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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
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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