Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: Other
Life Threatening? No
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 know one says that there is no evidence in the literature that HPV vaccine is related to those CPRS cases. But so far, no one in the world really performed a strong case-control study in order to define whether HPV vaccine could be related to CPRS etiology. In fact, I''m not sure whether a case-control study with worldwide proportion is feasible. In addition, I''m not aware about a phase IV study on GARDASIL or CERVARIX (do you know?). As you are one of the most respectable name in HPV research in the world, I''m writing to know your opinion. In addition, I believe Merck CO should be carefully notified about this possible and terrible severe adverse event. A deep and careful evaluation MUST be performed worldwide in terms of GARDASIL safety. This request does not come from someone lay or from media, but someone who is very enthusiastic on HPV vaccination and cancer prevention and also is involved in HPV vaccine research. I''m really concerned.
Copyright © 2017 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166