Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Dizziness, Headache, Platelet count normal, Pyrexia
Clinical narrative: DURAL VENOUS SINUS THROMBOSIS; CEREBRAL HEMORRHAGE; SEVERE HEADACHE  IN THE RIGHT POSTERIOR  PORTION OF HER HEAD; HEPARIN ANTIBODY POSITIVE; HEPARIN RESISTANCE; AST AND ALT ELEVATED; This spontaneous self-report was received from a patient and concerned a 38 year old female. Initial information received on 17-APR-2021 was processed with additional information obtained via telephone follow up from the patient on 19-APR-2021. The patient's height and weight were not reported. The patient's concurrent conditions included sulfa allergy, seasonal allergies, alcohol use (rare, may be twice monthly), migraines, sinus problems, no smoking, no drug abuse or illicit drug usage. The patient was not taking birth control. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiration date unknown) dose was not reported, administered into the left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included spironolactone.  On 01-APR-2021, the patient awoke with a severe headache at 2 AM (reported pain scale 10 out of 10). The pain was sharp and was in the right posterior portion of her head. She also felt like she had sinus pressure. The pain started to subside and she went back to sleep. The next morning she saw a nurse practitioner and was told it was only a headache, but she insisted on a computerized tomogram (CT scan). On 2-APR-2021, she had the CT scan, which showed a cerebral hemorrhage. She was told to go to the hospital where a second CT scan confirmed the bleed. The patient was admitted to intensive care unit on the same day. On 4-APR-2021, a magnetic resonance imaging (MRI) was performed showing a posterior bleed. On the same day a magnetic resonance  angiography (MRA) showed a dural venous sinus thrombosis. On 5-APR-2021, heparin was started; platelet count on that day was 235. The patient was resistant to heparin (negative for heparin antibodies and liver became "agitated"). On 09-APR-2021, laboratory data showed AST 78, SGPT 89, bilirubin 0.2. Heparin was stopped after 8 days. Heparin antibody test was positive on 14-APR-2021. Patient was switched to unspecified blood thinner and  became responsive, international normalized ratio (INR) increased. On 16-APR-2021, platelet count was 177,  D-Dimer 0.49, AST 46, and ALT 137. The patient was discharged on 16-APR-2021 on warfarin sodium (Coumadin). At the time of report, she still had a 2 out of 10 headache, and anti-PF-4 was still pending. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dural venous sinus thrombosis, cerebral hemorrhage, and severe headache in the right posterior portion of her head, and the outcome of heparin antibody positive, heparin resistance and ASTand ALT elevated was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0: This case concerns a 38-year-old patient who experienced a dural venous sinus thrombosis (CVST) and cerebral hemorrhage 19 days after receiving covid-19 vaccine ad26.cov2.s for prevention of symptomatic SARS-CoV-2 virus infection. The patient experienced severe headache (reported as 10 out of 10) that was sharp and located in the right posterior head. The next day a CT scan showed a cerebral hemorrhage. She was told to go to the hospital where a second CT scan confirmed the bleed, and she was admitted to intensive care unit. A magnetic resonance angiography (MRA) showed a dural venous sinus thrombosis. The next day, 23 days after vaccination, heparin was started, and she was noted to be heparin resistant. A heparin antibody test was found to be positive 9 days later and the heparin was stopped, replaced by an unspecified anticoagulant. The transaminases were mildly elevated during hospitalization. The platelet counts were normal at 235, 3 days after admission and 177 on the day of discharge, 34 days after vaccination. The D-dimer was 0.49 on the day of discharge. The subject is recovering with headaches that are 2 out of 10.  In this case the platelet counts were within the normal range and the positive heparin antibody is confounded by the use of heparin. Although the CVST could represent background incidence of such event in general population, a relationship with Janssen Covid-19 vaccine cannot be ruled out.  Therefore, the relationship is indeterminant. Additional information has been requested.