Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound scan
Clinical narrative: BLOOD CLOT IN LEFT LEG; LEFT LEG CALF PAIN; This spontaneous report received from a patient concerned a 78 year old Asian, Not Hispanic or Latino male. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included stent (unknown where stent was placed), and concurrent conditions included non alcohol user, and non smoker. The patient had no known drug allergies and no any drug abuse / illicit drug use. The patient was previously treated with Clopidogrel bisulfate for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included amlodipine, metformin, metoprolol, and vitamin b complex all for drug used for unknown indication. On 28-MAR-2021, the subject experienced left leg calf pain. Patient reported that he experienced left leg pain below calf muscle and went to hospital and was further diagnosed with blood clot in left leg on 16-APR-2021. He was on Plavix and asked to stop Plavix on 16-APR-2021 by physician and placed on Eliquis 10 mg for the first 7 days twice a day and then 5 mg once a day for blood clot in left leg as treatment administered and with further concern to physician. He had appointment to hematologist for further follow up on 26-APR-2021. Laboratory data included: Diagnostic ultrasound (NR: not provided) Blot clot to left lower leg on 16-APR-2021. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left leg calf pain, and blood clot in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a 78 year old male patient,  who experienced left leg calf pain 10 days after receiving the Janssen COVID-19 vaccine on his left arm. 29 days after receiving the vaccine, patient sought consult for the left leg pain and was further diagnosed with blood clot on the left leg by diagnostic ultrasound. Patient's weight is 220 pounds and has a height of 67 inches. Patient is non smoker and does not take alcoholic beverages. Patient has no known history of drug allergies or drug abuse. Past medical history include having stent placed on him but he could not recall where the stent was placed. Patient was on Clopidogrel bisulfate but was asked to stop on the day he was diagnosed with the blood clot. Other concomitant medications include: amlopidpine, metformin, and vitamin B complex,. Indication for all medications being taken is unknown.  Age and obesity (BMI = 34.5 per weight and height provided) are known risk factors for developing blood clot in the lower leg. Having a stent and concomitant medication suggest a cardiac problem. Based on the available information and considering the temporal relationship, the events of left leg calf pain and blood clot are assessed as indeterminate per WHO causality classification of adverse events following immunization.