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Administered by: Other Purchased by: Unknown
Life Threatening? No
Write-up: This solicited report has been obtained from a web site published on a newspaper via a vendor''s representative as part of a patient support program where a female patient of unknown age was reported. The patient''s medical history, concurrent condition and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (strength, dose, route, lot number and expiration date were not reported) indicated to protect her against cervical cancer. It was reported, that on an unknown date, the patient was paralyzed in hospital after having the "controversial" GARDASIL at school. On an unknown date (reported as shortly after vaccination), the patient stated that she felt ill (malaise) with stomach spasms, dizziness, pain, headache and fatigue. It was also reported, that her muscles became weaker, and in May, on an unspecified date, two years after she had the GARDASIL, she woke up with no feeling in her legs. Additionally, the patient stated that she had since lost all sensation in her right arm (sensory loss) and she was virtually bed-bound (Bedridden), unable to eat, she had incontinence and also she was too week to lift her head (asthenia). It was also reported that the doctors were unable to diagnose her with anything and had dismissed it as being psychological, refusing to acknowledge any link to the GARDASIL. However, her parents were convinced that her condition was caused by the GARDASIL. They stated that they were 100 percent sure that the events were down to the GARDASIL. It was also reported that GARDASIL was the name of the HPV vaccine that was offered to 12-13 year-old girls to protect against Sexually Transmitted Disease (STD) Human Papilloma virus, which could cause cervical cancer. Moreover, it was reported that the patient had missed 2 years in school after she had these events. She stated that it was so scary and the doctors kept telling that it was all in her head. The patient stated that this had totally changed her life and she was in pain all the time If she had not got it she would not be like this. National Health Service (NHS) stated that the GARDASIL was safe and said that there were "very few girls" who were not suitable for it. Also it was reported that 63 woman in the country the GARDASIL caused them serious neurological conditions (MARRS#1701GBR003232). Moreover, it was reported that on an unknown date (reported as "before"), another girl, dancer, suffered the same ordeal after having GARDASIL, her muscles were so weak and she was confined to a wheelchair for six months (MARRS#1701GBR003233). At the time of the report, the outcome of the events were unknown. Upon internal review, the events were determined to be serious due to disability criteria. Also upon internal review, paralysis was determined to be a medically significant event. This is one of two reports from the same reporter. Additional information is not expected as the reported did not consent for follow up attempts. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational vaccine and the reported event cannot be established. Lack of adequate medical substantiation precludes a proper causality assessment. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck continues to monitor the safety profile of the investigational vaccine.
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