Search Results - "Hennig, Renald"

Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation by Rothstein, Edward, Kohl, Katrin S, Ball, Leslie, Halperin, Scott A, Halsey, Neal, Hammer, Sandra Jo, Heath, Paul T, Hennig, Renald, Kleppinger, Cynthia, Labadie, Jerry, Varricchio, Frederick, Vermeer, Patricia, Walop, Wikke

“…The Working Group concluded that the paucity of information on onset [5], duration [2,11,37], and size of nodules at injection site in the published literature…”
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Safety of MF59™ adjuvant by Schultze, Viola, D’Agosto, Vicente, Wack, Andreas, Novicki, Deborah, Zorn, Juergen, Hennig, Renald

“…Abstract The need to enhance the immunogenicity of purified subunit antigens has prompted the development of new adjuvants. The adjuvant emulsion MF59™ has…”
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Immunization site pain: Case definition and guidelines for collection, analysis, and presentation of immunization safety data by Gidudu, Jane F, Walco, Gary A, Taddio, Anna, Zempsky, William T, Halperin, Scott A, Calugar, Angela, Gibbs, Neville A, Hennig, Renald, Jovancevic, Milivoj, Netterlid, Eva, O’Connor, Terri, Oleske, James M, Varricchio, Frederick, Tsai, Theodore F, Seifert, Harry, Schuind, Anne E

“…The literature search was performed within Medline, the Cochrane library, and Embase from 1966 to April 2001 with the following search terms: pain, local…”
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Post-marketing surveillance of immediate allergic reactions: polygeline-based versus polygeline-free pediatric TBE vaccine by Zent, Olaf, Hennig, Renald

“…Scattered cases of immediate allergic reactions occurred in the nineties after widespread use of the original (polygeline-based) pediatric tick-borne…”
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A local reaction at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data by Gidudu, Jane, Kohl, Katrin S, Halperin, Scott, Hammer, Sandra Jo, Heath, Paul T, Hennig, Renald, Hoet, Bernard, Rothstein, Edward, Schuind, Anne, Varricchio, Frederick, Walop, Wikke

“…Abstract The need for developing a case definition and guidelines for a local reaction at or near the injection site, methods for the development of the case…”
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Swelling at or near injection site: Case definition and guidelines for collection, analysis and presentation of immunization safety data by Kohl, Katrin S, Walop, Wikke, Gidudu, Jane, Ball, Leslie, Halperin, Scott, Hammer, Sandra Jo, Heath, Paul, Varricchio, Frederick, Rothstein, Edward, Schuind, Anne, Hennig, Renald

“…[...]the Working Group decided to define all local swelling reactions as "swelling at or near injection site". [...]one has to be careful in selecting the most…”
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Induration at or near injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data by Kohl, Katrin S, Walop, Wikke, Gidudu, Jane, Ball, Leslie, Halperin, Scott, Hammer, Sandra Jo, Heath, Paul, Hennig, Renald, Rothstein, Edward, Schuind, Anne, Varricchio, Frederick

“…The appropriate Brighton Collaboration documents defining these conditions need to be consulted and the local reaction(s), which best fits the description…”
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Biologics safety preclinical, clinical and regulatory by Hennig, Renald

“…Biologicals offer particular challenges for all concerned, whether they be scientific researchers, profit-oriented companies (including not yet…”
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Safety of MFS9™ adjuvant by SCHULTZE, Viola, D'AGOSTO, Vicente, WACK, Andreas, NOVICKI, Deborah, ZORN, Juergen, HENNIG, Renald

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Electronic Reporting for Clinical Drug Safety and Pharmacovigilance. 29 - 30 October 2002, Amsterdam, The Netherlands by Hennig, Renald

“…The 31 January 2003 deadline for electronic reporting to the European Agency for the Evaluation of Medicinal Products has helped to focus industry and…”
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Cellulitis at injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data by Halperin, Scott, Kohl, Katrin S, Gidudu, Jane, Ball, Leslie, Hammer, Sandra Jo, Heath, Paul, Hennig, Renald, Labadie, Jerry, Rothstein, Edward, Schuind, Anne, Varricchio, Frederick, Walop, Wikke

“…Because cellulitis after immunization can occur due to unsafe injection techniques or vaccine vial handling or storage, and because it can clinically be…”
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Abscess at injection site: Case definition and guidelines for collection, analysis, and presentation of immunization safety data by Kohl, Katrin S, Ball, Leslie, Gidudu, Jane, Hammer, Sandra Jo, Halperin, Scott, Heath, Paul, Hennig, Renald, Labadie, Jerry, Rothstein, Edward, Schuind, Anne, Varricchio, Frederick, Walop, Wikke

