Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Nocturnal dyspnoea, Orthostatic intolerance, Pain, Pallor
Clinical narrative: polyarthralgia; postural orthostatic tachycardia syndrome/migraines; severe body aches; sensitivity to light; dizziness and lightheadedness; nausea; fainting; pallor; dark circles under his eyes; constant abdominal pain; constant stomach upset; decreased appetite; Autoimmune Disease/ Gardasil-induced autoimmune disorder.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 19-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. Prior to receiving his vaccination, the patient had no autoimmune diseases, no autonomic issues and no orthostasis and was a star athlete in three different sports.  Patient agreed to receive the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) injection after having been convinced by years of relentless online, in print and television marketing. On 01-JUL-2015, the patient received his first dose with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported).  Later, on 14-AUG-2015, the patient received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (lot#, expiration date, dose, route of administration and anatomical location were not reported), both doses for preventing cervical, penile and anal cancers.  On 16-AUG-2015, two days after receiving his 2nd dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), the patient awoke feeling foggy and he was unable to answer questions appropriately during the football practice that day. At the end of the practice, he began to feel lightheaded and dizzy, and he collapsed. The patient lost consciousness for about 10 minutes and was transported by ambulance to the emergency room. Upon arrival to the emergency room, he was shaking, he had a number of muscles twitching in his right lower extremity, he was unconscious, and his eyes were fluttering. The emergency room record indicates that patient was sleepy, unresponsive, and still very lethargic even after over 45 minutes in the emergency room.  He underwent extensive lab work and diagnostic testing. The lab work was suggestive for dehydration, but diagnostic testing did not reveal any significant findings. Patient was treated for dehydration and syncope and discharged from the hospital the same day. Following discharge from the hospital, the patient continues to have symptoms of fatigue, weakness, syncope, headache, limb shaking, loss of consciousness, and dizziness.  On 18-AUG-2018, he followed up with his primary care physician, how recorded that patient has "not been correct since 14-AUG-2015" and that "quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) 2nd vaccine given that day". The phyisician order additional diagnostic testing including electroencephalogram (EEG), magnetic resonance imaging (MRI) of the lumbar spine and a 24-hour Holter Monitor. The results of this testing was normal and did not reveal the reason for patient's symptoms. Following the diagnostic testing, the physician referred the patient to a neurologist. The physician's records note stated: "[c]ertainly concerning for primary neurologic or cardiac process[c]ertainly human papiloma virus vaccine could be a contributorwould be report to CDC." The patient was seen by a cardiologist and complained of "feelings of loss of consciousness and spinning" and he described these symptoms as lasting for 2-5 minutes. He described his symptoms as fatigue, vision changes, syncope, and seizure-like activity. The physical exam showed patient was experiencing vertigo, light-headedness, decreased alertness, frequent headaches, unsteady walk, tremors/convulsions, vision problems, ringing in ears, joint stiffness, muscle weakness, and shortness of breath at night. Patient was advised to follow-up with a neurologist and ophthalmologist. Over a month after the initial syncope event, he was still experiencing symptoms including daily migraines; severe body aches; sensitivity to light; dizziness and lightheadedness; nausea; fainting; pallor; dark circles under his eyes; constant abdominal pain; constant stomach upset; decreased appetite; severe joint, muscle, and bone pain; leg weakness, tingling, numbness, and legs giving out; vision impairment and occasional blurry vision; cognitive processing impairment where he would become easily confused; problems with concentration; short-term memory loss; chest pain; shortness of breath, occasional lower back pain.  Due to the continued symptoms with no answers from medical testing, the patient was seen at another clinic for further work-up. Following examination by a neurologist; it was suspected that patient was having orthostatic intolerance and possibly postural orthostatic tachycardia syndrome (POTS). A multitude of additional testing and specialty consults was ordered, including a tilt table test. While most of the testing came back normal, the tilt table test results demonstrated evidence of POTS. While patient was relieved to finally know why he was experiencing these symptoms, his life was changed forever. He now had to take many prescriptions, he was limited in his ability to live a normal life, and he eventually had to have a port placed in his chest so that he could give himself his weekly saline infusions. As a result of his post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms, patient a triple star athlete, was unable to engage in normal activities and was forced to withdraw from college, football, and sports all together. Based upon his chronic and severe post-quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) symptoms and adverse events as outlined above and the tests performed by his medical providers, patient has been diagnosed with various medical conditions, including but not limited to, Postural Orthostatic Tachycardia ("POTS") and polyarthralgia.  The outcome of all the events was reported as not recovered/not resolved. The reporter considered all events to be disabling and related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL).  Upon internal review, the autoimmune disorder was considered as a medically significant event.