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This is VAERS ID 379857

Case Details

VAERS ID: 379857 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Indiana  
Vaccinated:2009-06-30
Onset:2009-07-07
   Days after vaccination:7
Submitted: 2010-02-05
   Days after onset:213
Entered: 2010-02-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0940X / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Activities of daily living impaired, Condition aggravated, Fatigue, Loss of consciousness, Lymphadenopathy, Neurological examination normal, Similar reaction on previous exposure to drug, Syncope, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPRINTEC
Current Illness: Sulfonamide allergy; Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Physical examination, negative--a complete work up from a gastrologist and cardiologist; neurological, negative
CDC Split Type: WAES1001USA03374

Write-up: Information has been received from a medical assistant concerning a 16 year old female patient with sulfonamide and azithromycin allergy who on 30-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 659655/0940X). On 01-SEP-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 663452/0671Y). Concomitant therapy included SPRINTEC. On approximately 07-JUL-2009 ("a week after administration of her first dose of GARADSIL"), the patient experienced fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck and fatigue. It was reported that the patient experienced the same symptoms but more intense after her second dose of GARDASIL administered on 01-SEP-2009. When she experienced a fainting spell, she was exhausted for the rest of the day. The patient still continued to have episodes of blacking out and stomach pain once or twice a week. The patient had been examined and had a complete work up from a neurologist, gastrologist and cardiologist. All tests were negative. At the time of this report, the patient was recovering. Follow up information has been received from the medical assistant who confirmed the dates and lot #s for the two doses of GARDASIL and reported that there were no concomitant vaccines were administered. She clarified that the events, experienced a week after the first dose, persisted then worsened after administration of the second dose. The events were considered as disabling since the patient could not attend school. It was unknown if the patient was hospitalized. The patient had not seen in their office since 01-SEP-2009. Fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck, fatigue and episodes of blacking out were considered to be disabling. Additional information has been requested.


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