Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of personal independence in daily activities, Mast cell activation syndrome, Mechanical urticaria, Mobility decreased, Nervous system disorder
Clinical narrative: endometriosis; The patient was finally diagnosed with fibromyalgia; eosinophilic esophagitis; mood disturbances; Heavy menstrual bleeding; The patient was finally diagnosed with POTS; mast cell activation syndrome; First dosage: 10-JAN-20214; second Gardasil shot on 08-AUG-2019; depression; gallbladder disease; Gardasil-induced autoimmune, autonomic; sore arm; headache; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information about pt's concurrent conditions, medical history, and concomitant therapy was not reported. On 10-JAN-2014, the pt was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recombvaccine (GARDASIL) intramuscular injection. The pt did not suffer serious adverse reactions to her first injection of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL), only a sore arm and headache in an unspecified date in January 2014 (also reported as minor side effect). On 08-AUG-2019 (at 16 years old), she was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (Inappropriate schedule of product administration) intramuscular injection (strengths, lot numbers, expiration dates, doses, routes of administration, and anatomical locations were not provided), during a well-child and high school health check-up and the doctor informed the pt's mother that the pt required another dose. It was reported that the pt sustained serious autoimmune, autonomic, and neurological injuries as a result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections. On 16-AUG-2019 (reported as eight days following pt's second human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccination), the pt broke out an unusual rash on her thighs and went to the doctor. She was prescribed a steroid cream, hydroxyzine, and antibiotics. Two weeks later, pt went to urgent care for severe abdominal pain. The pt following symptom was dysmenorrhea. She was prescribed birth control pills but discontinued them after they caused month-long menses and mood disturbances. Soon after that, she suffered constant stomach pain that worsened over time. She started fainting when standing and eventually became bedridden and unable to leave the house. The pt had had virtually every gastrointestinal (GI) test in the book, swallowed cameras, and endured many painful tests to find a diagnosis. She had also tried dozens of medications. After numerous tests and scans, pt was finally diagnosed with postural orthostatic tachycardia syndrome (POTS) using a tilt table test and fibromyalgia.She has traveled  the only POTS physician and across the country with her parents to see specialists at a clinic. As time progressed, so did pt's symptoms. She had seen multiple physicians and specialists for her complaints, which included (POTS), fibromyalgia, eosinophilic esophagitis, mast cell activation syndrome, endometriosis, anxiety, anorexia, depression, gallbladder disease, dermographia, and eczema. As a result of her post quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, the pt had been unable to engage in activities she usually would enjoy. For example, prior to receiving her second dose, the pt was a cross country runner and black diamond skier, she owned her own pottery business as a teenager and sold at a local farmers market, she sang in her high school choir and was planning to go away to college on scholarship; all which she have no longer been able to do. Now, her mobility, for which she used a wheelchair, was unable to function in a work environment, and was dependent upon her parents. As a proximate result of company's alleged 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 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. 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 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 suffered and continued to suffer economic losses, including considerable financial expenses for medical care and treatment and diminished income capacity, and she would continue to incur these losses and expenses in the future.  At the time of reporting, pt had not recovered from the events. The reporter considered all the abovementioned events related to quadrivalent human papillomavirus (types 6,11,16,18) recombvaccine (GARDASIL).   All the claimed events were considered disabling by a reporter.  Upon internal review, the event of autoimmune disorder was determined to be medically significant.