Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Infertility female, Laboratory test, Menopausal symptoms, Ovarian failure
Clinical narrative: began to experience abdominal pains and headaches/by the time pt was 15 years old, she had still not started menstruating/diagnosed with premature ovarian failure/insufficiency/autoimmune POF/symptoms of a menopausal woman/serious and debilitating; she received her first dosage of Gardasil on 08-MAR-2016/receive her second dosage of Gardasil on 10-JUN-2016/received her third and final dosage of Gardasil on 02-AUG-2018; Information has been received from a lawyer regarding a case in litigation concerning an adolescent, female patient (pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. On 08-MAR-2016, the pt was 12 years old and received her first dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) at physician's office. On 10-JUN-2016, the pt returned to physician's office to receive her second dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On 02-AUG-2018, the pt received her third and final dosage of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (exact doses, formulations, lot #, expiration dates, sites and routes of administration were not provided for any dose; all received for prophylaxis) (inappropriate schedule of product administration). On or around the first week of November 2018, the pt began to experience abdominal pains and headaches. Since the pt had not yet started menstruating, her family suspected that these pains were related to menarche, but that was not the case. By the time the pt was 15 years old, she had still not started menstruating. On an unknown date in August 2019, the pt's mother took her to a gynecologist. After a laboratory workup and ultrasound, the pt was diagnosed with premature ovarian failure (POF)/insufficiency. Genetic and other tests (unspecified) revealed no abnormalities that might have explained pt's POF, leaving autoimmune POF as the only likely explanation. As a result of her post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt would have to take replacement reproductive hormones for the rest of her life. The pt had been under the care of a pediatric fertility specialist, who had advised that the pt would not be able to get pregnant on her own. The pt had been forced to accept the heartbreaking reality that she might not be able to had her own children in the future, even through artificial means. She was experiencing symptoms of a menopausal woman, decades ahead of when those same symptoms would normally occurred. Based upon her chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, the pt had been diagnosed with various medical conditions, including but not limited to, POF/insufficiency. The pt contended that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injections caused her to develop serious and debilitating autoimmune injuries, including but not limited to POF/insufficiency, 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. As a proximate result of wrongful acts and omissions and its negligent and fraudulent testing, labeling, manufacturing, and promotion of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), the pt had suffered and would continue 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). The outcome of event was considered to be not recovered. The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL).  The event of POF was considered as disabling by the reporter.