Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Antiphospholipid antibodies, Arthralgia, Beta-2 glycoprotein antibody, Body mass index
Clinical narrative: THROMBOCYTOPENIA; LEFT LEG DVT; RIGHT TRANSVERSE SINUS; INTERNAL JUGULAR VEIN THROMBOSIS; SIGMOID SINUSES; SWELLING OF LOWER EXTREMITIES; LEFT LOWER EXTREMITY PAIN; SHOULDER PAIN; NECK SPRAIN; MUSCLE SPASM; RIGHT SIDE NECK PAIN; SHORTNESS OF BREATH; CHILLS; INTERMITTENT HEADACHE; MYALGIA; This spontaneous report was originally received from the patient via the United States Regulatory Authority Food and Drug Administration (FDA) Vaccine Adverse Event Reporting System (VAERS), case reference number 1218651and concerned a White, not Hispanic or Latino 37-year-old female. The patient's weight and height were not reported. The patient's concurrent conditions included migraine headaches and 7 months post-partum. The patient did not have known allergies. The patient's BMI was 24 with no history of smoking or cancer. The patient did not have these previous events prior. The patient was not pregnant. It is unknown as to history of autoimmune disease, genetic or acquired risk factors or previous clotting disorders. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number 1808609) dose not reported, administered once on 23-MAR-2021 at 14:30 into left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the patient developed myalgias, headache, shortness of breath, and chills which resolved in 24 hours. On 02-APR-2021, the patient developed headache intermittent from right to left side of head for which patient was seen at an urgent care. The patient was prescribed butalbital/acetaminophen/caffeine (Fioricet). On 05-APR-2021, the patient developed right-sided neck pain. On 06-APR-2021, the patient was tested for COVID-19 virus test and was negative. On 08-APR-2021, the patient experienced neck sprain, muscle spasm and shoulder pain. The patient was seen in the emergency department (ED) for headache and head and shoulder. The patient took ibuprofen. Platelets were 90,000/mcL. Computed tomography (CT) scan of the head without contrast was unremarkable. The patient was diagnosed with headache and neck sprain and was prescribed ibuprofen 600 mg, take 1 tablet by mouth every 8 hours, and diazepam 5 mg, take 1 tablet by mouth 3 times a day as needed for muscle spasm. On 12-APR-2021, the patient experienced left lower extremity (LLE) pain. The left foot was weak and pressure could not be put upon it. On 14-APR-2021, the patient followed up with neurologist outpatient as directed by the emergency department provider and was advised to get an magnetic resonance venography (MRV) and left lower extremity Doppler. The patient was prescribed tramadol 50 mg and butalbital/acetaminophen/caffeine by the neurologist. On 15-APR-2021, the patient presented with headache, neck pain and left leg pain. Platelet count was 122,000.The patient experienced thrombocytopenia, right transverse sinus, sigmoid sinuses vein and internal jugular thrombosis. The patient went to the ED before outpatient magnetic resonance venography (MRV) and LLE Doppler could be done due to worsening right-sided neck pain and inability to ambulate comfortably due to lower extremity pain that had been worsening over several days. Upon examination, there was subtle swelling to left lower extremity and Doppler revealed multiple deep vein thrombosis (DVT) in left lower extremity. CT head without contrast was unremarkable, however, CT venogram of the brain revealed thrombi of the right transverse sinus and sigmoid sinuses, as well as internal jugular vein thrombosis (IJ). The patient was initiated on argatroban and admitted to inpatient at the time of this report. The patient remained stable. Laboratory data included: Left lower extremity venous Doppler revealed acute occlusive deep venous thrombus in both left posterior tibial veins, acute occlusive deep venous thrombus in distal aspect of one of the bifid popliteal veins, and acute occlusive deep venous thrombus in the proximal aspect of the left popliteal vein. Laboratory data included: Magnetic resonance venography of the left lower extremity revealed the subtle swelling to left lower extremity.  