Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dysmenorrhoea, Gait disturbance, Heavy menstrual bleeding, Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: serious autoimmune, autonomic, and neurological dysfunctions/ Gardasil-induced autoimmune, autonomic, and neurological diseases/ serious and debilitating autoimmune, autonomic, and neurological, injuries; serious autoimmune, autonomic, and neurological dysfunctions/ Gardasil-induced autoimmune, autonomic, and neurological diseases/ serious and; difficult to walk; serious autoimmune, autonomic, and neurological dysfunctions/ Gardasil-induced autoimmune, autonomic, and neurological diseases/ serious and debilitating autoimmune, autonomic, and neurological, injuries; first dosage of Gardasil on January 15, 2020, and June 12, 2020, third dosage of Gardasil on March 12, 2021; polycystic ovary syndrome/ menstrual cycle lasted for 28 days/ excessive bleeding and pain/ periods completely stopped/ terrible pain/ she had two ovarian cysts; urinary tract infections; other menstrual irregularities; Information has been received from a lawyer regarding a case in litigation concerning a 15-year-old female patient. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the patient was happy and healthy, had normal menstrual cycles, she played sports and was working for her ironman metal. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 15-JAN-2020 (at the age of 15 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), and on 12-JUN-2020, with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration dates, doses, routes of administration and anatomical locations were not provided for both doses) as prevention of cervical cancer, as recommended by her physician and consented by the patient's mother.  In June 2020 (reported as following the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations), the patient started having terrible urinary tract infections multiple times a week. Also in June 2020, her menstrual cycle lasted for 28 days. She had excessive bleeding and pain. She was advised to get an intrauterine device (IUD) to help with the excessive bleeding and pain, but her symptoms continued to worsen. On an unspecified date (reported as after some time), the patient's periods completely stopped but she continued to have terrible pain. On 18-AUG-2020, the patient had an urgent appointment with her obstetrician-gynecologist (OBGYN) and after examination and tests (unspecified), it was found that she had two ovarian cysts, one on each ovary. The physician discussed with her the possibility of infertility. The pain that remained following the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations had prevented the patient from going to school regularly and resulted in missed work as it was difficult to walk. She was no longer able to engage in the physical activities she had done prior to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was diagnosed with various medical conditions, including but not limited to, polycystic ovary syndrome and other menstrual irregularities. She contended, that the 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 polycystic ovary syndrome and other menstrual irregularities, 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.  On 12-MAR-2021 (at the age of 16 years old), the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, dose, route of administration and anatomical location were not provided) as prevention of cervical cancer (inappropriate schedule of product administration).   As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the patient suffered and continued to suffer severe and permanent physical injuries and associated symptomatology 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 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, she also 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 of polycystic ovarian syndrome, urinary tract infection, other menstrual irregularities, neurological disorder, autonomic disorder, autoimmune disorder and difficulty in walking was not recovered at the time of the report.   The events were considered to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb vaccine (GARDASIL).  The events of polycystic ovarian syndrome, urinary tract infection, other menstrual irregularities, neurological disorder, autonomic disorder, autoimmune disorder and difficulty in walking were considered to be disabling.  Upon internal review the events of polycystic ovarian syndrome, autonomic disorder, and autoimmune disorder were determined to be medically significant.