“…[...]the Working Group recognized that the distinction between abscesses of infectious etiology and sterile abscesses could not always be made on the basis of…”
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Immediate allergic reactions after vaccinations: a post-marketing surveillance review by ZENT, Olaf, ARRAS-REITER, Cornelia, BROEKER, Michael, HENNIG, Renald

“…Immediate systemic allergic reactions after vaccination with commonly used vaccines are very rare. Consequently, the risk of these reactions cannot be verified…”
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Protection against tick-borne encephalitis with a new vaccine formulation free of protein-derived stabilizers by ZENT, Olaf, HENNIG, Renald, BANZHOFF, Angelika, BRÖKER, Michael

“…Vaccination against tick-borne encephalitis (TBE) has been successfully employed for many years in TBE-endemic countries. Post-marketing experience gained from…”
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Induration at or near injection site : Case definition and guidelines for collection, analysis, and presentation of immunization safety data : Brighton collaboration standardized case definitions and guidelines for adverse events following immunization (anaphylaxis, encephalitis/ADEM, aseptic meningitis, fatigue, unesplained sudden death (DIDS), rash, thrombocytopenia, cellulitis, abscess, induration, swelling, vaccinia virus adverse events, hypotonic-hyporesponsive episode) by KOHL, Katrin S, WALOP, Wikke, VARRICCHIO, Frederick, GIDUDU, Jane, BALL, Leslie, HALPERIN, Scott, JO HAMMER, Sandra, HEATH, Paul, HENNIG, Renald, ROTHSTEIN, Edward, SCHUIND, Anne

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Cellulitis at injection site : Case definition and guidelines for collection, analysis, and presentation of immunization safety data : Brighton collaboration standardized case definitions and guidelines for adverse events following immunization (anaphylaxis, encephalitis/ADEM, aseptic meningitis, fatigue, unesplained sudden death (DIDS), rash, thrombocytopenia, cellulitis, abscess, induration, swelling, vaccinia virus adverse events, hypotonic-hyporesponsive episode) by HALPERIN, Scott, KOHL, Katrin S, VARRICCHIO, Frederick, WALOP, Wikke, GIDUDU, Jane, BALL, Leslie, JO HAMMER, Sandra, HEATH, Paul, HENNIG, Renald, LABADIE, Jerry, ROTHSTEIN, Edward, SCHUIND, Anne

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Swelling at or near injection site : Case definition and guidelines for collection, analysis and presentation of immunization safety data : Brighton collaboration standardized case definitions and guidelines for adverse events following immunization (anaphylaxis, encephalitis/ADEM, aseptic meningitis, fatigue, unesplained sudden death (DIDS), rash, thrombocytopenia, cellulitis, abscess, induration, swelling, vaccinia virus adverse events, hypotonic-hyporesponsive episode) by KOHL, Katrin S, WALOP, Wikke, HENNIG, Renald, GIDUDU, Jane, BALL, Leslie, HALPERIN, Scott, HAMMER, Sandra Jo, HEATH, Paul, VARRICCHIO, Frederick, ROTHSTEIN, Edward, SCHUIND, Anne

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Abscess at injection site : Case definition and guidelines for collection, analysis, and presentation of immunization safety data : Brighton collaboration standardized case definitions and guidelines for adverse events following immunization (anaphylaxis, encephalitis/ADEM, aseptic meningitis, fatigue, unesplained sudden death (DIDS), rash, thrombocytopenia, cellulitis, abscess, induration, swelling, vaccinia virus adverse events, hypotonic-hyporesponsive episode) by KOHL, Katrin S, BALL, Leslie, VARRICCHIO, Frederick, WALOP, Wikke, GIDUDU, Jane, JO HAMMER, Sandra, HALPERIN, Scott, HEATH, Paul, HENNIG, Renald, LABADIE, Jerry, ROTHSTEIN, Edward, SCHUIND, Anne

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Nodule at injection site as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation : Special Section: Measurement and Recording of Vaccination Related Parameters 1 by ROTHSTEIN, Edward, KOHL, Katrin S, VARRICCHIO, Frederick, VERMEER, Patricia, WALOP, Wikke, BALL, Leslie, HALPERIN, Scott A, HALSEY, Neal, HAMMER, Sandra Jo, HEATH, Paul T, HENNIG, Renald, KLEPPINGER, Cynthia, LABADIE, Jerry

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