Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Imaging procedure artifact, Impaired driving ability, Insomnia, Loss of consciousness, Loss of personal independence in daily activities
Clinical narrative: Appetite loss; Restless leg syndrome; Chronic and acute skin problems; severe pain; brain MRI: additional pinpoint focus of hemosiderin in the subcortical white matter or the left parietal lobe, suggesting a prior microbleed or perhaps vascular anomalies such as capillary telangiectasia; brain MRI: additional pinpoint focus of hemosiderin in the subcortical white matter or the left parietal lobe, suggesting a prior microbleed or perhaps vascular anomalies such as capillary telangiectasia; brain MRI: artifact within posterior left putamen may represent focal asymmetric basal ganglia mineralization; brain MRI: punctate focus of hemosiderin and some surrounding gliosis in left inferior posterior putamen/lateral anterior commissure on the left, suggested remote my lobe hemorrhage/microbleed; whole body convulsions/conversion disorder/could not walk for a period of time; minor car accident; lymph nodes enlarged; did not have any energy; Leg pain/frequent unexplained leg pain in both legs/muscle pain both legs; Dysautonomia/sleep disorder/headaches/severe fatigue/dizziness and nausea/vomited/trouble sleeping/loss of consciousness/dehydration/blackout; Pots: Postural orthostatic tachycardia syndrome/essential tremor/syncope/headaches/severe fatigue/cognitive issues/dizziness and nausea/hand tremors/vomited/trouble sleeping/postural tremor; Information has been received from a lawyer regarding a case in litigation and referred to a 15-year-old female patient (pt). Prior to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, her most significant health problems included ADHD, asthma, anxiety, and dislocations of her right knee and right hip; she was also diagnosed with morphea. Information on the pt's concomitant therapies was not reported. It was reported that she was a physically active and normal teenage girl who participated in activities such as cheerleading and tumbling. On 07-NOV-2014, the pt's health care provider (HCP) recommended that pt receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. On the same date (at the age of 15), and under the consent of her mother, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (lot #, expiration date, dose, route of administration and anatomical location were not reported). Soon after the pt was vaccinated with the first dose, she developed dizziness and nausea. In December 2014, she began experiencing frequent and unexplained leg pain in both of her legs. Within two months after receiving the first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she first began to experience hand tremors. On 09-JAN-2015 and on 10-JUN-2015, the pt received the second and third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration dates, doses, routes of administration and anatomical locations were not reported). After the second and third dose were administered, she experienced dizziness and nausea, as well. On 10-JUN-2015, before leaving the physician's office after vaccination, she vomited. Following the third vaccination, pt was sick for two days. She vomited repeatedly and continued to experience leg pain, dizziness, and nausea. She did not have any energy, had trouble sleeping, and could not participate in extracurricular activities due to dizziness and nausea. Shortly after receiving the third dose, she was forced to quit tumbling permanently due to dizziness and nausea when changing postural positions and due to leg pain. During the week of 26-JUL-2015, pt's mother observed pt's tremors for the first time and immediately made an appointment with the pediatrician. On 29-JUL-2015, less than two months after receiving her third quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, pt was examined by her pediatrician. That visit resulted in the first medical record documenting her tremors. The doctor noted that she appeared "not sickly". None of the typical signs of infection were present and, other than the tremors, the record reflected that she was normal and healthy. However, her lymph nodes were enlarged (lymphadenopathy), suggesting that an immunologic reaction was occurring or had recently occurred within her body. On 01-SEP-2015, she was evaluated by a board certified neurologist, who diagnosed her with essential tremor for the first time. On 11-SEP-2015, she underwent a sleep study conducted which observed head movement tremors during pt's sleep which were not assigned an etiology. Her tremors continued to worsen throughout September 2015. Additionally, she developed whole-body convulsions, after which she could not walk for a period of time. In late September 2015, Plaintiff was involved in a minor car accident (road traffic accident) caused by her loss of consciousness. When she regained consciousness, her body was convulsing uncontrollably. On 21-SEP-2015, she first began receiving school accommodations due to the severity of her tremors. On 24-SEP-2015, a brain magnetic resonance imaging (MRI) was performed, which revealed a "punctate focus of hemosiderin and some surrounding gliosis in the left inferior posterior putamen/lateral anterior commissure on the left". According to the physician, the MRI suggested a "remote my lobe hemorrhage/microbleed" of uncertain etiology (cerebral microhaemorrhage). Around that same time, she became dependent on a wheelchair or walker for mobility following her whole-body convulsion episodes. On 08-OCT-2015, pt's condition, including her recurrent syncope and whole-body