Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired gastric emptying, Inappropriate schedule of product administration, Injection site pain, Irritable bowel syndrome, Laboratory test abnormal
Clinical narrative: gastroparesis/stomach issues, bad gas, belching, discomfort, and experiencing gastric distress; intermittent paralysis in leg; POTS/breathing/fatigue/hot flashes/headaches/dizziness/abdominal pain/inability to focus/brain fog/anxiety/increased heart rate/stomach pain/nausea/visual disturbance/disturbed sleep/autonomic dysfunction/light sensitivity/confusion/chest tightness; chronic fatigue syndrome; irritable bowel syndrome (IBS); occasional pharyngitis/throat pain; a strep infection; missed menstrual cycle; back pain; sensitivity to smells; thinning eyelashes and eyebrows; thinning hair; other symptoms/constellation of adverse symptoms, complications, injuries, and other adverse events; other symptoms/constellation of adverse symptoms, complications, injuries, and other adverse events; rash or hives; other symptoms/constellation of adverse symptoms, complications, injuries, and other adverse events; rash or hives; Autoimmune/inflammatory syndrome induced by adjuvants/constant fatigue/joint pain/dry mouth/positive ANA; transaminitis/elevated liver enzymes; pain in her arm at the injection site that was spreading to her shoulder/a painful arm for a week; dose 1 on 13-JUL-2016 and dose 2 on 09-OCT-2017; dysmenorrhea/painful menses; Information has been received from a lawyer regarding a case in litigation and refers to an approximately 15-year-old female patient (pt) (currently as an adult). No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 13-JUL-2016, at the age of 15-year-old, the pt received her first dosage 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. Over the 15 months following her first quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt experienced occasional pharyngitis, a strep infection, episodic cluster headaches, generalized abdominal pain, painful menses, and other symptoms that the pt and her parents did not at the time attribute to quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL). On 18-MAY-2017, the pt was diagnosed with dysmenorrhea. On 14-JUL-2017, the pt reported to her pediatrician that she had experienced some trouble breathing, however, there were no abnormal findings upon examination. On 09-OCT-2017, the pt returned to her pediatrician's office and received her second dosage 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). Immediately following the second vaccination of quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt went to the bathroom and felt dizzy and nauseous. Within a couple of days following, the pt was still experiencing pain in her arm at the injection site that was spreading to her shoulder. She was advised to take ibuprofen (ADVIL), and heat and ice the area. On 19-OCT-2017, the pt's mother reported to the pediatrician that for four days the pt had been experiencing stomach issues, bad gas, belching, discomfort, and experiencing gastric distress. She also reported that the pt had a rash or hives, and a painful arm for a week. On 05-JAN-2018, the pt was diagnosed by her neurologist with transaminitis, postural orthostatic tachycardia syndrome (POTS), and autoimmune/inflammatory syndrome induced by adjuvants (ASIA), especially with autonomic dysfunction. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: daily headaches, disturbed sleep, dizziness, nausea, tingling in hands and feet, intermittent paralysis in leg, throat pain, stomach pain, chest tightness, increased heart rate, visual disturbance, back pain, side pain, light sensitivity, sensitivity to smells, hot flashes, joint pain, thinning eyelashes and eyebrows, thinning hair, fevers, constant fatigue, loss of appetite, missed menstrual cycle, dry mouth, burning while urinating, inability to focus, brain fog, confusion, and anxiety. On 23-JAN-2019, the pt saw a pediatric cardiologist for her symptoms and POTS diagnosis. Orthostatic testing was done, which verified her symptoms were consistent with POTS. As a result of her post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a normal young person would enjoy. She had to give up competitive swimming in high school. She lost many friends, as she was no longer able to participate in social activities like she had prior to receiving quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL). The pt had to be homeschooled for the second half of her junior year and struggled through her senior year of high school because of her injuries. Currently, the pt worked hard to manage her myriad symptoms, which have made it very difficult to complete the education necessary to pursue her intended career as a teacher. Based upon her chronic and severe post-quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, as she contended that her vaccinations caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to, POTS, ASIA, irritable bowel syndrome (IBS), gastroparesis, elevated liver enzymes, chronic fatigue syndrome, anxiety, and positive ANA, all resulting in she experiencing daily headaches, disturbed sleep, dizziness, nausea, tingling in hands and feet, intermittent paralysis in leg, throat pain, stomach pain, chest tightness, increased heart rate, visual disturbance, back pain, side pain, light sensitivity, sensitivity to smells, hot flashes, joint pain, thinning eyelashes and eyebrows, thinning hair, fevers, constant fatigue, loss of appetite, missed menstrual cycle, dry mouth, burning while urinating, inability to focus, brain fog, confusion, 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 (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 autoimmune disorder. The pt had suffered and 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 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. The lawyer considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  All the events were considered to be disabling by the lawyer.   Upon internal review, the events of agency, gastroparesis and intermittent paralysis in leg were determined to be medically significant.