Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Postural orthostatic tachycardia syndrome, Presyncope, Proctalgia, Syncope, Tachycardia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with history of migraine, gastrooesophageal reflux disease (GERD), asthma and severe acute respiratory syndrome (SAR) and acne. No illness at the time of vaccination was reported. On 03-MAR-2008, the patient was vaccinated intramuscularly with the third dose of GARDASIL (dose not reported, reported lot# reported as 14864 was not valid) into her left arm. On 01-MAY-2008, the patient developed recurrent syncope, postural lightheadedness, marked fatigue, headaches, recurrent nausea, headaches, tachycardia starting in early 2008 and approximately 4-6 weeks after last GARDASIL. The 22 year old patient (current age) was diagnosed with dysautonomia, postural orthostatic tachycardia syndrome (POTS). Current medication included: FLORINEF, midodrine hydrochloride also reported as Medodrine, metoprolol, MESTINON, CYMBALTA and DEPLIN. ER visit was required. The listing indicated that one or more of the events required hospitalization (3 days). The original reporting source was not provided. The VAERS ID# is 435748. Follow up information has been received on 04-NOV-2011 from physician via company representative concerning his daughter. The reporter stated that he was "not convinced" of a causal relationship with GARDASIL because his daughter "traveled to a foreign country about the same time". According to physician the patient was completely disabled. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Follow up information has been received on 23-NOV-2011 from physician who was a father of the patient. The physician stated that on 20-AUG-2007 the patient received the first dose of GARDASIL (lot # 0515U). The patient received the second dose of GARDASIL (date and lot # not reported) while traveling in another state. On 03-MAR-2008, the patient received the third dose of GARDASIL (lot# 1486U). After the patient had received the third dose of vaccine she had traveled out of the country. While out of the country the patient contracted Giardiasis and Bronchitis. The patient was treated while out of the country (treatment not specified). The patient improved with treatment. On an unspecified date in April 2008 also reported as about one month after receiving the third dose of GARDASIL, the patient had episodes of "black-outs", fatigue, lightheadedness, and "tracing" with no seizures. The physician stated that the patient has seen a Cardiologist. The reporter stated that the patient had a Peripheral Inserted Central Catheter (PICC) place to receive IV fluids. The physician stated that when the patient received increased fluids her condition seemed somewhat improved. Follow up information has been received from physician who was patient's father. The patient required hospitalization (3 days). No other vaccine was administered to the patient within 4 weeks prior 03-MAR-2008. It was reported that the patient did not experienced illness at time of vaccination. No adverse event following prior vaccination was reported. Follow-up information was received on 03-FEB-2012 from the patient's father (a physician) who provided medical records concerning his 18 year old daughter with a history childhood orthostatic hypotension, syncope (since approximately 2005), surgery for a deviated septum, allergies to RETIN-A and SINGULAIR and a family history of orthostatic hypotension (both parents). On 07-MAY-2008 (also reported as early May 2008), the patient developed recurrent syncope, postural lightheadedness, marked fatigue, headaches, recurrent nausea and tachycardia. These symptoms started four to six weeks after her last GARDASIL vaccination on 03-MAR-2008. She was diagnosed with dysautonomia and hospitalized for three days. Medical records revealed the following: On 23-JAN-2010, the patient was hospitalized. The discharge summary revealed the following: The patient had a five year history of syncope. During childhood, she experienced orthostatic hypotension. Some five years previously, her symptoms became worse and at the same time she began developing migraine headaches. At times, she felt dizzy climbing stairs and at times had to crawl up the stairs to avoid passing out. She was give treatment for migraines (unspecified) and she gradually improved. However, "last year", her symptoms began to increase again with episodes of presyncope and syncope associated with rectal pain, vomiting and nausea. At this time, the patient had a Giardia infection (onset previously reported as approximately March 2008) which she acquired in another country. Her symptoms again improved but during the past semester of school, her symptoms began to worsen again. Symptoms included marked lightheadedness and she began passing out with shorter prodrome. She had to drop out of school because of her symptom complex. The patient's father, who witnessed many episodes, stated there had been no tonic-clonic movements with the episodes. Her mother indicated she appeared to be in a trance at times and she also did not notice seizure activity. The patient had had no head trauma. Prior to this admission, she had a trial of FLORINEF which did not help and was "recently" started on midodrine 5 mg three times a day but this did not garner relief. At a dose of 10 mg three times a day, she did have some improvement. She had had a head CT and head MRI (dates unspecified) both of which were negative. On 23-FEB-2010, a magnetic resonance angiogram of the cervical vasculature (with and without contrast) was unremarkable. She also underwent a tilt test at which time she was off midodrine for two days. The test was interpreted as "positive". Baseline blood pressure was 106/86 and pulse was 93 and regular. At minute 13 of the tilt test, she began to complain of dizziness and then at minute 15 she passed out with a blank stare on her face. "Remarkably", a drop in her blood pressure was not identified as her blood pressure was 128/88 during these symptoms. The test was "positive" in that she lost consciousness but did not have a drop in her blood pressure. "Because of the conflicting data" and a desire to titrate the patient's midodrine, she was admitted for observation and midodrine up-titrating. While in the hospital, the patient's midodrine was increased to 15 mg three times a day. On 24-Feb-2010, in the early evening, she began having repeated episodes of a dazed look on her face, a severe left-sided headache and visual symptoms consisting of many dark lines. The episodes came and went at 10 minute intervals. She also became very photophobic. Blood pressure was in the 170-180/100 range. She had no nausea or vomiting. It was noted her symptoms were consistent with migraine headaches. She was given isometheptene mucate, dichloralphenazone, and EPIDRIN times two and morphine sulfate intravenously and her symptoms resolved over a two hour period. On 25-Feb-2010, she was seen by a neurologist who thought the patient had experienced an acute migraine headache with aura the day before. He noted the episode was likely precipitated by midodrine although the patient had had no headaches the previous three week while on midodrine. He also thought the patient had "periodic limb movement of sleep" versus nocturnal seizures. He recommended an outpatient EEG and EMG. Finally, he thought the patient had complex partial seizures. On the discharge summary, a cardiologist noted "it is difficult to tell which of these diagnoses is the most prominent and whether there is any unifying hypothesis in this case. I was very struck by the intensity of the patient's migraine headaches which clearly needed to be treated. However, the patient has had episodes of orthostatic in the past yet did not have a positive tilt test in the sense that her blood pressure fell". A consulting endocrinologist saw no evidence of an endocrine cause of her symptoms and noted the patient had undergone a workup on 22-Jan-2010 (initiated by the patient's father who was a family practitioner) which showed normal cortisol and ACTH, a slightly above normal aldosterone and a random blood glucose of 79. The patient was discharged on 25-JAN-2010. Dysautonomia with postural orthostatic tachycardia syndrome was considered disabling. Additional information has been requested. All available medical records will be provided upon request. This report is linked with another report MARRS #1202USA01349 (Same Patient Link). It has been determined that case # 1111USA00688 is a duplicate of case # 1110USA02890. Therefore, case # 1111USA00688 is being deleted from our files and the cases are consolidated into case # 1110USA02890. Additional information has been requested.