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Life Threatening? Yes
Write-up: Information has been received from Sanofi Pasteur MSD (reference # IE-1577272925-2016001773) on 01-MAR-2016. This is the initial spontaneous case report received from a member of the public (patient''s mother) via RA Ref no. (025988) on 26/Feb/2016 which concerns an 11 year old female patient who experienced Fatigue, Syncope, Seizure, Paraesthesia, Hypoaesthesia, Skin disorder and Headache following vaccination with GARDASIL. Concomitant medications: None. Medical history/concurrent conditions: None reported. The patient was vaccinated with 3 doses of GARDASIL - dose 1 on 30/Nov/2011 (batch/lot no. G005669, expiry date 31-JUL-2013), dose 2 on an unspecified date (batch/lot no. G005669, expiry date 31-JUL-2013) and dose 3 on 28/Mar/2012 (batch/lot no. NM31130, expiry date not reported). Post vaccination, reported as 11/Feb/2012, the patient experienced extreme fatigue, fainting, seizures, headaches, fingers tingling and going numb and a skin condition. The reporter added that the patient''s symptoms became very prominent after dose 3 and is having ongoing hospital treatment. The reporter considers the patient''s reactions as debilitating and effecting her life and future. At the time of reporting the patient''s symptoms were persisting. The reporter assessed the causal relationship between the adverse reactions and GARDASIL as Unknown. Upon internal review the batch numbers of GARDASIL were changed from (GOO5669 to G005669).
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