Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head abnormal, Computerised tomogram thorax abnormal, Device failure, Echocardiogram, Gene mutation
Clinical narrative: BLOOD CLOT IN LEFT POPLITEAL ARTERY; This spontaneous report was received from a patient and concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included bovine prosthetic aortic valve, moderate alcohol use, and non-smoker, and other pre-existing medical conditions included no known allergies and no history of drug abuse/ illicit drug usage. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, frequency 1 total administered in left arm, on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the patient experienced Charlie horse in calf and quad (muscles) /weirdness the leg (Charlie horse), which resulted in numbness and pins and needles in foot. On 20-MAR-2021, the patients foot went cold. On an unspecified date in MAR-2021, the patient experienced calf pain. On 21-MAR-2021, the patient went to hospital and did computed tomography (CT) with contrast which showed blood clot in left popliteal artery. Management of the blood clot included the performance of a procedure that went in through the calf and removed the clot. The patient was admitted for three days and put on heparin. She reported that initially everyone dismissed connection between blood clot and vaccine as she has a prosthetic bovine aortic heart valve. Also reported doctors had not yet identified anything wrong with valve. It was reported that the patient was following up with hematologist and cardiologist and had not pursued any othropedist follow up at time of reporting. The patient got discharged on 23-MAR-2021 and prescribed Eliquis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blood clot in left popliteal artery. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: This 46 year-old White female with medical history significant for a bovine prosthetic aortic valve who was hospitalized for a blood clot in the left popliteal artery 14 days after receiving the Janssen Covid-19 vaccine. Twelve days post-vaccination, she experienced an atypical post-run sensations of "Charlie horse" in her calf and quad muscles and numbness with pins and needles in her foot followed by coldness in her foot the next day. Fourteen days post-vaccination, she went to the hospital where a CT with contrast found a blood clot in her popliteal artery. She was hospitalized for 3 days, treated with heparin, and then discharged with apixaban. She is following up with her hematologist and cardiologist. AS of the report, an abnormality with her valve has not been detected. Based on the available information, the relationship of the serious events with Janssen Covid-19 vaccine is considered indeterminant. More information (e.g. platelet count, D-dimer, fibrinogen, anti-platelet factor 4 antibodies, medical records) is being sought.