Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal distension, Abdominal pain upper, Amenorrhoea, Autoimmune disorder, Flatulence
Clinical narrative: Gardasilinduced autoimmune disorder; premature ovarian failure/Hot flush/amenorrhea; headaches/chronic headaches; abdominal distention; stomach ache; nausea; gassiness; vomiting; This initial spontaneous report was received from a lawyer and patient's mother regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On 25-FEB-2008, at the age of 11 years, the pt. received her fists dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prevention of cervical cancer (lot#, expiration date, dose, and route not specified).  On 06-FEB-2010, the pt. was seeing in the clinic for stomachache that she was experiencing for the past two months, in December 2009.  Pt. was seen again in the clinic by a gastroenterologist (GI) expert on 25-FEB-2010, who noted  that she had experienced stomachache  and mentioned now that  she was experienced this event for the last six months, in September 2009 (previously reported as December 2009 by the same reporter, conflicting information ).Additionally, it was reported that the pt. noted that she had experienced nausea, vomiting, gassiness for the last six months (in September 2009).   On 29-JUL-2010, the pt. visited the same clinic for pain, nausea, vomiting, gassiness, and it was reported that the pt. experienced abdominal distention, experienced on an unknown date in 2010.  In May 2012, the pt. experienced her last menses.The pt. returned to the clinic, on 03-DEC-2012, where she informed her provider that she had been experiencing hot flashes headaches, experienced on an unknown date in 2012 and  nausea. It was also noted that her menses were normal until 30-MAY-2012. She was diagnosed with amenorrhea, chronic headaches, and nausea. Based upon her chronic and severe post- quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) symptoms, Plaintiff has been diagnosed with premature ovarian failure (onset: approximately in June in 2012). It was reported that her quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) injections caused her to develop serious and debilitating injuries, including but not limited to autoimmune disease, as well as a constellation of adverse symptoms, complications, injuries, and other adverse events, many of which were mentioned 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, onset date unspecified.  As a proximate result of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) for prevention of cervical cancer, the pt. suffered and would continue to suffer severe and permanent physical injuries, and associated symptomatology and has suffered severe and permanent emotional injuries, including pain and suffering. Pt. also has 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 disease and other injuries caused by quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL). The outcome of the events were reported as not recovered.  The events were considered disabling by the reporter.  Upon internal review the events premature ovarian failure/Hot flush/amenorrhea (Premature menopause) and autoimmune disorder were considered to be medically significant.