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Life Threatening? No Write-up: Information has been received from a registered nurse concerning a 9 year old patient with a history of premature puberty and asthma and a drug reaction/allergies that included an unknown reaction to flu vaccine, who on 09-APR-2008 was vaccinated IM with a dose of VARIVAX (Merck) (lot number: 659610/1654U). Suspect therapy included GARDASIL. On 10-APR-2008 the patient developed local swelling, redness and a lump under the skin at the injection site. Recommended treatment was ice and MOTRIN. There were no lab diagnostic studies performed. Unspecified medical attention was sought, via phone call to the office. The outcome was reported as recovering. There was no product quality complaint. Follow-up information from the reporting medical assistant (also reported as registered nurse) indicated that the 9 year old female who on 09-APR-2008 at 12:00 was vaccinated IM with her second dose of VARIVAX (Merck) (lot# 659610/1654U). After vaccination the patient developed redness and swelling. Additional information has been requested. | ||||||||||||||||||||
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