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This is VAERS ID 525630

Case Details

VAERS ID: 525630 (history)  
Age: 9.0  
Gender: Female  
Location: Foreign  
   Days after vaccination:60
Submitted: 2014-03-12
   Days after onset:688
Entered: 2014-03-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route

Administered by: Other       Purchased by: Other
Symptoms: Atrophy, Complex regional pain syndrome, Decreased appetite, Depression, Muscular dystrophy, Pain
SMQs:, Congenital, familial and genetic disorders (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 60 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1403BRA005302

Write-up: This spontaneous report as received from a Physician, who sent an email to Global Medical Affairs, refers to his niece a 9 year old female patient. On unspecified dates the patient was vaccinated with GARDASIL dose 1 and 2, 0.5 mL, intramuscular. On 23-FEB-2012 the patient was vaccinated GARDASIL dose 3, 0.5 mL, intramuscular - UAE. On 23-APR-2012, 61 days after onset of therapy the patient begin to present several symptoms, which were diagnosed later, by a rheumatologist, as Complex Regional Pain Syndrome (hospitalization and disability). Approximately on June 2012, the patient experienced surgical procedure to insert a electrical stimulation device on patient''s spinal cord (medically significant). On an unknown date the patient experienced depression and anorexia. The outcome of complex regional pain syndrome, anorexia and depression was reported as not recovered/not resolved. The reporter considered complex regional pain syndrome, anorexia and depression to be related to GARDASIL. Additional information has been requested. Following there is a copy of the message sent by the reporter to Merck: "This is my niece''s case. She was 9 yo when received the third dose of GARDASIL in Feb 23, 2012 (she was living there on that time). Two months later the last shot, she started to have some neurological symptoms, such as allodynia and severe pain in left foot. It was initially considered as a muscle strain and treated with foot immobilization and medicines. The clinical signs did not improve and, in fact, started to get more severe. She came here, a rheumatologist has given her a diagnosis of Complex Regional Pain Syndrome (CRPS). The diagnosis was also confirmed in Hospital and some months later as well. In mid-2012 she has undergone a surgical procedure because of untreatable pain even using high doses of opioid drugs. This procedure inserted an equipment in the spinal cord in order to make an electrical stimulation. Pain was partially controlled after this procedure. A few months later, she spent two months in a specialized hospital to treat the CRPS with intensive physiotherapy. Unfortunately, the treatment was not able to stop the disease progression, and pain started to get worse again even using the electro stimulator equipment. A muscular dystrophy in the left lower limb has progressively become evident (atrophy of the left foot, which twisted internally). According to the orthopedists, this situation has low chances to be reverted. I''ve read something about this Syndrome and, when the disease is not well controlled, the dystrophy is the natural course of it. Meanwhile, she developed a severe depression and anorexia. In fact, I''m very concerned about the outcome. Currently, she has been treated with a specialized team on chronic pain and children psychiatry. Sadly we haven''t seen any significant improvement since she started the treatment in 2012. In fact, as a physician, I''m not so helpful of seeing her getting better. In spite of all efforts in defining the reasons for the CRPS, no evident etiological factor was found. Vaccine has been always refused by her physicians as the reason for her CRPS. But now, they are strongly considering this possibility since there is no reasonable explanation for the disease after a comprehensive investigation. You know better than me how enthusiastic I am in terms of HPV vaccination. We have wonderful results, those that we recently published. We had no severe adverse events in our cohort. I always refused all negative media reports about GARDASIL, such as Guillain-Barre, neurological dysfunctions, depression, CRPS, and so on. But, to be honest, I''ve started to be concerned about vaccine safety after the report of a couple of cases of CRPS supposedly related to GARDASIL. This came in the same time my own niece has been fighting against a weird disease with no evident etiological factor. So, I''m strongly considering that my niece''s disease can be a severe adverse event related to GARDASIL. I k

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