Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Gait disturbance, Gastrointestinal disorder
Clinical narrative: Postural Orthostatic Tachycardia Syndrome (POTS)/ trouble sleeping/ difficulty breathing/ heart palpitations and chest pains/ trouble concentrating/body aches/ pain in her feet and abdomen; Dysautonomia/ brain fog/ blurred vision/ dizziness/ nausea/ gastrointestinal issues/ Walking became difficult/ Autonomic and Neurological Injuries/; Tendonitis/ joint pain/body aches/ pain in her feet and abdomen; vocal cord dysfunction; Autoimmune; constellation of adverse symptoms, complications, injuries, and other adverse events; constellation of adverse symptoms, complications, injuries, and other adverse events; injuries; Information has been received from a lawyer regarding a case in litigation and referring to a female (conflict information, also reported as male) patient (pt) of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 19-AUG-2019, at the age of 11 years old, the pt was vaccinated with the 1st 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 a nurse practitioner, with her mother's consent, for prophylaxis. On 19-FEB-2020, the pt was vaccinated with the 2nd dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location and route of administration were not provided). Following her 2nd vaccination, pt began experiencing trouble sleeping, brain fog, blurred vision, dizziness, nausea, difficulty breathing, heart palpitations and chest pains, body aches, joint pain, gastrointestinal issues, trouble concentrating, and pain in her feet and abdomen. Walking became difficult, particularly walking upstairs, and she was required to use the elevators at school. As the months progressed, so did pt's symptoms. Pt was seen by multiple physicians and specialists. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her injections, and Pt had been diagnosed with various medical conditions, including but not limited to, Postural Orthostatic Tachycardia Syndrome (POTS), dysautonomia, tendonitis, and vocal cord dysfunction, 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 result of her post- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt had been unable to engage in activities that a normal child would enjoy and her ability to function had been negatively impacted. Her academic performance suffered, and she had to be homeschooled. Her involvement in multiple sports, such as volleyball, color guard, archery, and her participation in other activities were severely limited. As a proximate result of company's wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), pt had suffered and continued to suffer severe and permanent physical injuries, 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 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, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and she will continue to incur these losses and expenses in the future. The outcome of all the events was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered all the events to be disabling. Upon internal review, autoimmune disorder was determined to be medically significant.