Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Magnetic resonance imaging, Pain, Pain in extremity, Peripheral swelling, Postural orthostatic tachycardia syndrome
Clinical narrative: neurological; Autonomic Dysfunction/dysautonomia; Postural orthostatic tachycardia syndrome; as well as a constellation of adverse symptoms; heterogenous autoimmune disease; Henoch-Schonlien Purpura; complex regional pain syndrome; amplified musculoskeletal pain syndrome; Information has been received regarding a case in litigation from a lawyer and referred to an approximately 12 years old male patient (pt). His age at vaccination was 11 years old. No information was provided regarding the pt's concomitant medications.  Prior to receiving his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, the pt had no autoimmune diseases, and no autonomic issues. He was healthy, active, personable and an outstanding student. For several years, he played sports three seasons out of the year- soccer in the fall and spring; basketball in the winter. He maintained a 4.0 GPA and was on the honor roll all three trimesters of the school year. He was well liked by his classmates and teammates and had a large group of friends. He had had a severe peanut/tree nut allergy since he was a baby, but had otherwise always been a kind, sweet, healthy and happy boy. On 10-OCT-2017, the pt's health care provider recommended that the pt received the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine in two doses, six months apart, which was stated as a safe and effective vaccine for preventing cervical cancer. Pt's mother consented to pt being injected with the "cervical cancer vaccine," quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On the same day, the pt received his first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cervical cancer. On 12-APR-2018, the pt received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cervical cancer.  The dose, strength, route, lot number and expiration date were unknown. On or around 22-APR-2018, pt started to develop a rash consisting of raised, red, circular bumps on both legs and arms. At the same time, he began to experience pain in his left foot along with swelling, discoloration (redness), temperature change (coldness) and peeling/sensitive skin. It was so painful he struggled to walk and eventually his doctor ordered crutches. He missed school, physical education class and sports due to the pain in his left foot. Pt was also extremely worried about what was going on with him. Pt had several additional visited with his pediatrician for the rash and swollen/painful foot. His pediatrician became more concerned and ordered pt to go to the emergency room at Hospital on 26-APR-2018. At the emergency room, he had an intravenous (IV) placed, blood drawn for lab work and an examination. He was diagnosed with Henoch-Schonlien Purpura but the doctor could not determine what was causing the symptoms in pt's left foot. The doctor administered IV antibiotics. The pt was instructed to continue with oral antibiotics and follow up with a rheumatologist, infectious disease doctor, and his pediatrician, which pt did. On 02-MAY-2018, pt treated with his rheumatologist and was diagnosed with complex regional pain syndrome (CRPS). As the months progressed, so did pt's injuries. He was seen by multiple physicians and specialists for his complaints which now included: continued rash on his legs, reoccurring and prolonged bouts of left foot pain, swelling and redness, continued symptoms associated with his diagnosis of CRPS and a further diagnosis of amplified musculoskeletal pain syndrome (AMPS). The pt continued to receive periodic emergency room care at Hospital for his rash and swollen, painful and red left foot. Throughout the course of pt's treatment, he was frequently placed on IV medication and had blood drawn. The pt was terrified of needles and he often had to be sedated before the IV could be administered. He also received ultrasound and MRI of his left leg. He had additional consultation with neurologists and rheumatologists. His treating rheumatologist for CRPS ordered physical therapy and psychological treatment both through Hospital. He received sessions of physical therapy as well as psychological counseling for a year and a half. The pt's rheumatologist advised that CRPS was a lifelong autoimmune condition and that pt would continue to have amplified pain episodes in the future. The pt's treating doctors noted Human papilloma virus (HPV) reaction in relation to the onset of pt's symptoms. As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt was unable to engage in normal activities that a normal young person would enjoy. The pt was unable to attend school and participate in developmental activities like soccer and basketball. pt now lived with a permanent autoimmune disease and its ongoing residual pain. Based upon his chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been diagnosed with various medical conditions, including but not limited to, CRPS, AMPS, and autonomic dysfunction. The pt contended that his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused him/her to develop serious and debilitating injuries, including but not limited to CRPS, AMPS, autonomic, neurological, heterogenous autoimmune disease, postural orthostatic tachycardia syndrome (POTS), and dysautonomia, 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 to autonomic, neurological and heterogenous autoimmune injuries and resulting sequalae that the pt sustained as a result of receiving injections of the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. The pt sustained autoimmune disease, autonomic dysfunction and other Serious Injuries, as a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and Its Ingredients Caused the pt's Autoimmune Disease and other related injuries and has resulted in him suffering from severe, debilitating, disabling and painful chronic injuries. As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continues to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. pt also has 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, pt had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and he will 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 heterogenous autoimmune disease was determined to be medically significant.  The reporter considered the events to be disability.