Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Muscle twitching, Nausea, Nervous system disorder, Orthostatic intolerance, Pain
Clinical narrative: POTS/extreme headaches, abnormal heart rate, tingling in arms and legs, insomnia/diarrhea/tingling in arms and legs/chest pain and pressure/abnormal resting heart rate/black out/trouble sleeping every night/wake up in cold sweats/hyperventilation; chronic fatigue syndrome(CFS)/chronic fatigue/headaches/sensory sensitivity/light and noise/wear sunglasses due to the light sensitivity that caused his headaches/was found with towel over face/hardly remember/numb and could not walk/severe weakness; severe weight loss; anxiety; depression; orthostatic intolerance (OI)/severe weakness/sudden urge to throw up; physically hurt to eat; Gardasil-induced autoimmune disorder; a constellation of adverse symptoms complications/ other adverse events; This initial spontaneous report was received from a lawyer and patient regarding a case in litigation referring to an adult male patient (pt) of unknown age. The pt's concurrent condition included minor Tourette's syndrome. His medical history or concomitant medications were not reported. The pt was was happy, healthy, and enjoying his life even with minor Tourette's syndrome. The pt was excited to begin college courses after graduating high school. He enjoyed surfing, hiking, working out, playing basketball, going to the movies, building things around his family's house, working on his car, and playing instruments such as the guitar, violin, trumpet, saxophone, amongst others. On 15-JUL-2016, the pt went in for a doctor's visit. During the visit, the doctor recommended the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), which she stated was a safe and effective vaccine for preventing cancer and if the pt cared for his future sexual partners health, he should receive the vaccine. The pt did not consent to receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. Although the pt did not agree to receiving the vaccine, he was exposed to various marketing materials stated that the suspect vaccine was very safe, effective and prevented cancer. Without obtaining his consent and notwithstanding pt's specific refusal to be injected, the doctor injected the pt with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). The pt was 18 years-old when he received his first dosage of suspect vaccine on 15-JUL-2016, at the recommendation of the physician. On an unknown date after receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt went to the doctor's office after having extreme headaches and intermittent tingling in his legs. He was numb and could not walk. He could hardly remember the visit as he was not cognitively there and was slowly blacking out. During this visit, he had a lumbar puncture because of his symptoms from the vaccine. All pt recalled was receiving a shot in his spine and the doctor removing some fluid. After receiving the lumbar puncture due to symptoms, pt presented with a feeling of jolts and twinges in his legs, severe weakness, and extreme headaches that were unresponsive to treatment. On an unspecified date after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt returned to the doctor's office with his father. He had chest pain and tightness and was now highly sensitive to light and noise. When the doctor came in to examine the pt, he was found with the lights shut off and a towel over his face. He let the doctor know that he was experiencing headaches, weakness, muscle spasms, nausea, sharp pains to the chest, and sensitivity to light and noise. Subsequently, the pt started his first semester at the college intending to get degree. Though, unlike his peers, it was not an attainable goal. He was never able to finish a semester without dropping a class or going through a semester without failing a course because of his symptoms. The pt would have to wear sunglasses due to the light sensitivity that caused his headaches. He also had trouble sleeping every night and would wake up in cold sweats and hyperventilate. The pt also suffered from extreme fatigue. After attempting to complete two semesters, the pt transferred to different college hoping to achieve an associate degree in business entrepreneurship. Unfortunately, his symptoms would not let him focus. Whenever he ate or merely drank water, his body would get the sudden urge to throw up and it physically hurt to eat. He would also have bouts of diarrhea and consequently lost much weight. After trying to keep up with his classes amidst dealing with his symptoms, he was academically suspended. As the months progressed, so did pt's injuries which "now" included: chest pain and pressure, chronic fatigue, headaches, diarrhea, abnormal resting heart rate, muscle spasms, tingling in arms and legs, severe weight loss, insomnia, cold sweats, sensory sensitivity, anxiety, and depression. As a result of his suspect vaccine symptoms, pt could not engage in normal activities that a young adult would enjoy. He can no longer be physically active or participate in the activities he used to. The pt "currently" was no longer attending school and has had trouble finding work. Based upon his chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms and adverse events as outlined above, and the tests performed by his medical providers (no results were reported), the pt has been diagnosed with various neurological, autonomic and/or autoimmune medical conditions. It was also stated, that the medical literature documented other pts who had suffered serious autonomic, neurological and autoimmune dysfunctions, and who experienced the same side effects as those the pt had suffered, and who were diagnosed with post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autonomic, neurological and autoimmune diseases (published articles citation provided). The pt contended that his suspect vaccine injection caused him to develop serious and debilitating injuries, including but not limited, chronic fatigue, headaches, diarrhea, abnormal heart rate, muscle spasms, tingling in arms and legs, severe weight loss, insomnia, cold sweats, sensory sensitivity, anxiety, depression, chronic fatigue syndrome (CFS), postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance (OI), as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder (it was also stated, that the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and it's ingredients caused the pt's autoimmune disease and other related autonomic and neurological injuries and had resulted in his suffering from severe, debilitating, disabling and painful chronic injuries). As a proximate result of company's wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) manufacturing defects, pt suffered and would continue to suffer severe and permanent physical injuries and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The pt also had 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of his suspect vaccine-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 he would continue to incur these losses and expenses in the future. The outcome of the events was provided as not recovered (permanent). The reporter considered the events to be related to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon lawyer's assessment, all events were determined to be disabling. The chronic fatigue, muscle spasms, chest pain and pressure/sharp pains to the chest, extreme headaches, sensory sensitivity/highly sensitive to light and noise, sudden urge to throw up, diarrhea, abnormal (resting) heart rate, tingling in arms and legs, insomnia, numb and could not walk, severe weakness, and cold sweats were considered to be symptoms of diagnoses: CFS, POTS, and OI.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.