Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Loss of personal independence in daily activities, Memory impairment, Muscular weakness, Nausea
Clinical narrative: chronic headaches,achy all over her body,constant fatigue,nausea,loss of appetite,tremors,dizziness,faintness to the point of feeling like she was going to pass out,chest pains,shortness of breath,feeling off balance,weakness in her legs,memory issue; gastroparesis, loss of appetite; MCAS; tics; tingling sensation; epilepsy condition; autoimmune injuries; first dose administered in September 2015, the second dose administered in December 2018; Information has been received from a lawyer regarding a case in litigation and refers to an adolescent (reported also as a minor) female patient (pt) (exact age not provided). The pt's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date in September 2015, at the age of 13 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided), for prophylaxis (reported as "touted as a safe and effective vaccine for preventing cervical cancer"), as recommended by the pt's physician and consented by the pt's mother. On unknown dates, following her first quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, the pt suffered headaches, tics, and felt achy all over her body, however, these symptoms were not serious enough to interfere with her daily functioning. The pt and her parents believed they were transient, and she was able to go on with her life. On an unspecified date in December 2018, at the age of 16 years old, she received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, lot #, expiration date, route of administration, and anatomical location were not reported) (inappropriate schedule of product administration). Thereafter, she developed chronic headaches, constant fatigue, body aches, nausea, loss of appetite, tingling sensations, tremors, dizziness, faintness to the point of feeling like she was going to pass out, chest pains, and shortness of breath. These symptoms caused her to miss many days of school, requiring her to drop out of high school and sign up for home schooling for her remaining high school years. As the months progressed, so did the pt's symptoms. She was seen by multiple physicians and specialists for her complaints which now included tingling sensations, feeling off balance, weakness in her legs, feeling she was going to pass out, chest pains, shortness of breath, difficulties concentrating, memory issues, coldness in her hands, nausea, and abdominal pain. The pt was ultimately diagnosed with postural orthostatic tachycardia syndrome (POTS) by her cardiologist in October 2020. Despite her diagnosis, in December 2020, a neurologist suggested her symptoms were all in her head and referred her to see a psychiatrist. Between the time she received her second vaccine in late 2018 (and developed serious symptoms) and her POTS diagnosis in October 2020, the pt's parents were taking her to one doctor after another trying to figure out what was wrong with her. It would sometimes take months to get an appointment to see certain specialists. During this time, neither parent quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was the cause and they believed their daughter's symptoms were transient and would resolve. After her POTS diagnosis in October 2020, and in the midst of the coronavirus disease (COVID) pandemic, they continued to believe their daughter's symptoms were transient and did not believe quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was the cause. They thought her symptoms might be related to her epilepsy condition or that her epilepsy medications needed to be adjusted. However, as the pt's symptoms persisted, her father started researching whether quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) could possibly be the cause of his daughter's now clearly chronic condition. The first time the pt discovered that her injuries could have been caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was in February 2023. It was then that her father conducted research on POTS and whether quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) could be related to his daughter's condition, and encountered an article, which led him to a website discussing quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and the possible link to POTS. Until 27-JUN-2020, she was a minor and she did not discover that the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine may have caused her injuries, until February 2023. On 17-MAR-2023 (reported also as a month later, and more than 36 months after her symptoms first began), the pt filled her vaccine injury compensation program (VICP) petition. The pt and her parents were unaware of the VICP, and not given a vaccine information sheet (VIS) at any time. Further, the pt and her parents had no reason to suspect the causes of her injuries were related to the vaccine. As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was unable to engage in activities that a normal young person would enjoy. Prior to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she was an active teenager and an avid animal lover with aspirations to become a veterinarian. Post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she was unable to finish high school in person, she was unable to go to college to pursue her dream of becoming a veterinarian, and she could not work. At the age of 20, she spent most of her time at home instead of going to college, riding horses, participating in sports, or socializing with friends. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to, POTS, gastroparesis, and as possibly having mast cell activation syndrome (MCAS). The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune, autonomic, and neurological injuries, including but not limited to POTS, gastroparesis, and MCAS, 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 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 autoimmune disorder. As a proximate result of the suspect vaccine, 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. 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 suffered and continued to suffer 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. The outcome of POTS, gastroparesis, MCAS, tics, tingling sensation, and autoimmune disorder was considered to be not recovered/not resolved. The outcome of epilepsy was not reported. The reporter considered POTS, gastroparesis, MCAS, tics, tingling sensation, and autoimmune disorder to be related to human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The causality assessment between epilepsy and the suspect vaccine was not provided.  Upon internal review, the events of gastroparesis, MCAS, epilepsy, and autoimmune disorder were determined to be medically significant. The reporter considered POTS, gastroparesis, MCAS, tics, tingling sensation, and autoimmune disorder to be disabling.