Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Headache, Heart rate, Hypertension, Loss of consciousness
Clinical narrative: PULMONARY THROMBOSIS; HIGH BLOOD PRESSURE; INCREASED PULSE RATE; PASSED OUT; TIREDNESS; ACHES; HEAVY FEELING IN BODY; PASSING OUT FEELING; PAIN IN THE JOINTS; WEAKNESS; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 59 year old female. Initial information received on 15-APR-2021 was processed with additional information received from the patient via telephone communications log on 22-APR-2021. The patient's height was 66 inches and weight was 198 pounds. The patient's past medical history included atrial fibrillation and atrial flutter approximately 30 years ago during her pregnancy, chickenpox approximately 25 to 30 years ago, gall bladder removal in 2015, and appendectomy in 2018. Concurrent conditions included high blood pressure, non-smoker, and lupus. There no history of trauma or recent travel. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 27-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 06-APR-2021, the patient experienced aches, pain in the joints, heavy feeling in body, weakness and passing out feeling at night before bed. On 11-APR-2021, the patient felt weak, tired, achy and stayed in bed the whole day. The patient had gone out driving and she had passed out in the passenger seat. The patient was taken to the local fire department where the first responders checked her vitals and had found she had high blood pressure of 220/110 mmHg and high pulse rate of 100-120/min, weak and "stroking out". They called the ambulance and transported her to the hospital. At the hospital, the patient was suspected to have a blood clot. A blood test and a computerized tomogram were performed. The blood test returned abnormal and the computerized tomogram scan showed a left pulmonary embolism. An ultrasound was also performed on her legs and the report was normal, no clot detected.  Laboratory data included: APTT (NR: 24.3 - 39.1) 32.6 sec, Beta-2 glycoprotein antibody (NR: not provided) 9.4, Fibrin D dimer (NR: not provided) 0.62 ug/mL{eqv}, Lupus anticoagulant (NR: 30.7 - 52.1) 43.2, and Platelet count (NR: 150000 - 450000) 245000 mL Treatment medications included: apixaban, and metoprolol tartrate to lower the blood pressure and regulate the heart rhythm. The patient continued to have a passing out feeling which lessened with the stabilized blood pressure. The patient during her hospital stay experienced headache and nausea. The patient was hospitalized for two nights and was discharged on 13-APR-2021 with apixaban, metoprolol tartrate, ondansetron, and unknown migraine medication. On 13-APR-2021, the patient was contacted by the hematologist and stated that he had done some deeper studies considering the patient had gotten covid-19 vaccine ad26.cov2.s vaccine and the recent issues with blood clots and informed the patient that her platelets were normal which were not indicative of someone who would be likely to have a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high blood pressure and passed out, was recovering from passing out feeling, and the outcome of aches, pain in the joints, weakness, tiredness, headache, increased pulse, heavy feeling in body, pulmonary thrombosis and nausea was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: The case concerns a 59- year- old obese female with BMI of 32 kg/m2 who experienced pulmonary embolism 15 days after Janssen COVID-19 vaccine was administered for the prevention of symptomatic SARS-CoV-2 virus infection. The patient's past medical history included atrial fibrillation and atrial flutter approximately (30 years ago) and concurrent high blood pressure and lupus. She is a non-smoker. The symptoms included weakness, tiredness, achiness and she had passed out.  Her blood pressure was 220/110 mmHg, pulse 100-120/min and she was sent to the hospital with a suspicion of a blood clot. A venous dupex ultrasound was normal (no clot detected). A computerized tomogram scan showed a left pulmonary embolism.  APTT 32.6 sec, Beta-2 glycoprotein antibody 9.4, D -dimer 0.62 ug/mL, Lupus anticoagulant 43.2, and platelet count of 245000 mL.  She was discharged after 2 days on apixaban, metoprolol tartrate, ondansetron, and unknown migraine medication. The patient was contacted by the hematologist who had performed additional blood tests and informed the patient that her platelets were normal and not indicative of someone who would be likely to have a blood clot. The patient recovered from a high blood pressure and the status of pulmonary embolism is unknown. History of atrial fibrillation and risk factors of obesity, age, tachycardia, increased diastolic blood pressure and sedentary position provide plausible explanation and the events of pulmonary embolism, high blood pressure, tachycardia and passing out are assessed to have an indeterminate causal association to immunization, per the per organization causality classification of adverse events following immunization. Given normal coagulation tests and hematology consult opinion the company causality is considered not related. Additional information is requested.