Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Hypoaesthesia, Immunoglobulin therapy, Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: mast cell activation syndrome; neuropathy in his legs; dysautonomia; memory and cognitive issues; chronic fatigue/Chronic fatigue syndrome; Muscle pain/Fibromyalgia; his gait changed/abnormal gait; brain fog; gastrointestinal issues; unexplained sweating; Numbness in the arms/intermittent arm numbness/intermittent numbness in arms, face, and lower extremity; a constellation of adverse symptoms, complications, and injuries, many of which are alleged herein and all of which were caused by the vaccine or otherwise linked to his vaccine- induced autoimmune disorder; inability to sleep; knees gave out; memory and cognitive issues; leg weakness; Orthostatic intolerance; osteopenia; osteoporosis; postural orthostatic tachycardia syndrome (POTS)/visual disturbances upon standing/dizziness upon standing; a rash in his armpits/rashes; Burning sensation in the skin; small fiber neuropathy; tremors, his body would shake uncontrollable whenever he walked/leg tremors; weight loss/extreme weight loss; inflammation of the cerebral B cells which could have been related to an inflammation of the immune system; vaccine-induced autoimmune injuries; cold-like symptoms; Join pain/multiple joint pain/ chronic pain in joints; weakness; feelings of fainting; Headaches; enhanced lymph nodes in his neck; low grade fever; vasovagal syncope; Hives; ataxia; Ankle sprain; Tingling/Wet sensation; autonomic neuropathy; need a cane to walk/inability to walk any significant distance without a cane/in a wheelchair because he lost control of his ability to walk or physically get around; incorrect schedule of vaccine administration; ear infection/he had ear pain; Information has been received from a female consumer referring to her son, an 18-year-old male patient (pt) with scoliosis at a 16-degree angle. On 27-NOV-2012, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot # H014645) 0.5 ml (expiration date and route were not available) injection in the arm for immunization against human papillomavirus (HPV). After the first dose there was no adverse event. On 13-OCT-2014, the pt was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot # K004205) (Inappropriate schedule of product administration). The pt also received a meningococcal vaccine (unspecified) concomitantly with the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and an influenza virus vaccine (unspecified) on 16-OCT-2014. On an unknown date in 2014 (reported as "within a few weeks" after receiving the second dose), the pt started experiencing joint and muscle pain. The pt also got sick and started running a fever. When the pt was not getting better, the pt's mother brought him to the doctor on 18-NOV-2014 and he was given an azithromycin (ZITHROMAX Z-PAK). The fever went away, but when the pt finished the azithromycin (ZITHROMAX Z-PAK), the fever came back and he had ear pain and could not hear. The doctor determined this to be an ear infection and prescribed another azithromycin (ZITHROMAX Z-PAK). On an unknown date in November 2014, the pt's doctor was concerned about his lymph nodes so the pt was sent to a head and neck surgeon who did x-rays but did not see anything that concerned him. The pt had been occasionally experiencing the following additional adverse events that began at unspecified time periods after the second shot: "abnormal sensations" (burning sensation in the skin, numbness in the arms, tingling, a "wet sensation" and headaches), a rash in his armpits that lasted a few months and weight loss. On 03-FEB-2015, the pt was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot # K006960). After the third shot, the pt started to need a cane to walk. On 14-FEB-2015 the doctor referred the pt to a rheumatologist who was "totally stumped" and who referred him to a geneticist who had "no idea" what it could be. The doctor then referred him to a neurologist who did an electroencephalogram (EEG) and detected neuropathy in his legs. The neurologist did a spinal tap in October or November of 2015 and he saw inflammation of the cerebral B cells which could have been related to an inflammation of the immune system. The neurologist thought it could be cancer, so he referred the pt to a hematologist/oncologist who determined that it wasn't cancer, but there were "markers from the spinal tap", but the yields weren't high. The doctor also referred the pt to an acupuncturist who referred him to a physical therapist, but the physical therapist didn't want to start any therapy until it could be determined what the problem was to be sure that he didn't do anything that could worsen the pt's condition. On an unknown date in February 2016 (reported as "last week"), the pt visited another neurologist who stated that the all this occurred because he wasn't exercising. The pt had also been to a gastroenterologist and a nutritionist. The pt had also had to quit his job because he was no longer physically able to do it. The pt received nortriptyline, nabumetone, cyclobenzaprine hydrochloride, anti-inflammatory supplements and acupuncture as treatment. At the time of the report, the pt did not recover from the events.  Upon internal review, the events of ear infection and inflammation of the cerebral B cells were considered to be medically significant.   Follow up information has been received on 04-MAR-2016. The call could not be completed.  