Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Feeling abnormal, Fibromyalgia, Gait disturbance, Gait inability
Clinical narrative: severe TMJ; vaso vagal event; super migraines; very irritable; gastrointestinal problems; swelling in her face , jaw and wrist; lost a lot of weight; rash that goes across her shoulders; pseudoseizure; aluminum toxicity in hair; aluminum toxicity in urine; Guillain-Barre syndrome; she had damage to her brain, stomach and vagus nerve; thinking straight; psychiatric disorder; gastroparesis; patient had an injury to her vagus nerve; having trouble eating; she had damage to her brain, stomach and vagus nerve; numbness; myalgia; headache; light hurts her eye; depression; irritable bowel syndrome; gastroenteritis; Patient started falling down; Lost the ability to walk; Could not move her jaw; Back and neck swelling; Head presure that would press from her skull down to her jaw and into her neck/back; Patient could not handle noise; Touble with her vision; Could not feel her legs; could not move; seizures; persistent weakness; floating sensation (nausea); constant pain; fainting; could not speak; dizziness; loss of consciousness; Information has been received from a consumer, concerning her daughter a 22-year-old patient. The patient's pertinent concurrent condition included asthma. Concomitant therapy included topiramate (TOPAMAX). The patient's medical history was not reported. The patient's drug reactions or allergies were unknown.  On 26-JUN-2007, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (0.5 ml, frequency, lot number, expiration date, anatomical location and route of administration were not reported) for prophylaxis.  On approximately 29-JUN-2007, the patient experienced seizures and leg pain that would come and go. She also experienced problems breathing. On 24-AUG-2007, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (0.5 ml, frequency, lot number, expiration date, anatomical location and route of administration were not reported) for prophylaxis. After receiving her second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), all of her symptoms progressed extremely. On an unknown date in August 2007, She was very irritable and could hardly walk. She could crawl but she was mainly bed ridden and needed to use crutches or a wheel chair to get to her physician's office. She experienced problems breathing and had "super migraines" that never went away and were there 24/7. She also had gastrointestinal problems and can hardly eat or digest well. She had lost a lot of weight. She also had a rash that went across her shoulders. In 2007, the doctor found there was aluminum toxicity in her urine and hair. She had swelling in her face, jaw and wrists. The patient was diagnosed with Guillain-Barre syndrome, myelin sheath degeneration and peripheral neuropathy. Patient was hospitalized twice: 19-OCT-2007 to 24-OCT-2007 and on 14-DEC-2008 to 15-DEC-2008. She also visited an emergency room (ER) for a few hours but she was not admitted. Patient only received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the series was not completed. The consumer reported a multiple labs done to the patient. At the time of reporting, the patient had not recovered from symptoms. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.   The event of super migraines was considered to be disability by the upon internal review.  Follow up information has been received from a physician concerning the white patient on 18-MAR-2009. The patient's pertinent concurrent condition included with fibromyalgia and migraines. On 27-JUN-2008, the patient experienced persistent weakness and increased migraines. There was severe occipital pain. The patient was in wheel chair now. Numerous neurology tests (test unspecified) were performed and all the results were negative. The outcome of all events was not recovered. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.  The event of persistent weakness was considered to be disability by the upon internal review.  Follow up information has been received from a medical assistant on 22-APR-2009. she visited the physician on 04-JUN-2008 and was diagnosed with fibromyalgia, depression, gastroenteritis, irritable bowel syndrome, migraines, severe temporomandibular joint syndrome (TMJ), vaso-vagal event and adverse reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The medical assistant stated it was documented that on 10-SEP-2008 the patient was seeing by another physician who diagnosed the patient with headache and non allopathic lesions of head, cervical, thoracic, lumbar, pelvic regions and lower extremities. On 04-FEB-2009, the patient went to the office in a wheel chair, the patient diagnosis was myalgia and reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 14-JUN-2009 the patient's mother went to the physician's office, the patient was not able to go to the office. The patient's mother stated that the patient was homebound. It was reported that at that time the patient had irregular pupil size. The patient was referred to a neuro ophthalmologist. The patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # 658488/0930U). On 14-JUL-2009 information received from the physician reported that the patient was never diagnosed with Guillain Barre Syndrome by a neurologist. It had been suspected by a Clinic and it had been talked about and discussed but the patient was never actually diagnosed with Guillen Barre syndrome. The patient Electromyography (EMG) and Magnetic Resonance Imaging (MRI) had been completely normal. The physician stated the "the child was an odd child, who left his practice and went to a different practice were she received of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The patient returned to the reporting physician practice because she was unhappy with her family physician. The physician stated that the "patient was extremely