Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Exercise tolerance decreased, Fatigue, Feeling abnormal, Feeling jittery, Gastrointestinal disorder
Clinical narrative: first dose: 31-MAR-2015, second dose: 08-JUN-2017; Acquired Postural Orthostatic Tachycardia Syndrome (POTS)/ Orthostatic intolerance (OI)/ racing heart/tiredness/dizziness/trouble breathing/no energy/shortness of breath/lightheadedness/muscle aches/brain fog/ /nausea/nervousness/a jittery feeling/; Primary Autonomic Dysfunction/ Gardasil -induced autonomic disease/ heat intolerance/ exercise intolerance/weakness/trouble swallowing/vertigo/chronic constipation/blurry vision/insomnia/light and sound sensitivity/GI tract shutdown/numbness/tingling; depression; blood pooling; Gardasil-induced autoimmune disease; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a 13-year-old female patient (pt). Information about pt's concurrent conditions, medical history and concomitant therapy was not reported. On 31-MAR-2015, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection, and on 08-JUN-2017, she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Inappropriate schedule of product administration) intramuscular injection (strengths, lot numbers, expiration dates, doses, routes of administration and anatomical locations were not provided), administered for prevention of cervical cancer. On an unknown date in 2017, following her second vaccination, pt experienced: racing heart, weakness, tiredness, trouble swallowing, numbness in her hands and feet, constipation, migraines, dizziness, trouble breathing, no energy, vertigo, shortness of breath, blurry vision, lightheadedness, muscle aches, brain fog, blood pooling (cardiovascular disorder), gastrointestinal (GI) tract shutdown, tingling, heat intolerance, nausea, nervousness, a jittery feeling, trouble focusing, insomnia, exercise intolerance, faintness, light and sound sensitivity, anxiety, and depression. On an unknown day in November 2017, pt was referred to a doctor in a diagnostic and complex care center and she was diagnosed with acquired postural orthostatic tachycardia syndrome (POTS), primary, autonomic dysfunction (dysautonomia), migraine without aura and without status migraineurs, not intractable; and chronic constipation. Pt contended that human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries/dysfunctions, including but not limited to POTS/ orthostatic intolerance (OI) and dysautonomia, as well as a constellation of adverse symptoms, complications, injuries (also reported as resulting sequelae), and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced autoimmune disorder. Despite following her doctor's recommended course of treatment, pt's symptoms have not improved, and have continued without resolution. As a result of these post- human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt was unable to engage in activities a normal young person in her early twenty's would enjoy. As a proximate result of alleged company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), pt suffered and continued suffering severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. She 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 injuries caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, pt suffered and continued suffering 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. At the time of reporting, pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).   All the events were considered as disabling by reporter.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.