Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Laboratory test abnormal, Ovarian failure, Premature menopause
Clinical narrative: premature ovarian failure; autoimmune disease; the pt received third dose of Gardasil on 10-AUG-2011; Information has been received from a lawyer regarding a case in litigation, concerning adolescent female patient (pt). Medical history, concurrent conditions and concomitant medications were not provided. Prior to receiving her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections the pt had no autoimmune disease. On 26-JUN-2009, at the age of 12 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as a safe and effective vaccine for preventing cervical cancer. On 26-AUG-2009 and 10-AUG-2011, the pt returned to her medical provider and received the second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of vaccine administration). On 16-AUG-2012, the pt presented to her primary care provided with concerns about amenorrhea since she had not yet started her period. On 05-SEP-2012, she was evaluated by a pediatric endocrinologist for primary amenorrhea. Her laboratory results indicated that she had high follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels and she was diagnosed with primary amenorrhea and ovarian failure. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with premature ovarian failure. The pt contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to autoimmune disease, 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. As a proximate result of 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), the pt suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. Plaintiff 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 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/not resolved. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of autoimmune disorder was considered to be medically significant. The reporter considered aforementioned events to be disabling.