Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Somnolence, Stress, Throat tightness, Upper respiratory tract infection, Vomiting
Clinical narrative: Information has been received from a consumer concerning a her daughter 21 year old with penicillin allergy and no pertinent medical history who in June-2008 was vaccinated with first dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. After the patient received first dose of vaccine she experienced nausea and recovered from rash. On 20-SEP-2008 the patient received second dose of GARDASIL (Lot # not provided) 0.5ml, intramuscularly. There was no concomitant medication. Then after the patient received second dose of GARDASIL she became nauseous again, developed a fever, and had headaches "all the time". It was reported that she no longer had the fever but she still felt nauseous and had headaches. She also "had no energy", "no appetite" and lost 25 pounds. She received NEXIUM and Omeprazole and "each one worked for a day" and then stopped working. She also received ZITHROMAX for her fever and she developed a rash after she stopped taking it. Blood test was performed to check her stomach and her gall bladder (results not reported). At the time on the report on 07-JAN-2009 the patient was recovering. The patient sought unspecified medical attention. Follow up information was received from doctor's office and medical record. It was reported that the patient had variable bleeding from 02-APR-2008 to 06-MAY-2008 and moderate bleeding 22-MAY-2008 to 17-JUN-2008. On 17-JUN-2008 the female patient with cyst and always bowel problem was vaccinated with a first dose of GARDASIL (Lot # 660393/0067X) 0.5ml, intramuscularly into left deltoid. She was having some menstrual irregularity at the time of her first vaccination. Since she had no bleeding when she was on DMPA. On 14-JUN-2008 her bleeding was very light. At that time she was prescribed FEMCON. The physician's impression was that the patient had abnormal uterine bleeding. On 19-AUG-2008 she was vaccinated with the second dose of GARDASIL lot # 660612/0229X into right deltoid IM. Approximately on 19?AUG-2009 the patient experienced nausea, anorexia, low grade fever, headache, fatigue, dizziness since receiving vaccine. It was also reported that the patient had a documented twenty five pounds weight loss. On 11-SEP-2008 patient visited the doctor's office. Her menstruation was regular and she was doing well on FEMCON but would like to see how menstruation are off FEMCON. The patient was prescribed NECON 0.5/35 #28. On 04-NOV-2008 patient went to doctor's office and complained of burping, rolling stomach. She could not eat in the morning and had nausea, diarrhea with eating it came and went. She complained of having "chest hurts" a while getting worse. Patient had no shortness of breath and vomiting. Assessment was that patient's symptoms were of gastroesophageal reflux disease (GERD) and the patient was prescribed treatment with PRILOSEC 20 mg daily. Her blood pressure was 110/62, heart rate was 80 and body temperature was 98.0 F. Patient was to return for follow up visit in two weeks or sooner if symptoms worsen or there were any complication. On 20-NOV-2008 patient came for recheck and complained of feeling worse, unable to eat due to nausea and pain to stomach area. The patient had diarrhea and constipation which were reported that patient always had bowel problems. The patient denied vomiting. She was to have a gallbladder ultrasound for evaluation and was prescribed treatment with trial phenergan 25 mg PRN Q6H for nausea and will switch to NEXIUM 40 mg for possible GERD symptoms. Her blood pressure was 114/76, heart rate was 104 and respiration was 12. She was instructed to cal the office if no improvement in one week or to return sooner if symptoms worsen or there was complication. On 28-NOV-2008 patient had a hepatobiliary scan with gallbladder ejection fraction. The gallbladder ejection was 44% (normal values are in excessive of 35%). Therefore this represents a normal study. On 02-DEC-2008 patient visited the doctor's office for recheck and stated that she was feeling much worse. She reported feeling very dizzy, "bilateral ears will close", head hurts and still had stomach pain with nausea. She stated that she was feeling very tired and sleeping a lot and had a lot of burping. At times she had some diarrhea and when she felt really bad would have some tightness to chest and shortness of breath (SOB). The patient denied vomiting. Laboratory blood work which included complete blood count (CBC), complete metabolic profile (CMP), Amylase/Lipase, serum thyroid-stimulating hormone test (TSH), Free T4 and mono spot were ordered. It was noted that patient's abdominal pain appeared to be peptic in nature however she had not responded to esomeprazole magnesium 40 mg daily once which will be increased to twice daily. Patient's dizziness with had congestion would be treated empirically with azithromycin and she was prescribed ANTIVERT 12.5 mg 1-2 every 8 hours PRN for dizziness and ZITHROMAX susp 200mg/5 cc 30 cc 2.5 tsp on that day and then 1.5 tsp daily x 4 days. the NP's assessment was GERD, Fatigue and upper respiratory infection (URI) for the patient in this visit. Her blood pressure was 112/78, heart rate was 100, respiration was 16 and body temperature was 97.2 F. She was to return to office if no improvement in one week. On 08-DEC-2008 patient visited the physician's office. The patient reported a three month history of nausea and she had intermittent nausea throughout the day and had very little appetite due to nausea. She had lost approximately twenty pounds. Her pain was intermittent abdominal pain primarily in her epigastrium. Her ultrasound was normal. Her hepatobiliary radionuclear (CCK-HIDA) scan was also normal. Her treatment with NEXIUM 40 mg twice a day without much significant improvement of her nausea. She had trouble with frequent belching which was improved with NEXIUM. Patient noticed tightness sensation in her throat suggestive of globus but denied to have dysphagia or odynophagia. She experienced fullness sensation in her ears. She stated that they were intermittently "popping" as if she was on a plane. She denied headache or visual problems. She recently was given a course of antibiotics for sinusitis. She developed diarrhea on the antibiotics though this did not seem to be improving. She reported to have a fair amount of stress related school and had difficulty falling asleep. She denied having bowel movement today and any rectal bleeding and any nonsteroidal anti-inflammatory drug (NSAID) use. The twenty pound weight loss was significant as per the physician and he reported that the fact that the patient had not responded to a proton- pump inhibitor (PPI) makes an acid peptic disorder such as GERD or peptic ulcer disease (PUD) unlikely. However the physician planned to obtain an gastrointestinal endoscopy (EGD) for further evaluation and a small bowel biopsy was ordered to exclude celiac sprue. It was reported that patient felt somewhat better since taking antibiotics for sinusitis. The physician stated that the nausea could relate to sinusitis. The physician reported that the patient was on birth control pill until three weeks ago and it was possible that some of her symptoms were related to side effect from the medication. The physician advised her to stay off the birth control pill. Her trouble sleeping and stress related to school might be underlying anxiety causing her symptoms. Patient was put on treatment with LEXAPRO 10 mg daily and probiotic ALIGN. Patient's blood pressure was 124/78, heart rate was 86/minute, respiration 14/minute and temperature was 100.1 F at this visit. On 11-DEC-2008 an upper gastrointestinal endoscopy was done and it was reported that patient had normal esophagus, normal stomach and normal examined duodenum. On that day an intestinal biopsy was done and no pathological change was found and the serology laboratory diagnostic test "Hp FAST" was negative. On 16-DEC-2008 the patient called the doctor's office and reported that she was sick in stomach, had low grade fever and had some other problems which she believed was associated with the vaccination. She reported that she had not been feeling well since she got the second injection on 19-AUG-2008. She had been having headache, fatigue, stomach pain, nausea and vomiting and she lost twenty three pounds. She stated all kinds of tests were done by the physician but nothing was found. She stated she was not pregnant. She stopped that birth control medication FEMCON which she used for cyst and she had not been on it for a month and there was no change noticed. On 07-JAN-2009 patient came to the doctor's office with her mother. She complained of having nausea, upset stomach at times "severe stomach cramping making patient double over", headaches, no energy, unable to eat until later in the afternoon hours. Patient also had loose stools, at times diarrhea and then had constipation. She was referred to ear, nose, throat (ENT) and was diagnosed with Eustachian acute dysfunction. Patient was to continue use of fiber and also PROBIOTICA. If symptoms persisted she was to have blood drawn in two weeks for repeat monospot and Epstein Barr IgM and IgG titer. Patient and her guardian had stated that her symptoms may have began after second vaccination. Assessment at this visit was GERD, Fatigue and URI. On 27-FEB-2009 it was reported that the patient called in December and stated that she lost twenty three pounds (also reported as thirty pounds) and complained of flu like symptoms. She had seen gastrointestinal (GI) specialist and "everything came out normal". They (patient's mother and herself) felt that her symptoms were due to the injection. It was also reported that patient was tired, had no energy, nausea, headache, diarrhea (yellow color), dizziness, "can't eat", "can't function", severe cramps with period which she never had before. Her cramps were in the week of her period and week after. On 03-MAR-2009 a chest x-ray was done and result was reported as no acute abnormalities. Slight hyperinflations might be non specific or might be due to bronchial asthma otherwise unremarkable. On 04-MAR-2009 the following laboratory tests were done: Lyme Ab screen result was negative. Serum antinuclear antibodies test (ANA) was negative and blood neutrophil count was 4.80 which was high. On 04-MAR-2009 blood culture was done and on 05, 06, 07 and 08 March, 2009 the result showed no growth. On 10-MAR-2009 patient visited doctor's office and reported having problems after she received vaccination in "JULY" and then worsened in August after the second injection. She still had nausea all the time. She felt like something was in her throat, decreased eating, low grade temperature in 99's, severe headaches, dizziness with light activity, fatigue seems a lot but not rested. She has had headaches but since January 2009. She reported them as frontal for which she took liquid TYLENOL since she could not swallow pills. She still had increased cramps, back pain and headaches. She was off the oral contraceptives and her menstruation was regular but painful. She took aspirin, PAMPRIN for cramps which helped little. At the time of reporting she was sexually active and used condoms for birth control. The outcome of events was unknown. The reporter indicated that the events of nausea, anorexia, low grade fever, headache, fatigue, dizziness and documented twenty five pounds weight loss were disabling. Additional information is not expected. All medical records will be provided upon request.  7/24/09 Medical records received DOS 5/9/08 to 4/16/09. Patient presents with burping, 'rolling stomach', can't eat mornings, nausea, diarrhea, constipation, symptoms of GERD, chest hurts. Epigastric tenderness. Positive Murphy's sign. Dizzy, 'ears close', tired, sleeping a lot. Tightness to chest and SOB. Weight loss. Stress, difficulty falling asleep. 'Something in throat'. Avascular septated ovarian cyst, hemorrhagic ovarian cyst.