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This is VAERS ID 337817

Case Details

VAERS ID: 337817 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: California  
   Days after vaccination:67
Submitted: 2009-01-20
   Days after onset:63
Entered: 2009-01-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Alanine aminotransferase normal, Aspartate aminotransferase normal, Asthenia, Basophil count normal, Beta globulin normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose abnormal, Blood potassium normal, Blood sodium normal, Blood urea normal, Chest pain, Chills, Cough, Culture stool negative, Diarrhoea, Dizziness, Eosinophil count normal, Haematocrit normal, Haemoglobin normal, Headache, Lymphadenopathy, Lymphocyte count normal, Malaise, Mean cell haemoglobin, Mean cell volume normal, Mean platelet volume normal, Monocyte count normal, Myalgia, Nausea, Neutrophil count, Neutrophil count normal, Oropharyngeal pain, Pallor, Platelet count normal, Protein total normal, Red blood cell count normal, Red blood cell sedimentation rate normal, Red cell distribution width normal, Vomiting, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None. PMH: none
Diagnostic Lab Data: Stool Giardia lamblia, 12/23/08, negative; WBC count, 12/18/08, 7.3 thou; Red blood cell count, 12/18/08, 4.73 mill; Hemoglobin, 12/18/08, 14.0 g/dL; Hematocrit, 12/18/08, 39.9%; Mean corpuscular volume, 12/18/08, 84 fL; Mean corpuscular, 12/18/08, 29.6 pg; Mean corpuscular, 12/18/08, 35.1 g/dL; RDW, 12/18/08, 12.4%; Platelet count, 12/18/08, 270 thou; Mean platelet volume, 12/18/08, 8.8 fL; Neutrophil count, 12/18/08, 52%; Lymphocyte count, 12/18/08, 37%; Monocyte count, 12/18/08, 6%; Eosinophil count, 12/18/08, 5%; Basophil count, 12/18/08, 1%; Absolute neutrophil, 12/18/08, 3796 cell; Absolute lymphocyte, 12/18/08, 2701 cell; Absolute monocyte count, 12/18/08, 438 cell; Absolute eosinophil, 12/18/08, 365 cell; Absolute basophil count, 12/18/08, 73 cell; Erythrocyte, 12/18/08, 2 mm/h; Serum glucose, 12/18/08, 101 mg/d; Serum blood urea, 12/18/08, 9 mg/d; Serum creatinine, 12/18/08, 0.55 mg/d; Serum calcium, 12/18/08, 10.3 mg/d; Serum sodium, 12/18/08, 139 mmol; Total serum carbon, 12/18/08, 24 mmol; Serum potassium, 12/18/08, 4.6 mmol; Serum chloride, 12/18/08, 102 mmol; Total serum protein, 12/18/08, 7.5 g/dL; Serum albumin, 12/18/08, 4.8 g/dL; Serum globulin test, 12/18/08, 2.7 g/dL; Serum albumin/globulin, 12/18/08, 1.8 rati; Total serum bilirubin, 12/18/08, 0.4 mg/d; Serum alkaline, 12/18/08, 184 U/L; Serum aspartate, 12/18/08, 16 U/L; Serum alanine, 12/18/08, 9 U/L; Serum Epstein-Barr VCA, 12/18/08, negative; Serum Epstein-Barr VCA, 12/18/08, positive; Serum EBV nuclear, 12/18/08, positive; Stool culture, 12/31/08, no salmonelia, shigelia, or campylobacter SP. isolated. Labs and Diagnostics: Stool studies all (-). CBC WNL. EBV capsid Ab IgG 3.59. EBV nuclear Ab IgG $g5.0. EBV IgM (-).
CDC Split Type: WAES0901USA01174

Write-up: Information has been received from a physician concerning a 11 year old female with no pertinent medical history who on 12-SEP-2008 was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot #660618/0572X). There was no concomitant medication. "Three months after administration of her first dose of GARDASIL", on 12-DEC-2008 the patient experienced weakness, sore throat, nausea, vomiting, diarrhea, paleness and abdominal pain. "One month later", the patient''s symptoms had not resolved and she was also experiencing chest pain, headaches, dizziness, swollen lymph nodes, chills and myalgia. The patient had office visits. "White blood cell differential count and white blood cell count" were normal. "Four weeks ago", on approximately 12-DEC-2008, the patient was prescribed PRILOSEC. At the time of the report, 09-JAN-2009, the patient had not recovered. Follow-up information received on 12-JAN-2009 from the physician via medical records indicated that on 18-DEC-2008 the patient was taken to the physician''s office for follow-up. It was reported that the patient had a sore throat and abdominal pain which persisted one month. The patient vomited for four times on 08-DEC-2008 (previously reported as 12-DEC-2008) and had a diarrhea "last week". There was no blood. The patient was treated with omeprazole, 2-3 times daily for 3 weeks. At the time of the follow-up visit, the patient''s abdominal pain worsened and she also had chest pain with deep breath, cough, headaches which happened "every day for one week" and cough. Lab tests performed on 18-DEC-2008 included: giardia antigen was negative, stool culture revealed no salmonella, shigella or campylobacter SP. isolated, white blood cell count and white blood cell differential count were normal, Epstein-Barr viral capsid antigen immunoglobulin M antibody was negative, EBV capsid antigen immunoglobulin G antibody and nuclear antigen immunoglobulin G antibody were positive. It was reported that the patient''s mother was suspecting that her daughter''s "recent medical troubles may be a side effect of GARDASIL". Per mother, the patient also experienced "generally feeling unwell" and bad stomach ache. The reporter considered the patient''s adverse events to be disabling. Additional information has been requested. All available medical records will be provided upon request. 2/2/09 MR received from PCP from 9/12/08 to 12/18/08. Seen for 12 yr WCC 9/12/08 with normal exam. ? DUB for 2 prolonged periods with recent menarche. Acne. Vax given. OV 12/18/08 for c/o sore throat, diarrhea, chest pain, R sided neck pain, migraines, cough and abd pain x 1 month. 4 episodes of vomiting 12/5/08. PE (+) for epigastric, RLQ and LLQ discomfort. Assessment: H/A. Abd pain. Hyperemesis. ? GER. ? (unreadable) ? AGE. Sent for labs. Letter from parent 1/4/09 ? suspect HPV vax in symptomology as above in addition to nausea, dizziness, swollen glands, tiredness, weakness, chills, feeling unwell, aching muscles and bad stomach aches.

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