Age: 13.0
Sex: F
Vaccine: HPV4, UNK
Symptoms: Non-24-hour sleep-wake disorder, Obstructive sleep apnoea syndrome, Pain, Pain of skin, Paraesthesia
Clinical narrative: acute confusional migraine; POTS; conversion disorder; altered taste; complaining of hearing noises/ suggestive of hallucination; skin has been turning a grayish color; expressed suicidal ideations; other convulsions and unspecified psychosis; delusions; sensitive to light; benign joint hypermobility; hallucinations/ visual hallucinations; encephalopathy, inability to talk, sleeping 15-17 hours day,  amnesic spells/ foamed at the mouth/ short-term memory loss/ amnesic spells/ confusion/ seizures/ lethargic and somnolent/ dysarthria; neurological injury/ altered mental status; suspected heat exhaustion; out of consciousness/ spells; Autonomic dysfunction, inability to walk,  severe headaches,  dizziness, fainting, blurred vision, syncope; painful Goose bumps; EDS onset at age fourteen (14); Autoimmune Disease, chronic fatigue and tiredness, chronic joint pain, heterogenous autoimmune injuries/ SEVERE chest pain (excruciating)/ weight loss/ abdominal pain/suffered nausea and vomiting; without seeming benefit from Topamax; Information has been received regarding a case in litigation from a lawyer and referred to a 14-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. The pt received first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (GAR) on 11-JUN-2013 and received second GAR on 25-FEB-2014 (both: dose, route, lot# and expiration date were not reported) for preventing cervical cancer. Within appro 2 weeks after 25FEB2014 of vaccination, pt began experiencing adverse reactions, consisting of tiredness, painful goosebumps, fatigue, and headaches that progressed in intensity over the next several months. On 12JUN2014, the assessment was pt was a healthy girl. She was given a hepatitis A vaccine. On 22JUN2014, pt developed abdominal pain, sudden severe headache, her face contorted, foamed at the mouth, had a blank stare, and exhibited slurred speech with inappropriate words. Pt's mother (MO) reported the events. Pt was examined by paramedics, who noted she obeyed most commands, but she had slurred speech with inappropriate words. Pt continued to follow some commands but not others, and her speech improved. The actual symptom were general: confused; gastrointestinal: abdominal pain; neurological: gait problem; dysphasia (difficulty speaking; slurred speech) and headache/migraine. Pt suffered nausea and vomiting with some syncope prior to admission with a sudden and sharp headache. Pt was given two liters of IV fluids for suspected heat exhaustion; she discharged with a prescription ondansetron for nausea and FIORICET for headache. Pt was given ZOFRAN and TORADOL. Pt was discharged with final diagnoses of heat exhaustion, altered mental state, headache and nausea and vomiting. On 04AUG2014, at appro 12:06 a.m., MO reported pt had mental status changes began on 03AUG2014. MO reported pt was talking out of her head and had been doing so for about 25 mins, had a headache, also had some abdominal pain. On 04AUG2014, at appro 4:19 p.m. MO reported last evening, pt complained of dizziness. Pt was crying, yawning, and "talking like delirious". Pt reported feeling a sensation of vertigo followed by the onset of a headache. Pt was unable to describe the character of one headache or associated symptoms because she could not remember anything about her headache last night. MO said pt acted "delirious" and reported she can't see anything and was writhing with pain. At one point, pt was on the floor prone with her right arm flexed stiffly against her body. Pt then fell asleep. After examination and review of the history, his assessment was headache and mental status alteration. He remarked "mental status changes had been episodic and self-resolve. Strongly suspect complicated migraines." On 11AUG2014, the pt was seen for complex migraines she had suffered over the past week (three) with one that was 1.5 months ago. MO reported on 10-AUG-2014, pt had another headache, was dizzy, and was unable to walk. Pt was evaluated by a physician in the headache clinic on 19AUG2014. The history included complaints of complex headaches with a history of not feeling well when playing outdoors, began crying, then while in the car with her mother, pt became confused, had tiny pupils, was in and out of consciousness, yawned frequently, was foaming at the mouth, her left arm was tingling, she had blurred vision, with a severe headache. After being seen in the ED on 22JUN2014, she was discharged home and slept the next day for 18 hours. Appro ten days prior to 19AUG2014, pt suffered a severe headache and was confused, but felt better after sleeping 15 hours and was amnestic to the event. Several days later, pt had three consecutive headache days with the same symptoms of yawning, delusional, painful, crying, imbalanced, nonsensical in conversations but resolving with sleep. The diagnosed acute confusional migraine and benign joint hypermobility. He found concerning "pt's roster of unusual symptoms in the midst of headaches, with confusion, amnesia, yawning, with subsequent