On 15-APR-2021, Laboratory data included: activated partial thromboplastin time (APTT) increased (NR: not provided) high at 82 (PTT-LA [lupus anticoagulant]), fibrin D dimer high (NR: not provided) high at 6.7, Heparin-induced platelet antibody (NR: not provided) positive (optic density units more than 0.5000 equals positive), international normalised ratio (NR: not provided) was 0.9, and prothrombin time (NR: not provided) was 13 seconds. Lupus anticoagulant evaluation was indeterminate for lupus anticoagulant. The results are suggestive of heparin or direct thrombin inhibitor effect, both of which can compromise testing to detect lupus anticoagulant. DRVVT (dilute Russell's viper venom time) screen was negative, with value of 86 seconds (high). Coagulation result 'O.D.' was 0.530 (above 0.500 indicates a positive result). At 19:40 on 15-APR-2021, thrombin time (NR: not provided) was 72 seconds. Laboratory data of 16-APR-2021 included INR of 1.8, platelet count (NR: not provided) of 143,000. Cardiolipin IgG was less than or equal 14 (negative), cardiolipin IgA  was less than or equal 11 (negative) and cardiolipin IgM was less than or equal 12 (negative).Beta-2 glycoprotein IgA was less than 9, beta-2 glycoprotein IgM was less than 9, and beta-2 glycoprotein IgG was less than 9. On 16-APR-2021, the patient was discharged from the hospital. Treatment medications (dates unspecified) included: ibuprofen, diazepam, tramadol and argatroban. The action taken with COVID-19 vaccine Ad26.CoV2.S was not reported. The patient recovered from shortness of breath, chills, intermittent headache and myalgia on 25-MAR-2021, and the outcome of right side neck pain, shoulder pain, left lower extremity pain, swelling of lower extremities, deep vein thrombosis, neck sprain, muscle spasm, thrombocytopenia, right transverse sinus, sigmoid sinuses vein and internal jugular thrombosis was not reported. This report was serious (Hospitalization Caused / Prolonged). The case was linked with the case 20210452809 due to same patient and with 20210436506 as a duplicate case.  Additional information was received on 03-MAY-2021 from a doctor of pharmacy. The following information was updated and incorporated into the case: additional laboratory test results of 15-APR-2021 and 16-APR-2021 were added to the case.; Sender's Comments: V6:  Follow-up adds lab data which does not change prior assessment. This case received via VAERS (VAERS# 1218651) concerns 37-year-old White female, 7-months post-partum, who was diagnosed with thrombocytopenia and thrombosis of right (rt) transverse sinus, sigmoid sinuses, rt internal jugular vein, & deep vein thromboses (DVT) of left lower extremity (LLE) 23 days after receiving the Janssen Covid-19 vaccine.  Medical history includes episodic migraine headaches.  1 day post-vaccination, she developed myalgias, headache, shortness of breath, & chills which resolved in 24 hours. 10 days post-vaccination, she had intermittent headaches which prompted an urgent care visit; Fioricet (butalbital/acetaminophen/caffeine) was prescribed.  13 days post-vaccination, she developed rt-sided neck pain. The next day, COVID-19 test was negative.  16 days post-vaccination, during emergency department (ED) consult for muscle spasm & neck/shoulder pain, platelet count (PLT) 90K & CT scan head was unremarkable; she was prescribed ibuprofen & diazepam.  22 days post-vaccination, she saw a neurologist for painful & weak LLE & was prescribed tramadol & Fioricet and advised MRV & LLE doppler. 23 days post-vaccination, patient went to ED for worsening pain in neck & LLE; CT venogram of brain showed thrombi of rt transverse sinus, sigmoid sinuses & rt internal jugular vein; doppler showed multiple LLE DVT. She was hospitalized & started on argatroban. Labs: PLT 122K, elevated D-dimer 6.7, positive heparin induced platelet antibody test with optic density 0.53 (>0.50 positive), indeterminate lupus anticoagulant evaluation, negative cardiolipin antibodies, negative B2 glycoprotein antibodies. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination.