Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Heart rate increased, Hepatic enzyme increased, Hepatomegaly, Human papilloma virus test positive
Clinical narrative: her liver enlarged; pancreatitis; throat infection; her gall bladder that was enlarged; trouble breathing; Liver enzymes elevated; Chronic tonsillitis/The infection returned soon/another throat infection; had a positive Pap smear for HPV; Obsessive compulsive disorder; Endometriosis; panic attacks; Vomiting; gaining weight; Sugar levels were out of controll/Blood sugar was high; The patient was diagnosed with Autonomic Dysfunction/dizziness/ iarrhea/tremor; Narcolepsy/trouble sleeping/Muscle spasms/Hypersomnia/sleep terro/sleep paralysis; Myalgic Encephalomyelitis/ anxiety/headache/depression; Chronic Fatigue Syndrome("CFS"); Postural Orthostatic Tachycardia Syndrome ("POTS")/fast heart rate; Small Fiber Neuropathy("SFN"); Brain fog; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a 18 year old female patient (pt) . No information was provided regarding concomitant medications, concurrent conditions, or medical history.   On 15-JUL-2014 (at 18 years old), the pt was vaccinated with the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) (strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prevent cancer.  In June 2014, (also reported as: Within a month of receiving the first dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL)), the pt experienced autoimmune disease and Other Serious Injuries, Including but not limited to, Autonomic Dysfunction, Narcolepsy, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome (CFS), postural orthostatic tachycardia syndrome (POTS) and small fiber neuropathy (SFN), as a Result of her Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) injection.  Plaintiff was found to have chronic tonsillitis; her tonsils were so enlarged that they were blocking her airways so she was sent to a hospital after the university felt that they could not handle her health case. After sending her to the hospital, they hydrated her as they determined that her blood sugar was high after finding ketones in her urine. They eventually sent her home with a prescription for antibiotics. Patient experienced symptoms of fatigue, headaches, joint pains, brain fog (cerebral disorder), vomiting and dizziness soon after her tonsillitis incident. Daily tasks became extremely difficult because she was tired and in constant pain. Standing up was too taxing on her body and she would always feel dizzy. She could not sleep at night, no matter what she tried. By middle of September 2014, while in college, she started having cyclical vomiting sessions accompanied with severe diarrhea. The diarrhea eventually stopped, but the vomiting persisted. She would vomit undigested food throughout the day and was, oddly, gaining weight (weight increased) The pt's sugar levels were out of control and difficult to keep down (diabetes mellitus inadequate control). She had to resort to using huge amounts of insulin all the time to maintain normal sugar levels. The pt would have constant tremors, a fast heart rate and began to have severe anxiety. Pt's mother took her to various doctors, endocrinologists, gastroenterologists, and psychiatrists, all 'of which could not find anything wrong with the pt. The doctors put her on omeprazole (PROTONIX) for her stomach acid and increased the settings on her insulin pump to deliver more insulin. In the spring of 2015, pt was beginning to feel a bit better. On 19-AUG-2015, the pt returned to the physician office to receive her second dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL) and four days following the shot, pt developed severe headaches to the point where she had to remain sitting. She also had severe joint pain and developed another throat infection (pharyngitis). The throat infection was examined by an ear, nose and throat ("ENT") physician and she was informed that her tonsils needed to be removed. The following months, pt continued to experience severe headaches, joint pain, and extreme vomiting. She vomited so much that she had to resort to liquids to help retain anything in her system. Throughout the nights, she had trouble breathing (dyspnea) and chest pains and extreme cramping when on her period to the point of hospitalization. She was having trouble sleeping and when she finally was able to sleep, she would sleep for 18-20 hours a day. She also experienced night terrors and sleep paralysis that were disruptive to her college roommates. The pt was also having severe pain by her liver and the doctors told her that they believed it may be her gall bladder that was enlarged (gallbladder enlargement) but a sonogram showed possible pancreatitis. Pt's liver enzymes elevated, her liver enlarged (hepatomegaly), and she was hospitalized overnight. The pt was seen by multiple physicians and specialists for her complaints which now included: dizziness, brain fog, joint pains, breathing difficulties, fatigue, severe stomach issues, obsessive compulsive disorder (OCD) tendencies, endometriosis, insomnia, anxiety, depression, and panic attacks. She also saw a gynecologist and had a positive Pap smear for HPV (human papilloma virus test positive). The pt had to have a colposcopy, and also surgery for polyps as she was not ovulating. Pt currently medications for sleep, anxiety, and panic disorders included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ondansetron (ZOFRAN), solriamfetol hydrochloride (SUNOSI), clonazepam (KLONOPIN).  The outcome of all adverse events was not provided. Causal relationship of the events was reported as related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(GARDASIL).  The primary reported considered autonomic nervous system imbalance, small fibre neuropathy, postural orthostatic tachycardia syndrome, chronic fatigue syndrome, post viral fatigue syndrome and narcolepsy as disability adverse events.  Upon internal review, gallbladder enlargement, pancreatitis, diabetes mellitus inadequate control, chronic tonsillitis and narcolepsy were determined to be medically significant.