Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Insomnia, Laboratory test normal, Muscle contractions involuntary, Muscle spasms
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old female, who on 16-JAN-2007 was vaccinated IM in the left arm with a 0.5mL first dose of GARDASIL (Lot# 653978/0955F). There were no adverse events post vaccination. On 030-AUG-2007 the patient was vaccinated in the left arm with a second dose of GARDASIL (Lot# 658558/1061U), approximately 2 weeks post vaccination the patient experienced muscle weakness, night sweats, and hormonal changes. On 18-DEC-2007 the patient was vaccinated in the right arm with a third dose of GARDASIL (Lot# 659441/1446U). The symptoms worsened after the third dose. The patient was seen at the clinic. It was reported that all of the tests performed were negative, including the test for muscle weakness. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Additional information has been requested. 02/18/2010 The possibility of myasthenia was rained and pursed witn an IMG examination. It was reported that reprtitive stimulation was normal, but on a motor unit analysis there were some small motor unit and predominantly proximalinnervated musles which raised the possiblity of mild myopathy. The doctor was consulted and did not fee that myopathy explained her neurological findings. It was also recognized that the patient has experienced a number of stressors in the past year. Her wedding in March was called off, she had a friend die of cancer, and her 17 year old cousin was killed. In September the patient was started on PAXIL 10mg per day and was increased in December. In December the patient was seen by a psychiatrist who felt that the patient had adjustment disordere with a depressed mood. Psychological counseling was recommended. The patient has participated in counseling and felt that the depressive reaction is no longer an issue, since December the patient's nightsweats have resolved. However, the patient experienced new symptoms including episodic parestheias involving the fingers, face, and occasionally the arms that lasted 10 to 15 minutes at time. The patient also experienced intermitten visual symptosm which consisted of an inability to focus or a sensation of a blurry spot in one eye that lasted a few minutes. It was reported that on one occasion when driving the patient experienced an episode of parethsias accompained by sweats and weakness. The patient pulled over and the episode lasted two hours. On this occasion there was an associated left frontal temporal headache. Since that episode the visual and sensory disturbances have continued intermittently and are unrelated to a specific time of day, food intake, or relationship to activity or position. It was reported that the patient was still experiencing a continuing aching predominantly in the lower extremities and a sensation that "they want to move or jump." The patient reported that her arms feel weak as well. It was discussed that there was not a lose of strength but a fatigability. It was reported that when the patient would exercise she "would be wasted for the rest of the day." Proior to her illness the patient was working three 12 hour shifts during her off-time would walk or participate in sports. Now it is difficutl for her to be up for more than half hour at a time without feeling headaches that average on per week and lasted  hours. The headaches were associated with photophobia. The headaches were treated with a combination of aspirin 325mg by mouth as neede and caffeine. The patient also experienced fascinaton occassionally in the legs, involuntary movement, and occasionl tremor. The patient was frequently constipated and had difficulty sleeping due to discomfort. The patient gained weight with reduced activity level. The patient was diagnosed with myalgia and fatigue. An electromyography was performed, the patient was going to be seen back at the offive with the reults of the EMG. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review possible Guillain-Barre syndrome was considered to be other important medical event. Additional information has been requested.