Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Hot flush, Hypermobility syndrome, Insomnia, Lethargy, Musculoskeletal pain
Clinical narrative: Dysautonomia; Autoimmune disorder; Nauseus; Have a severe lack of appetite; Lethargic; Lost 7 pounds (from 123 to 116 lbs); Abnormal loss of weight; Musculoskeletal pain; Fatigue; Fatigue; Pain; Ehlers-Danlos syndrome; Hot flush; Hypermobility syndrome; Insomnia; Back pain; Musculoskeletal pain; Dizzines postural; Orthostatic intolerance; This report was identified from a line listing obtained on request by the Company from the FDA (HA # 740875) under the Act.  This spontaneous report referred to a 15 year old female patient. On 09-FEB-2016, after getting the first of 3 scheduled shots for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (route, strength, batch/lot # and expiration date were unknown) in the left arm from her pediatrician, the patient started to feel nauseus, lethargic, and have a severe lack of appetite on the same date. This happened gradually, and they did not connect it to the shot at first. The patient's parent followed up with the 2nd shot in approximately April 2016 (reported as 2 months later) as they still did not make the connection to the shot. She went in for an unrelated doctor's visit on 26-MAY-2016 where they noted she had lost 7 pounds (from 123 to 116 lbs) since her February physical. The doctor wanted them to see some specialists and get blood work done. Initial blood tests were done by pediatrician on 26-MAY-2016. All tests came back normal. The subsequent visits to Cardiology and Genetics found nothing wrong. They ended up at an Adolescent Specialist who has worked with the patient for the past one and a half years. While waiting to get an appointment with the Specialist the patient had her 3rd shot of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), as they still had not made the connection. After many visits with the Specialist and subsequent blood, urine, feces tests and many medications from December 2016 to December 2017, he diagnosed her with anautoimmune disorder, dysautonomia, which he said may have been brought on by the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccination.   There were no other events or diseases they could connect to the sudden start of extreme symptoms. He was the one who told them to make this report. One way he helped them connect it to the vaccine was because patient's younger sister, got the same shot and started to display slightly less severe symptoms that were the same as patient had just after her shot. They stopped after only 1 shot for her sister. After the patient's parent did a lot of research on vaccinations, and the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine in particular, the parent discovered that there had been reports of over 700 girls who had recieved the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine and then all had started to experience the same symptoms patient has. The patient's parent said the agency had supplied the vaccine and has denied any connection, but the evidence was there. Certain genetic factors make the vaccine trigger this autoimmune response. There are many other reports of similar findings in other places, including here.   The patient's parent has 2 other kids who also had 1 or 2 doses of the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine before they made the discovery that it was the likely trigger for the problems, and they did not display any symptoms. The parent said they were very different, genetically, and were both being treated for other issues, unlike the patient and her sister, who were both very healthy prior to the vaccination. The patient had no other medications, no current illnesses and no medical history before the vaccine. The only health complaint was the patient requested to watch her spine for a possible slight curvature. The outcome of the events was reported as not recovered. The reporter considered all events to be serious as they caused disability.  Follow-up information was identified from a line listing obtained on request by the Company from the FDA under the Act. Information regarding a patient. Patient's past medical history included irregular menses.  22-MAR-2018. Primary care physician (PCP) records DOS 20-DEC-2016 to 22-NOV-2017.  Diagnostic (DX): abnormal weight (wgt) los, low back pain (BP); nausea and vomiting (N/V); chronic pain syndrome; hypermobility syndrome; chronic fatigue; other disorders of autonomic nervous system. Chief company of patient (CC):  1-year history of weight loss of unexplained etiology, fatigue, BP, orthostatic dizziness/intolerance, insomnia, hot flashes; right shoulder pain; chronic musculoskeletal pain; hypermobility; nausea and vomiting.  Referred to adolescent med; patient; genetics. Condition gradually improving with medical management.   22-MAR-2018. Consultant records (cardiology, genetics) DOS 31-OCT-2016; 09-JAN-2018. DX: hypermobile form of Ehlers-Danlos syndrome. CC: same as above, plus work-up Marfan syndrome. Referred to patient lifestyle modification recommended.    By the time of the report, the patient had not recovered from the events. The agency stated that the events required doctor or other healthcare professional office/clinic visit and caused a disability or permanent damage. Causality assessment beween the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.  Follow-up information was received from a registered nurse via telephone memo on 08-AUG-2019. The reporter informed that there was no way to identify the patient from back in 2016. A request was made for the patient's use of the product, co-morbid medical issues and concomitant medications. Finally, the reporter confirmed that the physician related as contact physician in this case no longer practices.   Upon internal review, it was determined that the medically significant serious criteria for the event autoimmune disorder was marked in error in previous version, therefore, it was removed.