Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Anticoagulant therapy, Arteriogram carotid normal, Computerised tomogram head abnormal, Computerised tomogram neck
Clinical narrative: HEPARIN-INDUCED THROMBOCYTOPENIA TEST; ARTERIOGRAM CAROTID NORMAL; COMPUTERISED TOMOGRAM NECK; SUBARACHNOID HAEMORRHAGE; SEIZURE; ANGIOGRAM CEREBRAL ABNORMAL; CONDITION AGGRAVATED; HEADACHE; VENOGRAM ABNORMAL; COMPUTERISED TOMOGRAM HEAD ABNORMAL; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; ANTICOAGULANT THERAPY; INTENSIVE CARE; PLATELET COUNT DECREASED; FULL BLOOD COUNT; CEREBRAL VENOUS THROMBOSIS; TRANSVERSE SINUS THROMBOSIS; JUGULAR VEIN THROMBOSIS; THROMBOCYTOPENIA; This spontaneous report received from a health care provider via a Regulatory Authority [Vaccine Adverse Event Reporting System, VAERS IDs 1270168, 1273220] concerned a 48 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included seizure disorder, urinary tract infection, diabetes mellitus type 1, hypertension, hyperlipidemia, cardiovascular accident, and vagus nerve stimulation. The patient experienced drug allergy when treated with levetiracetam. The patient was not pregnant at the time of vaccination. The patient had no adverse event following any previous vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose and anatomical vaccination site were not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included insulin glargine for dm type 1, insulin lispro/insulin lispro protamine suspension for dm type 1, clonazepam, empagliflozin, lacosamide, lamotrigine, lisinopril, lorazepam, perampanel, semaglutide, simvastatin, ubidecarenone and multivitamins. On NOV-2020, Laboratory data included: Platelet count (NR: not provided) 280 (baseline).  On 26-APR-2021, the subject experienced cerebral venous thrombosis, jugular vein thrombosis, transverse sinus thrombosis, thrombocytopenia, full blood count and was hospitalized (date unspecified). On 27-APR-2021, the subject experienced subarachnoid haemorrhage, platelet count decreased, seizure, condition aggravated, headache, angiogram cerebral abnormal, venogram abnormal, magnetic resonance imaging head abnormal, computerised tomogram head abnormal, arteriogram carotid normal, computerised tomogram neck, anticoagulant therapy, intensive care. On 28-APR-2021, the patient had heparin-induced thrombocytopenia test negative. It was reported the patient experienced cerebral vein thrombosis - saggital sinus, right sigmoid and transverse extending to right jugular vein, thrombocytopenia, subarachnoid hemorrhage bilateral frontal sulci; also noted as right transverse sinus thrombus with bilateral subarachnoid hemorrhage. Presented with headache and seizure. Initially was treated on 27-APR-2021 with heparin drip but on 28-APR-2021 changed to bivalirudin drip. The patient remained in Intensive Care Unit (ICU) as of the morning of 30-APR-2021 on bivalirudin drip and would be transitioned to oral anticoagulants if CT of head was stable. Patient was reported to be recovering and would require a stay at a rehab/skilled facility at discharge for continued recovery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from transverse sinus thrombosis, subarachnoid haemorrhage, seizure, headache, angiogram cerebral abnormal, anticoagulant therapy, arteriogram carotid normal, computerised tomogram head abnormal, computerised tomogram neck, condition aggravated, heparin-induced thrombocytopenia test, intensive care, magnetic resonance imaging head abnormal, platelet count decreased, and venogram abnormal, and had not recovered from cerebral venous thrombosis, full blood count, jugular vein thrombosis, and thrombocytopenia. This report was serious (Hospitalization Caused/Prolonged, and Life Threatening). This case is a duplicate of 20210522710.  Additional information was received on 27-MAY-2021. The following information was updated and incorporated into the case narrative:  Other identification number was updated in AER at units (VAERS ID: 1315775), additional reporter added (other health care professional). The patient's race, ethnicity and medical history updated. Upon review following information was amended Lacosamide was deleted as its trade name was coded Vimpat and indications to all the concomitant medications added. It was determined that nullification and deletion was required for Manufacturer Report Number (20210522710) as it was duplicate of Manufacturer Case Number (20210528458). All relevant information regarding Manufacturer Report Number (20210522710) will be submitted under Manufacturer Case Number (20210528458).; Sender's Comments: V2:  Additional information regarding updates with case identifiers, concomitant medications, patient's race/ethnicity and medical history did not alter prior causality assessment. This spontaneous report received from a health care provider via VAERS (IDs: 1270168, 1273220] concerned a 48-year-old black female (non-Latino/Hispanic) who experienced cerebral venous thrombosis (CVST), jugular vein thrombosis, transverse sinus thrombosis, and thrombocytopenia. Concurrent conditions included seizure disorder, urinary tract infection (UTI), diabetes mellitus type 1, hypertension, hyperlipidemia, "cardiovascular" accident, and vagus nerve stimulation. Concomitant medications included clonazepam, empagliflozin, insulin glargine, insulin lispro/insulin lispro protamine suspension, lacosamide, lamotrigine, lisinopril, lorazepam, perampanel, semaglutide, simvastatin, ubidecarenone, and vitamins nos. On day 16 after vaccine, the subject experienced cerebral venous thrombosis, jugular vein thrombosis, transverse sinus thrombosis, thrombocytopenia, and was hospitalized. Platelet count was 111,000 (baseline 280,000.)  On day 17, the subject experienced subarachnoid haemorrhage. On day 18, the patient had heparin-induced thrombocytopenia test negative. Presented with headache and seizure. Initially was treated on day 17 with heparin drip but on day 18 changed to bivalirudin drip. The patient remained in Intensive Care Unit (ICU) as this repot and would be transitioned to oral anticoagulants if CT of head was stable. Patient was reported to be recovering. Although the underlying cerebrovascular risk factors and concurrent UTI may have contributed, based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration - BC) and considering the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination.