Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Pain, Pain in extremity, Paralysis, Poor quality sleep, Post viral fatigue syndrome
Clinical narrative: Immune-mediated Encephalitis; Tunnel vision on standing; Gastroparesis; POTS; Complex Regional Pain Syndrome; sleep drunkenness; unrefreshing sleep; Numbness; Muscle aches; he was not administered the 3rd shot; migraine headaches; Idiopathic Hypersomnia / hypersomnolence; Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome; Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome and Immune Dysfunction Syndrome; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 14 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    It was claimed, that the patient sustained autoimmune disease, including postural orthostatic tachycardia syndrome ("POTS"), idiopathic hypersomnia ("IH"), myalgic encephalomyelitis/ chronic fatigue syndrome ("ME / CFS"), complex regional pain syndrome ("CRPS"), and other serious injuries, as a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections. It was claimed that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and its ingredients caused patient's autoimmune disease and other related injuries and resulted in him suffering from severe, debilitating, disabling and painful chronic injuries. Prior to receiving his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections, patient had no autoimmune diseases, no autonomic issues and no orthostasis.  On 06-MAY-2014, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported). Immediately following the injection, patient experienced a burning, painful sensation over a large area of his arm, including his shoulder. The deep burning pain was constant and severe for two full days. In the months following his first injection of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the patient began to have trouble staying awake for the latter part of the school day. He was exhausted and could barely keep his head up while sitting at his desk. He began to avoid the activities that he used to love due to his extreme fatigue.  On 09-JUL-2014, the patient was vaccinated with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported). Much like the first injection, it caused a similar deep, burning pain in his arm and shoulder. By August 2014, patient was having severe foot pain and needed crutches at school. His fatigue also increased during this time and he was having difficulty waking up in the morning and getting out of bed. He was also having memory problems, started performing poorly in school and developed terrible headaches. He was scheduled for his third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection in November 2014, but his pediatrician felt that the foot pain might have been a result of an adverse reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), so he was not administered the third shot.  As the months progressed, so did patient's injuries. He was seen by multiple physicians and specialists for his complaints which now included: migraine headaches; extreme pain in his leg and foot; body pains and muscle aches; chronic fatigue; hypersomnolence (sleeping 15-22 hours in a 24-hour period), sleep drunkenness, unrefreshing sleep; excessive sweating, lightheadedness, and tachycardia; tunnel vision on standing; difficulty with concentration and memory; confusion and brain fog; intermittent or episodic paralysis, numbness; and stomach pain making it difficult to eat.  As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms, patient was unable to engage in normal activities that a normal teenager would enjoy. He could no longer attend school in the same manner he used to prior to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections, and he missed the majority of high school and had to complete most of the work at home. Patient had been accepted to a university and required extensive accommodations, including: missing classes, assignments and exams due to disability flare, exams in evening only, extended test time, mobility assistance, having a note-taker, and part-time status due to sustained illness.  As an adult, patient was disabled and would likely be unable to hold down a normal job or participate in the same activities that he used to prior to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)-induced injuries. After trying dozens of therapies and medications, patient is currently taking a regimen of 10 strong medications each day. He is able to walk about 500 steps per day and must be pushed in a wheelchair by his parents if he attempts to do anything more strenuous.  Studies, including serum samples from July 2018, demonstrated that patient had tested positive for the anti-alpha-1 adrenergic antibodies and anti-Muscarinic Cholinergic Receptor 4 - Antibodies, and an "at risk" result for anti-AT1R antibodies and anti-ETAR antibodies.  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 dozens of medical providers, patient had been diagnosed with various medical conditions, including but not limited to POTS,  IH, ME / CFS, chronic fatigue and immune dysfunction syndrome (CFIDS), immune-mediated encephalitis (IE), CRPS, and gastroparesis.  Patient contended that his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injections caused him to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, IH, ME / CFS, CFIDS, IE, and CRPS, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are 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.  As a proximate result of Company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), patient has suffered and continues to suffer severe and permanent physical injuries, including his autoimmune disease and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. Patient also has a substantial fear of suffering additional and ongoing harms, including but not limited to now being at an increased risk of cancer, fertility problems and future symptoms and harms associated with his autoimmune disease as a result of his exposure to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). As a direct and proximate result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)-induced injuries, patient has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, diminished income capacity and he will continue to incur these losses and expenses in the future.  The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Information regarding this patient was also received via media. It was reported that in the months following patient's first injection, exhaustion and extreme fatigue forced him away from the sports and hobbies that had been centerpieces of his life. He had trouble staying awake during the school day. After his second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection, patient developed severe foot pain in both feet, so severe that he needed crutches to attend school. He had trouble waking up in the morning and getting out of bed. As his symptoms worsened, multiple physicians and specialists treated him for migraine headaches, body pains and muscle aches; chronic fatigue, hypersomnolence, sleep drunkenness, unrefreshing sleep, excessive sweating, lightheadedness, tachycardia, tunnel vision on standing, difficulty with concentration and memory, confusion and brain fog, intermittent or episodic paralysis, numbness and stomach pains. Patient's post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injuries and diagnoses including POTS, IH,ME/CFS, CRPS and gastroparesis, kept him from his passions, sports and hobbies. He missed most of high school and only his formidable self-discipline allowed him to complete his school work at home - he could not walk or move unassisted.  Upon internal review, the events of tunnel vision, gastroparesis and immune-mediated encephalitis were considered to be medically significant.