Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet factor 4, Protein C, Protein S, Prothrombin time, Pulmonary embolism
Clinical narrative: TRANSIENT ISCHEMIC ATTACK; PULMONARY EMBOLISM; THROMBOCYTOPENIA; This spontaneous report was received from literature: Pulmonary embolism, transient ischaemic attack and thrombocytopenia after the Johnson and Johnson COVID-19 vaccine. This report concerned a 43 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included dyslipidaemia, depression, gastro-oesophageal reflux disease, obesity, anxiety, and obstructive sleep apnea. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 10 days after receiving vaccination, the patient presented to the emergency department with a 3-day history of generalized headache, fever, body aches, chills, mild dyspnea and lightheadedness. She decided to seek evaluation due to the progressive nature of her headache, which had become unbearable at the time of her evaluation. A computed tomography (CT) angiography of her head and neck was performed and was significant for low-density rounded filling defect in the venous sinus confluence, worrisome for Cerebral Venous Sinus Thrombosis (CVST). Complete blood count (CBC) and Basic metabolic profile (BMP) were performed at this time and were significant for thrombocytopenia with platelets 27000x10^9/L. COVID-19 testing was negative. At this point, the patient was transferred to facility for further workup and management. On arrival, a magnetic resonance imaging (MRI) of the head was performed for further evaluation of the filling defect. The MRI revealed a focal filling defect in the region of the sinus confluence, characterizing it as the typical appearance for an arachnoid granulation. No intracranial hemorrhage or mass lesion was present on MRI. Vital signs were stable and included a respiratory rate of 20 breaths/min and an oxygen saturation of 96% on room air. On respiratory examination, the patient had good air entry bilaterally with no wheezing throughout the lung fields and no crackles at the lung bases. Neurological examination was within normal limits, with no focal motor or sensory deficits. Further laboratory evaluation was performed, and her D-dimer came back elevated at 35.20 mg/L. In conjunction with her dyspnea, her elevated D-dimer prompted evaluation for a pulmonary embolism (PE) with CT pulmonary angiogram, which turned out positive for right upper lobe, right lower lobe, and left lower lobe lobar and segmental pulmonary emboli. Hematology was consulted for the further workup of an underlying hypercoagulable condition. She denied any history of experiencing a blood clot in the past or any significant contributory family history. While on the intensive care unit, the patient was administered 60 grams of intravenous immunoglobulin (IVIG) and started on 7.5 fondaparinux (Arixtra) subcutaneously, with particular caution to avoid heparin products. Her pain was managed with as needed Fioricet (butalbital, acetaminophen, caffeine) and scheduled topiramate. She had an extensive hematological workup performed, which included a positive PF4 antibody, anti-nuclear antibody (ANA) and slide review/peripheral smear significant for thrombocytopenia with increased mean platelet volume and platelet insufficiency. She received two doses of 60 grams of IVIG, which did successfully improve her platelet count to 132 x 10^3/uL over her six-day admission. On discharge, she was prescribed apixaban 5 mg orally, two times per day for anticoagulation, and Fioricet and topiramate for cephalalgia. Ultimately, there was no alternative explanation available besides her recent exposure to the Johnson and Johnson COVID-19 vaccination as the inciting event in the cascade of events that led up to her hospitalization. One day after discharge, the patient presented with numbness and tingling of her face and right arm, and was evaluated for a possible stroke with MRI brain without contrast, CT angiogram of the head and CT head without contrast. MRI and CT of the head without contrast were negative for any intracranial processes, but CT angiogram of the head and neck was positive for non-occlusive right internal carotid artery (ICA) thrombus in the right carotid bulb/proximal right ICA. It measured 1.5 cm in the craniocaudal dimension. The patient was diagnosed with a transient ischemic attack (TIA) and admitted for further management. She was discharged home on fondaparinux 7.5 mg subcutaneously, once a day, for one month and is to transition to apixaban 5 mg orally, two times per day, for five months, totaling six months of