Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Dizziness, Headache, Immediate post-injection reaction
Clinical narrative: Gardasil-induced autoimmune disorder /serious and debilitating autoimmune injuries; dysautonomia; small fiber neuropathy; amplified pain syndrome; postural orthostatic tachycardia (POTS)/ chronic daily headaches/lightheadedness/predisposition of orthostatic intolerance which can be seen in POTS/vaccine reaction; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning a 12-year-old female patient (pt). Information about pt's concurrent conditions, medical history and concomitant therapy was not reported. Prior to receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection, pt had no autoimmune, autonomic, or neurological issues; and she enjoyed playing the piano, dancing and running cross country, she was identified as a gifted student and was in good health. On 03-OCT-2016, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) intramuscular injection (strength, lot number, expiration date, dose, route of administration and anatomical location were not provided), administered for preventing cervical cancer. Immediately after vaccination, pt became lightheaded and had a headache. She had to remain at the doctor's office for an additional 20-25 minutes until her color returned and she was able to go home. On 04-OCT-2016, pt's mother took her back to the clinic as pt's headache worsened and she was diagnosed with a vaccine reaction. On 06-OCT-2016, pt was taken to emergency department as her headaches were persisting. Her doctors consulted with one another and stated that her headaches were a possible side effect to the human papilloma virus (HPV) vaccination. On 10-OCT-2016, pt returned to doctor's office as she was still suffering from headaches. She was diagnosed with headaches and an adverse reaction to the vaccine. Over the next few months, pt continued to have headaches on a daily basis. On 13-FEB-2017, she was seen by a neurologist for her chronic daily headaches. The neurologist diagnosed her with a reaction to the HPV vaccination, possible postural orthostatic tachycardia syndrome (POTS) and amplified pain syndrome. On 16-JUN-2017, pt underwent a number of tests at a hospital and was diagnosed with small fiber neuropathy in addition to a predisposition of orthostatic intolerance which could be seen in POTS. On 06-JUL-2017, pt was diagnosed with dysautonomia by her cardiologist. Based upon her chronic and severe post- human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt was diagnosed with various medical conditions, including but not limited to, POTS, chronic headaches, small fiber neuropathy, and dysautonomia. Pt contended that her human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injection(s) caused her (reported as "him", conflicting information) to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to POTS and recurrent headaches, as well as a constellation of adverse symptoms, complications, injuries (also reported as resulting sequelae) and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or otherwise linked to her human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a result of her post- human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt was unable to engage in normal activities that a normal young person would enjoy. As a proximate result of alleged company's wrongful acts and omissions and its negligent and alleged fraudulent testing, labeling, manufacturing, marketing and promotion of human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), pt suffered and continued suffering severe and permanent physical injuries, and associated symptomology and 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 human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result of her human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL)-induced injuries, pt suffered and continued suffering economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she would continue to incur these losses and expenses in the future. At the time of reporting, 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 as disabling by reporter.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.