Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Body temperature abnormal, Dizziness, Erythema, Fatigue
Clinical narrative: Postural tachycardia syndrome (POTS): autonomic injuries, chronic fatigue, black-out of vision, dizziness, heart palpitations, breathing prob, abdominal pain, difficulty sleeping, insomnia,abnl changes in body tmp, headaches, white and red color mark; constellation of adverse symptoms, complications, injuries, and other adverse events; Autonomic, autoimmune, and neurological injuries; Autonomic, autoimmune, and neurological injuries; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 11-AUG-2021, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for preventing cervical cancer, when she was 11 years old, and on 11-AUG-2022, she received the second dose. It has been reported that the pt sustained serious autoimmune, autonomic, and neurological Injuries as a result. It was reported that on an unknown date, following the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccinations, the pt started experiencing chronic fatigue, she developed vision problems, such as daily temporary black-out of vision followed with dizziness. In addition, she developed heart palpitations, chronic headaches, breathing problems, abdominal pain, difficulty sleeping, and insomnia, the pt consistently experiences abnormal changes in body temperature, such as cold hands and arms while exercising, in addition to white and red color marks on her abdomen and legs, she was seeing a cardiologist for her heart palpitation and breathing problems. As the months progressed, so did pt's symptoms, she had been seen by multiple physicians and specialists for her complaints, which include chronic fatigue, vision problems, heart palpitations, dizziness, chronic headaches, abnormal body temperature changes, difficulty sleeping, and insomnia. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, she had been unable to engage in activities that a normal young person would enjoy, prior to receiving the vaccine, she exercised daily and played sports with no physical limitations imposed by her health. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, heart palpitations and chronic fatigue., she contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating Postural tachycardia syndrome (POTS)-like symptoms and chronic fatigue, 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 autonomic disorder. As a proximate result of company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering, she 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 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 had suffered and continued 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. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  All the events were considered disabling by the reporter.   Upon internal review, the event autoimmune disorder was determined to be medically significant.