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This is VAERS ID 359041

Case Details

VAERS ID: 359041 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Unknown  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2009-09-30
   Days after onset:9
Entered: 2009-10-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0216Y / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram abnormal, Computerised tomogram head, Facial bones fracture, Fall, No reaction on previous exposure to drug, Syncope, Tonic clonic movements, X-ray abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Unknown
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: head computed axial, nasal fracture; X-ray, nasal fracture
CDC Split Type: WAES0909USA03759

Write-up: Information has been received from a Registered Nurse (R.N.) concerning a 11 year old female who on 21-SEP-2009 experienced a syncopal episode with tonic-clonic movements after receiving her second dose of GARDASIL (lot# 0216Y). It was reported that when she fell during this episode she fractured her nose. The patient sought medical attention and was seen by the nurse. X-rays of nose indicated fractured nose. The outcome was unknown. Follow up information was received from a Licensed Practical Nurse (L.P.N.) on 24-SEP-2009 via telephone reported that the patient with no pertinent medical history and allergic to AUGMENTIN (hives) was vaccinated with her second dose of GARDASIL (lot#0216Y) on 21-SEP-2009. No other vaccines and concomitant therapies were given that day. After fall, the patient was not sent to emergency room but for an x-ray of the nose and a CT of the head. Both revealed a nasal fracture. The patient''s current status was recovering. She was referred to an ENT (name not provided) and surgery was planned. It was also reported that the patient was given the first dose of GARDASIL (lot# 662300/0100Y) in the left arm on 15-JUL-2009. Other vaccines given on that day included a dose of MENACTRA (lot# U2925AA) and a dose of VARIVAX (Oka) (lot# 0690Y). There was no problem after the first dose of GARDASIL. The reporter considered the fractured nose to be disabling. Additional information has been requested.


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