Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Autoimmune disorder, Hot flush, Premature menopause
Clinical narrative: other injuries caused by Gardasil; autoimmune disease; premature ovarian failure; Information has been received on 18-AUG-2022 from a lawyer, regarding a case in litigation concerning an adolescent female patient (pt). Her medical history, concurrent conditions and concomitant medications were not reported. Prior to receiving her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) injections, the pt was not suffering from premature ovarian failure, and in fact, as noted during her physical examination on 12-JUL-2012, she had regular menses. On 21-JUL-2012, at the age of 13 years old, the pt was vaccinated with a first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route and anatomical location of administration, lot# and expiration date were not reported). On 26-SEP-2012, she received the second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route and anatomical location of administration, lot# and expiration date were not reported). On 06-FEB-2013, the pt was vaccinated with a third and the last dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, units, route and anatomical location of administration, lot# and expiration date were not reported). The suspect vaccine was administered to prevent a handful of the hundreds of strains of the human papillomavirus (HPV). On 28-DEC-2013, the pt reported to her pediatrician that she was having hot flashes from an unknown date in 2013 (reported as for the past several months), but was still having regular menses. Around May 2014, she experienced amenorrhea. On 24-OCT-2014, the pt was seen for amenorrhea since May 2014, with hot flashes and was diagnosed with premature ovarian failure. As a direct and proximate result of suspect vaccine, the pt's symptoms and diagnoses have resulted in physical limitations not present prior to using the suspect vaccine. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The pt incurred and would continue to incur medical expenses and other economic harm as a direct result of use of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). The pt suffered and would continue to suffer severe and permanent physical injuries, including her premature ovarian failure and associated symptomology and 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, fertility problems and future symptoms and harms associated with her premature ovarian failure, and her autoimmune disease and other injuries, as a result of (caused by) her exposure to 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, the pt suffered and would continue 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. The outcome of all events was considered to be not recovered.  The reporter considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  All events were considered to be disabling by the reporter. Upon internal review, the event of autoimmune disorder was considered to be medically significant.