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Life Threatening? No
Write-up: Information has been received from a physician concerning a 16 year old female with exercised induced asthma and ZITHROMAX allergies, who on 21-JUL-2009 was vaccinated intramuscularly with a 0.5 mL first dose of GARDASIL (lot # 661953/1130X). The patient was vaccinated with a second dose of GARDASIL (lot # 663453/0249Y) on 20-OCT-2009. The patient developed back pain 2 weeks after receiving her second dose. The pain increased and spread to her head, neck, chest, abdomen and legs. She was also experiencing tingling and weakness of her legs, vomiting and difficulty urinating. The patient had not been able to attend school. The patient was hospitalized twice. The physician mentioned two diagnostic findings that have been ruled out as not significant: A syrinx on brain or spine MRI and a positive IGG titer for babesiosis from blood. The patient also had renal and abdominal ultrasounds, unspecified blood tests and an unspecified urologic testing. At the time of this report the patient had not recovered. Follow up information received from a physician indicated that the patient did not receive any concomitant vaccinations when she received the dose of GARDASIL. The patient started having symptoms approximately in November 2009. The physician stated that "so far all of the patient''s tests have been negative" (tests unspecified). The patient''s symptoms have been scattered. There was no diagnosis at this time. The physician stated that she had spoken to the patient''s mother by phone on a daily basis. Follow up information received from a physician via medical records indicated that the patient was a female with mild urinary reflux and an Achilles tendon repair in 2006. The patient''s mother had urinary system issues, a sacral nerve implant, and an ovariectomy done her father had asthma, allergies and disk problems, her brother had harlequin syndrome and her sister had severe allergies and asthma. On 20-OCT-2009 the patient was vaccinated intramuscularly with a second dose of GARDASIL (lot # 663453/0249Y). The patient developed significant back pain in November 2009. At the time she was playing soccer and swimming competitively. Her pain was stabbing in nature and was radiating to legs at times. Since November she had this pain as a baseline continuously and episodes of additional symptoms/pains intermittently. She developed severe headaches, neck pain and nausea/vomiting episodes. She had a severe abdominal pain episode. She developed intermittent tingling sensation of her arms and legs, had an episode of urinary incontinence, leg pain, burning sensation of thighs and feet, blurry/double vision, tinnitus and hearing loss (she was on QUININE for 24 hours when this happened, it was discontinued immediately). The following information from the physician is a time line created by the patient''s mother. From November to beginning of December 2009 she experienced increasing back pain and nausea. She was evaluated by neurologist, neurosurgeons, gastroenterologist, ID rheumatologists; ophthalmologists pain management and multiple diagnostic studies were done. The physician didn''t have a diagnosis which can explain the patient''s pain. On 08-DEC-2009 the patient was evaluated by a orthopedist (the patient had a back x-ray). On 12-DEC-2009 went to the ER, the patient developed increasing back pain, tingling/numbness legs,on 14-DEC-2009 the patient had a lumbar spine MRI done, From December 2009 to January 2010 the patient complained of neck pain off and on; on 06-JAN-2010 the patient visited her pediatrician for increase nausea and back pain; on 07-JAN-2010 the patient had pelvic and renal ultrasound done. From 08-JAN-2010 to 10-JAN-2010 the patient was hospitalized (first time) for several abdominal pain and nausea, back pain and headaches, on 09-JAN-2010 the patient had an abdomen CT scan. From 12-JAN-2010 to 15-JAN-2010 the patient was hospitalized (second time) for vomiting, severe headaches with pain behind eyes, increase back, neck and buttock/leg pain, blurry and double vision and "push urine out". On 13-JAN-2010 the patient had an abdomen and chest x rays and a head CT scan; on 14-JAN-2010 she had a brain MRI; a neurologist and a pediatrician saw the patient. On 19-JAN-2010 she saw her orthopedist, who recommended a bone scan and a back brace. On 21-JAN-2010 ad had a bone scan, on 27-JAN-2010 she saw her rheumatologist, on 29-JAN-2010 back brace; On 16-FEB-2010 she saw an spine specialist who ordered MRI of cervical and thoracic spine; on 20-FEB-2010 the patient developed neck and back pain worsening with pain in arms and occasional numbness of hands. On 23-FEB-2010 she had a cervical and thoracic spine MRI, she experienced headaches with pain behind eyes, severe neck and back pain with radiating pain and numbness. On 01-MAR-2010 she had neurosurgeon visit. On 03-MAR-2010 she visited her pediatrician and had a blood work done; on this date the patient had a severe "all over" headache (worst headache), severe neck and back pain radiating, "burning and shooting pain in legs". On 05-MAR-2010 she saw her neurologist; on 08-MAR-2010 she started antibiotic therapy for temporary hearing loss of low sounds; off antibiotics. On 16-MAR-2010 she saw her neurosurgeon; on 17-MAR-2010 she had a SSEP nerve study. At this point the pain was controlled with medication FAMOTIDINE, TYLENOL, MOTRIN, PERCOCET, EXCEDRIN). It was also reported that the patient had the following positive findings: tiny syrinx, small chiari minimal disk bulge at C3-C4 (neurology and neurosurgery did not think this was a reason). Back pain, leg pain, severe headaches, neck pain, nausea, vomiting, severe abdominal pain, intermittent tingling sensation of her arms and legs, urinary incontinence, burning sensation of thighs and feet, blurry vision, double vision, tinnitus, hearing loss, chest pain, difficulty in irination, leg weakness and not been able to attend school were considered to be disabling. Additional information has been requested. The patient was hospitalized twice at the hospital. All available medical records will be provided upon request.
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