Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test abnormal, Computerised tomogram thorax abnormal, Cough, Deep vein thrombosis
Clinical narrative: SUBACUTE PULMONARY EMBOLISM IN LEFT AND RIGHT LUNG; DVT IN LEFT CALF; UNABLE TO DRIVE; EXTREME EXHAUSTION; HEADACHE; SHARP SHOOTING PAIN IN RIGHT LEG; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known previous medical conditions and had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 21-JUN-2021) dose was not reported, once total administered on 06-APR-2021 15:00 in Left Arm for prophylactic vaccination. Concomitant medications included amlodipine, hydrochlorothiazide and losartan for which indication was not provided. On 06-APR-2021, the patient experienced headache while driving back to home and was not sure if it was due to vaccine or traffic conditions. At 18:30, patient got up to walk across the room and felt a strong sharp pain in her right and left leg described as incredible cramping type of pain which her husband had to help sit down to a chair. Patient states that although the pain was in both legs, the left leg felt as though someone had took a knife to her thigh, the pain lasted approximately 15 minutes. On 07-Apr-2021, patient states that she went for a routine doctors visit to her family care physician who wrote her a prescription for routine blood work. On 14-Apr-2021, patient went to get the blood work done and states at this time, she felt extremely exhausted and that due to a bloodwork mix up which required her to drive back to the lab, she was not able to drive back so her husband had to drive her. Around 17-Apr-2021 to 18-Apr-2021 patient had to chase the dog and found that she couldn't catch her breath and that she started coughing. Her daughter who happened to be there asked her why she was coughing and thought that it was not normal and that she should contact her doctor.On 19-Apr-2021, patient called the doctor. On 21-Apr-2021 patient saw the doctor and during examination, patient was instructed to run a D-Dimer test to rule out blood clots. On 22-Apr-2021, doctor stated patient to go to the Emergency Room as the result for the D-Dimer test came positive. The patient was immediately hospitalized where Doppler and CT scan was performed on her and was diagnosed with Deep Vein Thrombosis and Pulmonary Embolism on both the lungs. Patient mentioned that she was treated with Heparin drip from 22-Apr-2021 to 24-Apr-2021 and then she was given Xarelto. On 25-Apr-2021, the patient was discharged from the hospital after 4 days of hospitalization. Patient reports that she was still experiencing extreme exhaustion and that the pulmonologist states that this is the normal course of blood clots and it could take anywhere from 60-90 days for the body to clear up the blood clots. She states she still has bouts of shortness of breath but showing signs of improvement. Patient stated that she was scheduled for another Doppler on 19-Jun-2021 which was recommended by her primary care physician. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp shooting pain in right leg on 06-APR-2021 ,had not recovered from extreme exhaustion, and the outcome of pulmonary embolism in left and right lung, dvt in left calf, headache and unable to drive was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210550248-COVID-19 VACCINE AD26.COV2.S, The case concerns with a Caucasian female. Subacute pulmonary embolism in left and right lung, deep vein thrombosis in left calf. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.