Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pulse absent, Renal atrophy, Renal hypertrophy, Thoracic outlet syndrome, Ultrasound kidney abnormal
Clinical narrative: Information has been received from a medical assistant and a registered nurse concerning a 26 year old female with no pertinent medical history reported and no known drug allergies who on 16-APR-2008 and 16-OCT-2008, was vaccinated intramuscularly with first 0.5mL dose (Lot number 659329/1468U, valid for Varicella virus vaccine live (MSD) and second 0.5mL dose (Lot number 660620/0571X), respectively of GARDASIL. There was no concomitant medication. The medical assistant reported that on 16-APR-2008, the patient developed thoracic outlet syndrome. It was reported that the patient had no strength on her left arm and right arm. She had decreased "vascular" in her left arm with elevation. The registered nurse reported that the patient came to the office. She reported that her arms felt like blood was draining out of them when she raised them and got blue and cold. The left arm had no strength and the right arm had little strength. The condition had not improve since the second dose of GARDASIL. The vaccine was given to the patient consecutively in alternating arms. The registered nurse reported that the physician was looking into other causes like conditions relating to her chest region because he did not believe that this event was related to GARDASIL. As of 04-JUN-2009, the patient had not recovered from the event. The patient sought unspecified medical attention. Follow up information was received from a registered nurse which revealed that no other vaccines were administered at the time of the three GARDASIL doses. No labs/diagnostic tests were ordered for Thoracic Outlet Syndrome. No consults were requested. It was reported that the physician told the patient to be caution when lifting or doing heavy work. The registered nurse also reported that on 04-JUN-2009, when the patient was seen for a pap smear (results not provided), she complained of right flank pain. An ultrasound of the abdomen and pelvis, performed on 08-JUN-2009, showed severe atrophy of the left kidney with compensatory hypertrophy of the right kidney. Further testing was scheduled. It was reported that the physician did not note if he felt that the conditions were related to GARDASIL. Follow up information has been received from a registered nurse concerning a 26 year old female with no known drug allergies and no illness at the time of vaccination, who on 16-APR-2008 at 15:00, 16-JUN-2008 at 16:00 and on 16-OCT-2008 at 16:00 was vaccinated intramuscularly with first dose (site: left arm, lot number 659655/1486U), second dose (site: right arm, lot number 659655/1486U) and third dose (site: left arm, lot number 660620/0571X), respectively of GARDASIL. There was no concomitant medication. It was reported that the patient had no strength in the left arm and had diminished strength on her right arm. When the patient assumed military position, pulses disappeared. The patient had bilaterally decreased circulation. With elevation, her extremities became pale and cool (left arm more than right arm). It was reported that it had not changed or lessened. At the time of reporting the patient had not recovered from the events. Thoracic outlet syndrome, moderately sever atrophic changes of left kidney and compensatory hypertrophy of right kidney were considered to be disabling by the reporter. Additional information has been requested.