Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pollakiuria, Polycystic ovaries, Postural orthostatic tachycardia syndrome, Quantitative sudomotor axon reflex test, Rectal haemorrhage
Clinical narrative: Information was received on 29-JUL-2016 in the form of an initial legal complaint regarding an approximately 17 year old female consumer who was administered a series of three GARDASIL injections from 04-MAR-2010 through 20-JAN-2011. As a result of the three GARDASIL injections the patient experienced serious adverse immunological and other disease reactions beginning approximately in March 2011 and continuing thereafter until this date. Due to the complexity and heterogeneous nature of her disease process the patient's actual disease process remained medically undiagnosed until approximately August 2015, when diagnosed as a postural orthostatic tachycardia syndrome (POTS) with a further diagnosis in February 2016 of an underlying small fiber neuropathy existing within and throughout her body. Prior to February 2016, without an adequate medical diagnosis of the patient's underlying disease process, it was not reasonably known, ascertainable or ascertained that there was a casual connection between GARDASIL and the disease processes. However based upon the foregoing diagnoses plaintiff believes that the GARDASIL vaccinations were the proximate cause of her underlying disease process. Information has been received on 30-JAN-2017 from a lawyer regarding a case in litigation concerning a 15-year-old female who had received three vaccinations with GARDASIL. The first vaccination was administered on 03-MAR-2010 (date was also reported as 04-MAR-2010) by licensed vocational nurse (LVN), second vaccination administered on 29-JUN-2010 and the third vaccination administered on 20-JAN-2011. (The site of vaccinations, Lot # and expiration dates were not reported.)  The patient had adverse reactions experienced from GARDASIL. Other vaccines (dose and lot number not reported) administered to the patient since 01-JAN-2009 were Influenza attenuated virus, intranasal (INFV) (01-OCT-2010) and influenza split virus (INF) (12-SEP-2011). The lawyer reported that after 04-MAR-2005 and prior to 27-APR-2007, the pt's medical, hospital and related medical history was unremarkable with only typical and common childhood medical office visits. On 27-APR-2007, pt was injured in a motor vehicle accident (MVA) sustaining various muscular, orthopedic and related injuries. In her course of treatment for her injuries, she was noted to have a congenital abnormal curvature of the spine for which a back brace was applied. Treatment for the injuries due to the MVA continued through approximately APRIL 2009. However, residuals from the injuries, including off and on lightheadedness, headaches which seem to have affected her concentration, some neck and low back problems, sleeping problems, and accident flashbacks continued. Also, as of NOVEMBER 2007, she was having problems off and on with skin irritations, sores and wounds under her left arm due to the positioning of a back brace. The back brace was removed in approx. MAY 2009, but the skin irritations, sores and wounds continued for a period of time thereafter. Also, due to continuing mental and emotional residuals from a MVA in 2007 she did see her school psychologist on about 4 occasions. As of 04-MAR-2010, the pt's residuals from the MVA had subsided to the extent there was no impact on her daily living and academic endeavors. From the summer of 2009 prior to starting her Freshman year and continuing until her GARDASIL injury she actively participated in volleyball and basketball teams, also working out with a strength and conditioning coach at least 2x/week, and ran outdoors one or two more miles. On 04-MAR-2010 (date also reported as 03-MAR-2010), she was administered the first of the 3 series GARDASIL vaccines.  In about the middle of JUNE 2010, she experienced sharp stabbing pains in right and left ankle. However, she continued her daily and athletic activities as usual, and without any limitation, though with some ankle pain. The ankle pains, which did eventually interfere somewhat with her walking, were thought to be caused by tendinitis related to her physical activity. The ankle pain lessened in severity. On 29-JUN-2010, she was administered the second GARDASIL vaccination.  During the period from about the end of JULY or first part of AUGUST 2010, she experienced an onset of severe headaches, tender feeling over portions of her body, and was at times dizzy, nauseated, tired and fatigued. The medical assessment was a viral syndrome/cold. Later she experienced blurry vision and some blind spots in her vision. On 09-SEP-2010, pt reported continuation of her symptoms experienced in the summer including, among others, sharp 8/10 severity headaches (HA) beginning on both sides of head in the occipital region and radiating to temples, increased fatigue, nausea commencing at the same time as the HA but not associated with the HA, a need to sleep long hours and nap during the day, need to sleep during class, no energy for sports, weakness and chronic low back pain. Her headaches with prophylactic medication had improved. Pt was administered a FLUMIST (as reported) intranasal vaccine (No date reported) [It was not specified if this FLUMIST intranasal vaccine was the same as a live attenuated vaccine (FLUMIST).] 01-OCT-2010, she reported her migraines with medication were better now; sleeping 8-10 hours per night with 2 hours of napping her tentative diagnosis was fatigue. On 07-OCT-2010, she reported similar symptoms with continuation of her symptoms even after sleeping 15-16 hours. 