Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Fatigue, Hormone level abnormal, Premature menopause, Somnolence
Clinical narrative: premature ovarian failure (POF)/ amenorrhea; her period ceased/ her hormone levels were that of an elderly woman; Autoimmune injuries; neurological injuries; autonomic injuries; somnolence; exhaustion; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) whose exact age/age group at the time of events could not be established unequivocally but who was an adult at the time of report. The pt's concurrent conditions, medical history and concomitant therapies were not provided. On unknown dates, all reported as when the patient was 12 years old, she was vaccinated with the first and second dose (two doses in total) of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided for any of administered doses) for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by the pt's physician and consented by the pt's mother. On unknown dates, reported as following human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, the pt experienced exhaustion and somnolence, and her periods ceased. She took a blood test and discovered that her hormone levels were that of an elderly woman. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints. Based on her chronic and severe post-human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she was diagnosed with amenorrhea and premature ovarian failure (POF). The pt contended that her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to amenorrhea and premature ovarian failure (POF), 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 human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. The pt contended that her human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations caused her to develop serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries and resulting sequalae. As a proximate result of the suspect vaccine, 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. 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 autoimmune disease and other injuries caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). As a direct and proximate result of her 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 all the events to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events of autoimmune and autonomic injuries were determined to be medically significant. The reporter considered all events to be disabling.