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Life Threatening? No
Write-up: Information has been received from a nurse concerning a 17 year old female who on 30-MAY-2007 was vaccinated with Gardasil (Lot #657621/0387U). There was no concomitant medication. On 30-MAY-2007 the patient developed impressive swelling and pain in her left shoulder down to her wrist. This occurred after the patient went swimming. It was reported that "the swelling gets less when the arm is not used but comes back when the patient uses the arm". A physician in the office told the patient to elevate and ice the arm in the area for a couple of days, but this did not help. On 04-JUN-2007 a Doppler ultrasound was performed which revealed thrombosis in the arm. It was reported that the swelling and pain were disabling to the patient. The patient''s swelling and pain persisted. No further information is available at this time. Additional information has been requested. 6/21/07-records received for DOS 6/11 and 6/17/07- Letter from PCP indicated that DVT is not thought to be due to vaccine it has probably been present for a few weeks. unfortunately it began to grow around the time of HPV thus the apparent association. Received HPV 5 days ago from this visit of 6/4/07-developed impressive swelling and pain that day while swimming. Arm literally twice normal size with pitting edema into arm pit. Swelling lessesn when not using arm but returns when she tries to swim or exerices. PE:left arm with non pitting swelling over entire arm, skin over arm is warm and well perfused fingers are cool on both hands but well perfused. ROM fine. Treatment, thrombolysis and mechanical thrombectomy, subclavian vein was virtually completely freed of thrombus. An underlying compression of the vein at the thoracic inlet was documented
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