Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Fear, Gait disturbance, Hypotension, Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: dysautonomia/reduced appetite; small fiber neuropathy; chronic autoimmune demyelinating illness; cyanosis; nonrheumatic mitral valve prolapse; nonrheumatic mitral insufficiency; anaphylaxis; neurocardiogenic syncope; postural orthostatic tachycardia syndrome ("POTS")/dyspnea/vomiting/diarrhea/weight loss; hives-like rash around the vaccination site; first dosage of Gardasil on 04-MAY-2015, second on 19-OCT-2016 and third 15-DEC-2016; first dosage of Gardasil on 04-MAY-2015, second on 19-OCT-2016 and third 15-DEC-2016; Information has been received from a lawyer regarding a case in litigation and referred to a 13-year-old female patient (pt). Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections, the pt had no autoimmune diseases, and no autonomic issues and was in good health. The patient's medical history and concomitant therapies were not reported.   On 04-MAY-2015, the pt's health care provider recommended that the pt receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), which was stated as a safe and effective vaccine for preventing cervical cancer. On 04-MAY-2015, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) quadrivalent human injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The second dose and third doses were received on 19-OCT-2016 and 15-DEC-2016, respectively (Inappropriate schedule of vaccine administered).   On 15-DEC-2016, within an hour of receiving her third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt began suffering with shortness of breath, a hives-like rash around the vaccination site on pt's arm, and near-fainting/low blood pressure. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: shortness of breath on exertion, lightheadedness, fatigue, dizziness, palpitations, reduced appetite, vomiting, diarrhea, and severe weight loss. By April 2018, the pt was unable to walk without feeling like she was unable to catch her breath. On 02-NOV-2018, after months of consultations and testing with doctors and visits to the Emergency Room to address her constant symptoms, the pt was diagnosed with postural orthostatic tachycardia syndrome (POTS).  As a result of her post-Gardasil symptoms, the pt was unable to engage in normal activities that a young person would enjoy. The pt had to finish high school at home, she was unable to participate in physical activities, she was unable to work, and she was most mostly bedbound. The pt had little hope of attending college, holding a job, or living a normal life. Based upon her chronic and severe post-Gardasil symptoms, the pt was diagnosed with various medical conditions, including but not limited to, POTS, dysautonomia, small fiber neuropathy (SFN), neurocardiogenic syncope, anaphylaxis, chronic autoimmune demyelinating illness, cyanosis, hypotension, syncope, nonrheumatic mitral valve prolapse, and nonrheumatic mitral insufficiency. She 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. 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 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 has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she will continue to incur these losses and expenses in the future. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered all the events related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All the events were considered as disabling events.  Upon internal reviewed the event of chronic autoimmune demyelinating illness, nonrheumatic mitral insufficiency, anaphylaxis, neurocardiogenic syncope were considered to be medically significant.