Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Platelet count decreased, Pyrexia, Scan with contrast abnormal, Thrombosis with thrombocytopenia syndrome
Clinical narrative: NAUSEA; ABDOMINAL PAIN; PERSISTENT HEADACHE; FEVER; CHILLS; BODY ACHES; COMPUTERISED TOMOGRAM HEAD ABNORMAL; FIBRIN D DIMER INCREASED; MAGNETIC RESONANCE IMAGING HEAD ABNORMAL; FULL BLOOD COUNT; VENOGRAM ABNORMAL; VENOUS THROMBOTIC CAVERN SINUS; THROMBOCYTOPENIA; PLATELET COUNT DECREASED; This spontaneous report received from a patient via a Regulatory Authority VAERS (Vaccine Adverse Event Reporting System), VAERS identification number: 1238777, 1218171, and concerned a 47-year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included aspirin allergy, hypertension, migraine. The patient never had an adverse event following any previous vaccine. On 31-MAR-2021 (also reported as 21-MAR-2021), the patient received COVID-19 Vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: 042A21A) dose was not reported, administered in left arm for prophylactic vaccination. The concomitant medications included losartan, metoprolol tartrate, amlodipine besilate, withania somnifera root, lithium orotate, ergocalciferol, and unspecified natural pills.  On "30-MAR-2021," the patient experienced nausea, abdominal pain, persistent headache, fever and was hospitalized (dates unspecified). On 05-APR-2021, the patient was hospitalized for venous thrombotic cavern sinus and thrombocytopenia 25,000, computerized tomogram head abnormal, fibrin d-dimer increased, magnetic resonance imaging head abnormal, developed platelet count decreased, venogram abnormal, and full blood count. It was reported that on 06-APR-2021, the patient started having nausea and stomach pain.  On 08-APR-2021, the patient had a fever (100 degrees Fahrenheit), chills, body aches, and headaches.  On 09-APR-2021, the headache got intense and no more fever.  On an unspecified date, the patient kept having intense headache and went to the  Emergency Room (ER). A complete blood count (CBC) showed low platelets level (25, 000 units, normal range not specified) and the patient was admitted to the hospital the morning after. A head computerized tomogram (CT) was negative. On an unspecified date, intense headache came back and a head CT scan was performed with positive result.  Another CT scan with the contrast and a magnetic resonance imaging (MRI) the day after confirmed the positive result for a blood clot in the head. The patient was transferred to the Intensive Care Unit (ICU) for 5 days, then transferred to regular room for 2 days. The patient was diagnosed with vaccine-induced immune thrombotic thrombocytopenia (VIITT) and released with rivaroxaban 20 mg and methylprednisolone 4 mg treatment with follow-up in a week. The patient also had scheduled appointment with a neurologist and a hematologist. The patient was hospitalized (dates unspecified) for 12 days. The action taken with COVID-19 Vaccine Ad26.COV2.S was not applicable. The patient had not recovered from cavernous sinus thrombosis, thrombocytopenia, nausea, abdominal pain, persistent headache, chills, body aches; the patient recovered from fever on 09-APR-2021; and the outcome was not reported for computerized tomogram head abnormal, fibrin d dimer increased, magnetic resonance imaging head abnormal, platelet count decreased, venogram abnormal, and full blood count. This report was serious (Life Threatening, Hospitalization Caused / Prolonged). This case was a duplicate of Adverse Event Report (AER) case numbers 20210506021 and 20210500191.  Upon review, it was determined that AER Number 20210500191 was nullified in error. All relevant information will now be submitted under this case (Adverse Event Report Case Number, 20210520237).; Sender's Comments: V0: This case obtained via VAERS (VAERS ID 1238777 & 1218171) concerns a 47-year-old female who experienced life-threatening cavernous sinus thrombosis with thrombocytopenia approximately 5 days after receiving the Janssen Covid-19 vaccine. Concurrent conditions include hypertension & migraine. Concomitant medications include losartan, metoprolol, amlodipine, withania somnifera root, lithium, ergocalciferol, and unspecified natural pills. After vaccination, the patient experienced nausea, abdominal pain, persistent headache, and fever and was hospitalized. Initial CT of head was negative. Repeat CT of head with contrast & MRI/MRV were abnormal and positive for thrombosis of cavernous sinus. Labs showed low platelet count (25,000) & elevated D dimer (unspecified). She was diagnosed with vaccine-induced immune thrombotic thrombocytopenia and after a total of 12 days, was discharged with rivaroxaban 20 mg and methylprednisolone 4 mg as corrective treatment with follow up in a week. She has scheduled appointments with a neurologist and a hematologist. Based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition), the low platelet count and temporal relationship to vaccination (Criteria level 1), the events are assessed to have a plausible relationship with vaccination.