Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Back pain, Balance disorder, Chest pain, Chronic fatigue syndrome
Clinical narrative: fibromyalgia/extreme fatigue/lack of concentration/pain throughout her entire body/short-term memory difficulties/weakness in her legs/depression/joint pain/memory problems/inability to focus/chronic pain/muscle weakness/menstrual issues; postural orthostatic tachycardia syndrome/extreme fatigue/lack of concentration/ unable to stand or sit for longer/tachycardia/lightheadedness/dizziness/inability to walk or stand for more than two hours/shortness of breath/tachycardia syndrome/auton; chronic fatigue syndrome/fatigue/short-term memory difficulties/lack of concentration/joint pain/muscle weakness/imbalance; adverse reaction to HPV vaccine; depression; a swollen arm and sharp pulsing pain throughout the arm where the vaccine was administered; autoimmune injuries/ autoimmune dysfunctions/ Gardasil-induced autoimmune disorder/autoimmune disease/joint pain; a swollen arm and sharp pulsing pain throughout the arm where the vaccine was administered; high fever; Information has been received from a lawyer regarding case in litigation and refers to a 17-year-old female patient (pt) who at the time report was an adult. The pt's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, at the age of 17 years old, the pt was vaccinated with the first and only dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, lot # and expiration date were not provided) in the arm (unspecified which one), for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by her physician (referred to as a doctor and also as a health care provider) at a clinic and consented by the pt's mother. On an unknown date, reported as hours after quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) administration, the pt experienced a swollen arm and sharp pulsing pain throughout the arm where the vaccine was administered. On an unknown date, reported as the day after the suspect vaccine was received, she began experiencing tachycardia, shortness of breath, and pain throughout her entire body, including neck, face, back, legs, and chest. Thereafter, the pt continued to experience pain throughout her entire body, as well as weakness in her legs, extreme fatigue, short-term memory difficulties, lack of concentration, and depression. In addition to this, she was unable to stand or sit for longer than two hours at a time. The pt frequently visited her doctors' office and emergency room for these symptoms. She was diagnosed with fibromyalgia and postural orthostatic tachycardia syndrome. The pt was seen by multiple physicians and specialists for her complaints which then included: tachycardia, shortness of breath, lightheadedness, dizziness, joint pain, imbalance, inability to walk or stand for more than two hours, high fever, fatigue, memory problems, inability to focus, and depression. Her medical records stated that she suffered an 'adverse reaction to the human papillomavirus (HPV) vaccine, 'recent hospitalization for evaluation of chronic symptoms felt to be related to allergic reaction to HPV vaccine' (unclear for which events the pt was hospitalized, therefore criterion of hospitalized conservatively applied to all events) and 'diagnosis (DX) adverse reaction to HPV vaccine' . As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she was unable to engage in activities that a normal young person would enjoy. She was unable to participate in sports, running, and dancing as she had done prior to receiving the suspect vaccine. It was difficult for her to function in her daily life. In addition, the pt's academic career was affected. Her goal of studying medicine was shattered due to her symptoms. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the, pt was diagnosed with various medical conditions, including but not limited to, fibromyalgia, chronic pain, chronic fatigue syndrome, muscle weakness, menstrual issues, tachycardia syndrome, and postural orthostatic tachycardia syndrome. She contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to fibromyalgia, chronic pain, chronic fatigue syndrome, muscle weakness, menstrual issues, tachycardia syndrome, and postural orthostatic tachycardia syndrome, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events (also referred to as resulting sequalae), many of which alleged herein and all of which were caused by suspect vaccine 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 suspect vaccine, she suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. The pt had a substantial fear of suffering additional and ongoing harms, including but not limited to then being at an increased risk of cancer, and future symptoms and harms associated with her 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, she 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 the events was considered to be not recovered/not resolved. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autoimmune disorder was determined to be medically significant. The reporter considered all events to be disabling.