Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Fatigue, Feeling abnormal, Headache, Hypersomnia, Inappropriate schedule of product administration
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS)/problems with memory and concentration/ brain fog/dizziness/lightheadedness/faintness/shakiness/intermittent chest pain/a loss of stamina/mood problems/ autonomic dysfunction/dysautonomia/fatigue; neuropathy/small fiber neuropathy sensations/loss of muscle strength/ intermittent sensations of pins and needles, tingling, burning, and a shock-like pain in the head, feet and hands/ chronic pain; autonomic, neurological, heterogenous autoimmune disease/Gardasil-induced autoimmune disorder; On April 2, 2020, M.R. received the second Gardasil vaccination.; Information has been received from a lawyer, regarding a case in litigation and concerning a male patient (pt) of an unknown age. Prior to receiving the suspect vaccine, he had no autoimmune diseases, and no autonomic issues. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 12-OCT-2018, at the age of 12 years old, the pt received his first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. As the months progressed, so did the pt's injuries. He was seen by multiple physicians and specialists for his complaints. On an unknown date, the pt experienced small fiber neuropathy sensations, including intermittent sensations of pins and needles, tingling, burning, and a shock-like pain in the head, feet and hands. He also developed chronic pain, persistent muscle aches, pain and fatigue, a loss of stamina and muscle strength, and mood problems. He had extreme fatigue, problems with memory and concentration, headaches, and dizziness with moving from lying down to sitting or standing up. He would sleep for a long time, and still was feeling exhausted. The pt developed lightheadedness, faintness, brain fog, extreme fatigue, shakiness, intermittent chest pain, and exercise intolerance. On 02-APR-2020, the pt received his second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of vaccine administered). His symptoms worsened. As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities. On unknown dates, based upon his 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, chronic pain, chronic fatigue, neuropathy, and autonomic dysfunction. The pt's mother contended that the pt's quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused him to develop serious and debilitating injuries (also reported as disabling and painful chronic injuries), including but not limited to autonomic, neurological, heterogenous autoimmune disease, postural orthostatic tachycardia syndrome (POTS), and dysautonomia (also reported as autonomic dysfunction), 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. The pt had suffered and at the time of report continued to suffer severe and permanent physical injuries, and associated symptomatology and had suffered severe and permanent emotional injuries, including pain and suffering. He 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, the pt suffered and at the time of report 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 of POTS, small fibre neuropathy, and autoimmune disorder was considered to be not recovered. The lawyer considered the events of POTS, small fibre neuropathy, and autoimmune disorder 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 events of POTS, small fibre neuropathy, and autoimmune disorder was considered to be disabling.