Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Foot operation, Gait disturbance, Hypoaesthesia, Hypocomplementaemia, Inappropriate schedule of product administration
Clinical narrative: systemic lupus erythematosus (SLE)//pain/limp/foot discoloring/tingling/numb/throbbing/arterial occlusion and thrombosis/positive ANA and double stranded DNA/hypocomplementemia/autoimmune disorder; lupus nephritis of both kidneys/stage four of lupus nephritis/systemic lupus erythematosus/kidney disease; toes had fallen off / was going to lose the toes on his left foot and they needed to allow the toes to fall off naturally, for healing purposes; initial dosage of GARDASIL on 29-NOV-2011 / second injection on 15-NOV-2012; Information has been received from a lawyer regarding a case in litigation and concerning a male, adolescent patient (pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. On 29-NOV-2011, when the pt was 11 years old, he received his initial dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 15-NOV-2012, he received his second injection (inappropriate schedule of vaccine administered), and on 15-MAR-2013, his third, final shot of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (exact doses, strengths, lot #, expiration dates, sites and routes of administration were not provided for any doses; all received for prophylaxis). All vaccinations were administered by a physician at a hospital/medical center. On an unknown date in 2013, some months after his final quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, the pt began experiencing pain in his left foot, eventually causing him to limp and to have difficulty placing weight on his left foot. In December 2013, several of the toes on the pt's left foot started discoloring and turning bluish red in color. The pt also told his mother his toes were tingling and numb. The pt's mother took him to urgent care doctors. The doctors in the emergency center were unable to identify a particular cause for the pt's condition, doing many blood tests (results not reported), calling in interventional radiology specialists and others to diagnose the pt's condition. No answers were found and the pt was sent home with his mother to wait and watch to see if the condition improved over time. On 03-JAN-2014, seeing that the pain in his foot had progressed, the pt's mother took her son to the emergency room for further evaluation. All lab work performed came back normal and the doctor was unable to pinpoint the cause of the pain. The doctor referred the pt to other hospital for further evaluation. The following day, on 04-JAN-2013, the pt complained of increased throbbing and pain in his foot. The pt's mother took him to the emergency department at a hospital where, upon performing a Doppler ultrasound, an arterial occlusion and thrombosis of both the left peroneal and popliteal arteries were found. The pt was admitted into the pediatric intensive care unit (ICU) for anticoagulation treatment. On 08-JAN-2014, the pt was transferred to other hospital for further treatment. Surgery was performed to remove a portion of his left popliteal artery. While hospitalized, tests revealed that the pt possibly had antiphospholipid antibody syndrome (APS) and/or lupus. The pt was in the hospital almost a month and was finally discharged on 26-JAN-2014. Prior to discharge, the pt and his mother were told the pt was going to lose the toes on his left foot and they needed to allow the toes to fall off naturally, for healing purposes. While waiting for this "natural" loss of toes to occur, the pt and his mother returned to the hospital on 05-MAR-2014, where a lupus panel confirmed a positive antinuclear antibody (ANA) and double stranded deoxyribonucleic acid (DNA) as well as hypocomplementemia, causing the pt's doctors to believe he could be developing systemic lupus erythematosus (SLE). By roughly June 2014, the pt's toes had fallen off and in July 2014, he had surgery to pare back some of the protruding bones in his left foot. He could only walk with the help of crutches. Subsequent tests confirmed that the pt had developed SLE. In 2016, the pt developed lupus nephritis in both of his kidneys. He received oral chemotherapy as he was in stage four of lupus nephritis. Although at the time of report (provided as currently) he was in remission, it could strike back at any time. The pt had to have monthly infusion of steroids (unspecified) to help reduce the inflammation and pain caused by the condition. At the reporting time (reported as now), the pt had kidney disease, lupus nephritis and would need to take medication (unspecified) for the rest of his life. The pt contended that his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), caused him to develop serious and debilitating autoimmune injuries, including but not limited to systemic lupus erythematosus (SLE), lupus nephritis of both kidneys (which would likely required transplantation), loss of his toes, leading to other complications, as well as a constellation of adverse symptoms associated therewith, 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 linked to his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder (also referred to as serious autoimmune/autoimmune, autonomic, and neurological injuries/dysfunctions/diseases). As a proximate result of wrongful acts and omissions and negligent and fraudulent testing, labeling, manufacturing, marketing and promotion of the suspect vaccine, the pt had suffered and would continue to suffer severe and permanent physical injuries, and associated symptomology and had 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 now being 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). At the reporting time, the outcome of events was not recovered/not resolved. The reporter considered all the events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).   The reporter considered all events to be disabling. Upon internal review, the events of systemic lupus erythematosus, lupus nephritis, and spontaneous amputation were determined to be medically significant.