Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Headache
Clinical narrative: autonomic injuries; neurological injuries; severe menstrual pain / unexplained severe menstrual pain / gynecological injuries; gastrointestinal issues; autoimmune injuries / GARDASIL-induced autoimmune injuries; headaches; chronic fatigue; Initial spontaneous information has been received from a lawyer, regarding a case in litigation, and refers to an adolescent female patient (pt) whose exact age at the time of events was unknown and who was conflictingly referred to at the time of report as an adult. The pt's medical history, concurrent conditions and concomitant medications were not provided. On 29-JUL-2019, 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) intramuscular injection (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by a physician and consented by the pt's mother. On 29-JUN-2020, the pt was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On unknown dates, reported as following her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, the pt began experiencing unexplained severe menstrual pain (also reported as sustained serious gynecological injuries), headaches, chronic fatigue, and gastrointestinal issues (all also referred to as serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries and resulting sequalae). It was contended that the pt's quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating medical conditions, including but not limited to, severe menstrual pain, headaches, chronic fatigue and gastrointestinal issues 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 Company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to, at the time of report, 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, the pt's mother had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and they would continue to incur these losses and expenses in the future. The outcome of all events was considered not recovered/not resolved. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  All events were considered by the reporting lawyer to be disabling.  Upon internal review, the events of autonomic neuropathy and autoimmune disorder were determined to be medically significant.