Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Gastrointestinal disorder, Headache, Hypersomnia, Inappropriate schedule of product administration
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS)/ chronic headaches, stomach issues, body aches, tremors, rashes, severe anxiety and pains/ weight loss/ serious autonomic, and neurological dysfunctions/ Gardasil-induced autonomic neurological disease; sleep constantly; severe anxiety/ anxiety and depression worsened; anxiety and depression worsened; serious autoimmune, autonomic, and neurological dysfunctions/ Gardasil-induced autoimmune, autonomic, and neurological diseases/ autoimmune, autonomic, and neurological, injuries; hives; first dosage of Gardasil on November 26, 2019; second dosage of Gardasil on December 2, 2020; Information has been received from a lawyer regarding a case in litigation concerning a female patient of an unknown age. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the patient was a normal, healthy child. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 26-NOV-2019 (at the age of 11 years old), the patient was vaccinated with the first 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, as recommended by her health care provider (physician assistant) and consented by the patient's mother.  On an unspecified date (reported as following the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination), the patient had constant complaints of chronic headaches, stomach issues, hives, body aches, rashes, tremors, severe anxiety, and pains. The patient had also severe weight loss and she slept constantly. On 02-DEC-2020 (at the age of 12 years old), the patient was vaccinated with the second 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 recommended by her health care provider (nurse practitioner) and consented by the patient's mother. On an unknown date, the patient sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections. The symptoms worsened after second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The patient sought treatment with multiple physicians and specialists for her complaints and was eventually diagnosed with postural orthostatic tachycardia syndrome (POTS). 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 normal young person would enjoy. The patient was pulled out of school due to her medical condition and numerous absences. At the time of reporting, she was in online school. As a result of constantly being sick, the patient's anxiety and depression worsened. 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 POTS. 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 POTS, 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. 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 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 POTS, autoimmune disorder, hives, depression, anxiety and hypersomnia 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, autoimmune disorder, hives, depression, anxiety and hypersomnia were considered to be disabling.  Upon internal review the event of autoimmune disorder was determined to be medically significant.