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Administered by: Private Purchased by: Other
Life Threatening? No
Write-up: Information has been received from a registered nurse (RN), via a company representative, concerning the RN''s 13 year old daughter, who in May 2007, was vaccinated IM, with the first dose, 0.5ml, of Gardasil. The nurse reported that her daughter experienced dizziness after receiving the vaccination, and then recovered (duration not specified). The patient sought unspecified medical attention. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 6/14/2007: 7/6/2007. Initial and follow up information has been received from a physician and a registered nurse, concerning the RN''s 13 year old daughter, with a one week prior onset of dizziness and shortness of breath and no other medical history, who on 03-May-2007, was vaccinated IM in the left arm, with the first dose, 0.5ml, of GARDASIL (Lot #655618/0186U). The nurse originally reported that her daughter experienced dizziness after receiving the vaccination, and then recovered (duration not specified); however, follow up information clarified that her daughter had been in training for track, and one week prior to the vaccination had been experiencing both dizziness and shortness of breath. The physician noted that the baseline dizziness recurred three days after the vaccine was administered. When her daughter stopped running, the RN reported the dizziness resolved (date not specified). The physician confirmed that no treatment or office visit was required. Follow up information from the nurse indicated that the physician "believed the incident was not related to the vaccine", however, information received directly from the physician noted only that it was "likely not vaccine associated". Additional follow up information received from a healthcare professional at the physician''s office indicated that on 06-JUL-2007, the patient was vaccinated in the left arm with the second dose of GARDASIL (Lot #655324/0088U). On 07-JUL-2007, she reported left breast pain. Treatment included unspecified non steroidal anti-inflammatory drugs, and the pain was relieved. On 08-JUL-2007, the patient had recovered. No further information is expected.
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