Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure, Septic shock, Syncope, Temperature intolerance, Visual impairment
Clinical narrative: stroke and decreasing neurological activity; Her body went into septic shock; stroke and decreasing neurological activity; progressively worsening vision; Unprovoked triggering of the fight or flight; dysautonomia,; Sensitivity to lights and sounds; Sensitivity to lights and sounds; seizures; seizures; POTS/HRwas 160/BP was low/dizziness/palpitations/headache/autonomic, neurological, heterogenous autoimmune disease/other autonomic nervous system dysfunctions/hypotension/sensitivity to hot and cold/fainting or collapsion; Information has been received from a lawyer regarding a case in litigation and referred to a 11-year-old female patient (pt). Prior to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she had no autoimmune diseases, and no autonomic issues. She was attending school, playing softball, cheering, and playing golf for her middle school team. She loved going to school, walking her dog, playing sports, and going to church. Before receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection she had medical history of asthma, positive antinuclear antibody (ANA), corrective eye surgery, and amplified musculoskeletal pain, however she was still active and carrying out her normal activities. Information on the pt's concomitant therapies was not reported. On 12-SEP-2019, 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 age of 11), the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as safe and effective vaccine for preventing cervical cancer (prophylaxis) (lot #, expiration date, dose, route of administration and anatomical location were not reported). On or about 03-OCT-2019, the school nurse called to inform her that her daughter heart rate was 160 and her blood pressure was low and that should be taken to an emergency department (ED) for assessment. She went by ambulance to the Hospital for stroke (cerebrovascular accident) and decreasing neurological activity (neurological symptom). Her body went into septic shock. On 06-OCT-2019 (reported as after 4 day and 3-night hospitalization), she was given papers of postural orthostatic tachycardia syndrome (POTS) and discharged home. The pt required the use of a walker to help her move. She did not have the ability to move like she did before, could not get up alone, and could barely walk without fainting or collapsing. After being released from the hospital she attempted to return to school but was instead placed on a homebound schedule. On 16-OCT-2019, she was again taken to the hospital, she was suffering from palpitations, dizziness, and headaches, like her previous POTS episodes. On 08-NOV-2016, she had a POTS flare during her sister's birthday party. It led to seizures. She was carried out of the skating rink and take to the local ER. They completed blood work (results not provided), and sent her to the hospital by ambulance, the seizure lasted 14 hours on and off throughout the night. She went home the next morning. On 13-NOV-2019, she attended a Wednesday night church service. During the service, she started having seizure was transported to a hospital and was tested and referred once again and sent to another hospital. This time the seizure lasted 12 hours and off throughout the night. She was monitored for neurological activity and was released again the following morning. As the months progressed, so did pt's injuries. She was seen by multiple physicians and specialists for her complaints which now included: fainting spells, seizures, hypotension, sensitivity to lights (photophobia) and sounds (hyperacusis), sensitivity to hot and cold, dizziness, brain fog, nausea and unprovoked triggering of the fight or flight response (acute stress disorder).  As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she was unable to engage in normal activities that a normal young person would enjoy. She was unable to returned to school and was placed on a homebound schedule through 2019. In unspecified date in January 2020, she attempted to return to school, but her condition did not allow her to attend on a regular basis. She had further been forced to forgo the extracurricular activities she enjoyed before her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, including academic competitions, softball, cheering, golf and other sports, because her condition she was unable to independently care for her basic needs, and the severity of her symptoms had left her unable to shower.  Based upon her chronic and severe post quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) she had been diagnosed with various medical conditions including but not limited to POTS, progressively worsening vision, seizures, and other autonomic nervous system dysfunctions. Pt's contends that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 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 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 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 was considered as not recovered. The reporter considered all the events related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All the events were considered as disabling events.   Upon internal reviewed the event of cerebrovascular accident, septic shock, and seizure were considered to be medically significant.