Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Balance disorder, Dysphemia, Extremity contracture, Fatigue, Headache
Clinical narrative: postural tachycardia orthostatic syndrome (POTS) (headaches, chronic fatique, rapid heart rate, tunnel vision, brain fog, shortness of breath, autonomic neurological injuries); balance issues; uncontrolled twitches; stuttering episodes; contraction in her hands; Autoimmune injuries; 16 seizure-like episodes; 1st dose of Gardasil received on 28-AUG-2012, 2nd on 21-FEB-2020; Information has been received from a lawyer, regarding a case in litigation and concerning an adult female patient (pt), who at the time of the vaccination was 11 years old. Before receiving quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt was in an usual state of health, she enjoyed an active lifestyle. No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 28-AUG-2012, at the age of 11 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 21-FEB-2020, as an adult, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). On unspecified day, following her second quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced headaches, fatigue, rapid heart rate, and seizure-like episodes. She was rushed to the emergency room where she had over 16 seizure-like episodes. She was seen by multiple physicians and specialists for her complaints which then included: chronic fatigue, balance issues, tunnel vision, uncontrolled twitches, stuttering episodes, and contraction in her hands. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. The pt then took medications for her heart, must monitor her salt intake, can no longer engage in the same physical activities, fears driving a car, and suffers from chronic fatigue, brain fog, and shortness of breath. Her symptoms have interfered with her daily life and made it difficult to function. On unknown dates, based upon her 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, postural tachycardia orthostatic syndrome (POTS). The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) caused her to develop serious and debilitating autonomic, and neurological, injuries, including but not limited to postural tachycardia orthostatic syndrome (POTS), 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. 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. 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 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 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 she would continue to incur these losses and expenses in the future. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events were considered to be disabling.  Upon internal review, the events of autoimmune disorder and seizure were determined to be medically significant.