Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood fibrinogen, Cardiolipin antibody, Cerebral haemorrhage, Computerised tomogram abnormal, Computerised tomogram head
Clinical narrative: SUPERIOR SAGITTAL SINUS THROMBOSIS; multifocal hemorrhage within the left frontal lobe; THROMBOCYTOPENIA; EPILEPTIC SEIZURES; PLATELET COUNT DECREASED; FIBRIN D-DIMER INCREASED; COMPUTERISED TOMOGRAM ABNORMAL; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; FULL BLOOD COUNT ABNORMAL; APHASIA; HEMIPARESIS; MUSCULAR WEAKNESS; ANGIOGRAM; COMPUTERISED TOMOGRAM NECK; COMPUTERISED TOMOGRAM HEAD; ELECTROENCEPHALOGRAM; VENOGRAM; HEADACHE; PERIORBITAL PAIN; This spontaneous report received from a health care professional via Regulatory Authority, Vaccine Adverse Event Reporting System (VAERS reference number 1226180-1), concerned a 52 year old female. The patient's weight, height, and medical history were not reported. No concomitant, home prescription medications or hormone supplementations were reported. The patient did not have allergy to medications, foods, or products. No other illness at the time of vaccination and up to one month prior was reported. No chronic or long-standing health condition was reported. Patient did not have an adverse event following any previous vaccine. It was unknown if patient was pregnant at the time of vaccination. The patient, at age of 52 years, received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) 1 dose, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. It was reported that the symptoms started 7 days after vaccination and 11 days to hospital admission. A previously healthy female patient started having periorbital right headaches, coded to periorbital pain and headaches, starting on or about 14-APR-2021. Headaches were alleviated with over the counter Advil. On the morning of 18-APR-2021, patient woke up with right arm weakness which, over the course of several hours, progressed to include right-sided leg  muscle weakness, hemiparisis and aphasia. On 18-APR-2021, the patient was hospitalized. Initial CT head showed multifocal haemorrhage within left frontal lobe. The course was reported to be complicated by an epileptic seizure. MRI brain with and without contrast and CT venogram brain were notable for superior sagittal sinus thrombosis involving the mid and anterior segments of the superior sagittal sinus. The patient was found to have new thrombocytopenia on admission with platelet level of 78k. Previously, on 04-JUN-2019, the patient had normal platelets. D-dimer was elevated at >4.00 mcg/ml. The patient was started on argatroban drip, nicardipine, and Intravenous immunoglobulin (IVIG). Additional laboratory data included  electroencephalogram (EEG) and complete blood count (CBC). Results were not reported.  On an unspecified date, Laboratory data (dates unspecified) included: APTT (NR: not provided) 26.9 s, Anticardiolipin antibodies (NR: not provided) Negative IgM, IgG, Beta-2 glycoprotein antibody negative (NR: not provided) Negative IgM, IgG, Fibrinogen (NR: not provided) 332 mg/dL, Heparin-platelet factor 4 antibody complex test positive (NR: not provided) Positive, Lupus anticoagulant negative (NR: not provided) dRVVT negative, Platelet count (NR: not provided) 15 10*3/uL, and SARS-CoV-2 test negative (NR: not provided) negative.  The patient was hospitalized for 1 day at the time of reporting.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, multifocal hemorrhage within the left frontal lobe, thrombocytopenia, platelet count decreased, epileptic seizures, superior sagittal sinus thrombosis, fibrin d-dimer increased, full blood count abnormal, periorbital pain, angiogram, aphasia, computerised tomogram neck, computerised tomogram abnormal, computerised tomogram head, electroencephalogram, hemiparisis, magnetic resonance imaging head abnormal, muscular weakness, and venogram. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).    Addition information was received 22-JUN-2021 on via literature. The following information was updated and incorporated into the case narrative: Laboratory data and latency information.; Sender's Comments: V5: Follow up from literature provided dates & clinical details that do not change the previous assessment. This case obtained via VAERS (VAERS ID 1226180) concerns a 52-year-old female who was hospitalized with life-threatening superior sagittal sinus thrombosis, multifocal hemorrhage within the left frontal lobe, thrombocytopenia, elevated D-dimer, seizures and headache 11 days after receiving Janssen Covid-19 vaccine. The symptoms started 7 days post-vaccination with periorbital pain & right-sided headaches which improved with ibuprofen. Approximately 4 days later, she woke up with right arm weakness which, over the course of several hours, progressed to include right leg weakness, hemiparesis, and aphasia. An initial CT of head showed multifocal hemorrhage within left frontal lobe. MRI of brain with & without contrast and CT venogram of brain were notable for superior sagittal sinus thrombosis. The patient was also found to have new thrombocytopenia on admission with platelet count 78K (normal platelet count 2 years & 10 months prior) & nadir of 15K; additional labs: elevated D-dimer >4.00 mcg/ml, anticardiolipin antibodies negative, Beta-2 glycoprotein antibody negative, Fibrinogen 332 mg/dL, Heparin-platelet factor 4 antibody complex test positive, Lupus anticoagulant negative, and SARS-CoV-2 test negative. The patient was started on argatroban, nicardipine, and intravenous immunoglobulin (IVIG). Her course was completed by epileptic seizures. As of the time of the report, the patient had not recovered. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Agency), the low platelet count and temporal relationship to vaccination, the events are assessed to have a plausible relationship with vaccination.