Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Electrocardiogram, Fatigue, Malaise, Pain in extremity
Clinical narrative: CLOTS IN LEG; PULMONARY EMBOLISM; FELT WEAK/WEAKNESS; WAS NOT FEELING GOOD; SPORADIC TIREDNESS; SORE ARM; This spontaneous report received from a patient concerned a 73 year old Hispanic or Latino male. The patient's height, and weight were not reported.  The patient's past medical history included exposure to agent orange with vision, high pressure in eyes, glaucoma, few eye surgeries, high cholesterol, high blood sugar, and pain in knees, and concurrent conditions included non-smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, 1 total administered on 27-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  Symptoms were started after 15 days of vaccination, the patient took a trip on 01-APR-2021 and was feeling ok. The patient returned on 16-APR-2021 from trip. On 17-APR-2021, the patient experienced fast heart rate and stated that he used to be a long distance runner and he felt like running marathon again but worst. On 17-APR-2021, the patient felt weak and faint, lightheaded. On APR-2021 the patient experienced sore arm. The patient went to hospital and then his wife continued to provide information over call. On 17-APR-2021, the patient was not feeling good and heart started racing. The patient and his wife waited for one day and on 19-APR-2021 patient went to hospital for check-up. The patient had to be released from hospital by 15:00, however by 20:00 the doctor called to patient's wife and told that patient rushed to intensive care unit (ICU) because they discovered one clot that disintegrated and went to both the lungs on 19-APR-2021 as the reason for patient's slow breathing and accelerated heart rate which were occurred on 17-APR-2021. The doctor said there were many other clots still in patient's leg on 19-APR-2021. The patient was prescribed a very strong anticoagulant in hospital and at home on a different anticoagulant. The patient was on very strict regimen with no exercise. On APR-2021, the patient experienced weakness, difficulty breathing and sporadic tiredness. The patient was admitted on 19-APR-2021 for 4 days and discharged on 22-APR-2021. Laboratory data included: Electrocardiogram (EKG) (NR: not provided) Blood clots in both lungs and leg and lots of other test performed at hospital which were unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pulmonary embolism, and the outcome of sore arm, felt weak/weakness, was not feeling good and sporadic tiredness was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender's Comments: V0 -Covid-19 vaccine ad26.cov2.s-1) Pulmonary embolism. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 2)-Clots in legs. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).