Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Coma scale abnormal, Computerised tomogram head abnormal, Computerised tomogram head normal, Condition aggravated
Clinical narrative: CEREBRAL HEMORRHAGE; DURAL VENOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; seizure; LOSS OF CONSCIOUSNESS; SEVERE FRONTAL HEADACHE, OCULAR HEADACHE; NAUSEA, VOMITING; PHOTOPHOBIA; SODIUM LEVEL HIGH; This spontaneous report received from a health care professional via a Regulatory Authority the VAERS (Vaccine Adverse Event Reporting System) concerned a 35 year old female. Additional information was also received on 22-JUN-2021 from a literature article:  The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, migraines, depression, and chronic thrombocytopenia. Patient had no adverse events following any previous vaccine and no recent abortive therapy. The patient had no cerebral venous sinus thrombosis risk factors. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805025) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included aripiprazole, bupropion hydrochloride, butalbital/caffeine/paracetamol, fluoxetine, propranolol hydrochloride, risperidone, and topiramate.  On an unspecified date in APR-2021 around 8 PM, patient presented to emergency room (ER) with a severe frontal headache since around 2 PM. She took TYLENOL and marijuana candy for relief at 4 PM with no help. Patient had computerized tomography (CT) venogram and CT head at 10:19 PM with normal results. She was given Toradol, Compazine, Decadron, and magnesium and discharged at 2 AM. Her platelet count at that time was 114 x10*3/mcL and was consistent with the patient's description of chronic thrombocytopenia. On an unspecified date in APR-2021 at 2 AM,  the patient presented to ER. She again had an ocular headache that was different and clearly more severe than her typical migraines. Still had significant nausea and vomiting along with photophobia. Unspecified laboratory results and imaging were reviewed. She again received morphine, Toradol, Reglan, Benadryl, dexamethasone. She was discharged at 06:00 feeling a little bit better. On 15-APR-2021 at 22:30, the patient had an acute worsening of headache and experienced  loss of consciousness. At 23:30, her husband found her unresponsive and called EMS. The patient presented to emergency room at 01:30 after sustaining a seizure in route and was subsequently intubated on arrival. She had a Glasgow coma scale of 1 with fixed pupils and no gag reflex. Platelet count was 10 x10*3/mcL and reached a nadir of 9 x10*3/mcL. The D-dimer peak value was 13.47 mcg/mL, the fibrinogen nadir was 128 mg/dL, international normalized ratio (INR) was 1.2 and the activated partial thromboplastin time (aPTT) was 24.1 seconds. The result of a SARS-CoV-2 polymerase chain reaction (PCR) test was negative, and Heparin-platelet factor (PF)4 test result was positive (value of 2.2). CT head without contrast was performed which revealed intraparenchymal and subarachnoid hemorrhage with significant sulcal and cisternal effacement and mild migration of the cerebellar tonsils below the level of the foramen magnum. Intracranial hemorrhage locations were also reported as the right temporal lobe and left cerebellar hemisphere within the literature article. Increased density within the right transverse, sigmoid and superior sagittal sinus and questionably with in the sagittal sinus may reflect underlying dural venous sinus thrombosis. The patient was also found to have sigmoid sinus thrombosis. Neurology and neurosurgery evaluated the patient around 03:00 in person. Independently, imaging and clinical presentation was deemed to be incompatible with life. Because of the sedating medications required for intubation and subsequently her sodium rising to 170, the brain death physical examination by neurology was not performed. Repeat imaging to evaluate central nervous system vasculature was under consideration by the clinical team. Action taken with vaccine was not applicable. The outcome was recovering for severe frontal headache, ocular headache, nausea, vomiting, and photophobia, and the outcome of seizure, thrombocytopenia, cerebral hemorrhage, dural venous sinus thrombosis, loss of consciousness and sodium level high was not reported. This report was serious (Hospitalization Caused / Prolonged, Life Threatening, and Disability Or Permanent Damage). This case, from Same Literature article is linked to 20210354798, 20210408478, 20210428484, 20210407314, 20210416236, 20210444498, 20210415297, 20210439653, 20210444501, 20210444497 and 20210448310.  Additional information was received on 22-JUN-2021 from a literature article.  The following information was updated and incorporated into the case narrative: no cerebral venous sinus thrombosis risk factors, additional late signs/symptom included loss of consciousness (added as event), additional location of sigmoid sinus thrombosis and (intra)cerebral hemorrhage locations of the right temporal lobe and left cerebellar hemisphere, timeline of events, platelet nadir, other laboratory results, and linked case numbers.; Sender's Comments: V3: Follow-up from literature confirms no CVST risk factors, symptoms, anatomic location of CVST, and lab tests.  This case concerns a 35-year-old female with a history of migraines, depression, and chronic thrombocytopenia who was hospitalized for cerebral venous sinus thrombosis (CVST) and thrombocytopenia 7 days after vaccine. Concomitant medications included aripiprazole, bupropion hydrochloride, butalbital/caffeine/paracetamol, fluoxetine, propranolol, risperidone, and topiramate. On an unspecified date the patient presented to the emergency department (ED) with a severe frontal headache. A computerized tomography (CT) venogram and CT of the head were unremarkable. She was given Toradol, Compazine, Decadron, and magnesium and discharged. Her platelet count at that time was 114, thought to be consistent with the patient's description of chronic thrombocytopenia. The patient later presented again to the ED with a severe ocular headache. She was evaluated and discharged again with morphine, Toradol, Reglan, Benadryl, dexamethasone.  On day 7, the patient had an acute worsening of headache and was found unresponsive that night. She was taken back to the ED by EMS, sustained a seizure in route and was intubated on arrival. She had no gag reflex. Sodium was 170, platelet nadir was 10, D dimer was 13.47 mcg/mL, Anti-PF4 ELISA was 2.2 and COVID test was negative. A CT revealed intraparenchymal and subarachnoid hemorrhage with mild migration of the cerebellar tonsils below the level of the foramen magnum as well as a suggestion of an underlying dural venous sinus thrombosis. She was determined to have brain death. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration), the low platelet count and temporal relationship to vaccination, we consider the events to have a plausible relationship with vaccination.