05-NOV-2010, reported good control of headaches was suffering with myalgias and severe fatigue. She was diagnosed with fibromyalgia. On 11-JAN-2011, she reported sleep was improved. Still having joint pain-elbows, knees and ankles; diffuse muscle soreness. Also tender headaches but no longer migraines. On 20-JAN-2011 was administered her third of the 3 series GARDASIL vaccines. Nausea which had been at a 10/10 severity was now at 3/10 severity. Vomited 4 days ago and emesis for 2 days, 4 time with diarrhea. She had limited participation in her basketball games as she would get tired, mostly watched from the sidelines and could not participate in games. On 21-MAR-2011, pt reported having done well without HA and back in school until 3 wks ago when she experienced the commencement of sharp shooting pains in her legs, arms, neck, and collar bones lasting a long time. Also a new pain in her abdominal areas as well as numbness in fingers and toes, blurry vision, lightheaded, and severe nausea. She was so fatigued that she was unable to concentrate or even lift her arms. As set forth in the medical records (as reported) over approximately the next 4 and a half years, the pt reported a continuation of her prior, as well as new medical problems including without limitation severe fatigue, sleep disorder, disorientation, impaired concentration, light sensitivity, odor sensitivity, weakness of the rt side of her body progressing to the Lt side body, difficulty standing and walking, imbalance, need for supportive equipment when walking, muscle spasms, dysuria, urinary frequency and urgency, urine dripping, abnormal endocrine function, blurred vision, muscle spasms and weakness, episodes of severe numbness and tingling in hands, feet, arms, and legs, numbness and tingling in her tongue and the roof of her mouth as well as both sides of face and ears, stabbing/tingling pain and burning sensation throughout her body and menstrual irregularity, polycystic ovary syndrome, body tremors after her period, vaginal discharge, eosinophlic esophagitis, alternating constipation & diarrhea, urinary constipation (as reported), rectal bleeding, hypoglycemia, nipple discharge, purple discoloration under her toenails, anxiety and depression. These disease processes were treated with, among others, medications, physical therapy (PT), chiropractic tx, dietary regulation and psychological services. Over these years she has fluctuations in the foregoing disease processes.  As of 05-MAY-2016, the pt's complaints included, without limitation, the inability to stand up long enough to take a shower due to extreme dizziness, slipping when getting into and out of bathtub, dizziness, almost falling several times, unable to wash lumbar area due to arm trembling, weakness and dizziness, using a roller to walk around the house for stability, instances where leg goes completely numb, unable to drive, extremely difficult to leave the house, needing family member assistance, inability to move toes, severe muscle spasms, loss of sensation, numbness and tingling in both legs, etc. Currently, in addition to her prior signs and symptoms, is experiencing serious body jerking episodes unrelated to epilepsy. The body jerking, which commenced on or about 08-SEP-2016, consists of uncontrolled full body jerking as well as jerking limited to either or both arms and/or either or both legs. These are continuing to date randomly increasing and decreasing in frequency. [The diagnosis of POTS was initially made after a Positive Tilt Test at a medical facility on 28-AUG-2015. The initial diagnosis of a small fiber neuropathy was based upon an abnormal quantitative sudomotor axon reflex test (QSART) test in FEBRUARY 2016 at a neuroscience health center. The diagnosis of a small fiber neuropathy was discussed by the physician with the pt's mother and included in medical records. The lawyer reported there is also an entry in the medical records that the QSART test was normal which the physician allegedly confirmed. However, the diagnosis based upon a small fiber neuropathy was confirmed based in part upon an abnormal QSART test on approx. 09-MAY-2016. Additional tests to determine if the pt has a small fiber neuropathy were just recently performed at a specialty clinic, results are still pending.] The patient reported a list of physicians who provided consultation and /or treatment to her. Her treatment is ongoing. The lawyer reported that due to the complexity of the female's multi-body injuries sustained from the GARDASIL doctors rendered examination or treatment through referrals. The lawyer reported the pt identified the following communications she used regarding GARDASIL: She has e-mail access to communicate with her physicians; She on occasion has mentioned and /or discussed with her friends on internet matters related to GARDASIL and her medical condition including, without limitation, when she has a flare up in her symptoms and the symptoms of an adverse reaction to GARDASIL. Also, she has participated in POTS support groups. [Prescriptions known to have been prescribed for the patient commencing 30-APR-2007 (exact dates not reported) include but may not be limited to, the following: Ibuprofen, cyclobenzaprine, clindamycin phosphate, FLUVIRIN, EPIDRIN, escitalopram, topiramate, MIDRIN, topiramate, naproxen, ZOFRAN, ondansetron, promethazine, gabapentin, azithromycin, LEXAPRO, omeprazole, sulfamethoxazole-trimethoprim, prednisone, LYRICA, CYMBALTA, BENADRYL, meclizine, Vitamin D, Vitamin D3, Vitamin B1, Vitamin B12, lidocaine, bupivacaine, KENALOG, cholecalciferol, TYLENOL, pregabalin, ranitidine, drospirenone, fluticasone, pregabalin, zolpidem, tramadol, baclofen, polyethylene glycol, nitrofurantoin monohydrate, sucralfate, ZYRTEC, quetiapine, indomethacin, methocarbamol, diclofenac sodium, metoclopramide, sodium chloride, ketorolac, rizatriptan, magnesium oxide, doxycycline monohydrate, nortriptyline, ethynodiol diac-ethinyl estradiol, fludrocortisone, amitriptyline, atenolol, fluoxetine, famotidine, lorazepam, low dose naltrexone. Recently prescribed by a specified clinic (No dates reported): Carbidopa, Nadolol, and cromolyn.] Upon internal review, the event of rectal bleeding was determined to be medically significant. The event of Difficulty standing and walking, using a roller to walk around the house for stability/need for supportive equipment when walking was considered to be disabling. Additional information has been requested. Sender's Comments: MERCK 1608USA000622:Mfr number.