strange with strange diagnosis such as fibromyalgia on one side of her body and not to the other". The physician stated that he felt there was a huge, huge psych element overlying the case. On 24-JUL-2009, a phone call was received from the neurologist, who reported that the patient was not diagnosed with Guillain Barre Syndrome, Demyelination or Peripheral Neuropathy. The patient had an EMG and a "Spinal tap" in 2008 which did not show neuropathy. The patient had trouble walking but the physician stated that there was "nothing organic" which caused the difficulty walking. The physician stated that the patient did not have muscle weakness. The patient complained of spells. The patient was monitored for seizures and there were no reported seizures that occurred. The patient complained of a constant headache. The Neurologist stated that the patient came to her office in a wheel chair. The Neurologist stated that she encouraged that the patient go to Physical Therapy. The patient had a scheduled visit to see the Neurologist sometime later this summer. The outcome of depression, gastroenteritis, irritable bowel syndrome was unknown. The outcome of other events was not recovered. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.  The event of myalgia was considered to be disability by the upon internal review.  Follow up information received from a physician on 04-AUG-2009. The patient did not have GBS, peripheral neuropathy or neuropathy. The patient did have pseudoseizures on 29-JUN-2007. The outcome of pseudoseizure was recovered. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.   Follow up information had been received from an internet. The mother wrote to the reporter indicating that the patient had been suffering from the side effects of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). In September 2008, she was lying on the couch covered up with a blanket and she needed to wear dark glasses because light hurt her eyes terribly. What the reporter saw was a very upset young woman with twinkling in her eyes when she took off her dark glasses for me. The reporter also witnessed one of her seizures. She had gotten so used to them that she knew when one was coming most of the time. In 2007, The patient was suffering with constant pain, seizures, nausea, weakness and dizziness and needed a wheelchair to get around. The patient was warrior in the reporter's opinion. She was doing the best she could to not let this get her down. She fought every day and night, 24/7. The patient received her first shot in June of 2007 and her second in August of 2007. It was reported that "The adverse reactions began slowly, a fainting spell within 24 hours for no reason, then an odd occurrence a few days later - she was on a date and suddenly could not move or speak though her eyes remained open and she could hear. A floating sensation came over her, then slowly she began to lose consciousness. This lasted about five to eight minutes. Her date thought she had died. After she came to, she thought the whole episode was somehow related to her fibromyalgia in a new way. Nothing like it had ever happened before to her. One week later. The patient was with a group of friends at an amusement park when her legs suddenly gave out, hammering pain ran up and down her thighs and calves. This lasted about 15 minutes, and it ended as abruptly as it came on. None of this made any sense when taken as isolated incidents - but I kept track of all of them since they made me very concerned. The leg pain would come and go the rest of the summer, but in a much less intense. The patient was finally able to use crutches and a walker to get around. Her family was hoping that the wheelchair will eventually be a thing of the past when she was able to get braces. The outcome of could not speak, dizziness was recovered. The outcome of floating sensation was unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.  The event of could not speak was considered to be medically significant by the upon internal review. The events of dizziness, floating sensation and constant pain were considered to be disability by the upon internal review.  Follow up information had been also received from a physician who received the information from a consumer that provided him a link to a forum concerning a female patient with fibromyalgia who was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) first dose in June of 2007 and her second dose in August of 2007. In 2007. The adverse reactions began slowly, a fainting spell within 24 hours for no reason, then a few days later - the patient's suddenly couldn't move or speak though her eyes remained open and she could hear. A floating sensation (also reported as "nausea") came over her, and then slowly she began to lose consciousness. This lasted about five to eight minutes. The person she was with thought she had died. After she came to, she thought the whole episode was somehow related to her fibromyalgia in a new way. Nothing like it had ever happened before to her. One week later, the patient suddenly experienced, hammering pain ran up and down her thighs and calves. This lasted about 15 minutes, and it ended as abruptly as it came on. The leg pain would come and go the rest of the summer, but in a much less intense manner (also reported as "constant pain"). In approximately the September 2008, the patient experienced light hurts her eyes. At the time of reporting, the patient had not recovered from constant pain, seizures, nausea, weakness and dizziness and needed wheelchair or crutches and a walker to get around. The patient had recovered from fainting, could not move or speak, loss of consciousness, and strong pain down and up in thighs and shins. The outcome of light hurts eyes was unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and events was related.   