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This is VAERS ID 351970

(NOTE: This result is from the 12/8/2009 version of the VAERS database)

Case Details

VAERS ID: 351970 (history)  
Form: Version .0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2009-05-08
Onset:2009-06-22
   Days after vaccination:45
Submitted: 2009-07-20
   Days after onset:28
Entered: 2009-07-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: AIDS encephalopathy, Acute respiratory failure, Aphasia, Blood HIV RNA increased, Blood pressure fluctuation, Brain death, Brain herniation, Brain oedema, CD4 lymphocytes decreased, CSF culture negative, CSF glucose decreased, CSF protein increased, CSF test normal, Cerebrovascular disorder, Computerised tomogram abnormal, Condition aggravated, Confusional state, Death, Drug abuse, Dysarthria, Encephalitis, Endotracheal intubation, Facial palsy, HIV antibody positive, HIV infection, Haematocrit decreased, Haemoglobin decreased, Heart rate irregular, Hypoaesthesia, Hyporeflexia, Hypoxic encephalopathy, Kidney fibrosis, Lumbar puncture abnormal, Lymphadenopathy, Lymphocyte count decreased, Lymphocyte percentage decreased, Meningeal disorder, Meningitis, Mental status changes, Migraine, Monocyte percentage increased, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Pleocytosis, Pulmonary congestion, Pupil fixed, Red blood cell count decreased, Red blood cell sedimentation rate increased, Spinal cord disorder, Unresponsive to stimuli, Vasculitis cerebral, White blood cell count decreased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Cerebrovascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2009-07-02
   Days after onset: 10
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: None
Current Illness: HIV infection
Preexisting Conditions: Migraine; Amphetamine abuse; Bell''s palsy
Allergies:
Diagnostic Lab Data: head computed axial tomography, 06/22/2009, see narrative; spinal tap, 06/23/2009, see narrative; spinal tap, 06/23/2009, normalization of glucose; magnetic resonance imaging, 06/23/2009, brain: see narrative; head computed axial tomography
CDC Split Type: WAES0907USA01529

Write-up: Information has been received from an investigator concerning a 37 year old female with HIV and a history of migraine headaches and methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema); left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased neurological reflexes grade 4 (life threatening), pupils fixed and dilated bilaterally grade 4 (life threatening), and death. The report was as follows: The patient presented to emergency department on 22-JUN-2009 with migraine-like headache, left hand numbness, dysarthria and anomia. CT read as normal, patient discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia. At that time, she was not on treatment for HIV and her CD4 count was 263. She was admitted to the neurology service and empirically treated with antibiotics for bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose, elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow cytometry was not performed. JC virus PCR was ordered, but results not reported. Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was positive without subsequent isoniazid treatment chest X ray during admission was negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral edema with leptomeningeal enhancement. Repeated lumbar puncture showed normalization of glucose. During the hospitalization, her symptoms had improved.


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