Age: 11.0
Sex: F
Vaccine: HPV4, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: POTS/autonomic, and neurological injuries/chronic fatigue, heart palpitations, dizziness, difficulty concentrating, brain fog, memory issues, chronic headaches; generalized abdominal pain (irritable bowel syndrome)/abdominal pain, and stomach issues; disorder of bilirubin metabolism; disorder of bilirubin metabolism; hypophosphatemia; Hashimoto's disease/irregular menstrual cycle/joint pain; osteopenia; subclinical hypothyroidism; terminal ileitis/weight loss; first and second dosage of Gardasil on November 14, 2012, and March 13, 2013. She received a third dose on November 5, 2019 when she was 18; Information has been received from a lawyer, regarding a case in litigation and concerning a female patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided.   On 14-NOV-2012, at the age of 11 years old, the pt received her first dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for preventing cervical cancer. On 13-MAR-2013, the pt received her second dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported) (inappropriate schedule of product administration). Prior to receiving the third quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt was healthy, bright, active and sociable. On 05-NOV-2019, the pt received her third dose of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). Following the third quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced symptoms consistent with postural orthostatic tachycardia syndrome (POTS), chronic fatigue, heart palpitations, dizziness, difficulty concentrating, brain fog, memory issues, chronic headaches, joint pain, irregular menstrual cycle, abdominal pain, and stomach issues, which led to weight loss. The pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) injections (also reported as serious and debilitating injuries, including but not limited to autonomic, autoimmune, and neurological injuries and resulting sequalae). As a result of her post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been unable to engage in activities that a young person her age would normally enjoy. She enjoyed participating in sports, including gymnastics and skating. She enjoyed being outdoors and attending social gatherings. Pt lived a comfortable, outgoing day to day lifestyle. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints. Based upon her chronic and severe post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt has been diagnosed with generalized abdominal pain (irritable bowel syndrome), disorder of bilirubin metabolism, hypophosphatemia, Hashimoto's Disease, osteopenia, subclinical hypothyroidism, terminal ileitis. The pt contended that her third quadrivalent human papillomavirus (HPV) (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 POTS-like symptoms, generalized abdominal pain (irritable bowel syndrome), disorder of bilirubin metabolism, hypophosphatemia, Hashimoto's Disease, osteopenia, subclinical hypothyroidism, terminal ileitis, 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 (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries. The pt had suffered and at the time of report continued to suffer severe and permanent physical injuries, and associated symptomatology and had 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, the pt suffered and at the time of report 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 POTS, IBS, metabolic disorder, blood bilirubin abnormal, hypophosphatemia, Hashimoto's disease, osteopenia, subclinical hypothyroidism and terminal ileitis was considered to be not recovered.   The lawyer considered the events of POTS, IBS, metabolic disorder, blood bilirubin abnormal, hypophosphatemia, Hashimoto's disease, osteopenia, subclinical hypothyroidism and terminal ileitis to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event of Hashimoto's disease, subclinical hypothyroidism and terminal ileitis was determined to be medically significant. All of the reported adverse events were considered to be disabling.