Age: 34.0
Sex: F
Vaccine: HPV4
Symptoms: Polychondritis, Rash, Throat irritation
Clinical narrative: Dizziness; throat irritation; painful mouth sores; hair loss; Relapsing polychondritis/Gardasil-induced autoimmune disorder; had rashes all over her body; Headaches; Information has been received from a lawyer and refers to a 34-year-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-AUG-2021 and 08-NOV-2021, the patient was vaccinated with the first and second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, respectively, administered to prevent cancer (also reported as preventing cervical cancer) (strength, dose, frequency, lot #, expiry date, anatomical location, and route of administration were not provided).  Within weeks of receiving the second quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose, on an unspecified date in 2021,  the patient experienced her nose and ears turning red from inflammation. She had rashes all over her body and crippling joint pain. The redness and inflammation were severe enough to cause her eyes to appear black, and her ears to swell shut. She began suffering from headaches. She scheduled an appointment with an eyes, nose, and throat (ENT) who conducted several blood tests (results not provided) before being diagnosed with relapsing polychondritis by one ENT and confirmed by another ENT before being treated for her diagnosis. She was informed that her condition was extremely rare, and she was the only patient in her physician's system with this condition. Patient was also informed that her illness might necessitate heart surgery or the use of a ventilator as she ages. Patient endured daily joint pain, dizziness, swelling, redness in her nose and ears, rashes, and throat irritation. On 20-APR-2022, the patient was vaccinated with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection. She was currently prescribed three medications, one of which was given by infusion and not covered by insurance. Some of the medication had caused hair loss and painful mouth sores, and another carries the risk of retinal detachment. Along with seeing her ENT, she needed continuous monitoring of labs and future cardiologist appointments to monitor her heart. Before the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine, patient eagerly anticipated starting a family and completing her PhD. She maintained a 4.0 GPA, graduated with her master's degree, and held a full-time job. She enjoyed exercise and visiting the zoo, but now cannot because of her joint pain and exhaustion. She had contemplated taking time from school and leaving the job she loved due to the difficulties of commuting caused by her joint pain. Because her future health was uncertain, she was now uncertain about starting a family. Patient contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine injections caused her to develop relapsing polychondritis, 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) or otherwise linked to her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced autoimmune disorder. Patient 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. She 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 autoimmune and neurological disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine. As a direct and proximate result of her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)-induced injuries, patient had 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, the outcome of the events was not recovered.  The reporter considered thee events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  Upon internal review, the event relapsing polychondritis was determined to be medically significant. The reporter considered relapsing polychondritis to be Disability event.