Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Aphthous ulcer, Arthralgia, Asthenia, Attention deficit hyperactivity disorder, Autoimmune disorder
Clinical narrative: motor vehicle accident; L2 compression fracture of her spine (back pain); sepsis; coma; acute hypoxemic respiratory failure; bilateral pneumonia (fatique, low-grade fever, chest pain, leukocytosis, extreme pain); chronic tonsillitis; rectal bleeding; common variable immunodeficiency; degenerative disc disease; cervical somatic dysfunction; attention deficit hyperactivity disorder (ADHD); menstrual issues; amenorrhea; ovarian cysts; migraines (photosensitivity); depressive disorder; anxiety disorder; ovarian and pelvic pain; ovarian and pelvic pain; Stiffness in joints; Autoimmune injuries; seizure; dextrose scoliosis with a 22-degree spinal curve; chronic fatigue syndrome (CFS) (joint pain, insomnia); fibromyalgia; mast cell activation syndrome ("MCAS") (diarrhea, abdominal pain, rash, edema, rash and bruising, ecchymosis, gastrointestinal issues, poor digestion); POTS (Autonomic, neurological injuries, headaches, extreme fatigue, irregular heartbeat, tachycardia, numbness, tingling,brain fog, confusion, disorientation, trouble concentrating, diarrhea, lost consciousness); gastroesophageal reflux disease (severe sore throat, pharyngeal swelling, chest pain); Bechet's disease (oral aphthous ulcer, worsening mouth ulcers, fever, painful blisters on lip and mouth); Information has been received from a lawyer, regarding a case in litigation and concerning an adolescent female patient (pt) of an unknown age. No information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 15-JUN-2016, the pt saw her pediatrician to recheck her liver enzymes and monitor her recovery from a recent bout of mononucleosis and jaundice. Despite being physically unwell, the doctor recommended her quadrivalent human papillomavirus (HPV) (types 6,11,16,18) recomb. vaccine (GARDASIL).  On 15-JUN-2016, at the age of 17 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 prophylaxis. On 28-JUN-2016, the pt visited her pediatrician with a sore throat, fatigue, and low-grade fever. Despite concerns about the pt's recent mononucleosis infection, her laboratory test results for liver enzymes and monocytes were normal. On 13-JUL-2016, the pt saw a physician for persistent sore throat, fatigue, low-grade fever, and mouth ulcers. Doctor also noted that pt's laboratory results looked normal, indicating that mononucleosis was not the cause of her symptoms. Throughout June and July 2016, the pt continued to experience a severe sore throat and intermittent low-grade fevers. She was diagnosed by her pediatrician with sore throat, gastroesophageal reflux disease and oral aphthous ulcer. The pt continued to see doctor for sore throats and worsening mouth ulcers. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included: sore throat, mouth ulcers, joint pain, chest pain, headaches, photosensitivity, extreme fatigue, near syncope, irregular heartbeat, tachycardia, menstrual issues, pharyngeal swelling, chronic tonsillitis, painful blisters on lips and mouth, rash and bruising, ecchymosis, edema, ovarian and pelvic pain, numbness, tingling, stiffness in joints, insomnia, abdominal pain, gastrointestinal issues, poor digestion, diarrhea, rectal bleeding, brain fog, episodes of confusion and disorientation, and trouble concentrating. On 15-DEC-2018, the pt was taken to the hospital after a motor vehicle accident wherein she had a seizure and lost consciousness while driving. The pt drove straight across the road into an embankment and suffered a L2 compression fracture of her spine. She was diagnosed with new onset seizure disorder. She had back surgery to mend her broken vertebrae. She continued to suffer from back pain and has developed dextrose scoliosis with a 22-degree spinal curve because of her injury. On 19-AUG-2019, cardiologist conducted a tilt table test on the pt and diagnosed her with postural orthostatic tachycardia syndrome (POTS). On 05-NOV-2019, the pt was taken to the hospital because she was having trouble breathing and experiencing extreme pain. She was diagnosed with acute hypoxemic respiratory failure, bilateral pneumonia, and leukocytosis. She was put on a ventilator for six days and went into a coma. Plaintiff then developed sepsis and her parents were told they should say their goodbyes as Plaintiff would most likely not survive. By 19-NOV-2019, the pt improved significantly and was discharged to a rehabilitation facility to continue to gain strength and her ability to breathe on her own. She was subsequently discharged on 30-NOV-2019. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has not been able to participate in activities that a normal young adult would enjoy. She was on the brink of death and has continued to struggle with daily living. She had to take significant time off from college, yet, despite her health-related obstacles, she has continued to pursue her undergraduate degree, but with many accommodations. On unknown dates, based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been diagnosed with various medical conditions, including but not limited to: postural orthostatic tachycardia syndrome (POTS), chronic fatigue syndrome (CFS), fibromyalgia, mast cell activation syndrome (MCAS), Bechet's disease, common variable immunodeficiency, seizures, acute hypoxemic respiratory failure, bilateral pneumonia, leukocytosis, amenorrhea, degenerative disc disease, dextrose scoliosis, migraines, ovarian cysts, cervical somatic dysfunction, mixed headache disorder, attention deficit hyperactivity disorder (ADHD), depressive disorder, and anxiety disorder. The pt contended that her 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, POTS, CFS, fibromyalgia, MCAS, Bechet's disease, common variable immunodeficiency, seizures, acute hypoxemic respiratory failure, bilateral pneumonia, leukocytosis, amenorrhea, degenerative disc disease, dextrose scoliosis, migraines, ovarian cysts, cervical somatic dysfunction, mixed headache disorder, ADHD, depressive disorder, anxiety disorder, 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 autoimmune disorder. 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 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 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 was considered to be not recovered. The reporter considered the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The events were considered to be disabling. The event of sepsis was considered to be life-threatening.  Upon internal review, the events of sepsis, coma, acute hypoxemic respiratory failure, bilateral pneumonia, spinal compression fracture, chronic tonsilitis, rectal bleeding, mast cell activation syndrome, common variable immunodeficiency, Behcet's disease, seizure and autoimmune disorder were determined to be medically significant.