Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Asthenia, Back pain, Balance disorder, Disturbance in attention
Clinical narrative: POTS-like symptoms/dizziness/rapid heart rate upon standing/having trouble staying awake/often sleep for hours/not able to focus on her schoolwork/pain/not retaining what she was learning/weak/she needed to use a wheelchair/rib pain/chronic fatigue; irritable bowel syndrome/ frequent abdominal pain/ back pain; increased food allergies/ new and more intense food allergies and intolerances/ frequent abdominal pain; intense food allergies and intolerances/ frequent abdominal pain; balance issues; autoimmune injuries; allergic reaction to antibiotics; Information has been received from a lawyer regarding a case in litigation concerning a female patient on unknown age (reported as adult at the time of the report). Prior to receiving her of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccination, the patient enjoyed skiing down expert slopes, wakeboarding, and socializing with her friends. At school she participated in debate and speech competitions. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 30-AUG-2016 (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) (lot #, expiration dates, doses, routes of administration and anatomical locations were not provided) for preventing cervical cancer, as recommended by her physician, and consented by the patient's mother.  On an unspecified date, (after receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination), the patient began having trouble staying awake during classes. When she returned home, she often slept for hours. She was not able to focus on her schoolwork. The patient had severe pain all over her body, including frequent abdominal pain. She developed postural orthostatic tachycardia syndrome (POTS)-like symptoms, with dizziness, balance issues, and rapid heart rate upon standing. She developed new and more intense food allergies and intolerances. In September 2016, the patient's father initiated a Regulatory Authority disability plan because she was no longer able to focus and complete all her work. The patient's injuries progressed; in the Fall 2018 she was not retaining what she was learning in school. On 17-AUG-2018, the patient had to go to the emergency room (ER) due to an allergic reaction to antibiotics. In September 2018, she became so weak she could no longer walk and needed to use a wheelchair. She was seen by multiple physicians and specialists for her complaints which included: abdominal pain, lower rib pain, back pain and irritable bowel syndrome. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the patient was unable to engage in activities that a young person would normally enjoy. 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 chronic fatigue, chronic pain irritable bowel syndrome and increased food allergies. She contended, that the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to chronic fatigue, POTS-like symptoms, chronic pain, increased food allergies, and irritable bowel syndrome, 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 injures. 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 POTS-like symptoms, irritable bowel syndrome, food allergy, food intolerance, allergic reaction to antibiotics, balance disorder and autoimmune disorder 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 POTS-like symptoms, irritable bowel syndrome, food allergy, food intolerance, allergic reaction to antibiotics, balance disorder and autoimmune disorder were considered to be disabling.  Upon internal review the event of autoimmune disorder was determined to be medically significant.