prolonged sleep, in the absence of migraine family history." Pt was prescribed TOPAMAX, naproxen and MAXALT to be taken at the onset of her migraines. Pt's injuries progressed. Pt's episodes were becoming more frequent; she would suffer headaches and black out, asking crazy questions before falling asleep. By 10OCT2014, MO was reporting pt was suffering from memory problems at school. Since June 2014, pt suffered 10 significant events associated with confusion, headaches, amnesia, and dysarthria, all followed by bedrest for 3 to 15 hours. The physician assessed the spells; he also discontinued the MAXALT and TOPAMAX dose increased. On 23OCT2014, MO reported pt was having issues staying awake, and seemed to almost faint. A neurologist believed her spells were due to migraines and seizures. Pt's school nurse reported pt was able to respond to questions, she did so slowly. On 23OCT2014, at appro1:20 p.m., MO reported pt had severe headaches at school, seemed sensitive to light, and seemed wiped out (tired). Pt seemed flushed and reported her goosebumps were hurting. On 27OCT2014, MO called regarding an episode occurred on 26OCT2014. Pt crying and stating she was "burning up." Pt also stated she was dizzy and could not see during this episode. On 04NOV2014, pt visited with a chief complaint of seizures. Pt reported getting a headache and generally feeling tired. The seizures were characterized by loss of awareness with head, eyes rolled back, and foaming at the mouth. She was unresponsive during these episodes. Afterwards, pt hallucinations and delusions. The diagnoses were migraine, syncope, and collapse. On 17NOV2014, pt returned with a complaint of acute confusional migraines and spells. The impression was continuation of confusional migraine versus epileptic events, without seeming benefit from topiramate (TOPAMAX) (suspect product) (drug ineffective). Pt had been experiencing weight loss since being on this medication. It was recommended that pt switch from TOPAMAX to KEPPRA. On 10DEC2014, pt returned with a chief complaint of spells. MO discussed the results of pt's hospitalization the week prior to this appointment, despite have 2 typical episodes while in the hospital. Since her discharge, pt had 2 more episodes, the second of which was unusual enough that she was directed to the ER. Pt was responsive, but tired and groggy at the appointment. The diagnosis was confusional migraines (considered hospitalization due to this event). On 11DEC2014, pt returned with a chief complaint of migraines. The impression was acute confusional spells with autonomic sensitivity; pt was evidently unimproved on current dose of KEPPRA. Since pt's prior visit on 17NOV2014, she had difficulty controlling spells of syncope or near syncope, and acute confusional spells associated with headache. Pt was at the EMU on 01DEC2014, for about 5 days, pt experienced 2-3 prominent headaches, though without the usual level of confusion in the past. Since pt's return from the EMU, she had 3 events, during which time she was confused, stumbling, and word-searching. Pt had headaches with every other spell, and the spells occur about 3 times a week. The diagnoses were acute confusional migraine and benign joint hypermobility. On 17DEC2014, pt returned with a chief complaint of confusional spells. Pt had continued with KEPPRA. MO reported pt was trying to pump gas into the car and could not remember how. She had a severe headache, was lethargic and somnolent afterwards, and had other spells involving word finding difficulties, difficulties with memory, and repetitive movements. On 18DEC2014, she had abdominal pain for 3 days. Pt also discussed she was being worked up for "spells" she had had since August 2014. The frequency of these episodes had increased and was now happening quite frequently. The episodes were being followed by neurology and initially thought to be seizures. MO described episodes where pt complained of headaches/migraines, had repetitive movements, amnesia, and imbalance. These headaches had affected pt's school performance. She was weaned off of KEPPRA. On 20DEC2014, MO reported pt had very unusual symptoms often associated with headaches, however not always, but almost always associated with amnesia. On 29DEC2014, pt retuned for an MRI of her brain with and without IV contrast. The findings were that the intracranial structures were negative and unchanged. The final diagnoses were other convulsions and unspecified psychosis. On 06JAN2015, pt returned with a chief problem of spells. MO called regarding pt's chest pain and upper back pain that started at the right scapula and radiated up to her neck and into her chest. Pt needed to be seen in the ED for "severe chest pain (excruciating)." On 12JAN2015, MO reported pt was feeling dizzy, and she had fallen against a wall while blow drying her hair. Pt's mouth was drooping, her eyes were closed, and she was moaning. On 13JAN2015, the impression was that since switching from KEPPRA to PAMELOR, pt had increased headache frequency, but lower frequency of confusional episodes. Pt's "episodes" or spells were now occurring 1-3 times a week, wherein she seemed unable to carry on conversations, was sometimes curled up in a ball, had difficulty ambulating, and also at times had visual hallucinations. Pt necessitated sleep for at least another 15 hours after each spell. The most recent episode occurred on 12JAN2015, wherein pt became dizzy in the shower, and afterwards was leaning up against the wall in the hallway of her home, frowning at the mouth, and believing she was still at school. On 19JAN2015, a physician indicating she was being treated at a specialty headache clinic and had been diagnosed with complicated confusional migraines. On 21JAN2015, pt returned with a chief complaint of a headache and hearing fire alarm sounds in head. Pt suddenly started complaining of hearing noises and covering her ears. MO stated the frequency of these episodes was about twice a week. Pt's diagnosis was spells. The assessment was suspected confusional migraines and recurrent spells of unclear etiology. The symptoms suggestive of hallucination. On 03FEB2015, a plan indicated a medical diagnosis of confusional migraines with memory loss and cognitive and respiratory changes. Signs were noted that should necessitate emergency action when there was any observed change in neurological baseline; i.e., report headaches, slurred or slow speech, decreased response time, inappropriate responsiveness, morbidity, and instability. On 17FEB2015, pt visited Hospital with complaints of persistent headaches and spells, and episodes of confusion, lethargy, and memory loss, the latter of which was sometimes associated with a headache. The final diagnoses were persistent headaches and spells. The assessment was paroxysmal spells of lethargy and confusion. Appro half of her episodes were associated with headaches. The possibility of a confusional migraine had been considered. On 24FEB2015, MO called to discuss pt's diagnoses of acute confusional migraine (primary), spells, and benign joint hypermobility. The impression was that pt's headaches continued unabated, and she had spells several days per week as usual. Pt also continued to experience 5-6 headaches per day, each lasting about an hour, remitting for about half an hour, and resuming again. Pt was also experiencing 2-3 spells per week. Pt's most recent spell occurred the morning of 24FEB2015 and consisted of pt having droopy eyes and crying. MO also noted it was difficult to wake pt up every morning, and that pt slept for up to 18 hours a day. On 05MAR2015, pt had been to a Hospital, noted memory loss, and sometimes cannot walk or talk. On 19MAR2015, per MO, pt had been sleeping 16-17 hours per day since 14MAR2015. When pt was awake, she complained of pressure and pain in the middle of her forehead. Pt had also been complaining of joint pains. MO stated pt had 2 hallucinations during this time period. Finally, MO noted pt's skin had been turning a grayish color. On 24MAR2015, the impression was exacerbation in headaches and spells in the interim, with new headache pain in a "Mohawk' distribution since changes in her medications. Her spells had also increased, which MO described as visual hallucinations, difficulty standing, and difficulty walking. Pt did not remember these episodes and continues to sleep 15-18 hours each day. On 31MAR2015, MO called to report pt had expressed suicidal ideations the previous day. Pt had also been complaining of a headache and occasional hallucinations, similar to what had been happening to her over the past 9 months. On 14JUL2015, MO reported pt had 2 spells in the last month. Her diagnoses were a history of migraines and failed vision screen. The assessment noted history of confusional migraines. On 09SEP2015, pt returned with concerns of sleep issues. On 17SEP2015, MO stated pt's episodes were continuing and were more frequent now. While she was very well over the summer, the episodes had returned to increased frequency since going back to school. Pt had been sleeping for prolonged periods of time, had amnesia of events, and hallucinations. On 12NOV2015, pt returned with complaints of spells, headaches, and hyper somnolence. The impression was hyper somnolence, possible narcolepsy, EDS, hypnic hallucinations. The diagnoses were hypersomnolence and spells. On 07DEC2015, a multiple sleep latency test was performed. The indication was hyper somnolence. To end the study in the morning, repetitive attempted to arouse pt from stage NREM 2 sleep resulted in typical spells of unresponsiveness. During one awakening, pt mumbled coherently, but nonsensically. It was noted that pt showed strange behavior when attempting to wake her up. Pt did not respond and was very limp, but her EEG appeared to show wakefulness. Pt mumbled things about "not wanting to hit the deer" and "it was snowing and cold inside." On 29DEC2015, MO was seen for an evaluation of migraines. MO reported pt's first episode involved pt trying to open the car door while inside. She started "hallucinating" and saying strange things. The episode lasted a few hours, she continued to have episodes several times per week. The doctor's impression was episodes of confusion, hallucinations, and encephalopathy. On 26JAN2016, pt returned with complaints of spells, headaches, hyper somnolence, and