Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood count abnormal, Cavernous sinus thrombosis, Computerised tomogram, Computerised tomogram head abnormal, Fibrin D dimer
Clinical narrative: CAVERNOUS SINUS THROMBOSIS; THROMBOCYTOPENIA; COMPUTERISED TOMOGRAM HEAD ABNORMAL; FIBRIN D DIMER INCREASED; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; PLATELET COUNT DECREASED; VENOGRAM ABNORMAL; FULL BLOOD COUNT; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) and concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy, and hypertension. On 31-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered in left arm for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up for Batch/lot numbers. The concomitant medications included unspecified natural pills. On 05-APR-2021, the patient was hospitalized for venous thrombotic cavern sinus and thrombocytopenia 25,000, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, and developed platelet count decreased, venogram abnormal.  On 05-APR-2021, the subject experienced full blood count. The patient was hospitalized (date unspecified) for 12 days. The following laboratory data (dates unspecified) included: CT scan results not provided, Complete blood count results not reported, Fibrin D dimer was elevated (value not provided), MRI results were not reported and Venogram was abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cavernous sinus thrombosis, thrombocytopenia, computerised tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, platelet count decreased, venogram abnormal and full blood count was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).  This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added to the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report received from a patient via VAERS (ID: 1238777) concerned a 47-year-old woman who experienced cavernous sinus thrombosis with thrombocytopenia 5 days after vaccine. Concurrent conditions included hypertension and concomitant medications included unspecified natural pills. Five days after vaccine, the patient was hospitalized for venous cavernous sinus thrombosis and thrombocytopenia (25,000) with an elevated D dimer (unspecified.) CT head and MRV were performed with results not provided. The patient was hospitalized for 12 days and treatment details were not provided. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC), the low platelet count and temporal relationship to vaccination (BC Criteria level 1), the events are assessed to have a plausible relationship with vaccination. Reporter contact information was not provided which precludes meaningful additional information in this version.