Follow up information has been received from a physician on 08-MAR-2016. The pt's medical history included back pain from scoliosis. The pt had no concurrent comorbidities. It was reported the pt received three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscularly in the left deltoid. After vaccination on 03-FEB-2015 the pt developed chronic pain (multiple joint pain) and the intensity of the pain varied with walking. The recurrences were reported as yes and frequency of recurrences of the pain was reported as any time the pt walk. The pt also experienced intermittent arm numbness and had paraesthesia of unclear significance on an unknown date. The pt had no other symptoms accompanying the pain. It was reported the pt's daily walking was affected by the pain. The pt visited a medical institution and physical training, physical medicine and neurology treatment was given. At time of this reporting, the pain was reported as not resolved (also reported as unknown). The reporting physician stated that he/she didn't believe quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused the pt's symptoms.  Follow up information has been received from the pt's mother on 03-JUN-2016. The reporter stated that her son had received his initial dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) on an unspecified date back in 2012 and everything was fine with her son but then after her son received another dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) on 13-OCT-2014, he started developing a lot of health issues and reactions. The pt experienced tremors, his body would shake uncontrollable whenever he walked, ataxia, low grade fevers and his gait changed. The mother said currently her son was in a wheelchair because he lost control of his ability to walk or physically get around and he could not perform many of the routine things he used to be able to do. The pt hadn't been able to work and he quitted college and "now" lived at home with his mother who took care of him because of his many severe symptoms he had been experiencing since he received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose on 13-OCT-2014. The pt had seen over 50 different doctors during the period of time since getting vaccinated on 13-OCT-2014 and no one had been able to explain why the pt was experiencing all these side effects. The pt has had many lab tests and exams done and medical conditions like Multiple Sclerosis or Lupus had been ruled out as the cause to his symptoms. The pt's mother wanted to know if there was any treatment or anything that could be done to help the pt reverse the many side effects he had developed since getting the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine? The outcome of impaired work ability, physical disability, gait disturbance, pyrexia, ataxia and tremor were unknown. The causality between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the events impaired work ability, physical disability, gait disturbance, pyrexia, ataxia and tremor were not reported.   Upon internal review, "need a cane to walk" was considered to be medically significant and "in a wheelchair because he lost control of his ability to walk or physically get around" was considered to be disability.  Information has been received from a lawyer regarding a case in litigation referring to a male pt of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On 27-NOV-2012 (at 16-years-old), the pt was inoculated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed by a physician, without any incident. Prior to receiving his second vaccination, the pt was a happy, physically active (inconsistent information as it was previously reported among his concurrent conditions, that he was not exercising), and healthy teenager, just beginning his first year of college and a new job at a local movie theater. The pt enjoyed all the normal activities that teenagers undertake, including hanging out with his friends and girlfriend, attending classes, and looking forward to his future. On 13-OCT-2014, during an appointment for an ankle sprain (onset, treatment, outcome and causal relationship were not provided; unclear if prior to vaccination) the pt was inoculated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed by a physician. Shortly after his second vaccination, the pt to experience various medical issues including but not limited to body pains, headaches, cold-like symptoms, unexplained rashes, joint pains, ear pain, and enhanced lymph nodes in his neck, and had multiple visits to healthcare providers concerning these issues. On 03-FEB-2015, during an appointment wherein the pt continued to complain of the various above referenced complications the last shot, the pt was inoculated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed by a physician. The pt's mother, agreed to her son receiving the vaccine after having been exposed to various online, print, and television marketing materials. These materials stated that the vaccine was very safe, prevented cancer, and that good mothers must vaccinate their children with it. The pt's mother relied upon the company's ubiquitous representations concerning the safety and efficacy of the vaccine as well as the representations of the pt's medical providers concerning the safety and efficacy of the vaccine when she consented to her son's first vaccination; when he agreed to be injected with the vaccine, the pt likewise relied upon the representations of his medical providers that the vaccine was safe and effective and that it would protect his future sex partners from getting cervical cancer. Two days after the administration of his third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt's knees gave out, and he had to call his mother to take him home, as he was unable to be mobile. He began to have a host of other serious and disabling complications. As the months progressed, so did the pt's injuries. He was seen by multiple physicians and specialists for complaints, which included, among others: weakness, low grade fever, chronic pain in joints, abnormal gait, burning sensation on various parts of his body, hives, extreme weight loss, chronic fatigue, unexplained sweating, rashes, gastrointestinal issues, severe headaches, visual disturbances upon standing, inability to sleep, dizziness upon standing, sensory complaints (intermittent numbness in arms, face, and lower extremity), memory and cognitive issues, brain fog, leg