Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Loss of personal independence in daily activities
Clinical narrative: heart race/ POTS: fatigue, ligtheadedness, tachycardia/autonomic injuries; neurological injuries; constellation of adverse symptoms, complications, injuries and other adverse events; gardasil induced autoimmune disorder; first dose on 18-MAY-2015 and second dose on 22-AUG-2016; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, and concomitant medications were not provided. On 18-MAY-2015 (when she was 12-years old), the pt was inoculated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection as prevention of cervical cancer (dose, route of administration, anatomical location, lot number, and expiration date were not provided). Subsequently on 22-AUG-2016, she received the second dose of the vaccine (inappropriate schedule of product administration), both vaccines were administered under her physician's recommendation. On an unknown date, following her second vaccination, the patient began to feel her heart race whenever she did physical activity. As the months progressed, so did the pt's injuries. She was seen by multiple physicians and specialists for her complaints which included fatigue, lightheadedness, and tachycardia. 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. Prior to the Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccinations, the pt was a happy and healthy young woman who enjoyed playing softball and volleyball. She could no longer enjoy those activities as she has had a hard time walking up the stairs due to her high heart rate. She has continued to experience dizziness, fatigue, and high heart rate. Based upon her chronic and severe symptoms she was diagnosed with various medical conditions, included but not limited to postural orthostatic tachycardia syndrome (POTS) and tachycardia. In addition, the pt contended that her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to POTS and tachycardia, as well as a constellation of adverse events symptoms, complications, injuries, and other adverse events, many of which were 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. Moreover, as a result of company's alleged wrongful acts and breaches of warranties concerning the safety and efficacy of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the pt has suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and has 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 Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). Additionally, as a direct and proximate result of her vaccine-induced injuries the pt has suffered and will continue to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and will continue to incur. The patient had not recovered from the adverse events, and it was considered the events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  The reporter considered all the events to be disabling.   Upon internal review, the event autoimmune disorder was considered to be medically significant.