Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Brain death, Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram neck, Death
Clinical narrative: almost completely brain dead; autoinflammatory dysregulation; autonomic dysfunction/fatigue/vomited/completely non-responsive; not feel like himself; autoimmune disease/elevated autoimmune markers; viral infection/inflammatory markers elevated; Sinusitis/fevers again/sore throat; Encephalitis/fever 102.9 degrees/left leg went numb, face became numb as well, later his tongue/fatigue/vomited/completely non-responsive; white blood cell count tripled; Loss of weight/lost 20lb; swollen lymph node; Information has been received from a lawyer and the patient's parents regarding a case in litigation and referred to a 11-year-old male patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. It was reported that he had no autoimmune diseases, no autonomic issues, and was extremely healthy, having received a clean bill of health at his 11-year medical check-up, he enjoyed hunting and fishing with his dad, building Legos, and playing his drum set; loved school and was active in his church, loved spending time with his parents, sister, and grandparents. On 07-MAY-2018, tow days after his 11th birthday, the pt's pediatrician recommended that he receive quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. Under the pt's parents' consent, he was vaccinated with a single dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) as prevention for neck, mouth, penile and anus HPV-related cancers (dose, route of administration, anatomical location, lot number, and expiration dates were not reported). Approximately on 21-MAY-2018 (reported as two weeks following his vaccination), pt began experiencing fevers going as high as 102.9 degrees (unspecified). On 03-JUN-2018, the pt was taken to his pediatrician for his ongoing fevers. His symptoms continued, however, and one week later, his blood was checked to rule out Mononucleosis or other causes for the ongoing fevers. There was no "cause" found for these fevers, which came and went throughout the summer of 2018. At the end of September 2018, what was believed to be a sinus infection presented itself, causing the fevers again, along with a sore throat and other symptoms. The pt's mother took him to a pediatrics office where he was diagnosed with sinusitis and was prescribed cephalexin. A week later, he was not better, advice from the nursing helpline at pediatrics office was sought, they recommended the pt be taken to urgent care or an emergency room (ER). On 10-OCT-2018, pt was taken to an ER. After examination and blood tests, pt's mother was informed that her son's inflammatory markers were elevated, possibly due to a viral infection and he was referred to infectious disease department. Later, on an unspecified date in 2018, a visit to infectious disease department revealed that his white blood cell count had tripled in two weeks (white blood cell abnormal). Several days later, another physician found a swollen lymph node (lymphadenopathy) and ordered an immediate CT scan (results were not provided). A biopsy of the lymph node revealed that he did not have cancer. The pt was referred to pediatric gastroenterology due to weight loss issues he began experiencing. He was also referred to Pediatric Rheumatology to search for any autoimmune disorder responsible for his continuing physical illness and abnormal blood tests. The pediatric gastroenterologist recommended several tests ranging from a colonoscopy, endoscopy, and capsule camera study. The pt also saw a pediatric rheumatologist, in search of a possible autoimmune disease, who ordered a magnetic resonance imaging (MRI) scan and many different blood tests attempting to find the underlying cause of his extreme weight loss (weight decreased) with elevated autoimmune markers. On 07-MAY-2019, pt had an appointment for weight loss where the records stated "Over the past year, he has had a rough year. He was in his usual state of good health per Mother until he went for his 11-year-old vaccine and well child check-up. After that he continued to have fevers and fatigue. He had been seen by multiple specialists over the past 7 months  starting in October 2018. He had had one lymph node removed from his neck as well as CT scan (neck/abdomen) and MRI to evaluate what inflammatory process may be occurring. He continued to have fatigue and not feel like himself (feeling abnormal). It had been noted that over the past year he lost 20lb despite continued good vertical height growth and continued to eat fairly well..." His weight was 69 pounds, and his BMI was in the 4th percentile at 14.79. In May 2019, his inflammatory markers remained elevated. On 21-MAY-2019, during a pediatric gastroenterology consultation, the assessment discussed an "autoimmune or inflammatory process." On 29-SEP-2020, at approximately 12:45 pm, pt's left leg went numb. While his mother drove him to the ER, his face became numb as well, and later his tongue. When he arrived at the ER, he vomited, and by 6 p.m., he was completely non-responsive. He was transported to a university medical hospital, where his condition rapidly declined. On Wednesday, 30-SEP-2020, he was almost completely brain dead. Days later, on 08-OCT-2020, he passed away four hours after his breathing tube was removed; he took his last breath at 9:13 p.m. He died of encephalitis, caused by an autoimmune/autoinflammatory dysregulation process (autoinflammatory disease), which was caused-in-fact by the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccination. It was unknown if an autopsy was performed. At the time of his death, he had not recovered from the events. Therefore, it was claimed, that the pt sustained autoimmune disease (autoimmune disorder), autonomic dysfunction (autonomic nervous system imbalance), and other serious, debilitating and disabling injuries, including but not limited to autonomic, neurological, heterogenous autoimmune disease, 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). As a proximate result of vaccination, pt had suffered severe and permanent physical injuries and associated symptomatology and had suffered severe emotional injuries, including pain and suffering. The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the events encephalitis, brain death, and autoimmune disorder were determined to be medically significant. Upon medical review, the event lymphadenopathy was considered as medically significant due to surgical treatment received (lymphadenectomy).; Reported Cause(s) of Death: encephalitis