anticoagulant therapy. She will be followed up as an outpatient by her hematologist and primary care physician for further management. In conclusion, it was noted that she developed the TIA, despite being on an anticoagulation, and that it was likely that her TIA and associated arterial thrombus were also associated with her hypercoagulable state, attributing herein to the uptake of the vaccination just 10 days prior. Laboratory data (dates unspecified) included: activated partial thromboplastin time (normal range [NR}: not provided) 26.4 sec, anti-dsDNA antibody (NR: not provided) negative, anti-platelet antibody (NR: not provided) negative, antibody test (NR: not provided) negative, antiphospholipid antibodies (NR: not provided) negative, test suggestive of heparin effect, antithrombin III (NR: not provided) 143 %, blood pressure (NR: not provided) 124/80 mmHg, blood smear test (NR: not provided) decreased platelet sufficiency; on discharge, decreased platelet insufficiency; on admission, thrombocytopenia with high mean platelet volume (MPV), body temperature (NR: not provided) 37.9 C, CT scan (NR: not provided) thrombocytopenia and pulmonary embolism, cardiolipin antibodies (NR: not provided) 0.7/below 1.6/1.8 U/mL, coagulation test (NR: not provided) 113 %, creatinine (NR: not provided) 0.8 mg/dL, 0.8 mg/dL, 0.87 mg/dL, Doppler scan (NR: not provided) bilateral upper and lower extremities were negative, factor II mutation (NR: not provided) negative, factor V Leiden mutation (NR: not provided) negative, factor VIII antibodies in blood (NR: not provided) 180 %, fibrinogen (NR: not provided) 142 mg/dL, heart rate (NR: not provided) 65 {beats}/min, heparin-induced platelet antibody (NR and unit: not provided) 2.702, indeterminable ABO blood type (NR: not provided) O type, indirect Coombs test (NR: not provided) negative, international normalized ratio (NR and unit: not provided) 1.13; on admission, lactate dehydrogenase (NR: not provided) 233 U/L, neutralizing antibodies (NR: not provided) negative, platelet count (NR: not provided) 21 10*3/uL, 132 10*3/uL, 123 10*3/uL, 168 10*3/uL, protein C (NR: not provided) 113 %, protein C antigen (NR: not provided) 117 %, protein S (NR: not provided) 88 %, protein S antigen (NR: not provided) 113 %, prothrombin time (NR: not provided) 12.2 sec, rheumatoid factor (NR: not provided) 9 IU/mL, troponin (NR: not provided) 0.1070 ng/mL, 0.003 ng/mL, and white blood cell count (NR: not provided) 7.14 10*3/uL, 6.14 10*3/uL, 5.77 10*3/uL.  The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the pulmonary embolism, transient ischemic attack and thrombocytopenia was not reported. This report was serious (caused/prolonged hospitalization and other medically important condition).; Sender's Comments: V0: This is a spontaneous report received from literature concerning a 43 year old female, unknown ethnicity, noted to have pulmonary embolism and thrombocytopenia 10 days and experienced transient ischemic attack (TIA) 17 days after receiving the Janssen Covid-19 vaccine. Patient sought consult at the emergency department (ED) for fever, body aches, chills, mild dyspnea, lightheadedness and progressive headache that had been occurring for 3 days. Patient was admitted in the hospital and discharged. One day after discharge (17 days post vaccine), she had numbness and tingling of her face and right arm. Patient was readmitted, diagnosed with a transient ischemic attack (TIA), then discharged. Diagnostic results included: Platelet count (lowest) of 27000x10^9/L, COVID-19 test negative, D-dimer 35.20 mg/L (elevated), CT pulmonary angiogram showed right upper lobe, right lower lobe, and left lower lobar and segmental pulmonary emboli, CT angiogram of the head and neck showed right internal carotid artery (ICA) thrombus, positive PF4 antibody, positive anti-nuclear, peripheral smear showed thrombocytopenia, Factor V Leiden mutation negative, factor VIII antibodies in blood 180 %, heparin-induced platelet antibody 2.702.Treatment included IVIG, fondaparinux, Fioricet, topiramate and apixaban. Patient has no known history or predisposition to thrombosis nor family history of bleeding/clotting problems. The patient's height, and weight were not reported. The patient's concurrent conditions included dyslipidemia, depression, gastro-esophageal reflux disease, obesity, anxiety, and obstructive sleep apnea.  Patient denied use of nicotine products or hormonal replacement therapy/oral contraceptive pills. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC Level 1), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.