Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Adverse event, Alopecia, Amenorrhoea, Anxiety, Asthenia
Clinical narrative: cysts on her breast requiring surgery and reconstruction; Factor XII deficiency blood disorder/bruisability; autoimmune disorder/autoimmune disease; Hand numbness; gastritis (bloating, loss of apetite); tonsillitis/sore throat; gassiness; Back pain; lost about fifty percent of her hair, as it came out in clumps; polycystic ovarian syndrome/menstrual irregularities/her period completely stopped for 3-4 months/she had heavy periods for fourteen days at a time/ intense pain// extremely abnormal periods; POTS/hypersensitivity to noise and light/struggled to take a shower without passing out/ dizziness, vasovagal/vasovagal near syncope/postural changes in her blood pressure and heart rate/palpitations/orthostatic intolerance/autonomic dysfunction; Ehlers-Danlos syndrome/joint hypermobility/legs and hands always hurt/she would rub her thighs and complaint about the pain/leg cramps, generalized weakness, fatigue/easy bruisability; anxiety/adjustment disorder with mixed anxiety and depressed mood/sad and depressed mood, panic attacks, and cutting behavior/sleep disruption, increased irritability; depression/ transitioned from an energetic, athletic young woman to someone who didn't really laugh, smile or talk anymore/symptoms of depression and diagnosed her with major depressive disorder, single episode, mild/mostly slept; gastritis/GERD/various GI symptoms including abdominal pain, reflux, heartburn, vomiting, nausea and constant stomach complaints with pain and nausea/epigastric pain; She lost fifteen pounds over three months/a ten-pound weight loss over the past year; Information has been received from a lawyer regarding a case in litigation referring to a 13-year-old female patient (pt). The pt's concurrent condition included scoliosis. Her medical history included intermittent headaches. She had no autoimmune diseases, and no autonomic issues. The pt was happy, healthy, and active. She had no history of depression or anxiety prior to vaccination.  On 02-JUN-2015, the pt's healthcare provider recommended to receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), which was stated as a safe and effective vaccine for preventing cervical cancer. On the same date, the pt received her first and only dosage of "cervical cancer vaccine" quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). At the time of her vaccination on 02-JUN-2015, pediatrician noted that she ate a well-balanced diet, slept seven to eight hours nightly, was performing well in school, and was active in competitive swimming. No behavioral issues were noted. The pt sustained autoimmune disease, autonomic dysfunction and other serious injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection. Vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) resulted in her suffering from severe, debilitating, disabling and painful chronic injuries. Following the vaccination, the pt suffered a constellation of symptoms including constant headaches, anxiety, hypersensitivity to noise, and hypersensitivity to light. She would tell her parents to turn down the TV or radio because it was too loud. She struggled with feeling like she was going to pass out. The pt also had constant stomach complaints with pain and nausea to the point that she would even refuse to each her favorite foods. She lost fifteen pounds over three months. After receiving the vaccination, the pt also complained that her legs and hands always hurt. She would rub her thighs and complain about the pain. Her periods completely stopped for 3-4 months; when they restarted, they were extremely abnormal. She had heavy periods for fourteen days at a time. The pt complained of intense pain. She has also lost about fifty percent of her hair, as it came out in clumps. As the months progressed, so did the pt's injuries. By November or December 2015, the pt struggled to even take a shower without passing out. She would call out to her mother to come help her quickly when she felt like she was going to faint. During February 2016, the pt had an episode where she passed out at a basketball game. The pt transitioned from an energetic, athletic young woman to someone who did not really laugh, smile, or talk anymore; she mostly slept and complained about her pain. The pt's mother picked her up from school many times, and she missed more school in the school year following her vaccination than she did in her entire school career. The pt required a "504 plan" given her disability. According to the pt's mother, she began to experience symptoms in August 2015, consisting of regular headaches, anxiety, hypersensitivity to sound and light, abdominal pains, and pains in her hands and legs. She also began to experience menstrual irregularities. By November and December of 2015, the pt struggled to take a shower without passing out. On 17-MAR-2016, the pt presented to the emergency department (ED), where she was evaluated by two different physicians, who noted that since September 2015, she had developed intermittent headaches, back pain, leg cramps, nausea, and generalized weakness. The pt's mother was concerned her daughter's symptoms were related to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot she received. The prior day (considered as 16-MAR-2016), the pt was weaker than normal and had lightheadedness with vertigo. The pt complained that she felt like she and the room were spinning with feeling like she might pass out. In another record from this visit, it was stated, "Mother reported pt started having HA (considered as headache) and back pain since September. Mother reported pt has been very dizzy especially when getting "gout" of shower. Mother reported she thought this was related to (reported as r/t) human papillomavirus (HPV) vaccine." The pt was discharged home and advised to follow-up (FU) with her pediatrician. Further documentation from this visit described the pt as a 14-year-old female who presented with multiple complaints over the course of the last seven months; since September she had been having intermittent headaches, nausea, back pain, leg cramps, and generalized fatigue and lightheadedness. The pt's mother stated that she was concerned that this was a reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) shot. On 21-MAR-2016, the pt was seen by physician assistant (PA) for worsening headaches, leg pains, fatigue, epigastric pain, and a ten-pound weight loss over the past year. PA noted increased anxiety due to the divorce of the pt's parents and placed a referral to a counselor. On 20-APR-2016, the pt was evaluated by a pediatrician due to sore throat, who diagnosed her with tonsillitis and prescribed unspecified