Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Drooling, Dysphagia, Dyspnoea, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Hypokalemic Periodic Paralysis (HOKPP); Autonomic Dysfunction; drooling,; speech problems; choking; swallowing her tongue; eyes to roll back; Tics; menstrual issues; Postural Orthostatic Tachycardia Syndrome (POTS); Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS); Chronic Fatigue Syndrome (ME/CFS); Fibromyalgia; Complex cyst on her right kidney; large arachnoid cyst; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a currently adult female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 21-AUG-2013 (at 13-year-old), pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). It was reported, prior the vaccine the pt was in her usual state of health and enjoyed her adolescence. On an unknown date in 2013 (reported as few weeks of received the first dose), pt began to experience back pain going up and down her spine. Because, her pain never subsided the pt's mother decided to take to her primary care physician (PCP) (16-OCT-2013) and x-rays were done, and the results showed no signs of any abnormalities. The PCP recommended physical therapy. More tests were run after that, but pt symptoms worsened. She started experienced headaches, dizziness, pain all over her body, vision problems and fatigue. The pt was referred to a rheumatologist that diagnosed her with myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS). The doctor had also given her medication during this visit that triggered a paralysis episode. On 19-NOV-2013, the pt's mother took her to the doctor for her persistent back pain. The doctor ordered more blood work and test screenings and referred her to a neurologist. Simultaneously, she was seen by an orthopedic doctor who recommended started physical therapy sessions. The pt went to physical therapy once a week, but after a few months, she stopped attending. The pt found it very difficult to read and developed sensitivity to light, prompted her to wear sunglasses in classrooms. The pt would also get headaches made it more difficult to focus in class. In late December 2013, the pt was diagnosed with complex cyst on her right kidney. She continued to have multiple symptoms, included headaches. A magnetic resonance imaging (MRI) of her brain revealed a large arachnoid cyst. On 08-JAN-2014, after experienced abdominal and chest pain, the pt was sent to emergency room (ER). While there she had a seizure. The doctors checked her heart through electrocardiography (EKG) and the result was normal. In March 2014, her abdominal pain persisted along with other symptoms, included nausea. On 03-APR-2014, she returned to her doctor after had abdominal, chest, and back pain, nausea, excessive sweating, and fatigue. The doctor diagnosed fibromyalgia. She began to have paralysis episodes almost daily that became more intense and long-lasting over time. Pt continued to battle her symptoms and in May 2015, her doctor stated that she had to be treated for her hypokalemic periodic paralysis episodes. In the summer of 2015, she had new symptoms such as drooling, speech problems, weakness and muscle stiffening. Because of her periodic paralysis episodes, he vas majority of her schooling was done with a tutor home. By the end of sophomore year, pt had to be homeschooled as her symptoms were too complicated for the staff to handle. Pt had an increase in the frequency of her paralytic attacks, which lasted for hours. Her episodes involved choking, drooling, difficulty swallowing, shortness of breath, stiff muscles, and hand tremors. In November 2015, pt was also lost weight, despite maintained a balances diet. In December 2015, pt had and episode where her arms and legs were paralyzed. It was changed the medication, and she began experienced fewer paralytic episodes with shorter durations. Her appetite appeared to increase, but she still suffered from fatigue, chest, joint, abdominal pain, and headaches. In June 2016, she started to have and increased in her paralytic episodes again and began averaging daily episodes, along with her usual symptoms of nausea, fatigue, and pain on her joints, chest and abdomen. On 15-AUG-2016, pt experienced an episode where she felt like she was swallowed her tongue and having difficulty breathing, caused her eyes to roll back. Pt's mother was with her at the time and asked her is she was aware of what was occurred. Pt stated she was aware but could not react to it all. She was taken to ER, but they left after waiting for 3 hours and not received any treatment. Luckily, pt's symptoms subsided after returned home. However, the next day, she returned to the hospital and stayed there for three days as she had various paralytic attacks. The experienced was very traumatized for her. As the months progressed, so did pt's injuries. Multiple physicians and specialist saw her for her complaints which now included: headaches, nausea, sleep disorders, insomnia, night sweats, tic, dizziness, general weakness, body pains, general paralysis, abdominal pain, fatigue, brain fog, menstrual issues, fluctuating appetite, light sensitivity, tachycardia and stomach issues. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt could not engage in normal activities that a young teenager would enjoy in high school. She could no longer be physically active, participate in the activities she used to in person. It was reported she been applying for jobs, unfortunately, to no availed because of her condition. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above, and the test performed by her medical providers, pt had been diagnosed with various medical conditions, included but not limited to autoimmune disease and other serious injuries, included but not limited to, postural orthostatic tachycardia syndrome (POTS), hypokalemic periodic paralysis (HOKPP), fibromyalgia, ME/CFS and autonomic dysfunction. It was reported, quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and its ingredients caused pt autoimmune disease and other related injuries and had resulted in her suffered from severe, debilitating, disabling and painful chronic injuries. Pt contended that the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine caused her serious and debilitating injuries, included but not limited to POTS, KOKPP, fibromyalgia, ME/CFS, headaches, nausea, sleep disorder, insomnia, night sweats, tics, dizziness, general weakness, body pains, general paralysis, abdominal pain, fatigue, brain fog, menstrual issues, fluctuating appetite, light sensitivity, cysts, tachycardia, and stomach issues as well as a constellation of adverse symptoms, complications injuries, and other adverse events, many of which are alleged herein and all of which caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the pt's use of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she had suffered severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, included pain and suffering. Pt also had a substantial fear of suffering additional and ongoing harms, included but not limited to now being at an increased risk of cancer and future symptoms and harms associated with her autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) induced injuries, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. The outcome of arachnoid cyst, menstrual disorder, tic, eye movement disorder, tongue discomfort, choking, speech disorder, drooling, renal cyst, post viral fatigue syndrome, postural orthostatic tachycardia syndrome, fibromyalgia, familial periodic paralysis, chronic fatigue syndrome and autonomic nervous system imbalance was considered as not recovered/not resolved. The reporter considered postural orthostatic tachycardia syndrome, menstrual disorder, tic, eye movement disorder, tongue discomfort, choking, speech disorder, drooling, post viral fatigue syndrome, arachnoid cyst, renal cyst, autonomic nervous system imbalance, chronic fatigue syndrome, fibromyalgia and familial periodic paralysis to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporter considered, postural orthostatic tachycardia syndrome, menstrual disorder, tic, eye movement disorder, tongue discomfort, choking, speech disorder, drooling, post viral fatigue syndrome, arachnoid cyst, renal cyst, autonomic nervous system imbalance, chronic fatigue syndrome, fibromyalgia and familial periodic paralysis to be disable events.  Upon internal review, familial periodic paralysis was considered to be congenital anomaly event.