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This is VAERS ID 533434

Case Details

VAERS ID: 533434 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Foreign  
Submitted: 2014-06-10
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005626 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Postural orthostatic tachycardia syndrome, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: LIPITOR
Current Illness: Unknown
Preexisting Conditions: Asthma; Type IIa hyperlipidaemia; GARDASIL, Drug Reaction: Feeling abnormal
Diagnostic Lab Data:
CDC Split Type: WAES1406GBR004803

Write-up: Information was received from Sanofi Pasteur MSD (# E2014-04939) on 06-JUN-2014. This case was reported by the MHRA on 02-Jun-2014, MHRA Reference GB-MHRA-ADR 22548694. This case is medically confirmed. A 13 year old female patient with a history of familial hypercholesterolemia, received HPV vaccine GARDASIL, batch J005626, dose 2, intramuscularly on 02-Dec-2013. The patient became unwell and unreported time post vaccination in Dec-2013 and experienced fainting episodes also in Dec-2013. The patient was diagnosed with postural orthostatic tachycardia syndrome on an unreported date and was under the care of the hospital. The patient was being home tutored at the time of reporting and had not been able to return to school. The outcome of the events of unwell and fainting was unknown and the patient had not recovered from the event of postural orthostatic tachycardia syndrome. The patients mother was told that the history of familial hypercholesterolemia was unrelated to postural orthostatic tachycardia syndrome. The patient received dose 1 of GARDASIL, batch J007240 intramuscularly on 16-Oct-2013 and felt strange an unreported time post vaccination in Oct-2013, the outcome was unknown. The patient was taking concomitant medications of LIPITOR for an unreported indication, unspecified statins for an unreported indication and unspecified antiasthmatics for asthma. The case was considered serious and disabling by the reporter.

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