(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by the pfizer.Primevigilance did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
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Material no.: unknown, batch no.: unknown.It was reported that the patient experienced mild nausea, tiredness, flushing in face, bruising, and metallic taste in mouth while using chloraprep.Initial flushing in face and slight metallic taste in mouth lasting <5min.Then tiredness for 12-24 hours as well as mild nausea / in well feeling.Next 1-2 days bruising more than normal at site.
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