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This is VAERS ID 282581

Case Details

VAERS ID: 282581 (history)  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-03-16
Onset:2007-03-27
   Days after vaccination:11
Submitted: 2007-06-20
   Days after onset:85
Entered: 2007-06-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0244U / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Blood creatine phosphokinase, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Culture urine negative, Diarrhoea, Flushing, Haematology test normal, Hypokinesia, Hypotension, Infection, Inflammation, Myalgia, Nausea, Pharyngolaryngeal pain, Pyrexia, Rash, Red blood cell count increased, Streptococcus identification test negative, White blood cell count, X-ray normal
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Prevacid
Current Illness:
Preexisting Conditions: none
Diagnostic Lab Data: chest X-ray 04/04?/07 - normal, diagnostic laboratory 04/04?/07 - negative, Streptococcus oralis 04/04?/07 - negative, Streptococcus oralis 04/04?/07 - negative, serum C-reactive 04/04?/07 8.3, serum creatine kinase 04/04?/07 <7, WBC count 04/04?/07, urine culture 04/04?/07 - negative, serum antistreptolysin 04/04?/07 - negative, erythrocyte 04/04?/07 36, blood culture 04/04?/07 - negative
CDC Split Type: WAES0705USA05081

Write-up: This report was identified from a line listing on request by the Company from the FDA under the Freedom of Information Act. A 15 year old female patient with no medical history, was vaccinated IM in the left arm, on 16-MAR-2007, with the second dose of Gardasil (Lot #656051/0244U). On 27-MAR-2007 the patient experienced severe myalgias that progressed over 2 weeks until the patient was unable to sit up or walk. On 04-APR-2007, the patient developed a fever and within one hour of onset, became hypotensive and developed a flushing rash: she was admitted to the pediatric intensive care unit (PICU). The patient experienced the events of abasia, diarrhea, flushing , hypokinesia, hypotension, hypotension, inflammation, myalgia, nausea, pharyngolaryngeal pain, pyrexia and rash. Treatment included pressors (unspecified) and dopamine. As of 06-APR-2007, no source had been identified (the source of infection may have been an inflammed area on the back of the patient''s earlobe at an earring hole site), and the patient was improving. The listing indicated that one or more of the events required a visit to the emergency room, resulted in hospitalization, was considered to be life threatening. No further information is available. The original reporting source was not identified. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standards and was released. 04-Apr-2007 DA Streptococcus oralis culture negative, 04-Apr-2007 DA blood negative, 04-Apr-2007 DA chest X-ray normal, 04-APR-2007 DA diagnostic hematology blood test negative, 04-APR-2007 DA erythrocyte sedimentation rate 36 (units not provided), 04-Apr-2007 DA serum C-reaction protein test 8.3 (units not provided), 04-Apr-2007 DA serum antistreptolysin O antigen test negative, 04-Apr-2007 DA urine culture negative, 04-Apr-2007 DA white blood cell count elevated.


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