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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Categorization of 62 serious unlisted ADRs for Octaplas

 

Tabulation of 62 serious unlisted ADRs for Octaplas from 27 Oct 1989 to 31 Aug 2011:
 

Category in Table 6 of Clinical Overview
Number of Unrelated Cases
Number of Related Cases
Suspected transmission of infectious agent
38
0
Hypersensitivity reactions including anaphylactic and allergica type of reactions
0
3
Seroconversions (passive transfer of antibodies)
0
5
Cardiac disorder (not elsewhere classified)
4
1
Respiratory disorder (not elsewhere classified)
1
1
Thromboembolism
0
5
Hyperfibrinolysis
0
1
TRALI
1
0
Other (alkalosis, medication error, etc.)
2
1

 
 
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