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Pharmacoepidemiol Drug Saf. 2014 Nov;23(11):1192-204. doi: 10.1002/pds.3638. Epub 2014 May 10.

Risk of Guillain-Barré syndrome following pandemic influenza A(H1N1) 2009 vaccination in Germany.

Collaborators (370)

Gerber J, Heyden M, Klötzsch C, Linster E, Langel S, Bößenecker W, Bamberg C, Gerlach R, Reckhardt M, Borak P, Braun H, Harzheim M, Isenhardt K, Bader P, Glocker F, Reimers CD, Riesterer-Hemm G, Trabold R, Homberg V, Klee R, von Rosen F, Daffertshofer M, Hofler D, Hofstadt U, Baumsteiger C, Dreger J, Stachulski F, Harms H, Kauert A, Haas J, von Brevern M, Völzke E, Ducke F, Böhme H, Koennecke HC, Ecke A, Koennecke HC, Bähr D, Nabavi DG, Hopmann D, Porz D, Neumayer B, Müller T, Kitzrow M, Börnke C, Schröder A, Kowalski T, Günther J, Boeckler D, Reinshagen A, Sarholz M, Böhm KD, Weiland T, Kuhlmann RJ, Heide W, Heider S, Schüler O, Schepelmann K, