Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: ASIA syndrome, Abdominal discomfort, Asthenia, Autonomic nervous system imbalance, Blood pressure decreased
Clinical narrative: functional neurological illness (conversion disorder); syncope/vasovagal syncope/neurocardiogenic syncope; autoimmune/inflammatory syndrome; seizure; POTS/turned a strange pale green color/severe headache, nauseas, weak and fatigue/blurred vision/orthostatic hypotension/Dysautonomia; Information has been received from a lawyer regarding a case in litigation and refers to a 11-year-old female patient (pt). No other information concerning the pt's medical history, concurrent conditions or concomitant medications was provided. On 25-SEP-2015, at the age of 11-year-old, the pt received her first dosage of quadrivalent human papillomavirus (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. Within minutes of being injected, the pt turned a strange pale green color and fell to the floor. The pt's mother sat with her daughter for about an hour and was told this sometimes happened. The pt's color did not return to normal for hours. On 26-SEP-2015 (reported as the next day), the pt had a severe headache and told her mother she felt nauseas, weak and fatigued. The pt's mother attributed it to the incident the day before and kept the pt home from school. As the days passed, the pt's condition fluctuated. Every evening, it seemed that the pt had a headache and nausea. The pt also began complaining about blurred vision. On an unknown date, the patient received her second dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On 29-JAN-2016, the pt was at a church event with about 200 students and leaders when she had a seizure. Emergency Medical Technicians (EMT) and the police were called and when the pt recovered, she did not to know where she was. On 01-FEB-2016 (reported as the following Monday), the pt attended school, but she was pale and fatigued, going to bed early and sleeping the night through until 02-FEB-2016 (reported as the following day), when her mother took her to see her physician. On 02-FEB-2016, The pt had a follow-up visit with the physician, who noted a history of syncope. The physician noted seizures and orthostatic hypotension. The physician's nurse could not get a blood pressure reading because it was so low. Her physician then took it and found it extremely low at 50/30 (units not provided) and an accelerated heart rate of 120 (units not provided). The physician performed orthostatic vital signs at this visit and documented a supine blood pressure of 86/56 mmHg and heart rate of 64 bpm, and a standing blood pressure of 58/40 mmHg and heart rate of 102 bpm. This orthostatic challenge demonstrated an increase in heart rate of 38 bpm along with a drop in blood pressure approaching orthostatic hypotension. The pt was immediately referred to a neurologist. On 03-FEB-2016 (reported as the following day), the pt was sent home from school due to lightheadedness and low blood pressure. Shortly thereafter, she started missing more school and her family initiated a program. On 04-FEB-2016, the pt presented to the emergency department with symptoms of headache, dizziness, and nausea. She was given intravenous (IV) fluids and discharged home with a diagnosis of syncope. On 10-FEB-2016, The pt was evaluated by a cardiologist, who diagnosed her with vasovagal syncope. This same day, she was evaluated by a neurologist, who ordered several tests including an electroencephalogram (EEG) and a magnetic resonance imaging (MRI) of the brain. The EEG demonstrated right posterior temporal slowing during hyperventilation, a non-specific finding the records indicate can be seen in some patients with seizures. The pt's MRI returned normal. On 18-FEB-2016, the pt had a follow-up visit with the neurologist, who prescribed her fludrocortisone (FLORINEF), a medication commonly prescribed to patients with postural orthostatic tachycardia syndrome (POTS) to increase intravascular volume and blood pressure. On 02-MAR-2016, The pt had a follow-up visit with the neurologist, who noted that her symptoms had improved with fludrocortisone, although still present. The pt was prescribed cyproheptadine (PERIACTIN) for headaches. On 25-MAR-2016 (reported as 25-MAR-2015, considered as a typo per vaccination date), the pt was evaluated by another cardiologist, who noted the pt's history of syncope as well as symptoms of headaches and involuntary limb movements. The cardiologist concluded that the pt's symptoms were consistent with dysautonomia. He increased her fludrocortisone dose. On 28-MAR-2016, the pt had a follow-up with her physician who listed POTS in his assessment. On 15-APR-2016, The pt had a follow-up visit with the cardiologist, who noted that the pt had had several episodes of syncope, presumably since her last visit, although the frequency of the episodes was improving. Orthostatic vital signs were performed at this visit, which demonstrated a supine blood pressure of 91/56 mmHg and heart rate of 84 bpm, and a standing blood pressure of 98/59 mmHg and heart rate of 109 bpm. On 19-APR-2016, the pt presented to the emergency department with symptoms of pixelated vision changes, headaches and dizziness. She was admitted and evaluated by the inpatient neurology service. A diagnosis of functional neurological illness (conversion disorder) was suggested. On 25-APR-2016, the physician noted new symptoms of personality changes in the pt and a conversion disorder as a possible diagnosis. On 28-APR-2016, the pt was evaluated by another physician. The physician's assessment listed POTS as her primary diagnosis. On 03-MAY-2016, the pt was evaluated by the third cardiologist, who noted that the pt had passed out 5-10 times. He also noted that the pt continued to experience symptoms of orthostatic intolerance including dizziness/lightheadedness and black-out/tunneling of vision. The physician diagnosed the pt with neurocardiogenic syncope, another term for vasovagal syncope. On 22-JUN-2016, the pt had another syncopal episode while standing at church and was brought to the emergency department. On 18-AUG-2017, the pt presented to the emergency department with lightheadedness and presyncope (near-fainting), headaches and general weakness. She was given IV fluids and discharged. She had a follow-up with her physician on 06-SEP-2017, who noted she was feeling better, although still nauseated, and was prescribed ondansetron (ZOFRAN). On 12-SEP-2017, a  program form was submitted for the pt to continue her schooling at home. POTS was listed as the primary diagnosis. On 11-APR-2018, the pt was evaluated by a professor of cardiology, who noted that the pt continued to experience disabling symptoms of dizziness, nausea, abdominal discomfort, muscular discomfort around the neck and shoulder region, fatigue, sinus tachycardia, and cognitive and memory processing issues. The professor suggested a diagnosis of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) as a possible explanation for the pt's autonomic dysfunction. These conditions have continued without resolution. As a result of these post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt has been unable to engage in activities that a young person normally would enjoy. She was unable to live on her own, hold employment, or go to school. As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt has suffered and continues to suffer severe and permanent physical injuries, and associated symptomology and has suffered severe and permanent emotional injuries, including pain and suffering. The pt also has 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 has suffered and continues to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity and she will continue to incur these losses and expenses in the future.  The outcome of seizure was recovered. The outcome of other events was considered to be not recovered (some of the symptoms improved but still repeated and permanent). 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 ASIA, seizure and syncope were determined to be medically significant.