Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Deep vein thrombosis, Pain, Pulmonary embolism
Clinical narrative: BILATERAL DEEP VEIN THROMBOSIS TO LOWER EXTREMITIES; PULMONARY EMBOLISM IN BOTH LUNGS; BODY ACHE; CHILLS; This spontaneous report received from a consumer concerned a 54 year old female. The patient's weight was 190 pounds, and height was 66 inches. The patient's past medical history included cancer, and concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient had no known allergies and drug abuse/illicit drug usage.  The patient received JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin intramuscular, batch number: 1805031, and expiry:not reported) dose was not reported, 1 total, administered in left arm on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-MAR-2021, the patient experienced chills. On 06-MAR-2021, the patient experienced body ache. Since 09-APR-2021, patient started experiencing leg pain and was admitted to a hospital on 10-APR-2021. The patient was diagnosed with 2 deep vein thrombosis (DVTs) to the lower extremities with pulmonary embolism. The patient was on therapeutic Lovonox (enoxaparin sodium) and was prescribed Lovonox injection twice a day for 6 months. The patient had visited emergency room and hospitalized for 5 days. The patient was discharged from hospital on 13-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, and chills on 10-MAR-2021, and was recovering from bilateral deep vein thrombosis to lower extremities, and pulmonary embolism in both lungs. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This 54-year-old obese female with BMI of 30.7 was hospitalized due to bilateral deep vein thrombosis (DVT) to lower extremities and pulmonary embolism (PE) in both lungs 35 days after receiving JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) in left arm for prophylactic vaccination.  The patient's past medical history included cancer. The subject had chills 2 days prior to the vaccination and body ache 1 day post vaccination.  The symptoms resolved 5 days post vaccination. She started experiencing bilateral leg pain 33 days post vaccination and chest pain 34 days post vaccination. The patient visited emergency room and was hospitalized. She was diagnosed with bilateral DVTs to the lower extremities and PE in both lungs. Details of the hospitalization were not reported. She was discharged after 5 days of hospitalization with prescription of enoxaparin injection twice a day for 6 months. The patient was recovering from bilateral DVT to lower extremities and PE in both lungs.  Based on the available information, with risk factors of obesity and cancer, DVT and PE are assessed as indeterminate with causal association to immunization, per WHO causality classification for adverse events following immunization.  Company causality is considered not related to JANSSEN COVID-19 VACCINE. Additional information has been requested for further assessment.