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Life Threatening? No
Write-up: Information has been received from a physician concerning a 9 week old female with gastrooesophageal reflux who on 25-JAN-2008 was vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot# 657673/0904U) and vomited immediately after. Medical attention was sought via physician''s office. The outcome was unknown. There was no product quality complaint. Additional information has been requested. 02/11/2010 Follow-up information from the reporting physician concerning a 9 week old female who on 23-JAN-2008 was vaccinated PO with her first dose of GARDASIL (lot# 657673/0904U). There was to illness at the time vaccination. Concomitant vaccinations administered on that same day included the first IM dose of PEVENAR (lot#041339), the first IM dose of RECOMBIVAX HB and (DAPTACEL) (lot# C2933AB) and first IM dose of (IPOL) (lot# A047U). Immediately after the dose of GARDASIL (lot # 657673/0904U) the patient vomited and subsequently removed immediately after immediately after dose. Additional information has been requested.
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