Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Chest discomfort, Disability, Discomfort, Dizziness, Dyspnoea
Clinical narrative: Postural Tachycardia Syndrome (POTS); Polycystic Ovary syndrome (PCOS); tightness and pressure in throat; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; autoimmune disorder; Nervous system disorder; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On an unknown date, the pt was vaccinated with the first (15-year-old) and second dose (16-year-old) of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cancer. It has been reported that the pt sustained serious autoimmune, autonomic, and neurological Injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. The pt's mother, agreed to her daughter receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) after being convinced by marketing that was very safe and prevented cancer, she relied upon company's ubiquitous representations concerning the safety and efficacy of the vaccine in consenting to her daughter's vaccinations. Her health care provider (HCP) recommended that pt receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, which was touted as a safe and effective vaccine for preventing cervical cancer. Upon information and belief, pt's doctor, read and relied upon information from the company, through its labeling and/or marketing, that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was safe and effective. On an unknown date, following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, pt experienced disabling headaches, dizziness, shortness of breath, body aches, hot sweats, chronic fatigue, tightness and pressure in her throat and chest, blurry vision, and body tremors. As the months progressed, so did pt's symptoms, she was seen by multiple physicians and specialists. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been diagnosed with Postural Tachycardia Syndrome (POTS) and Polycystic Ovary Syndrome (PCOS). 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 PCOS, as well as a constellation of adverse 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, the pt had complied with the National Vaccine Injury Compensation Program Requirements. 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), pt had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering, pt 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). As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur those losses and expenses in the future. The outcome of all events was not resolved. The causality assessment between all the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was considered as related by the lawyer.    All the events were considered disabling by the reporter. Upon internal review, the events polycystic ovarian syndrome and autoimmune disorder were considered medically significant.