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Administered by: Private Purchased by: Other
Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 3/14/2007; 4/6/2007. Initial and follow up information has been received from a registered nurse concerning a 25 year old (previously reported as 22 year old), female patient with a history of "problems and reactions" to previous vaccinations who on 26-NOV-2006 was vaccinated IM in the left deltoid with a first dose of GARDASIL (Lot #654540/0800F). Subsequently, the patient developed swelling, describing as her "arm felt tight," around the injection site. The patient was placed on unspecified therapy, and subsequently, recovered. On 09-FEB-2007, the patient was vaccinated, IM in the right deltoid, with a second dose of GARDASIL (Lot #654720/0011U), the patient''s arm immediately reddened at the injection site, and she experienced a "tingly" sensation in her arm. The patient was treated with unspecified therapy, and the nurse confirmed she had recovered. The patient informed the nurse that she had "this type of reaction with all IM injections." No further information is expected.
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