The event of loss of consciousness, could not move, fainting was considered to be medically significant by the upon internal review.   Follow up information has been received from a blog in internet. The patient's father stated his injured daughter who was not as bad off as some of the others who had experienced this. The child suffered from the serious illness. The physician who recommended the HPV vaccine shot the patient, had refused to acknowledge the diagnosis of a reaction to HPV rL1 6 11 16 18 VLP vaccine (yeast), insisting upon the hypothesis that these symptoms were brought about by a deep seated psychosomatic cause or "something" else. The patient struggled just to walk and to deal with pain.  Follow up information was received from the current 27-year-old female patient who stated that after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). On an unknown date, she developed gastroparesis. She also stated that she had an injury to her vagus nerve. Patient also stated that it was no coincidence that she developed these adverse events after receiving Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). The outcome of all events was unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all events was related.  The events of gastroparesis and vagus nerve disorder were considered to be medically significant by the upon internal review.  Follow up information was received on 02-JUL-2016 from a transcript of a video on a webpage Internet page with Link discussing article quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (see MARRS # 1401USA003920) regarding a 22-year-old female patient who refers to herself. The patient reported in 2007 she was scared into taking the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot. In June 2007, she had her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot right after her 21 st birthday. With the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot the patient reported she was starting to get some signs (NOS) but didn't put it together with what was happening with her. On 24-AUG-2007, the patient had her second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot. After the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot the patient became very ill. The patient reported when she took the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot, "it was official, I had had an adverse reaction." In August 2007, the patient lost the ability to walk, could not feel her legs and started falling down. She could not move her jaw and ended up, as she described, "talking like a ventriloquist." The patient also had head pressure that would press from her skull down to her jawand into her neck and back. The patient reported she had large swelling on her back and neck which felt like a bag of water was on the back of her neck. The patient experienced seizures for a year and a half which have resolved (date not provided) but she still struggles. She also suffered problems with a rash, which she still has. The patient also experienced trouble with her vision (NOS), cannot handle noise or handle conversations. The patient reported she cannot be "normal", go to school, be out with her friends and have a good time.  Her doctors say that she is going to get better and they are working with her. She is taking supplements, vitamins and all these different things (NOS). Her doctors told her that it was going to take a very long time to recover. The patient stated that this was not what she wanted at the age of 23 for a life. She did not want to be stuck on one level of her house unable to be out driving or going to school to earn a degree. The outcome of seizures was recovered. The outcome of other events was unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all events was unknown.  The adverse event of reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), injury (04-FEB-2008) has been removed since information has been provided regarding the patient's specific adverse reactions to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events of lost the ability to walk and seizures were considered to be medically significant by the upon internal review.  Follow up information was received on a transcript of a video on a webpage Internet page with link social network account on 26-JAN-2024.  On an unknown date, the patient went to the hospital and the physicians said she was making it up. But according to the patient, it didn't explain why she was experiencing numbness, falling, having trouble eating and thinking straight, nor did it explain that her eyes were so sensitive that she needed to be in the dark, without noise. Then it was discovered that she had damage to her brain, stomach and vagus nerve (she specified "an important nerve that runs through the body"). She had Guillain-Barre syndrome for about 3 years, 3 and a half years, a chronic relapsing illness. Now (at the time the interview), she was better: the patient indicated that it took her 16 years to get there, with ups and downs. She had to use a wheelchair, then crutches, then cane to be able to walk or move around. Then, there were moments when she could walk without problem. Her stated of health depended on the physicians, the treatment, what was happening and if things were flaring-up. She explained that she had died twice and was brought back to life, the journalist asked her to explain what she meant by "she died twice" and the patient specified that she stopped breathing. The outcome of all events was unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and all events was unknown.  The events of guillain-barre syndrome, brain damage and thinking straight were considered to be medically significant by the upon internal review. The event of guillain-barre syndrome was considered to be disability.  This was one of four report due to the same reporter.; Sender's Comments:  US-009507513-1401USA003920:, MERCK0903USA03234:Mfr number