Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Hepatic enzyme abnormal, Immune thrombocytopenia, Immune-mediated adverse reaction, Immunisation reaction, Immunoglobulin therapy
Clinical narrative: idiopathic thrombocytopenic purpura (ITP)/autoimmune disease; osteonecrosis of at least four major joints; post-transplant lymphoproliferative disease; postural orthostatic tachycardia syndrome (POTS)/issues with his heart/dysautonomia; infertility; severe aplastic anemia/reticulocytopenia/neutropenia/pancytopenia/secondary bone marrow failure with severely hypocellular marrow/most likely an immune mediated insult on the bone marrow; Information was received on 28-JUL-2022 from a lawyer, regarding a case in litigation and concerning a 19-year-old male patient (pt). The pt's medical history included stress fracture of the left tibia. The pt was physically fit and active and participated in weightlifting and running. It was also reported that one of the pt's family members had recently been diagnosed with Human Papillomavirus (HPV) throat cancer. On 20-SEP-2017, pt's health care provider (HCP) recommended that pt receive Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), which was presented as a safe and effective vaccine for preventing cancer caused by HPV. On the same day, the pt received his first dosage of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route and anatomical location of administration, lot# and expiration date were not reported). On 29-SEP-2017 (also reported as nine days later), the pt presented to the emergency department (ED) with complaints of blood in his urine for the past 5 days (onset date of 24-SEP-2017) and petechiae (pinpoint round spots that appeared on the skin because of bleeding) at his ankles and thighs. His laboratory work-up in the ED revealed that his blood platelet count was 7000 platelets per microlitre of blood (normal ranges: 150000 to 450000, having less than 150000 was known as thrombocytopenia). The pt was admitted to the hospital for further evaluation. He was diagnosed with thrombocytopenia. The etiology of the pt's acute thrombocytopenia was unclear but the differential diagnosis included an immune mediated thrombocytopenia. On 30-SEP-2017, the pt was evaluated by onclogist/hematologist, who's conclusion was that the pt suffered from idiopathic thrombocytopenic purpura (ITP), possibly from suspect vaccine. The doctor ordered two days of intravenous immune globulin (IVIG) therapy, which was known to be an effective treatment for many autoimmune conditions. In a progress note from 10-OCT-2017, the oncologist noted that he had consulted with three other hematologists on the case. On 01-OCT-2017, the pt had a consult with gastroenterologist, for an evaluation of his abnormal liver enzymes. While the results of a few blood tests (unspecified) remained outstanding, gastroenterologist's conclusion was that the pt was suffering from suspected ITP secondary to suspect vaccine. On 02-OCT-2017, the pt was seen by internal medicine physician, who's records indicated that severe thrombocytopenia was most likely ITP due to medication, hematology consult was appreciated, most likely ITP caused by suspect vaccine, still could not rule out other causes per hematologist. On the same day, the pt underwent a bone marrow biopsy. The results noted that the findings were suggestive of an underlying auto-immune, inflammatory, or infectious process and the causes should be clinically investigated. Beginning on 03-OCT-2017, and continuing thereafter, internal medicine physician's records noted severe thrombocytopenia most likely ITP secondary to (2/2) Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. On 06-OCT-2017, on request of the pt's oncologist, an infectious disease specialist was brought in to review and consult on the pt's medical case. He noted that the pt had no prior febrile illness and was doing physical work outs until the time he began having symptoms of blood in his urine. The doctor reviewed the pt's lab work and concluded that no infectious etiology had been uncovered. The doctor's notes recognized that the pt received a suspect vaccine about five days prior to the onset of symptoms and his impression was that the pt was suffering from ITP and it was his belief that the condition was probably due to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). On 11-OCT-2017, after being hospitalized for 12 days, the pt was discharged from the hospital and instructed to follow-up with his oncologist. As instructed, the pt followed-up with his oncologist the next day, and the doctor ordered the pt to receive one unit of platelets that day and ordered the pt to continue to have blood work twice a week. On recommendation of the pt's oncologist, the pt was seen on 17-OCT-2017, by another doctor at the hematology clinic, and the doctor diagnosed the pt as having thrombocytopenia, reticulocytopenia and neutropenia. It was recommended that the pt should undergo a repeat bone marrow biopsy to rule out any other underlying bone marrow pathology. On 23-OCT-2017, the pt underwent a second bone marrow biopsy. On 03-NOV-2017, he was seen by his oncologist to go over results of the second bone marrow biopsy. After a review of the results and the collaboration with another doctor at the bone marrow transplant clinic, the conclusion was that they all believed the pt had most likely progressed into aplastic anemia with etiology unclear perhaps from Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). On 06-NOV-2017, the doctor at the bone marrow transplant clinic diagnosed the pt with pancytopenia due to secondary bone marrow failure with severely hypocellular marrow. The doctor's opinion was that the condition most likely an immune mediated insult on the bone marrow. He also stated that the temporal relationship of the suspect vaccine and the onset of symptoms was not entirely clear, however, the onset of symptoms after the vaccination raised the possibility of an autoimmune process triggered by the vaccination. Laboratory findings met the criteria for a very severe aplastic anemia. Therapies and treatment options were discussed and included a bone marrow transplant if a match could be found. The pt's sibling was a match and on 21-DEC-2017, the pt received a matched sibling donor bone marrow transplant. Following the procedure, the pt developed post-transplant lymphoproliferative disease. As a result of the pt's post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, the pt was unable to engage in normal activities that a normal young person would enjoy. At the reporting time (reported as currently), the pt continued to receive IVIG therapy. His immune system was impaired, he (reported as now) was having issues with his heart and osteonecrosis of at least four major joints and will likely need to have joint replacements in the near future. Based upon his chronic and severe post-Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, thrombocytopenia, reticulocytopenia, neutropenia, severe aplastic anemia, postural orthostatic tachycardia syndrome (POTS), and post-transplant lymphoproliferative disease. The pt contended that his Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injection(s) caused him to develop serious and debilitating injuries, including but not limited to heterogenous autoimmune disease, ITP, POTS and dysautonomia, infertility as well as constellation of adverse symptoms, complications, injuries, and other adverse events, many of which are alleged herein and all of which were caused by suspect vaccine or otherwise linked to the pt's Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL)-induced autoimmune disorder. It was reported that suspect vaccine and its ingredients caused the pt's autoimmune disease and other related injuries and had resulted in him suffering from severe, debilitating, disabling and painful chronic injuries. The pt had suffered and continued to suffer severe and permanent physical injuries, including, but not limited to, his autoimmune disease and associated symptomology and had suffered severe and permanent emotional injuries, including pain and suffering. He 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 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 his 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 he would continue to incur these losses and expenses in the future. The outcome of all events was considered to be not recovered/not resolved.  All reported events were considered to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the events of ITP, post transplant lymphoproliferative disorder, osteonecrosis, and aplastic anaemia were considered to be medically significant (also the procedure of bone marrow transplant, which was a treatment for aplastic anaemia, was considered to be medically significant procedure). The reporter considered all the events to be disabling.