Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ill-defined disorder, Laboratory test abnormal, Loss of personal independence in daily activities, Nervous system disorder, Systemic lupus erythematosus
Clinical narrative: Systematic Lupus Erythematosus; Thrombocytopenic Purpura; autonomic, autoimmune, and neurological injuries/issues; autonomic, autoimmune, and neurological injuries/issues; various medical conditions, including but not limited to, SLE and resulting hematologic problems/constellation of adverse symptoms, complications, injuries, and other adverse events; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a currently adult female patient (pt). Information about pt's concurrent conditions, medical history and concomitant therapy was not reported. The pt enjoyed playing the piano, dancing and running cross country, she had been identified as a gifted student and was in good health. The pt's mother had agreed for her daughter to be vaccinated after being exposed to the company's marketing and doctor's recommendation. On 28-MAY-2015 (at 14 years old), the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection (strength, lot number, expiration date, dose, route of administration and anatomical location were not provided), administered for preventing cervical cancer at a clinic. It was stated that prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s), the pt had no autoimmune, autonomic, or neurological issues. The pt presented serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries (autonomic nervous system imbalance and nervous system disorder) and resulting sequalae as a result of receiving the vaccine (ill-defined disorder); soon after vaccination, the pt began to show hematological problems that were eventually diagnosed as symptoms of thrombocytopenic purpura. Later testing showed that the pt was suffering from systemic lupus erythematosus (SLE), a chronic autoimmune disease known to cause hematologic problems, including thrombocytopenic purpura. As a result of his post-vaccine symptoms, pt had been unable to engage in normal activities that a normal young person would enjoy and based upon her chronic and severe post-vaccine symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, SLE and resulting hematologic problems; 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 vaccine-induced autoimmune disorder. As a proximate result of the company's alleged wrongful acts and vaccine's manufacturing defects, pt suffered and continued suffering severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. He 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 his 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 his 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 he (inconsistent gender) would continue to incur these losses and expenses in the future. At the time of reporting, pt had not recovered from the claimed events. The reporter considered all the claimed events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).   Upon internal review, systemic lupus erythematosus and thrombocytopenic purpura were determined to be medically significant event.  All the claimed events were considered as disabling by reporter.