Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune disorder, Carotid artery aneurysm, Cerebral haemorrhage, Computerised tomogram head abnormal, Haematemesis
Clinical narrative: autoimmune disorder; Carotid Terminus Aneurysm / pain / vomiting / vomiting blood; major brain bleed / pain / vomiting; Information has been received from a lawyer and the patient's mother regarding a case in litigation, and referred to a 12-year-old male patient (pt). The pt's medical history, concurrent conditions and concomitant medications were not reported. On 30-NOV-2021, the pt was vaccinated with the first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact dose, route, strength, lot# and expiration date were not provided) for preventing cervical cancer. On 30-NOV-2021, the pt had pain from the injection he received. On 14-DEC-2021 (reported as "two weeks later"), the pt's mother heard him from his room vomiting. She ran to see what happened and pt was standing in the middle of his room vomiting and holding his head due to extreme pain. Within 30 minutes pt was vomiting blood, so his mother called 911. The pt was rushed to the local hospital where he was immediately taken to have a computerized axial tomography (CAT) scan performed. He was diagnosed with a major brain bleed (cerebral haemorrhage), and life-flighted to a larger hospital for immediate surgery to save his life. At the larger hospital, an external ventricular drain (EVD) was placed into his brain to relieve the pressure. Pt had suffered a carotid terminus aneurysm (carotid artery aneurysm) and would require another surgery to stop the bleeding and close off the aneurysm. This procedure was to be done "on the next morning" because they had to assemble a team that could work on a child. As a result of his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injury, pt was now disabled. Mother contended that pt's quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused pt to develop carotid terminus aneurysm, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were alleged herein and all of which were caused by human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or otherwise linked to his human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. As a proximate result of company's wrongful acts and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)'s manufacturing defects, 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 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, pt had suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment, and diminished income capacity, and he will continue to incur these losses and expenses in the future. Outcome of all the events was not recovered. The reporter considered carotid artery aneurysm, autoimmune disorder and cerebral haemorrhage to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).     The reporter assessed the events carotid artery aneurysm, autoimmune disorder and cerebral haemorrhage as serious due to disability. Upon internal view, the events carotid artery aneurysm, autoimmune disorder and cerebral haemorrhage were determined to be medically significant. Event major brain bleed was considered to be life-threatening.