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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This case was reported by a healthcare professional, via a GSK representative and described the occurrence of chills in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 27 August 2010 at 10:30 the subject received 1st dose of CERVARIX (1 ml, unknown route and site). On 27 August 2010, within 45 minutes after vaccination with CERVARIX, the subject experienced chills, nausea, vomiting, shortness of breath, dizziness, lightheadedness and muscular pain all over the body. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was treated with ZOFRAN, TORADOL and Normal saline. At the time of reporting the events were resolved. The healthcare professional reported that the subject received 1st dose of CERVARIX at 10:30, and experienced all of the reported adverse events within 45 minutes of the dose. She was taken to a local Emergency Room (was not admitted to the actual hospital), received 2 doses of ZOFRAN IM, 1 dose of TORADOL IM (the mg dose of both is not known), and IV normal saline infusion (total amount not known). Admission to ER reported as 14:43, and discharge from ER at 17:00. At the time of discharge from ER the subject reported that all adverse events had resolved.
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