convulsions, were evaluated. Although the EEG appeared to be normal, treating physician considered that a diagnosis of epilepsy could not be entirely ruled out. From 12-OCT-2015 to 15-OCT-2015, she was evaluated at a Health Care facility by various physicians because, as one record stated, a "16-year-old previously healthy female present[ed] with increasing tremors over last 10 months, worsening such that [she] could not walk when episodes occurred  had episodes of full body tremors occurring approximately daily and lasting 15-30 minutes". During evaluation at the facility, another brain MRI was taken from which the doctors derived the impression that a "susceptibility artifact within posterior left putamen may represent focal asymmetric basal ganglia mineralization (cerebral calcification)  sequela of prior micro hemorrhage was considered much less likely, no additional brain parenchymal signal abnormalities to account for pt's symptoms". One treating physician noted that the "MRI [of her] brain revealed a 5mm hypodensity in the left putamen which had been felt to be of limited significance [I]t is interesting that the 'artifact' on [the] MRI that had been felt to have limited clinical significance occurs in the basal ganglia which could potentially cause tremor[.]". The treating physicians at the facility were unable to ascertain a biological cause for her numerous symptoms and, focusing mostly on her whole-body convulsions, diagnosed the pt with baseline essential tremor aggravated by anxiety and conversion disorder, resulting in whole body tremors that were believed to be psychogenic in origin. None of the treating physicians considered whether her symptoms might be caused by dysautonomia, postural orthostatic tachycardia syndrome (POTS), or the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. On 29-DEC-2015, her neurologist, noted that she was having a lot of muscle pain in both legs, that her tremors were worse with standing, and that she was experiencing some postural tremor. At this time, the neurologist initially agreed with the treating physicians at "that the pt had some element of conversion associated with her essential/postural tremor". The pt's severe whole body convulsions and syncope continued throughout 2016. She continued to rely on a wheelchair and a walker for mobility due to leg pain and potential loss of consciousness. Another brain MRI was performed on 23-SEP-2016, revealing an additional pinpoint focus of hemosiderin in the subcortical white matter or the left parietal lobe, suggesting a prior microbleed or "perhaps vascular anomalies such as capillary telangiectasia" (cerebral capillary telangiectasia and cerebral haemosiderin deposition). In comparison to a previous exam, the brain looked stable, without any changes. Between 26-JAN-2017 and 07-FEB-2017, her primary care physician (PCP) and her neurologist, conferred with each other and jointly diagnosed her with dysautonomia and POTS. On 03-APR-2017, pt's PCP evaluated her after a blackout episode surrounding which she experienced severe pain, dehydration, and nausea. In a letter dated 09-JUN-2017, her PCP explained that her POTS symptoms and essential tremor both began after receiving the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations. Pt's neurologist treated her disorders as potentially autoimmune in nature. In a visit on 14-AUG-2017, he noted: "I will have the pt undergo intravenous (IV) methylprednisolone sodium succinate (SOLUMEDROL) for 3 days to see if it might help with her symptoms. I question whether that it may be an autoimmune dysautonomia". As would be the case with an autoimmune etiology, her body responded well to the steroid treatment ordered by her neurologist. She experienced a significant increase in energy and regained her appetite. On 10-OCT-2017, she was reevaluated by her neurologist, who noted her improvement after receiving the steroid injections. The pt suffered from dysautonomia, POTS, essential tremor, whole body convulsions, sleep disorder, restless leg syndrome, syncope, appetite loss, headaches, leg pain, severe fatigue, chronic and acute skin problems, and cognitive issues. Her injuries were known to originate from dysfunction of the immune system. The onset of her injuries occurred within a sufficiently close temporal proximity to at least one, if not more, of the three quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations to constitute a medically acceptable timeframe for causation. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection(s) 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 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. As a proximate result of vaccination, pt had suffered and continued to suffer severe and permanent physical injuries including, but not limited to, her autoimmune disease and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. 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 quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). At the reporting time, the outcome of the events road traffic accident, cerebral calcification, cerebral capillary telangiectasia, cerebral haemosiderin deposition, pain, and lymphadenopathy was unknown; the remaining events had not resolved. The reporter considered all events related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All the events were considered as disabling events, except: cerebral microhaemorrhage, road traffic accident, cerebral calcification, cerebral capillary telangiectasia, cerebral haemosiderin deposition, pain and lymphadenopathy.  Upon internal review, the event cerebral microhaemorrhage was determined to be medically significant.