Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Fibrin D dimer, Peripheral swelling
Clinical narrative: A LEFT UPPER EXTREMITY DVT INVOLVING THE  SUBCLAVIAN AND AXILLARY VEIN; LEFT UPPER ARM SWELLING; LEFT UPPER ARM PAIN; This spontaneous report received from a health care professional (nurse practitioner) and concerned a 74 year old male. The patient's height, and weight were not reported. The patient's past medical history included DVT (deep vein thrombosis) of lower extremity and was not on anticoagulation since and was treated with warfarin times 3 months only. The concurrent conditions included type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension. The patient was previously treated with warfarin. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, and batch number: 1802070 expiry: 25-MAY-2021) dose was not reported, administered in left deltoid on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, the patient developed a left upper extremity DVT involving the subclavian and axillary vein, left upper arm swelling and had left upper arm pain.  On 19-APR-2021, the patient called and notified the office that the left arm was sore and swollen times 4-5 days. A registered nurse did a home visit on 20-APR-2021 and recommended an ultrasound to be done. On 26-APR-2021, the ultrasound confirmed a left upper extremity DVT involving predominantly the subclavian and axillary vein. On 26-APR-2021, Laboratory data included: CT Angiogram (to rule out pulmonary embolism) pending, COVID-19 virus test (NR: not provided) pending, Computerized tomogram thorax (NR: not provided) pending, Creatinine (NR: not provided) 1.59, ECG (Electrocardiogram) results not provided, Fibrin D dimer (NR: not provided) 3.95, Glomerular filtration rate (NR: not provided) 52, Hematocrit (NR: not provided) 33.2 %, Hemoglobin (NR: not provided) 10.4, International normalised ratio (NR: not provided) 2.8, NT-proBNP (NR: not provided) normal, Platelet count (NR: not provided) 309, and Prothrombin time (NR: not provided) 28.4. The patient was treated with rivaroxaban, 15 mg, oral, twice a day. The patient was currently in the emergency room with testing pending. The patient did not have other symptoms to report or note. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left upper arm swelling, left upper arm pain, and a left upper extremity dvt involving the subclavian and axillary vein. This report was serious (Life Threatening).; Sender's Comments: V0:  This 74-year-old male patient was found to have left upper extremity deep vein thrombosis (DVT) confirmed by ultrasound 17 days after receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection.  The patient has underlying type 2 diabetes, chronic hypoxemic respiratory failure, chronic kidney disease, anemia, and hypertension; the patient had prior history of DVT of lower extremity of unspecified date and was treated with warfarin for 3 months.  No concomitant medications were reported.  The symptom reported left upper arm pain and swelling 5 days after vaccination; persistence prompted consult with a registered nurse the recommended ultrasound; which revealed left upper extremity DVT involving predominantly the subclavian and axillary vein.  Platelet count 309, Prothrombin time 28.4, INR 2.8, NT-proBNP normal, Fibrin D-dimer 3.95, GFR 52; awaiting result of CT and CT angiogram, COVID test, and ECG.  The patient was treated with rivaroxaban.  No other details reported.  Based on the information that is available, the event is assessed as plausible with the causal association to immunization, per causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.