Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune disorder, Autonomic nervous system imbalance, Balance disorder, Brain fog, Cognitive disorder
Clinical narrative: Primary Generalized Epilepsy/ seizure / neurological dysfunctions /diseases / injuries; serious and debilitating injuries including but not limited to autoimmune injuries/dysfunctions and resulting sequalae; autonomic dysfunctions /constant headaches, trouble with his balance, did not have the same speed as usual, light sensitivity, eyes hurting, dizziness, brain fog, hot flashes, excessive sweating, shakiness, fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation, concerning 16-year-old male patient (pt). Information about pt's concurrent conditions, medical history and concomitant therapy was not reported. On 18-JUL-2019, 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 cancer. The pt sustained autonomic, autoimmune, and neurological injuries and resulting sequalae as a result of being vaccinated. On an unknown date in 2019 (reported as "in the months following first dose"), he began to experience constant headaches; he also seemed to have trouble with his balance while playing sports, did not have the same speed as usual, and also complained of light sensitivity, his eyes hurting, and dizziness. On 29-OCT-2019, pt returned to his pediatrician's office to be examined for his complaints of headaches. During this visit, pt received his second dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). On 13-NOV-2019 (also reported as "two weeks later"), pt had a seizure while getting ready for school. He was transported to the hospital for treatment and testing. Pt subsequently complained of brain fog and dizziness. On 07-DEC-2019, he had a second seizure, and then a third on 16-FEB-2020. Based upon his chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, he was diagnosed by his neurologist with primary generalized epilepsy. Despite being on therapeutic levels of levetiracetam (KEPPRA), pt continued having seizures on 10-MAR-2020, 18-APR-2020, and 02-JUL-2020. His medication was adjusted, and semisodium (DEPAKOTE) was initiated. In January 2022, pt was hospitalized while he was weaned off levetiracetam (KEPPRA) and started on lacosamide (VIMPAT). He continued to be on double therapy of lacosamide (VIMPAT) and valproate semisodium (DEPAKOTE), with high doses of both powerful anti-seizure medications, to maintain control of the seizures. As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, pt had to make major adjustments to his life. Due to the risk of seizures, his daily activities were severely limited. He tried to stay physically active, but he was no longer able to play team sports. He continued to struggle with cognitive issues, brain fog, headaches, hot flashes, excessive sweating, shakiness, balance and coordination issues, and fatigue. As a proximate result of the company's alleged wrongful acts and vaccine's manufacturing defects, pt suffered and continued suffering severe and permanent physical injuries, and associated symptomology and suffered severe and permanent emotional injuries, including pain and suffering. He 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 his autoimmune disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). As a direct and proximate result of his 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 he would continue to incur these losses and expenses in the future. At the time of reporting, pt had not recovered from the claimed events. The reporter considered all the claimed events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL).   All the claimed events were considered as disabling by reporter.  Upon internal review, the events of autoimmune disorder and primary generalized epilepsy were determined to be medically significant.