Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Gait disturbance, Hypersensitivity, Limb operation, Rash, Road traffic accident
Clinical narrative: anaphylactic reaction / Could not breathe; did not feel right; rash all over his body; dizziness; episodes of anxiety; hand tremors, shaking; difficulty walking; hand surgery; car accident; wisdom teeth removal; autonomic injuries; neurological inuries; Autoimmune injuries; acquired allergy to saline / trouble breathing, rash, anxiety, shaking, hand tremors, difficulty breathing, chronic Th2-driven allergic state/sensitivity to saltwater where he would break out in a rash; Information has been received from a lawyer regarding a case in litigation and refers to a 17-year-old male patient (pt). There was no information regarding the pt's medical history, concurrent conditions, and concomitant medication were not reported.  On 11-JUL-2018, the pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) intramuscular injection (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) as recommended by physician, with his mother's consent, for prophylaxis (also reported as "touted as a safe and effective vaccine for preventing cancer").   Within minutes of the shot, the pt could not breathe and did not feel right. He started to develop a rash all over his body and was rushed to an emergency room, where he was placed on oxygen and intravenous (IV) drips. The was admitted to the hospital where he remained for three days. In addition to the rash and difficulty breathing, he suffered dizziness, difficulty walking, episodes of anxiety, shaking, and hand tremors. The pt was given an EpiPen. As the months progressed, so did Plaintiff's symptoms. Plaintiff began noticing a sensitivity to saltwater where he would break out in a rash, which had never happened before. Plaintiff also had trouble breathing and broke out in a rash after undergoing hand surgery. He experienced a rash again after a car accident and being given an IV at the hospital. Again, he experienced anxiety, shaking and hand tremors. After having his wisdom teeth removed, he was given an "IV", and again had difficulty breathing and broke out in a rash. The pt was seen by multiple physicians and specialists for his complaints which at that time included an allergy to saline. Based upon his chronic and severe post- Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, he was diagnosed with various medical conditions, including but not limited to anaphylactic reaction and acquired allergy to saline. The pt contended that his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection caused him to develop serious and debilitating autoimmune injuries, including but not limited to an anaphylactic reaction and acquired allergy to saline, a chronic Th2-driven allergic state, 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 his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of quadrivalent 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. He also has 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 his injuries caused by Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). As a direct and proximate result of his 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 he would continue to incur these losses and expenses in the future. The outcome of autonomic injuries, autoimmune injuries, neurological injuries, anaphylactic reaction and allergy to saline was considered to be not recovered. The outcome of hand operation, car accident, and wisdom teeth removal was not provided.  The reporter considered the events of autonomic injuries, autoimmune injuries, neurological injuries, anaphylactic reaction and acquired allergy to saline/chronic Th2-driven allergic state to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). The causality assessment between hand operation, car accident, wisdom teeth removal, and the suspect vaccine was not provided.   Upon internal review, the events of autoimmune injuries, autonomic injuries, anaphylactic reaction and acquired allergy to saline/chronic Th2-driven allergic state were determined to be medically significant. The reporter considered the events of autonomic injuries, autoimmune injuries, neurological injuries, anaphylactic reaction and acquired allergy to saline/chronic Th2-driven allergic state to be disabling.