Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, International normalised ratio, Lipids, Liver function test, Magnetic resonance imaging head
Clinical narrative: vaccine-associated cerebral venous sinus thrombosis/left-side weakness/ fluctuating mental status; Thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of CEREBRAL VENOUS SINUS THROMBOSIS (vaccine-associated cerebral venous sinus thrombosis/left-side weakness/ fluctuating mental status) and THROMBOCYTOPENIA (Thrombocytopenia) in a 56-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.       The patient's past medical history included Thrombectomy (Patient was referred to endovascular mechanical thrombectomy. Subsequently, she underwent thrombectomy,  with successful restoration of venous blood flow.) and Intubation (patient was intubated in the ED for airway protection.). Concurrent medical conditions included Hypothyroidism, Hyperlipidemia and Obesity. Concomitant products included ATORVASTATIN for Hyperlipidemia, LEVOTHYROXINE for Hypothyroidism.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBRAL VENOUS SINUS THROMBOSIS (vaccine-associated cerebral venous sinus thrombosis/left-side weakness/ fluctuating mental status) (seriousness criteria hospitalization, medically significant and life threatening) and THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization and medically significant). The patient was treated with WARFARIN for Cerebral venous sinus thrombosis, at an unspecified dose and frequency; LEVETIRACETAM for Epilepsy, at an unspecified dose and frequency and HEPARIN for Cerebral venous sinus thrombosis, at an unspecified dose and frequency. At the time of the report, CEREBRAL VENOUS SINUS THROMBOSIS (vaccine-associated cerebral venous sinus thrombosis/left-side weakness/ fluctuating mental status) had resolved and THROMBOCYTOPENIA (Thrombocytopenia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time (27.2-39.6): 30.8 s (normal) 30.8 s. On an unknown date, Anti-platelet factor 4 antibody test: negative (Negative) negative. On an unknown date, Antinuclear antibody: positive (Positive) positive in a nucleolar pattern at low titers of 1: 80. On an unknown date, Antiphospholipid antibodies: negative (Negative) negative. On an unknown date, Antithrombin III (80-135): 105 % (normal) 105 %. On an unknown date, Blood creatinine (0.5-1.5): 0.6 mg/dl (normal) 0.6 mg/dL. On an unknown date, Blood potassium (3.5-5): 2.7 meq per (Low) 2.7 meq per. On an unknown date, Blood pressure measurement: 126/67 mmhg 126/67 mmHg. On an unknown date, Blood sodium (135-145): 136 milliequivalent per liter (normal) 136 milliequivalent per liter. On an unknown date, Blood thyroid stimulating hormone (0.4-4.5): 4.05 miu/l (normal) 4.05 mIU/L. On an unknown date, Body temperature: 37°c 37°C. On an unknown date, C-reactive protein: 56.48 mg/l (High) 56.48 mg/L  (reference range, less than 5). On an unknown date, Cardiolipin antibody: negative (Negative) negative. On an unknown date, Chest X-ray: normal (normal) The initial chest X-ray did not show any infiltrates. On an unknown date, Computerised tomogram head: abnormal (abnormal) underwent a CT scan of the head, which showed scattered hemorrhages and infarcts in both right and left cerebral hemispheres.. On an unknown date, Drug screen: negative (Negative) urine drug screen was negative.. On an unknown date, Fibrin D dimer (0-230): 16666 nanograms per (High) 16666 nanograms per  milliliter. On an unknown date, Glycosylated haemoglobin (4.7-6.4): 5.5% (normal) 5.5%. On an unknown date, Haemoglobin (12.0-16.00): 12.8 g/dl (normal) 12.8 g/dL. On an unknown date, Heart rate: 67 beats per minute 67 beats per minute. On an unknown date, International normalised ratio (0.85-1.14): 1.04 (normal) 1.04. On an unknown date, Lipids: normal (normal) normal. On an unknown date, Liver function test: normal (normal) normal. On an unknown date, Magnetic resonance imaging head: cerebral venous sinus thrombosis (abnormal) She underwent MRI brain with angiogram (MRA) and venogram (MRV), which confirmed infarcts in watershed areas, along with foci of hemorrhages, and signal void in superior sagittal and  inferior sagittal sinuses, left transverse sinus, left sigmoid sinus, and left internal jugular, suggestive of CVSST. On an unknown date, Physical examination: abnormal physical examination were notable for confusion and restlessness with the patient being non-communicative and with predominant left-side weakness. On an unknown date, Platelet count (150 000-400 000): 139000 per ml (Low) 139000 per mL. On an unknown date, Prothrombin time (9.9-13.3): 12.0 s (normal) 12.0 s. On an unknown date, Respiratory rate: 17 per minute 17 per minute. On an unknown date, SARS-CoV-2 antibody test: 1726 units per milliliter (Positive) antibodies against Spike protein for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were 1726 units per milliliter (reference range, non-reactive), signifying an adequate immune response to the vaccine and negative (Negative) antibodies against nucleocapsid protein were negative, signifying absence of prior SARS-CoV-2 infection. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested negative for COVID-19 based on reverse transcription polymerase chain reaction (RT-PCR) of a nasopharyngeal swab.. On an unknown date, Urine analysis: normal (normal) Urinalysis did not show any signs of infection.. On an unknown date, Venogram: abnormal (abnormal) Confirmed infarcts in watershed areas, along with  foci of hemorrhages, and signal void in superior sagittal and inferior sagittal sinuses, left transverse sinus, left sigmoid sinus, and left internal jugular, suggestive of CVST.. On an unknown date, White blood cell count (4800-10800): 10100 per cubic millimeter (normal) 10100 per cubic millimeter.