Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Orthostatic intolerance, Pallor, Paraesthesia, Peripheral coldness
Clinical narrative: gallstones; orthostatic intolerance / Postural Orthostatic Tachycardia Syndrome/ Autonomic Dysfunction/ she would lose all color, pale, persistent nausea, chronic headaches, fatigue, dizziness, dysautonomia symptoms including orthostatic fainting; myalgia; gastrointestinal motility; myoclonus; motor dysfunction; abnormal sensation including coldness in limb; limb paresthesia; photophobia; hypersomnia; insomnia; verbal dyspraxia; menstrual abnormalities; abnormal sensation including coldness in limb; chronic fatigue syndrome / prolonged general fatigue; migraine; gastroparesis / severe abdominal pain, nausea, and vomiting; shortness of breath; swelling at the injection site; diarrhea; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an approximately 12-year-old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.    On 21-AUG-2013, the patient received her first and only vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported), for prevention of cervical cancer. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection, patient was in her usual state of health and was physically very active. It was claimed that the patient sustained autoimmune disease and other serious injuries, including but not limited to postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance (OI), gastroparesis and autonomic dysfunction as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection. Quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) and its ingredients caused patient's autoimmune disease and other related Injuries and has resulted in her suffering from severe, debilitating, disabling and painful chronic injuries.  Soon after quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection, patient developed swelling at the injection site, followed by symptoms of shortness of breath and nausea that persisted and persisted throughout the week. Patient was often sent home from school because she would lose all color and need to lie down. Patient returned to the doctor's office on 18-NOV-2013 due to symptoms of nausea and headaches. A computerized tomography (CT) head scan was ordered, and the results were normal. Patient returned on 25-NOV-2013 again for nausea and headaches, as well as diarrhea and fatigue. On 13-JAN-2014, she was taken to the hospital for dizziness and persistent nausea. On the way to the emergency room, she was noted to be pale with her eyes rolling back in her head. By mid-January 2014, patient's symptoms were interfering with her ability to attend school, and she had to drop out of her private school and enroll in a homeschool program. Patient returned to the hospital on 21-MAY-2014 for severe abdominal pain, nausea, and vomiting. She was found to have gallstones and underwent a laparoscopic cholecystectomy; however, her gastrointestinal symptoms did not improve.  As the months progressed, so did patient's injuries. She was seen by multiple physicians and specialists for her complaints which now included prolonged general fatigue, chronic headaches, migratory joint pain, myalgia, myoclonus, dysautonomia symptoms including orthostatic fainting, gastrointestinal motility, motor dysfunction, abnormal sensation including coldness in limb, limb paresthesia, photophobia, hypersomnia, insomnia, verbal dyspraxia, and menstrual abnormalities.  As a result of her post - quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms, patient was unable to engage in normal activities that a person would typically enjoy. She had trouble keeping up with classes and was forced to be removed from school. She could barely attend online college classes and had to put her career dreams on hold due to her extreme fatigue. As a result of her gastroparesis, patient had to have a gastric pacemaker surgically inserted, and has already undergone another procedure to replace her first pacemaker. Based upon her 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 her medical providers, patient has been diagnosed with various medical conditions, including but not limited to OI, gastroparesis, autonomic dysfunction, migraines, and chronic fatigue syndrome (CFS). Patient contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL injection caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, OI, gastroparesis, 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 her 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 and associated symptomology and have 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 and future symptoms and harms associated with their autoimmune diseases and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL). As a direct and proximate result of 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, and diminished income capacity, and they will continue to incur these losses and expenses in the future.  The outcome of gallstones was unknown. The outcome of all other events was reported as not recovered/not resolved. The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the events of gastroparesis and gallstones (as they were treated by cholecystectomy) were considered to be medically significant.