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This is VAERS ID 261577

Case Details

VAERS ID: 261577 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Florida  
Vaccinated:2006-07-27
Onset:2006-07-27
   Days after vaccination:0
Submitted: 2006-08-10
   Days after onset:14
Entered: 2006-08-15
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0702F / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site pain, Loss of consciousness, Syncope, Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type: WAES0607USA05727

Write-up: Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post- ictal state. Unspecified medical attention was sought. Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 8/10/2006. Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 at 13:30 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 1/2 to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post-ictal state. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested.


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