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered CEREBRAL VENOUS SINUS THROMBOSIS (vaccine-associated cerebral venous sinus thrombosis/left-side weakness/ fluctuating mental status) and THROMBOCYTOPENIA (Thrombocytopenia) to be related.    Company comment: This is a literature case concerning a 56 year-old, female patient with a history of obesity, who experienced the serious (due to medically important condition, life-threatening and hospitalization) unexpected, AESI of Cerebral venous sinus thrombosis and thrombocytopenia, approximately 8 weeks after the second dose of mRNA-1273 vaccine. The patient presented to the emergency department with fluctuating sensorium and confusion for 5 days and left-side weakness for 1 day, she was intubated for airway protection. Platelet count was low (139000 per mL), D-dimer levels (16666 ng/ml) and C-reactive protein were high (56.48 mg/L); and tested negative for COVID-19 based RT-PCR. MRI brain with angiogram and venogram, confirmed infarcts in watershed areas, along with foci of hemorrhages, and signal void' in superior sagittal and inferior sagittal sinuses, left transverse sinus, left sigmoid sinus, and left internal jugular, suggestive of CVST. Anti-platelet factor 4 antibody was reported negative. The authors proposed the differential diagnosis of hypercoagulable state, malignant process, and Vaccine related thrombosis and thrombocytopenia syndrome. She had an episode of seizure, which was treated with levetiracetam. She was started on anticoagulation and received unfractionated heparin infusion but due to her rapid symptom progression, comatose state, and extensive CVST, she was referred for endovascular mechanical thrombectomy, with successful restoration of venous blood flow; after which she was extubated. She was discharged with warfarin, can perform activities of daily living with moderate assistance and walks using a cane. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Postmenopausal patient presented with fluctuating sensorium for 5 days and left-side weakness of 1-day duration. Patient was otherwise well until her daughter noticed a sudden onset of confusion, when patient was found to be mumbling incomprehensibly. Patient daughter reported the symptoms to be fluctuating. On the day of presentation, patient was noted to have sensory symptoms with a funny feeling in her left arm when she tried to open the door with  her left hand. Patient received first dose around 12 weeks before presentation and the second dose 8 weeks before presentation. Patient was found to be restless, non-communicative, afebrile and confused, with left upper- and lower-extremity weakness. Patient antibodies against Spike protein for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) were 1726 units per mL, signifying an adequate  immune response to the vaccine, and antibodies against nucleocapsid protein were negative, signifying absence of prior SARS-CoV-2 infection. After the MRV confirmed CVST, hypercoagulable state, malignant process, and TTS were considered to be the most probable causes, especially in the presence of thrombocytopenia. Patient was evaluated for hypercoagulable state, but her direct platelet IgG antibody were negative. Patient was started on anticoagulation and received unfractionated heparin  infusion according to weight-based nomograms, but in view of her rapid symptom progression, comatose state, and extensive CVST, patient was referred for endovascular mechanical thrombectomy. Patient improved after the procedure and  was extubated. Patient mentation and left-sided weakness improved and she was moved from the ICU to the stroke unit.  At 4-month follow-up, patient showed remarkable recovery. Patient can now perform activities of daily living with moderate assistance and walks using a cane. She is receiving coumadin with monitoring of INR, and is planned for further work-up for hypercoagulable state at follow-up.   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2022: Follow up received by safety on 07-Mar-2022 has Email with full text article received from team and contains significant information Literature information, Relevant history, Lab data, Product tab and Event tab were updated.; Sender's Comments: This is a literature case concerning a 56 year-old, female patient with a history of obesity, who experienced the serious (due to medically important condition, life-threatening and hospitalization) unexpected, AESI of Cerebral venous sinus thrombosis and thrombocytopenia, approximately 8 weeks after the second dose of mRNA-1273 vaccine. The patient presented to the emergency department with fluctuating sensorium and confusion for 5 days and left-side weakness for 1 day, she was intubated for airway protection. Platelet count was low (139000 per mL), D-dimer levels (16666 ng/ml) and C-reactive protein were high (56.48 mg/L); and tested negative for COVID-19 based RT-PCR. MRI brain with angiogram and venogram, confirmed infarcts in watershed areas, along with foci of hemorrhages, and signal void' in superior sagittal and inferior sagittal sinuses, left transverse sinus, left sigmoid sinus, and left internal jugular, suggestive of CVST. Anti-platelet factor 4 antibody was reported negative. The authors proposed the differential diagnosis of hypercoagulable state, malignant process, and Vaccine related thrombosis and thrombocytopenia syndrome. She had an episode of seizure, which was treated with levetiracetam. She was started on anticoagulation and received unfractionated heparin infusion but due to her rapid symptom progression, comatose state, and extensive CVST, she was referred for endovascular mechanical thrombectomy, with successful restoration of venous blood flow; after which she was extubated. She was discharged with warfarin, can perform activities of daily living with moderate assistance and walks using a cane. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.