Sex: F
Vaccine: HPV4
Symptoms: Right ventricular enlargement, Seizure, Sudden cardiac death, Syncope, Thrombosis
Clinical narrative: sudden cardiac death; blood clot blocking the left artery between the heart and lungs; coronary artery thrombosis; thrombosis; echocardiogram abnormal; began convulsing/had a seizure; cor pulmonale; pulmonary congestion; pulmonary edema; collapsed; eyes went glazy a little bit; Initial and follow up information has been received on request from the FDA under the Freedom of Information Act and from a physician and from an author of a published article found in the journal concerning a 19 year old female nonsmoker and non drug user with no medical history and no allergies, who on 12-MAR-2007 was vaccinated IM into the left arm with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) lot #655849/0263U). Concomitant therapy included drospirenone (+) ethinyl estradiol (YASMIN).   On 26-MAR-2007 the patient got dressed to go running with a friend to train for a half-marathon, as she was walking to the elevator she collapsed against the wall and had a seizure (previously reported as while exercising on a field collapsed, began convulsing and died secondary to emboli). It was reported that the patient was shaking a lot and her  eyes "went glazy." The patient was rushed to the hospital via ambulance. It was reported that "she had a whole bunch of little floating clots in her system." The patient was not able to be saved.   An autopsy was performed and showed that the patient died from a pulmonary embolism or blood clot that had blocked the left artery between the heart and the lungs. It was reported that on 25-JUN-2007 an autopsy report was received which revealed the following anatomic diagnosis: 1. Pulmonary embolism, occlusive a. pulmonary truck, left hilar and peripheral vessels b. acute cor pulmonale (by echocardiogram) 2. Pulmonary congestion and edema, bilateral a. no evidence of anomalous coronary artery distribution b. no evidence of ventricular dysplasia. The autopsy read "Everything in her body was unremarkable. The heart (280gm) is grossly unremarkable. There is no significant artery atherosclerosis. The relationship of the cardiac chambers and atrioventricular connections are unremarkable." On  the death certificate the following is documented "sudden cardiac death and pulmonary embolism." An Echocardiogram revealed a very enlarged right ventricle and small left ventricle as well as large blood clots within both the right atrium and right ventricle. Coronary artery thrombosis and thrombosis were also reported. A drug test was performed and was negative.   It was reported that the patient never had problems with a clot in her leg or anyplace in her body. The patient had surgery as a child and the doctors did not have concerns about abnormal clotting. The patient's family did not have a history of clotting problems. The patient's younger sister and mother were tested and showed nothing genetic.   Upon internal review convulsing was considered an other important medical event.  The original reporting source was not provided.  A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In  addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  No further information is available.  The VAERS ID number is 275438.  This is an amended report. It is unlisted "as determined listedness" fields.; Reported Cause(s) of Death: cor pulmonale; pulmonary congestion; blood clot blocking the left artery between the heart and lungs; pulmonary edema; sudden cardiac death