Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Asthenia, Autoimmune disorder, Autonomic nervous system imbalance, Chest pain
Clinical narrative: Mast Cell Activation Syndrome; Autoimmune Disease/neurological and heterogenous autoimmune injuries; migraine; Autonomic Dysfunction/autonomic/Dysautonomia; Ehlers-Danlos syndrome; Postural Orthostatic Tachycardia; difficulty speaking; as well as a constellation of adverse symptoms; Information has been received regarding a case in litigation from a lawyer and referred to a child (also reported as minor child) female patient (pt) of unknown age. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt had no autoimmune diseases and no autonomic issues. Prior to vaccination, the pt was a kid who loved to run, jump, climb and play sports. She began playing team soccer at 3 and later added t-ball followed by tennis. Most of all, the pt loved being in the water. She started swimming competitively on a neighborhood team while in kindergarten and then moved on to swimming year-round on club teams. In third grade, the pt began competing in triathlons and was a founding member of a local triathlon team. In addition to excellence in sports, the pt also excelled academically. The patient's historical condition and concomitant drug was not reported. On 28-AUG-2018, the pt's doctor recommended that she could receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, which was stated as a safe and effective vaccine for preventing cervical cancer. The pt was 11 years old when she received her first and only quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route, strength, lot number and expiration date were not reported) for prophylaxis on the same day. Within a few days, the pt began suffering from gastrointestinal issues including nausea, severe diarrhea and debilitating pain. In just a couple of months, the pt began to experience significant exhaustion and fatigue. Soon thereafter, she was experiencing joint pain and difficulty walking. The pt went from a healthy, robust child to a girl struggling to function. In little more than 5 months she went from swimming 30-50 laps in the pool without stopping to requiring a wheelchair because she couldn't walk or even remain conscious. As the months progressed, so did her injuries, she was seen by multiple physicians for her complaints which now included: nausea, severe diarrhea, migraines, inflammation, difficulty speaking, brain fog, severe exhaustion, difficulty sleeping, light sensitivity, leg pain and weakness, chest pain, heat intolerance, aches and pains in her joints and muscles, and exercise intolerance. As a result of post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities that a normal young person could enjoy. She was no longer permitted to participate in sports, and she could no longer participate in theater activities due to severe exhaustion. Due to her significant brain fog and exhaustion, she could not complete a full class schedule at school and had trouble remembering simple concepts and often became confused while reading to taking tests. The pt now required significant tutoring and academic assistance to keep up with her schoolwork. The pt sustained autoimmune disease, autonomic dysfunction and other serious injuries, as a result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, which had resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, migraine, dysautonomia, mast cell activation syndrome, Ehlers-Danlos syndrome, and postural tachycardia syndrome (POTS). The pt contended that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological and heterogenous autoimmune injuries, functional neurological disorder, functional limb weakness, functional movement disorder, functional vision disorder, functional speech symptoms, central and vestibular abnormalities, and POTS, as well as a constellation of adverse symptoms (Ill-defined disorder), 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 her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries, including, but not limited to, her autoimmune disease 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 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, the 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 the events was considered as not recovered. The reporter considered the events was related to the suspect vaccine.  Upon internal review, the events of autoimmune disorder and mast cell activation syndrome were determined to be medically significant.  The reporter considered the events to be disability.