100): 2646 pg/mL; Carbon dioxide (20-29): 16 mmol/L; Cardiolipin antibody (normal high range 15): 72.0, notes: unit: GPL; Cardiolipin antibody (normal high range 12.5): 21.7, notes: unit: MPL; Complement factor C3 (82-193): 55 mg/dl; Complement factor C4 (10-43): 8 mg/dl; Computerised tomogram head: no evidence of large vessel arterial occlusion; stable, notes: repeat; hypodensities of the deep white matter of both, notes: frontal lobes and the left parietal lobe. In regards to her confusion and memory loss; Cryptococcus test: Not Detected; CSF glucose: 110 mg/dl, notes: elevated; CSF protein: 40 mg/dl, notes: normal; CSF test: normal protein (40 mg/dL) but elevated glucose, notes: (110 mg/dL), and was negative for infectious causes of meningitis and encephalitis; Negative; Cytology: Negative, notes: for malignancy and there were no organisms identified on the culture; Cytomegalovirus test: Not Detected; Double stranded DNA antibody (normal high range 100.0): 25.0, notes: unit: AU/mL; Echocardiogram: no vegetations; neither of which indicated the presence of any, notes: vegetations on the cardiac valves; estimated left ventricular ejection fraction, notes: (LVEF) of 47%, estimated pulmonary artery pressure of 32mmHg, thickened posterior mitral valve leaflet, and severe mitral and tricuspid regurgitation; unremarkable, notes: one year prior; thickening of the mitral valve and severe mitral, notes: regurgitation at the time of this admission; partial recovery of LVEF at 50%, improvement in, notes: mitral regurgitation, and no evidence of left ventricular thrombus; performed 3 weeks after the initial admission; neither of which indicated the presence of any, notes: vegetations on the cardiac valves; Ejection fraction: reduced; Ejection fraction: 47 %; 35 %; 50 %, notes: performed 3 weeks after the initial admission; Electrocardiogram: evidence of a prior inferior and septal myocardial, notes: infarction; evidence of prior inferior and septal myocardial, notes: infarction, and troponin was elevated; Electroencephalogram: no epileptiform activity; Enterovirus test: Not Detected; Escherichia test: Not Detected; Globulin (2.2-4.0): 3.1 g/dl; Glomerular filtration rate (normal high range 60): 29, notes: unit: mL/min/1.73m2; Glucose urine: 50 mg/dl, notes: Ref Range: Negative; Haematocrit (35.4-44.2): 31.2 %; Haemoglobin (12.1-15.0): 8.9 g/dl; Haemophilus test: Not Detected; Heart rate: 78 bpm; Hepatic enzyme: elevated; Herpes simplex test: Not Detected; Not Detected; Human herpes virus 6 serology: Not Detected; Immunology test: triple-positive antiphospholipid syndrome; International normalised ratio: 1.9; initial evaluation: heart failure with reduced ejection fraction, notes: (HFrEF) and severe mitral and tricuspid regurgitation; at the outside hospital; 1 plus; Initial lab: leukocytosis, normocytic anemia, thrombocytopenia,, notes: acute kidney injury and elevated liver enzymes, and signs of cardiac myocyte injury and strain; Listeria test: Not Detected; Lumbar puncture: Cerebrospinal fluid analysis showed normal protein, notes: (40 mg/dL) but elevated glucose (110 mg/dL), and was negative for infectious causes of meningitis and encephalitis; Magnetic resonance imaging head: multiple hyperintense T2 FLAIR signal foci with, notes: restriction diffusion and enhancement involving the cerebral hemisphere; stability of the hyperintensities seen prior; hyperintense T2 FLAIR signal foci with restriction, notes: diffusion and enhancement; Magnetic resonance imaging heart: LVEF of 35%, subendocardial late gadolinium, notes: enhancement of the basal and mid-inferolateral wall, mid-anteroseptal wall, and the septal, inferior, and lateral walls of the apex involving approximately 50% of the myocardial thickness, apex and basolateral akinesis, severe mitral and tricuspid regurgitation, and a mobile left ventricular thrombus (1cm x 1cm); Mean cell haemoglobin (28-33): 27 pg; Mean cell haemoglobin concentration (32-35): 29 g/dl; Mean cell volume (80-100): 95, notes: unit: fL; Neisseria test: Not Detected; Nitrite urine: Negative; Nucleated red cells (normal high range 0.0): 0.2 %, notes: ref range: less than equal to 0.0; pH urine (5.0-8.0): 6.0; Physical exam: anxious female with a facial rash consistent with, notes: acne, Grade II/VI holosystolic murmur at the apex, crackles in bilateral lung bases, and 1+ pitting edema of the lower extremities bilaterally. There were no signs of ischemia or cyanosis of the extremities; Platelet count (150-400): 82, notes: unit: bil/L; Protein total (6.4-8.3): 5.9 g/dl; Prothrombin time (9.2-13.5): 21.6 seconds; Red blood cell count (3.87-5.08): 3.27, notes: unit: tril/L; Red blood cells urine: 0-2 (Negative); Red cell distribution width (12-15): 20 %; Russell's viper venom time (27-45): 121 seconds; Specific gravity urine (1.005-1.030): 1.012; Streptococcus test: Not Detected; Not Detected; Troponin: elevated; Troponin I (normal high range 0.03): 0.29 ng/ml; Urinary casts: 3-5, notes: Ref Range & Units: 0-2 (Negative) /lpf; Urinary sediment present: 1-5, notes: Ref Range & Units: Negative /lpf; Urine analysis: Clear; Yellow; hematuria and proteinuria without casts; Urine protein/creatinine ratio (0.00-0.20): 1.03; Urobilinogen urine (normal high range 2.0): less than 2.0; Varicella virus test: Not Detected; Viral test: Not Detected; Weight: 20-30 lbs, notes: weight gain; White blood cell count (3.3-10.7): 14.1, notes: unit: bil/L; White blood cells urine: Negative; 0-5 (Negative), notes: Ref Range & Units: 0-5 (Negative) /hpf. Therapeutic measures were taken as a result of antiphospholipid syndrome. Clinical course: Immunosuppressive drugs used included IV dexamethasone, Hydroxychloroquin (HCQ), and prednisolone. Symptoms improved as clinical outcome.   No follow-up attempts are possible.  Follow-up (28Feb2024): This is a literature report for the following literature source(s). 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: Reporter and literature information, RMH, Lab, Product details, dosage updated.; Sender's Comments: The event antiphospholipid syndrome is conservatively assessed as related to the suspect drug BNT162B2 based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. 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.