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This is VAERS ID 441365

Case Details

VAERS ID: 441365 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
   Days after vaccination:9
Submitted: 2011-11-03
   Days after onset:365
Entered: 2011-11-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute leukaemia, Cerebral haemorrhage, Coma scale abnormal, Computerised tomogram abnormal, Death, Effusion, Haemoglobin decreased, Headache, Hypertension, Hypokinesia, Hypotension, Intensive care, Mydriasis, Pain in extremity, Platelet count decreased, Purpura, Somnolence, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-11-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Computed axial tomography, 04Nov10, Numerous effusions; WBC count, 04Nov10, 500000; WBC count, 04Nov10, 426000; hemoglobin, 04Nov10, 9.5; hemoglobin, 04Nov10, 7; platelet count, 04Nov10, 51000; platelet count, 04Nov10, 45000; Glasgow coma scale, 04Nov10, 13; Glasgow coma scale, 04Nov10, 8
CDC Split Type: WAES1110USA04403

Write-up: Case received from a physician on 24-OCT-2011 and medically confirmed. A 15-year-old female patient received the second dose of GARDASIL (batch number not reported) via intramuscular route in the arm on 25-OCT-2010. On 03-NOV-2010, the patient was seen due to pain in calf and purpuric spots on both legs. The patient was not athletic and had been participating orienterring race the day before, and the physician thought it was a muscle strain. Blood count and differential white count was prescribed. On 04-NOV-2010, the patient experienced headaches and felt drowsy while being in classroom. Her mother picked her up and she remained at home. In the afternoon, her mother had difficulties waking her up. The patient was slow and had difficulties moving. EMU (Emergency Mobile Unit) was called and the patient was led to hospital on 04-NOV-2010. On admission diffuse hemorrhage cerebral and acute leukemia were discovered. White blood cells count was at 500 000. Hemoglobin was at 9, 5 and platelets at 51000. The patient was transferred to intensive care unit where her Glasgow coma scale quickly fell down from 13 to 8. Hemoglobin was at 7, platelets at 45000, white blood cells count at 426000. There was no adenopathy, no tumor. Liver and spleen were normal. CT scan showed numerous effusions. During the night, she experienced an episode of hypertension treated with EUPRESSYL and then hypotension and mydriasis. The patient died on 06-NOV-2010. To be noted that no clinical sign or symptom had been noticed prior to this episode. The patient used to be in good health and was not very often sick. She had received the first dose of GARDASIL via intramuscular route in the arm on 25-AUG-2010 which had been well tolerated. To be noted that the patient''s mother felt guilty and needed to "hold onto" something, including the vaccine. The hospital staff told her that there was no link between the vaccine and the events. Psychological follow-up was still ongoing. It was noteworthy that the general practitioner did not report any link with vaccination. Other business partner numbers included: E2011-06493. No further information is available.

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