Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Craniectomy, Haemorrhage, Haemorrhagic stroke, Headache, Life support
Clinical narrative: CONTINUED TO BLEED; HAEMORRHAGIC STROKE; VOMITING; HEADACHE; PLATELET COUNT DECREASED; BIOPSY SOFT TISSUE; BRAIN SCAN ABNORMAL; POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS; BRAIN COMPRESSION; BRAIN STEM HAEMORRHAGE; BRAIN STEM SYNDROME; CEREBRAL HAEMORRHAGE; HEMIPLEGIA; SEIZURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1244328 and 1199143) concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included pre-diabetic. It was unknown if patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at the time of vaccination. No allergies to medications, food, or other products was reported. The patient was not pregnant at the time of vaccination. The patient did not have an adverse event following any previous vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 (also reported as 27-MAR-2021) for prophylactic vaccination. Anatomical vaccination site were not reported. No concomitant medications were reported.  On 03-APR-2021, one week after vaccination, the patient had headache and vomiting.  On 05-APR-2021, the patient had seizure due to hemorrhagic stroke. On an unspecified date, the patient experienced brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, possible cerebral venous sinus thrombosis, biopsy soft tissue, and brain scan abnormal, and was hospitalized.  On 06-APR-2021, the patient had a surgery to remove pressure on brain and brain stem (craniectomy). The surgeon noted alarmingly low platelet counts (results unspecified). The patient had platelet transfusion. The patient was hospitalized for '4 days'. The patient continued to bleed on 06-APR-2021 and 07-APR-2021. The patient was removed from life support on 08-APR-2021. The patient died on 08-APR-2021. It was unknown if autopsy was performed. Laboratory data reported following: Brain scan was abnormal  and showed abnormal, multi-focal brain bleeds and increased compression of brain. On 07-APR-2021, Brain scan abnormal which showed increased bleeding and brain stem injury. On 08-APR-2021, the patient died from possible cerebral venous sinus thrombosis. Laboratory data (dates unspecified) included: Biopsy soft tissue (NR: not provided) unknown, Pathology test (NR: not provided) unknown. On 08-APR-2021, the subject died from possible cerebral venous sinus thrombosis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of possible cerebral venous sinus thrombosis, brain compression, brain stem haemorrhage, brain stem syndrome, cerebral haemorrhage, hemiplegia, seizure, haemorrhagic stroke and continued to bleed on 08-APR-2021, had not recovered from headache, vomiting, and platelet count decreased, and the outcome of biopsy soft tissue and brain scan abnormal was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, involving the same patient is linked to 20210441454.  Additional information was received on 24-MAY-2021. Following information was added and incorporated into the narrative. Additional events of haemorrhagic stroke and continued to bleed were added, seriousness of events platelet count, vomiting, and headache was updated, additional reference numbers were added, additional vaccination date added in narrative, labeling updated, and course of event and laboratory data updated. It was determined that Manufacturer Case Number 20210441454 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20210500861. Upon review, the following information was amended: events biopsy soft tissue and brain scan abnormal was updated from non-serious to serious as this was on the earlier VAERS report.; Sender's Comments: V2: Additional information received regarding updates in seriousness of events, labeling, course of events, case identifier; and additional evets of hemorrhagic stroke and "continued to  bleed" did not alter prior assessment.    This fatal spontaneous report (VAERS ID 1244328) concerned a 59- year- old female who experienced vomiting, headache and seizures and was hospitalized for brain compression, brain stem hemorrhage, brain stem syndrome, cerebral hemorrhage, hemorrhagic stroke, hemiplegia, possible cerebral venous sinus thrombosis 16 days after Janssen COVID-19 vaccine was administered for prevention of symptomatic SARS-CoV-2 virus infection. The patient's height, and weight were not reported. The patient was pre-diabetic with no known allergies. Concomitant medications were not reported. Biopsy soft tissue was done (results not reported) and brain scan showed multi-focal brain bleeds and increased compression of brain; the patient underwent neurosurgery.  The platelet count  was decreased (result not reported) and received platelet transfusion. Follow-up scan next day showed increased/continued bleeding and brain stem injury and a day later she died from possible cerebral venous sinus thrombosis. It was unknown if an autopsy was performed. Although the  subject's pre-diabetic status 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 5), the events are assessed to have a plausible relationship with vaccination.; Reported Cause(s) of Death: POSSIBLE CEREBRAL VENOUS SINUS THROMBOSIS