Age: 18.0
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Blood test abnormal, Cystitis interstitial, Fatigue, Impaired work ability, Intermenstrual bleeding
Clinical narrative: Severe UTI; abnormal periods/ irregular meses; breakthroug bleeding; Severe UTI; Constellation of Adverse symptoms; muscle aches and pains; POTS; adenomyosis; interstitial cystitis/ severe UTI infections; severe nausea; shaking; chronic and severe fatigue; seronegative rheumatoid arthritis; positive markers for Sjogren's Syndrome; autonomic dysfunction; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a 18-year-old female patient (pt). Information on pt's concurrent conditions, medical history or concomitant therapy was not reported. On 07-JUN-2018, the pt received her first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, administration route, lot number and expiration date were not reported) for prevention of cervical cancer. The pt physician read and relied upon information, through its labeling and/or marketing, that the vaccine was safe and effective. The pt received her second injection on 16-AUG-2018, and her final injection on 29-MAY-2019. The pt first two doses seemed to be without incident, however, following the third dose on 29-MAY -2019, the pt began experiencing muscle aches and pains, and fatigue, which the pt assumed was from exercise. At that time, the pt was a university student and was participating in the University Dance Team. As a dancer, her routines included ballet, jazz, tap, and modern dance, thus, she was quite used to experiencing joint and ligament pain. However, this pain felt different than what she had experienced when working out with her dance team and was much worse. In addition to debilitating muscle and joint pain, the pt also noticed her periods had become spotty. She had never experienced this problem before the vaccine. On 01-JUL-2019, she reported "irregular menses and breakthrough bleeding".   By December 2019, the pt was suffering from such debilitating pain, she quit the dance team at her university and then, because of chronic and severe fatigue, she decided to take the winter semester off school to focus on her health. During this break, she had bloodwork completed, which showed some things out of place, including an elevated Antinuclear Antibody (ANA) test result. The pt was seen by multiple physicians and specialists for her complaints which now included severe UTI infections, one of which led to hospitalization, a diagnosis of adenomyosis, and interstitial cystitis. She experienced tachycardia and orthostatic hypotension. She continued to suffer from abnormal periods, chronic fatigue, seronegative rheumatoid arthritis and had positive markers for Sjogren's Syndrome.As result of the pt post vaccination symptoms, she had been unable to engage in her normal activities. She can no longer attend University and is limited to school on-line. She was only able to engage in remote work. Based upon the pt chronic and severe post-vaccination symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, adenomyosis, interstitial cystitis, abnormal periods, chronic fatigue, seronegative rheumatoid arthritis and has positive markers for Sjogren's Syndrome and autonomic dysfunction. The pt contends that her human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) caused her to develop serious and debilitating autoimmune, autonomic, and neurological, injuries, including but not limited to ongoing symptoms of POTS, adenomyosis, interstitial cystitis, abnormal periods, severe nausea and shaking, chronic fatigue, seronegative rheumatoid arthritis, and positive markers for Sjogren's Syndrome and autonomic dysfunction, 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 papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  or otherwise linked to her Gardasil-induced autoimmune disorder. The outcome of the events was reported as not resolved.   The events were consider as disabling and the events rheumatoid arthritis and Sjogren's syndrome were consider medically significant.