Age: 33.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Hypersomnia, Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: Discoid Lupus Erythematosus/rash like marks on her face and arms;small at first but eventually grew into large marks on her skin/tired easily and felt like she was never rested enough/autoimmune injuries; vitamin D deficiency / get sick easier / some depression; feel ill / feeling ill for several days; lightheaded; since receiving Gardasil her migraines have increased in frequency and intensity; sleeps more than before receiving Gardasil; neurological injuries; autonomic injuries; effect of her medication; Gardasil 1st dose on 21-NOV-2019, 2nd on 10-JUL-2020, 3rd on 20-SEP-2021; Information was received from a lawyer regarding a case in litigation and refers to an adult (exact age not provided) female patient (pt). Her concurrent conditions included migraines. The pt's medical history and concomitant therapies were not provided. On 21-NOV-2019, at the age of 33 years old, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 10-JUL-2020, at the age of 34 years old, she received the second dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided). On 20-SEP-2021, at the age of 35 years old, the pt was vaccinated with the third dose of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) (Inappropriate schedule of product administration). All doses were administered for prophylaxis (also reported as "touted as a safe and effective vaccine for preventing cervical cancer"), with the pt's consent and recommended by her physician. On unknown dates, the pt experienced serious autonomic and neurological injuries as a result of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). On an unknown date, following the third quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, the pt started to notice changes in her health and skin. She noticed that if she stayed in the direct sunlight longer than thirty minutes, she would start to feel ill. This feeling would last a few days. She would also get tired easily and felt like she was never rested enough. The pt started getting rash like marks on her face and arms. The marks were small at first but eventually grew into large marks on her skin. 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 person would enjoy. Prior to receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), she loved being outdoors and enjoyed swimming, fishing, and hiking. The pt could no longer be in the sun for longer than fifteen minutes without feeling ill and lightheaded. If she was in the sun for too long, in addition to feeling ill for several days, a new area of her rash would start to grow. As a result of her inability to be in the sun for very long, she developed a vitamin D deficiency. The pt must be careful with what she was applying to her skin like soaps, lotions and makeup because certain products worsened her rash. She had migraines prior to receiving human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). However, since receiving human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) her migraines increased in frequency and intensity. The pt was also sleeping more than before receiving human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). She was also getting sick easier at that time than she did prior to receiving human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). She also had to leave her work early or call out of work more frequently due to the effects of the sun or her medication. The pt's condition caused her to develop some depression as she was no longer able to be as social as she used to be. Based upon her chronic and severe post- human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt was diagnosed with various medical conditions, including but not limited to, discoid lupus erythematosus and vitamin D deficiency. The pt contended that her 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 discoid lupus erythematosus and vitamin D deficiency, 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 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 proximate result of 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. The pt also had a substantial fear of suffering additional and ongoing harms, including but not limited to being at that time 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, 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 the events was considered to be not recovered.  The reporter considered discoid lupus erythematosus, vitamin D deficiency, feel ill, lightheaded, migraines increased in frequency and severity, sleeps more, neurological injuries and autonomic injuries to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The causality assessment between effect of her medication and the suspect vaccine was not provided.  Upon internal review, the events of discoid lupus erythematosus and autonomic injuries were determined to be medically significant. The reporter considered all events to be disabling.