Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.

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Title: Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.
Authors: Verstraeten T (AUTHOR), Davis RL (AUTHOR), DeStefano F (AUTHOR), Lieu TA (AUTHOR), Rhodes PH (AUTHOR), Black SB (AUTHOR), Shinefield H (AUTHOR), Chen RT (AUTHOR), Vaccine Safety Datalink Team (CORPORATE AUTHOR)
Source: Pediatrics. Nov2003, Vol. 112 Issue 5, p1039-1048. 10p.
Abstract: OBJECTIVE: To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. METHODS: A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 micro g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. RESULTS: In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. CONCLUSIONS: No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed. [ABSTRACT FROM AUTHOR]
Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases.
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  Data: <searchLink fieldCode="AR" term="%22Verstraeten+T%22">Verstraeten T</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Davis+RL%22">Davis RL</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22DeStefano+F%22">DeStefano F</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Lieu+TA%22">Lieu TA</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Rhodes+PH%22">Rhodes PH</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Black+SB%22">Black SB</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shinefield+H%22">Shinefield H</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Chen+RT%22">Chen RT</searchLink> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Vaccine+Safety+Datalink+Team%22">Vaccine Safety Datalink Team</searchLink> (CORPORATE AUTHOR)
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  Data: <searchLink fieldCode="JN" term="%22Pediatrics%22">Pediatrics</searchLink>. Nov2003, Vol. 112 Issue 5, p1039-1048. 10p.
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: OBJECTIVE: To assess the possible toxicity of thimerosal-containing vaccines (TCVs) among infants. METHODS: A 2-phased retrospective cohort study was conducted using computerized health maintenance organization (HMO) databases. Phase I screened for associations between neurodevelopmental disorders and thimerosal exposure among 124 170 infants who were born during 1992 to 1999 at 2 HMOs (A and B). In phase II, the most common disorders associated with exposure in phase I were reevaluated among 16 717 children who were born during 1991 to 1997 in another HMO (C). Relative risks for neurodevelopmental disorders were calculated per increase of 12.5 micro g of estimated cumulative mercury exposure from TCVs in the first, third, and seventh months of life. RESULTS: In phase I at HMO A, cumulative exposure at 3 months resulted in a significant positive association with tics (relative risk [RR]: 1.89; 95% confidence interval [CI]: 1.05-3.38). At HMO B, increased risks of language delay were found for cumulative exposure at 3 months (RR: 1.13; 95% CI: 1.01-1.27) and 7 months (RR: 1.07; 95% CI: 1.01-1.13). In phase II at HMO C, no significant associations were found. In no analyses were significant increased risks found for autism or attention-deficit disorder. CONCLUSIONS: No consistent significant associations were found between TCVs and neurodevelopmental outcomes. Conflicting results were found at different HMOs for certain outcomes. For resolving the conflicting findings, studies with uniform neurodevelopmental assessments of children with a range of cumulative thimerosal exposures are needed. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Pediatrics is the property of American Academy of Pediatrics and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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