weakness, orthostatic intolerance, dysautonomia, leg tremors, feelings of fainting, vasovagal syncope, osteopenia, osteoporosis, disability, and inability to walk any significant distance without a cane. A "tilt test" performed by his medical provider on or about 16-JUN-2016 was positive for postural orthostatic tachycardia syndrome (POTS). A prominent neurologist confirmed the pt's POTS diagnosis on 20-FEB-2018, commented that "the autonomic dysfunction appears to have come in the aftermath of Gardasil vaccine, something that I most certainly have seen". In addition to POTS, based upon his chronic and severe quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) post- symptoms and adverse events, as outlined above, and the various tests performed by his medical providers, the pt had also been diagnosed with, or was believed to also be suffering from, other potential conditions, including but not limited to, fibromyalgia (previously reported as myalgia), osteoporosis, mast cell activation syndrome, autonomic neuropathy, small fiber neuropathy (SFN), and chronic fatigue syndrome (CFS). As a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) post- symptoms, the pt had been unable to engage in the normal activities that a teenager and young adult would enjoy. As a result of his vaccine-induced injuries, he had to drop out of college, could no longer work, and could no longer engage in the activities that he once enjoyed. Currently, he was unable to be mobile without the aid of a cane for short distances and required a power assist wheelchair for longer distances. He was now legally disabled. The pt currently needed to live with his mother who was now his primary care giver, and he was visited by nurses at his home that administer his intravenous immunoglobulin therapy to help combat his vaccine-induced autoimmune injuries. He continued to experience many of the vaccine- induced symptoms outlined previously, and was forced to be homebound, bedbound, and remains generally inactive as a result of his injuries. His serious and disabling physical injuries, pain, and mobility limitations, as outlined herein, have also had a devastating impact on the pt's emotional wellbeing. The pt contended that his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, individually or in combination, caused him to develop serious and debilitating injuries, including but not limited to, dysautonomia, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance (OI), SFN, neuropathy, CFS, mast cell activation syndrome, autoimmune disease, fibromyalgia, as well as a constellation of adverse symptoms, complications, and injuries, many of which are alleged herein and all of which were caused by the vaccine or otherwise linked to his vaccine- induced autoimmune disorder. The pt and his mother had no knowledge of the alleged falsity or incompleteness of the company's statements and representations concerning quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The pt's mother was exposed to the ubiquitous promotional material and representations the company made in its direct-to-consumer advertisements and marketing materials concerning the safety and efficacy of the vaccine, including: that vaccine prevents cervical cancer, and cervical cancer was prevalent; that "good mothers" vaccinate their children and that it was perfectly safe. However, had the company in these advertisements not engaged in disease mongering and deception, but instead had informed her the truth about the serious risks of the vaccine (as outlined in this Complaint) and its lack of efficacy, she would never have consented to her minor son being injected with the vaccine, nor would the pt have consented to any of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections had he been adequately informed about the questionable efficacy and serious risks associated with the vaccine. As a proximate result of the company's wrongful acts and breaches of warranties concerning the safety and efficacy of the vaccine, the pt has suffered and continued to suffer severe and permanent physical injuries and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. the pt also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer and future symptoms and harms associated with his autoimmune disease and other injuries caused by the vaccine. As a direct and proximate result of his vaccine-induced injuries, the pt has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he would continue to incur these losses and expenses in the future.  The reporter considered arthralgia, asthenia, autoimmune disorder, autonomic nervous system imbalance, autonomic neuropathy, cognitive disorder, chronic fatigue syndrome, dizziness, ear infection, fibromyalgia, gait disturbance, gait inability, feeling abnormal, gastrointestinal disorder, headache, hyperhidrosis, hypoaesthesia, ill-defined disorder, insomnia, joint instability, lymphadenopathy, mast cell activation syndrome, memory impairment, muscular weakness, nasopharyngitis, neuropathy peripheral, orthostatic intolerance, osteopenia, osteoporosis, postural orthostatic tachycardia syndrome, pyrexia, rash, skin burning sensation, small fibre neuropathy, syncope, tremor, urticaria and weight decreased to be disabling events.  Upon internal review, autoimmune disorder, autonomic neuropathy, ear infection, gait inability, mast cell activation syndrome, neuropathy peripheral and syncope were determined to be medically significant events.  Upon follow-up information, the marker code of incorrect schedule of vaccine administration (onset: 03-FEB-2015) was deleted as the interval between the second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was correct, and the only incorrect interval of time was between the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL); the event Physical disability was deleted and the disability criteria was added to the event of gait inability; and the event Impaired work ability was deleted as an adverse event.