Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Scan with contrast abnormal, Thrombocytopenia, Venogram abnormal, Visceral venous thrombosis
Clinical narrative: OCULAR MIGRAINE; BLOOD CLOTS AROUND SPLEEN; PLATELET COUNT LOW; BLOOD CLOT IN BRAIN; PULMONARY EMBOLISM; STOMACH PAIN; This spontaneous report was received from a patient and concerned a 70 year old white female of unspecified ethnicity. The patient's height and weight were not reported. The patient's past medical history included pulmonary embolism, high blood pressure, and COVID-19 infection (Nov-2020), and concurrent conditions included non smoker and social drinker. The patient experienced hallucinating and itching when treated with hydrocodone bitartrate/paracetamol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: 07-AUG-2021) dose was not reported, 1 total, administered to her left arm on 27-APR-2021 at 11:00 for prophylactic vaccination. No concomitant medications were reported.  The patient was sick immediately within 4-5 days, which started with a headache. On a doctor's visit  "around May 16th or 26th" she was given a prescription for antacid for acid reflux. On 30-MAY-2021, patient experienced sickness which started with a headache followed by stomach pain, chest pain and vision issues. Vision issues were described as zig zag, and sensitive to light. Patient visited eye doctor on an unspecified date and was diagnosed with ocular migraine.   On 01-JUN-2021, the patient had severe headache and severe pain on right side of chest, "crazy stomach ache"/stabbing pains, and coughed up blood.  She was hospitalized and found to have a pulmonary embolism and blood clots. She was placed on heparin for 2 days in intensive care. On 01-JUN-2021, laboratory data included nucleated blood cell count, C-reactive protein, sedimentation rate manual, Chest X-ray, lipase, and urinalysis; normal ranges and results not provided for all tests. On 03-JUN-2021, laboratory data included: computed tomography angiogram of abdomen and pelvis, computed tomography angiography of head without contrast, and Heparin-induced platelet antibody; results not provided for all tests. On 06-JUN-2021, laboratory data included: magnetic resonance imaging of brain without contrast; result not provided. On an unspecified date abdominal ultrasound scan found that spleen was surrounded by blood clots. Blood clot was also verified in the brain by CAT scan. Heparin "wasn't doing what it was supposed to do". Additional treatment medication (dates unspecified) included: potassium and XARELTO (rivaroxaban). The patient was discharged from hospital on 10-JUN-2021.  As of 22-JUL-2021, platelets were still low, patient experiences headaches occasionally, random vision issues and  stomach ache after eating. She continued to take XARELTO (rivaroxaban) and had future appointment for verifying if the blood clots have been resolved. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach pain, and platelet count low, and the outcome of pulmonary embolism, blood clot in brain, ocular migraine and blood clots around spleen was not reported. Patient recovered from chest pain on 7-JUN-2021.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This spontaneous case describes a 70-year-old white female who developed a pulmonary embolism and was hospitalized 35 days after receiving the Janssen COVID-19 vaccine.  The patient has a history of pulmonary embolism, high blood pressure, and a COVID-19 infection in November 2020.  During the hospitalization she was also found to have an unspecified blood clot in her brain, blood clots around her spleen, and a low platelet count.  She was hospitalized for 9 days and discharged on Xarelto.  Test for heparin induced  platelet antibodies was performed but result was not provided.   The subject's history of pulmonary embolism and COVID-19 infection  may have increased the risk for the events to occur. However, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate.