Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Hormone level abnormal, Insomnia, Loss of personal independence in daily activities, Nervous system disorder, Oropharyngeal spasm
Clinical narrative: postural issues,, felling weak, could not hold her body upright, balance issues, while heart rate, headches, shaking, stuttering,insomnia, heart palpitations, dzziness, fainting, tingling, fatigue, brain fog, depression , anxiety, insom; Fibromyalgia: chronic widespread pain, fatigue, depression, anxiety; Gardasil-induced autoimmune disorder; diaphragm paralysis: shortness of breath, difficulty breathing while sleeping, fatigue, insomnia; hormone imbalance: loss of menstrual cycle; Panic attack; a constellation of adverse symptoms, complications, injuries and other adverse event; throat spasms; Autonomic injuries/Autonomic dysfunction; Neurological injury/ Neurological dynfuction; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a an adult (age not specified) female patient. Patient's current conditions, medical history and  concomitant therapy was not reported. On 19-AUG-2020, the patient (at 18 years old), the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, lot number, expiration date, route of administration and anatomical location were not provided) administered for prevention cancer. On an unknown date, following her vaccination, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injection; she developed symptoms of postural issues, pt felt weak and could not hold her body upright, she had balance issues and would fall over when standing, her heart rate would become very high while standing and she would have to lay back down, headaches. She was formally diagnosed with postural orthostatic tachycardia syndrome (POTS) and fibromyalgia. As the months progressed, so did the pt injuries, she was seen by multiple physicians and specialists for her complaints which included: chronic headaches, balance issues, difficulty walking, shaking, stuttering, weakness, insomnia, heart palpitations, dizziness, fainting, tingling sensations, chronic widespread pain, fatigue, loss of appetite, weight loss, throat spasms, chest tightness, shortness of breath, difficulty breathing while sleeping, diaphragm paralysis, loss of menstrual cycle, hormone imbalance, brain fog, panic attacks, depression and anxiety. 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. She can no longer walk long distances or work out. She spent months in bed due to her symptoms but was not able to sleep and suffered from severe insomnia. Based upon her chronic and severe post-papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, postural orthostatic tachycardia syndrome ("POTS") and fibromyalgia. The pt contends that her papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to POTS and fibromyalgia 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 papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of the company's alleged 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 suffered and continued to suffer severe and permanent physical injuries, and associated symptomology and 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 injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result, Plaintiff 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. At the time of reporting, plaintiff 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). The outcome of the claimed events were considered as not recovered.  All the events were considered as disabling by reporter.  Upon internal review, the event of autoimmune disorder and diaphragmatic paralysis were determined to be medically significant.