Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: PULMONARY EMBOLISM; FEVER; SLIGHT COUGH; FEELING ACHY; CHILLS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included right leg deep vein thrombosis (2011), arthroscopic meniscus surgery (2011), and superficial thrombophlebitis on left leg from mid-calf up to mid-thigh (AUG-2020), and concurrent conditions included factor V Leiden mutation. (2011). The patient was not on oral contraceptive pills. No immediate family had history of clots. A family member on mom's side has had clots. She had right leg deep vein thrombosis in 2011 after arthroscopic meniscus surgery on right knee, followed by long car ride. She was diagnosed with Factor V Leiden mutation in 2011 at the time of that clot. She was on warfarin for about 4 months then taken off. She did well for almost a decade. In last AUG-2020 had a superficial thrombophlebitis in left leg from mid-calf up to mid-thigh. She was Xarelto (rivaroxaban), monitored with ultrasound, taken off on 15/17-JAN-2021. The patient was previously treated with warfarin for right leg deep vein thrombosis, and rivaroxaban for superficial thrombophlebitis on left leg from mid-calf up to mid-thigh.  The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980), administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the patient felt good with slight cough on the day. She experienced achy by 7 PM, went to bed, then started getting the chills. At 2 AM on 31-MAR-2021 she had fever of 102 F.  The laboratory appointment on Thursday, 01-APR-2021 unrelated laboratory was ordered.  On 01-APR-2021, she was walking from parking lot to a building and was very short of breath. On 03-APR-2021, she was going up one flight of stairs, and felt severely short of breath and had dry cough. On 4-APR-2021, she experienced pain between shoulder blades in back. Oxygen saturation at home was 93-94% on RA while resting. On 4-APR-2021, she went to emergency room at a computerized tomogram (CT) of chest with contrast around at 6:30 PM showed massive pulmonary embolism. The right chamber the heart was enlarged due to the blockage from the embolism. Blood levels for "stress on heart" came back high. The patient went to cath lab for pulmonary angiogram on 4-APR-2021 and had EKOS catheter direct thrombolysis. She was started on heparin and transitioned to Xarelto (rivaroxaban) on 5-APR-2021.  She was on blood thinners and the left lung was cleaned up and removed. The clot was still on the right lung, unable may or may not be cleared. The patient was discharged on 06-APR-2021. The patient was hospitalized for 2 days. On 04-APR-2021, Platelet count was 181 (normal range 140-440), on 5-APR-2021, Platelet count was 160 (normal range 140-440), on 6-APR-2021 Platelet count was 154 (normal range 140-440). At the time of this massive PE event, the patient was not on any anticoagulation and since the event, had been restarted on Xarelto, and she was told she needs to continue for life. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism, and the outcome of feeling achy, chills, fever and slight cough was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: A 57-year-old woman with a history of Factor V Leiden deficiency (off anticoagulation for several months) and previous DVT 10 years ago was hospitalized for pulmonary embolism four days after vaccine. The same day after vaccine, the patient reported chills and a 102 F fever. Two days after vaccine she experienced shortness of the breath and four days after vaccine, the shortness of breath became worsened with pain in the back between the shoulder blades. The patient went to the hospital and was diagnosed with massive pulmonary embolism with enlargement of the right side of the heart. She underwent direct catheter thrombolysis in the cath lab and was started on Xarelto. The patient was hospitalized for 2 days and is doing well. Although there is a close temporal relationship, the history of Factor V Leiden with previous DVT provides plausible alternate explanation for the event.