Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Arthralgia, Burning sensation, Dizziness, Gastrointestinal disorder
Clinical narrative: PCOS / menstrual cycle irregular / weight gain / headaches; burning sensation in head / neurological injuries; oral trush; gastrointestinal issues; anxiety / tachycardia / rapid heart rate / dizziness; panic attacks / rapid heart rate / tachycardia / dizziness / headaches; autonomic injuries / neurological injuries; autoimmune injuries / chronic joint pain; chronic muscle pain; Information has been received from a lawyer regarding a case in litigation and refers to a female patient 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.. Her medical history, concurrent conditions and concomitant therapies were not reported. On 28-JUN-2018, 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) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) at a health department, as recommended by a certified nurse practitioner (CNP), and with consent of the patient's mother, for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"). On 04-OCT-2018, she was vaccinated with the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), and on 07-FEB-2019, with the third dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided), both at the health department, as recommended by her health care professional (HCP), with her and her mother's consent, for prophylaxis. On unknown dates, following her third vaccination, the patient developed a rapid heart rate, weight gain, and her menstrual cycle became irregular. As the months progressed, so did the patient's injuries. She was seen by multiple physicians and specialists for her complaints which at that time included: chronic joint and muscle pain, burning sensation in her head, oral trush, gastrointestinal issues, headaches, dizziness, tachycardia, anxiety, and panic attacks. As a result of her post-human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was unable to engage in activities that a normal young person would enjoy. Prior to human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she was a happy and healthy young woman who enjoyed working and going to high school. Following the human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, the patient's entire life was taken over by her medical issues. She had to quit her job due to her pain. She was no longer spending her time with her friends because she felt miserable. Based upon her chronic and severe post-human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she was diagnosed with various medical conditions, including but not limited to, polycystic ovary syndrome (PCOS) and tachycardia. The patient contended that her 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 PCOS and tachycardia, as well as constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were 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. 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 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 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 patient 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 events of PCOS, autonomic neuropathy and autoimmune disorder were determined to be medically significant. All events were considered to be disabling.