Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Lid sulcus deepened, Loss of personal independence in daily activities, Mental status changes, Mood altered, New daily persistent headache
Clinical narrative: Chronic fatigue syndrome/daily headaches, dizziness/chronic headaches/being tired most of the time; Uncontrollable shaking/arms and limbs shook; depressed, withdrawn; numbness in her arms; pain in her tailbone; emotional trauma; Her eyes sunk and her skin was pale; Her eyes sunk and her skin was pale; mental and emotional breakdowns resulting in hour long fits of screaming, kicking and rage/banging her head on walls and doors/fits of rage; anxiety; autoimmune disease, autonomic dysfunction/extreme, abnormal, debilitating mood and behavioral changes/unable to sleep/chest pain, racing heart/chronic headaches, fainting, dizziness; Information has been received from a lawyer regarding a case in litigation and referred to a 13-year-old female patient (pt). Prior to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination, she had no autoimmune diseases, and no autonomic issues and was an otherwise incredibly intelligent, witty, strong willed, healthy, active, athletic, personable, and engaging girl; she was a skilled soccer player, and was an A student. Information on the pt's concomitant therapies was not reported. On 15-MAR-2019, the pt's health care provider (HCP) recommended that pt receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. On the same date (at the age of 13), and under the consent of her mother, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prophylaxis (lot #, expiration date, dose, route of administration and anatomical location were not reported). On an unspecified date in March 2019 (reported as within a few days of receiving quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine) she experienced severe pain in her tailbone (coccydynia), it persisted for weeks; activities like running and sitting for classes were painful. On an unspecified date in 2019 (reported as a short time later), the pt suffered extreme, abnormal and debilitating mood and behavioral changes, she was unable to sleep, her arms and limbs shook, her eyes sunk (lid sulcus deepened), and her skin was pale (pallor). Her mental state continued to deteriorate. She suffered mental and emotional breakdowns resulting in hour long fits of screaming, kicking and rage (mental disorder). The pt's anxiety, emotional trauma and her shaking continued to get worse. As the months progressed, so did her injuries. She was seen by multiple healthcare specialists for her complaints which included: daily headaches, dizziness, fainting, fits of rage, being tired most of the time, shaking, anxiety, uncontrolled screaming, kicking and banging her head on walls and doors. She became depressed, withdrawn and could not participate in school or soccer. She later developed chest pain, racing heart, and numbness in her arms (hypoaesthesia). As a result of her post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt no longer had the same life. The inability to stop the numbness, shaking, anxiety and depression changed her life. It was stated that she sustained autoimmune disease, autonomic dysfunction (autonomic nervous system imbalance) and other serious injuries. She had been diagnosed with various medical conditions including but not limited to, chronic fatigue syndrome, chronic headaches, fainting, uncontrollable shaking (tremor), and dizziness. As a proximate result of vaccination, pt had suffered and continued to suffer severe and permanent physical injuries including, but not limited to, her autoimmune disease 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 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 had 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. At the reporting time, the outcome of the events was considered as not recovered. The reporter considered all the events related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). All the events were considered as disabling events.