antibiotics. On 27-APR-2016, the pt was evaluated by an ear, nose and throat (ENT) physician, who noted that following her vaccine shot, she had developed some malaise and weakness since then, and that "she was getting short of breath and was generally very tired". This represented a change for her in terms of her pre-injection function level". The physician also noted symptoms of dizziness, nausea, dysmenorrhea, muscle pain, migraine headaches, fainting, anxiety, and easy bruisability. On 04-MAY-2016, the pt was evaluated by a pediatric cardiologist, who noted dizziness that prevented her from taking showers, shortness of breath, fatigue, nausea, and abdominal pain. The physician noted that "prior to that receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) she was evidently fine with no symptoms or medical issues." The pt was diagnosed with "dizziness, vasovagal." On 08-MAY-2016, the pt was evaluated in the ED again for headache. She was diagnosed with migraine and discharged home. On 26-OCT-2016, the pt had a FU with PA for ongoing headaches. On 01-NOV-2016, she had another FU with PA for recurrent epigastric pains, belching, and nausea. She was diagnosed with gastritis and prescribed sucralfate (CARAFATE) and omeprazole. On 14-NOV-2016, the pt was evaluated in the ED for migraine headache. She was treated symptomatically and discharged home. On 01-DEC-2016 and on 21-DEC-2016, she had FUs with PA, who noted continued chronic headaches, as well as symptoms of depression and anxiety. On 28-DEC-2016, the pt was evaluated by pediatric neurologist, who noted headaches that were occurring daily. On 21-JAN-2017, the pt had a FU with PA who noted increasing depression and anxiety. On 24-FEB-2017, she had another FU with PA who noted episodes of tachycardia and dizziness, as well as epigastric pain with reflux. At this visit orthostatic vitals were performed. These demonstrated a heart rate that increased from 66 bpm supine to 104 bpm standing (38 bpm increase), without an abnormal drop in blood pressure. PA noted "tachycardia from supine to standing as noted" and referred the pt to cardiology for further evaluation. On 24-MAR-2017, the pt was evaluated by a pediatric cardiologist, who documented that pt was noted by her primary care provider to have postural changes in her blood pressure (conflicting information) and heart rate. Cardiologist noted symptoms of palpitations, dizziness while standing and while taking a shower, and daily headaches, and performed "orthostatic" at this visit. The pt's heart rate increased from 72 bpm supine to 69 bpm sitting, to 98 bpm standing, without an abnormal drop in blood pressure. Cardiologist diagnosed the pt with vasovagal near syncope, however provided her with a postural orthostatic tachycardia syndrome (POTS) handouton fluid therapy and dietary changes. She also prescribed fludrocortisone, a medication that increases blood pressure. On 13-APR-2017, the pt was evaluated by a geneticist for joint hypermobility and concerns of Ehlers-Danlos syndrome. The physician noted dizziness, sleep disruption, fatigue, shortness of breath, and intermittent hand numbness and ordered genetic testing which returned normal. On 02-JUN-2017, the pt was evaluated by a pediatric gastroenterologist, who noted various gastrointestinal (GI) symptoms including abdominal pain, constipation, reflux, heartburn, increased irritability, bloating, gassiness, vomiting, nausea and loss of appetite, ongoing the past 18-19 months (considered as since November 2015, abdominal pains were also provided as started in August 2015, conflicting information). In the review of systems from this visit, the physician noted symptoms of heart palpitations, dizziness, fainting, anxiety, and difficulty breathing, among others. The physician diagnosed her with gastroesophageal reflux disease (GERD) and prescribed her lansoprazole. On 23-AUG-2017, the pt had a FU with a physician who noted continued headaches. On 14-DEC-2017, the pt had a FU with gastroenterologist. A gastric emptying study was ordered which returned normal. On 12-FEB-2018, the pt had an appointment with her pediatrician at the time, requesting to be excused from physical education class because of POTS, Ehlers-Danlos syndrome, and migraine headaches. The physician composed a letter to this effect. On 07-MAY-2018, the pt was evaluated by licensed clinical social worker (LCSW) who noted that the pt reported a sad and depressed mood, panic attacks, and cutting behavior. A diagnosis of POTS and Ehlers-Danlos syndrome was noted on this visit. She was diagnosed with adjustment disorder with mixed anxiety and depressed mood. On 30-JUN-2018, the pt was evaluated by master of social work (MSW) who noted continued symptoms of depression and diagnosed her with major depressive disorder, single episode, mild (events were also provided as severe, conflicting information). As detailed herein, the pt was seen by multiple physicians and specialists for her complaints and was diagnosed with orthostatic intolerance (OI) and symptoms of autonomic dysfunction including orthostatic lightheadedness, shortness of breath, chronic migraine headaches, fatigue, and prominent GI dysfunction, none of which were present prior to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. On an unknown date, more recently, the pt has been diagnosed with polycystic ovarian syndrome, cysts on her breast requiring surgery and reconstruction, and Factor XII deficiency blood disorder. The onset of her injuries occurred within a sufficiently close temporal proximity to the pt's vaccination to constitute a medically acceptable time frame for causation, given the natural progression of the vaccine once introduced into the human body. The pt's injuries were caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) HPV vaccination received on 02-JUN-2015. The pt contended that her injection caused her to develop serious and debilitating injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, POTS, and dysautonomia, 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 the vaccine or otherwise linked to her vaccine-induced autoimmune disorder. As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), pt suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. The pt 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 this vaccine. As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, pt had 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 of was considered to be not recovered. The reporter considered the events to be related to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  All events were determined to be disabling.  Upon internal review, the events of autoimmune disorder and major depressive disorder, single episode were determined to be medically significant.