conversion disorder. As of 16JAN2016, pt had continued to have spells. The diagnoses were hyper somnolence and conversion disorder. On 12FEB2016, the disabilities noted were migraines, seizure disorder, sleep disorder, and conversion disorder. On 09SEP2016, pt visited for evaluation of hypersomnia. Pt presented with a chief complaint of excessive somnolence. MO's main concern was that pt had "cycles," where she would sleep for 12-18 hours, and if an attempt to wake her up was made, nothing would wake her up. Once pt did wake up, she was amnesic to previous events. The impression was excessive nocturnal sleep, but not daytime hypersomnia. On 21SEP2016, pt's diagnostic polysomnography report study showed insignificant obstructive sleep apnea, mild periodic limb movements, and mild sleep fragmentation. The sleep technician could not wake pt up; he tried for almost 30 minutes and she could not be woken. Pain was inflicted to wake pt up, but to no avail. On 26SEP2016, Pt's concerns included hallucinations, sleeping, headaches, joint pain, altered taste, and a dazed look. She had problems with prolonged sleeping for up to 15 hours, gut dysbiosis, heartburn, and sub-optimally frequent bowel movements. On 07OCT2016, pt returned to review the findings from her polysomnogram and multiple sleep latency tests that were performed on 21SEP2016 and 22SEP2016. There were notable impressive pseudo spindles in Stage 2 of pt's sleep. On 02NOV2016, Pt's medical history noted she developed neurologic complications, presumably after her second vaccine. Since then, pt had episodes of sleep inertia, from which it was difficult to arouse her and she would hallucinate. MO was also concerned about pt's short term memory loss. On 03NOV2016, pt returned with a chief concern of a reaction to the second dose of vaccine. Soon after the vaccine, pt had headaches, fatigue, and painful goosebumps. In August 2014, pt had her first hallucination. Pt's neurological symptoms included severe headaches, short term memory loss, spells that could last up to 3 days, light headedness, sleepiness, disturbed speech, and amnesia. The assessment was pt with an adverse reaction to the HPV vaccine, which included hallucinations and headaches. Pt also had problems with prolonged sleeping for up to 15 hours, especially if she was awakened. Pt had more headaches now and her short term memory loss was more obvious. On 17NOV2016, pt's friends noticed her sinking deep into her car seat. For the following 3 days, pt had a terrible headache. On 22NOV2016, Pt's history noted she developed neurologic complications, presumably after receiving her second dose of vaccine. Since then, pt had episodes of sleep inertia, from which she was difficult to arouse and would hallucinate. MO also described "unconscious events" in which she would try to wake pt from her sleep. MO was also concerned about pt's short term memory loss. On 09FEB2017, Pt had continuing episodes of headaches. MO's chief concerns included headaches, short term memory loss, and balance issues, recent return of spells (prolonged sleep), worsening headaches, and declining school performance. Since then, pt had encephalopathy, lethargy, and extreme fatigue. The assessment included hallucinations and headaches. As detailed herein, pt was evaluated her complaints were attributed to second GAR vaccination. Based upon chronic and severe post-GAR symptoms, pt had been diagnosed with but not limited to, inability to walk, talk, short-term memory loss, sleeping 15-17 hours day, severe headaches, chronic fatigue and tiredness, dizziness, fainting, hallucinations, chronic joint pain, amnesic spells, and encephalopathy. Pt contended that GAR injections caused her to develop serious and debilitating injuries (severe, disabling, and painful chronic injuries), including but not limited to autonomic, neurological, heterogenous autoimmune disease, Postural orthostatic tachycardia syndrome (POTS), and dysautonomia/ autonomic dysfunction, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events/other serious injuries, many of which were alleged herein and all of which were caused by GAR/ its ingredients or otherwise linked to her GAR-induced autoimmune disorder. As a direct and proximate result of the product, pt had suffered and continued to suffer severe and permanent physical injuries and associated symptomology. Pt also had a substantial fear of suffering additional and ongoing harms, including harms associated with autoimmune disease and other injuries caused by GAR. As a direct and proximate result of GAR-induced injuries, the pt had suffered and continued to suffer economic losses. Outcome for all events (except drug ineffective) was not recovered. Outcome of drug ineffective was not reported. The causality between GAR and all events (except drug ineffective) was related. The causality between GAR and drug ineffective was not reported.  All events (except drug ineffective) were considered to be disability by the reporter. Upon internal review, autoimmune disease, encephalopathy, visual hallucinations, loss of consciousness, hallucination (auditory), suicidal ideations were determined to be medically significant.