Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Gastrooesophageal reflux disease, Haemorrhagic ovarian cyst, Hallucination, auditory, Headache
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adolescent female patient. Information on the Pt's concurrent conditions, medical history or concomitant therapy was not reported.   On 17-AUG-2012, the Pt was vaccinated with a first dose of GARDASIL (lot#, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date in August 2012, reported as almost immediately, Pt experienced a seizure-like episode which included a staring spell, facial swelling, slurred speech and severe headache. Within a few days of receiving her first dosage of GARDASIL, the Pt developed migraines, dizziness, and numbness. Over the following months, she also experienced constant headaches and severe migraines, abdominal pain, nausea, vomiting, rapid heartbeat and palpitations, insomnia, and symptoms of auditory hallucinations and parasomnias. On an unknown date in February 2013, the Pt empierced a seizure and was taken to the emergency department at a hospital. A head CT was performed and returned normal, and she was diagnosed with a first-time seizure. On an unknown date in March 2013, after suffering from headaches, vomiting, and nausea for about five days, the Pt was taken to the hospital for a DHE protocol. Although the protocol resolved her nausea and vomiting, the Pt continued to have migraines and occasional hallucinations. On an unknown date in April 2014 (reported as in April/May of 2014), the Pt began to experience irregular menstrual problems, including heavy bleeding at the beginning of each cycle. After six months of suffering, the Pt's mother made an appointment for a consultation with a pediatrician. On 21-OCT-2014, the Pt was administered with the second dose of GARDASIL, by a physician. On 23-OCT-2014, the Pt collapsed at school while running in her P.E. class and was taken to the ED. By an unknown date in December 2014 (also reported as early December 2014), the Pt's menstrual problems had changed to an absence of menses and severe abdominal pain. An ultrasound performed on an unknown date in March 2015, showed that she had a hemorrhagic cyst in her right ovary and large Nabothian cysts in her cervix. Further testing indicated that the cysts were getting larger, and as the Pt was in constant pain, she decided to have the cyst on her ovary surgically removed. On unknown dates in May and June 2015, Pt experienced several more seizures and was taken to the hospital each time. As the months progressed, so did the Pt's injuries. She was seen by multiple physicians and specialists for complaints, which included, among others: constant nausea and abdominal pain; reflux and heartburn; multiple seizures; feeling faint and lightheaded; heart rate irregularities and palpitations; chest pains; dizziness and blurry vision; dyspnea with walking; significant fatigue; continued menstrual irregularities; joint hypermobility; hives and facial flushing; severe food allergies; chronic dehydration; and recurring ovarian cysts.  As a result of her GARDASIL symptoms, Pt had been unable to engage in the normal activities that a teenager and young adult would enjoy. As a result of her GARDASIL induced injuries, she had to drop out of high school to complete her schooling at home. She was unable to hold down a job for any significant amount of time due to chronic pain and poor health. Pt could not drive a car because of the risks of fainting or having a seizure while driving.  Pt was once a happy child, but as a result of her GARDASIL symptoms, she had experienced a significant decline in her mental health. Due to the significant stressors related to her physical illnesses, she experienced hallucinations and sustained severe emotional distress which led to her cutting herself as a young teenager (dates unknown).  Pt suffered from recurring ovarian cysts, endometriosis, and early onset menopause. She did not get regular periods, therefore would not be able to conceive naturally in the future. She had a high risk for seizure, stroke, heart attack and blood clots and was medically unable to undergo hormone therapy to relieve the pain from the ovarian cysts, or to restore her menses. Therefore, she must live with the chronic, debilitating pain from the recurring cysts, and have them surgically removed when necessary. To date, Pt has had four or more surgeries to remove ovarian cysts.  Based on her chronic and severe GARDASIL symptoms and adverse events as outlined above and the tests performed by a number of medical providers, Pt had been diagnosed with various medical conditions, including but not limited to, dysautonomia, postural orthostatic tachycardia syndrome ("POTS"), orthostatic intolerance ("OI"), mast cell activation syndrome ("MCAS"), complex migraine headaches, seizure disorder, vasculitis, eosinophilic esophagitis, endometriosis, and interstitial cystitis.  Pt contended that her injections of GARDASIL, individually or in combination, caused her to develop serious and debilitating injuries, including but not limited to, dysautonomia, postural orthostatic tachycardia syndrome (""OTS"), orthostatic intolerance ("OI"), mast cell activation syndrome ("MCAS"), complex migraine headaches, seizure disorder, vasculitis, eosinophilic esophagitis, endometriosis, and interstitial cystitis, as well as a constellation of adverse symptoms, complications, and injuries, many of which are alleged herein and all of which were caused by GARDASIL or otherwise linked to her GARDASIL-induced autoimmune disorder.  As a proximate result of Company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of GARDASIL, 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. 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 GARDASIL.  As a direct and proximate result of her GARDASIL-induced injuries, Pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished in come capacity, and he will continue to incur these losses and expenses in the future.  The outcome of the events was reported as not recovered. The reporter considered all events to be disabling and related to GARDASIL.  Information regarding this Pt was also received via social media. It was reported that on 17-AUG-2012, the Pt was vaccinated with GARDASIL. On 18-AUG-2012, also reported as one day after the first injection, Pt had an epileptic episode that included a "gaze spell", swelling of the face, slurred speech and severe headache. She later developed severe migraines, abdominal pain, and a host of other debilitating health problems. On an unknown date in January 2013, also reported as five months after her first injection, Pt had an epileptic seizure and was taken to the emergency room. At that time, she was also facing irregular menstrual problems, including heavy bleeding at the start of each cycle. Her health continued to deteriorate after receiving another dose of the GARDASIL. Just two days after the second injection, Pt collapsed during physical education class and was rushed to the emergency department of a hospital. Pt has had at least one surgery per year on her reproductive organs since she was 15-year-old. Doctors said she would not be able to get pregnant or consider in vitro fertilization. The Pt's clinical diagnoses included dysautonomia, postural orthostatic tachycardia syndrome ("POTS"), orthostatic intolerance ("OI"), small fiber neuropathy ("SNF"), neuropathy, mast cell activation syndrome ("MCAS"), seizure disorders and endometriosis. among others. Due to these and other sequelae, Pt was unable to maintain a job for a significant period of time. She also could not drive due to the risk of fainting or seizures while driving. The outcome of the events was reported as not recovered. The reporter considered all events to be disabling and related to GARDASIL.  Upon internal review, the events of mast cell activation syndrome (""MCAS"), seizure-like episode/seizure disorder/first time seizure, Epileptic episode, hemorrhagic cyst in her right ovary, recurring ovarian cysts, symptoms of auditory hallucinations, cutting herself and neuropathy) were considered to be medically significant .