Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Electrocardiogram T wave normal, Electrocardiogram normal, Fatigue, Feeling abnormal, Full blood count normal
Clinical narrative: Information has been received from a physician concerning his daughter who on an unspecified date was vaccinated with the third dose of HPV4 (dose, route and lot # not reported). The physician reported that on an unspecified date, his daughter was diagnosed with dysautonomia with postural orthostatic tachycardia syndrome (POTS) after receiving the third dose of HPV4. The interval between the third HPV4 and the onset of symptoms was not provided. The physician stated that he was "not convinced" of a causal relationship with HPV4 because his daughter traveled to a foreign country about the same time. The patient sought unspecified medical attention. It was mentioned that the patient was completely disabled. At the time of the report, the patient had not recovered. Follow up information has been received from a physician concerning his 18 year old daughter who on 20-AUG-2007, was vaccinated with the first dose of HPV4 (dose and route not reported) (lot number 657872/0515U). On an unknown date, the patient received the second dose of HPV4 (date and lot number not reported) while she was traveling. On 03-MAR-2008, the patient was vaccinated with the third dose of HPV4, (dose and route not reported) (Lot # 659655/1486U). After the patient had received the third dose of HPV4 she had traveled out of her country. While she was out of her country the patient contracted giardiasis and bronchitis. The patient was treated while she was out of her country (treatment not specified). The patient improved with treatment. About one month after receiving the third dose of HPV4 on approximately 03-APR-2008, the patient had episodes of "black-outs", fatigue, light headedness, and "tracing" with no seizures. The physician stated that her daughter had seen a cardiologist. The physician stated that her daughter had a Peripheral Inserted Central Catheter (PICC) placed to receive intravenous (IV) fluids. The physician stated that when the patient received increased fluids her condition seemed somewhat improved. Follow up information has been received from a physician concerning her 22 year old daughter (current age) with migraines, GERD (Gastrooesophageal reflux disease), asthma, SAR (Severe Acute Respiratory syndrome) and acne who on 03-MAR-2008 was vaccinated IM with the third dose of HPV4 into the left deltoid (lot number: 14864 (previously reported as 659655/1486U)). Concurrent medications included metoprolol, CYMBALTA, "Flosher", "midadse", MESTINON, "BCB" and DEPLIN. It was reported that the patient did not experienced illness at the time of vaccination. Approximately 4-6 weeks past HPV4 vaccination, in approximately early May 2008, the 18 years old patient developed recurrent syncope, postural lightheadedness, market fatigue, headache, recurred nausea tachycardia and "stror tihg". The patient was diagnosed with dysautonomia and POTS (Postural Orthostatic Tachycardia Syndrome). On unspecified date, abnormal cardiac impedance in conjunction with "tilt" table test was performed (results not showed). It was reported that the patient was hospitalized for 3 days. At the time of the report, the patient had not recovered of the adverse events 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 (height 66 inches, weight 103 pounds) with a history of childhood orthostatic hypotension, syncope (since approximately 2005), surgery for a deviated septum, allergies to RETIN-A and montelukast sodium (MSD) (see WAES #1202USA01349) 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 HPV4 vaccination on 03-MAR-2008. She was diagnosed with dysautonomia and hospitalized for three days. The patient had not yet recovered from the dysautonomia. Medical records revealed the following: On 23Jan2010, 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 given 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 no head trauma. Prior to this admission, she had a trial of FLORINEF which did not help and was "recently" started on midodrine 5mg 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 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 than 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 episode 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 sometheptene 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 no headaches the previous three week whole 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 orthostasis 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 were considered disabling. Additional information has been requested. All available medical records will be provided upon request. 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.