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This is VAERS ID 448390

Case Details

VAERS ID: 448390 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-05-07
Onset:2007-05-07
   Days after vaccination:0
Submitted: 2012-01-30
   Days after onset:1729
Entered: 2012-01-31
   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: Abdominal pain, Activities of daily living impaired, Asthenia, Disturbance in attention, Headache, Hot flush, Hypersomnia, Infection, Infectious mononucleosis, Loss of consciousness, Malaise, Migraine, Monoplegia, Muscle spasms, Myalgia, Palpitations
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Abdominal pain; Cephalgia; Asthenia; Loss of consciousness; Myalgia
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1201USA03726

Write-up: Case received from the Health Authorities in local country on 24-JAN-2012 under the reference BR20120026. Case not medically confirmed as reported by the patient''s father. A 16 year old female patient received the first, second and third dose of GARDASIL (Lot# and dose not reported), intramuscular route on 07-MAY-2007, 02-NOV-2007 and 07-MAY-2008. Following the first dose, the patient experienced abdominal pain, cephalgia and sever asthenia. Following the second dose, she experienced loss of consciousness, muscular pain and sever asthenia. She experienced infectious mononucleosis, transient paralysis of one hand, cramps, migraine, palpitations and abdominal pain after receiving the third dose. She recovered from all symptoms on unspecified dates. The patient''s father, who reported the case to the Health Authorities, stated that her daughter experienced post-exertional malaise, hot flushes and hypersomnia. She also had impaired concentration leading to difficulties to keep up with school courses or to do sports. She also experienced recurrent ENT and gastrointestinal infections. At the time of reporting, the patient had not recovered. Upon medical review the company judged relevant to code the following adverse event: "recurrent ENT and gastrointestinal infection" which was mentioned by the agency in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C2S1/l) according to the local method of assessment. The adverse events were considered to disabling by the reporter. Other business partner numbers include E-2012-00478. Additional information has been requested.


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