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This is VAERS ID 627312

Case Details

VAERS ID: 627312 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-16
Entered: 2016-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arrhythmia, Death, Electrocardiogram QT prolonged, Long QT syndrome, Product label issue
SMQs:, Torsade de pointes/QT prolongation (narrow), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electrocardiogram, long QT
CDC Split Type: WAES1603USA006278

Write-up: This spontaneous report was received from a pharmacist via a returned survey and refers to unspecified number of patients of unknown age and gender. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). On unknown dates, the patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT episodes. The reporter found out about those events from a Food and Drug Administration (FDA) document from 2010. Since the pharmacist had a patient with congenital Long QT syndrome and the patient''s family was unsure if GARDASIL was safe to give, the pharmacist wanted the same information for the most recent 6 years to make an educated assessment for the patient. The pharmacist complained that these serious events were not mentioned in the package insert, while that information was needed for the patient. The outcome of arrhythmogenic events and long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The reporter considered the events to be associated with GARDASIL. Additional information has been requested.


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