Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram abnormal, Hypoxia, Pulmonary embolism, SARS-CoV-2 test negative
Clinical narrative: PULMONARY EMBOLISM; This spontaneous report was received from a physician and patient and concerned a 68 year old female. Initial information received from the patient on 13-APR-2021 was processed with additional information obtained from follow up with both physician and the patient on 14-APR-2021. The patient's weight was 210 pounds, height was 64.75 inches, and BMI 35.2. The patient's concurrent conditions included seasonal allergies, non-smoker, right knee replacement, hysterectomy 20 years ago, varicose veins for "some years" but denied any swelling or redness in her legs, and migraines. Other relevant medical history included no previous history of pulmonary embolism or blood clots, nor in her family medical history, no drug abuse or illicit drug usage or alcohol intake, no known history of  hormone replacement therapy, trauma, or travel. The patient received COVID-19 VACCINE AD26.COV2.S  (suspension for injection, route of administration and dose not reported; batch number: 1805020) administered on 06-MAR-2021 to her left arm for prophylactic vaccination. Concomitant medications included zolmitriptan for migraine.  On 06-MAR-2021, the night of vaccination, the patient didn't feel good, was feeling fatigued and dizziness. By the next morning on 07-MAR-2021, she was having shortness of breath, problems breathing, dry cough, and exercise intolerance. She had a hard time walking due to the shortness of breath. Patient did not report the reaction right away since she assumed it was something that would pass. A few days later, the patient went to urgent care since the symptoms did not resolve. COVID test, was done and was negative. She was given an unspecified asthma inhaler since "they thought it was asthma". The inhaler was ineffective. She went to emergency room 4-5 days after the urgent care visit since she wasn't getting any better. Computerized tomography was consistent with acute bilateral pulmonary embolism and pulmonary hypertension based on dilatation of the main pulmonary artery. Echocardiogram showed pulmonary hypertension. Electrocardiogram and chest x-ray were normal. Complete blood count (WBC (white blood cell count) 6.5, Hb (hemoglobin) 12.4, platelets 245,000), basic metabolic panel, magnesium, troponin, thyroid, liver, kidney function were done; everything was normal. B-type natriuretic peptide  (BNP) was elevated at 921 pg/ml (reference range less than125). Diagnosis of pulmonary embolism was made. The patient was admitted on 18-MAR-2021 at 19:30, administered oxygen upon arrival to the room, and started on XARELTO (rivaroxaban). While hospitalized, ultrasounds were performed in her extremities and did not reveal thrombosis. The patient was discharged on 19-MAR-2021. She was under the care of internal medicine specialist and had appointment on 29-MAR-2021. At that time, CBC was repeated and was within normal (platelets 334,000). The physician confirmed that other work-up to assess hypercoagulable state was not performed; they usually perform those tests after XARELTO treatment is completed. The patient stated that cough was worse when moving around, and by the end of the night her lungs felt sore. At the start of her symptoms she had to take a lot of cough medicine to help her sleep at night; her physician advised to take unspecified over the counter cough medicine. At the time of report, the patient felt better and was slowly recovering. Patient no longer needed cough medicine to sleep at night. She was told it could take 2-12 months for the blood clots to go away and she had to be on XARELTO a minimum of 6 months, and it affected her quality of life due to medication cost. Patient was missing work and had lost wages due to symptoms. At work she could not do what she used to do. The patient was due to see the specialist in the next 3-4 weeks.  The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient stated "the Janssen COVID-19 vaccine was the cause of pulmonary embolism". The patient was recovering from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 68 year-old obese (BMI 35) female was hospitalized for bilateral pulmonary embolism 12 days after receiving the Janssen Covid-19 vaccine in her left arm. Medical history included right knee replacement 5-6 years ago, hysterectomy 20 years ago, varicose veins for "some years", and occasional migraines treated with zolmitriptan q3-4 weeks. She denied smoking, had no personal or family history of clotting disorders, had no recent trauma or travel history, and did not use hormone replacement therapy. On the evening of her vaccination, she felt fatigue and dizziness. The next day, she developed shortness of breath, dry cough, and exercise intolerance and went to an urgent care center when they did not resolve a few days later. She was given an asthma inhaler which did not improve her symptoms. Four to five days later, she went to the emergency room where she was found to have bilateral acute pulmonary embolism on CT scan. She was hospitalized and treated with oxygen and rivaroxaban. Blood tests including CBC (WBC 6.5, HB 12.4 PLT 245), BMP, TSH, Troponin, Mg were normal; BNP was elevated at 921 (ULN<125 pg/ml). Echocardiography showed dilatation of pulmonary artery and pulmonary hypertension. Ultrasound of the extremities did not reveal thrombosis (she denied any leg swelling or redness). Chest x-ray and ECG were normal. Tests for hypercoagulable state are planned after anticoagulation treatment is completed. She was discharged the next day and followed up with her physician 10 days later; repeat CBC was normal including PLT 334. She still has a cough but is recovering. Based on the limited information, the event is inconsistent with the causal association to immunization, causality classification for adverse events following immunization.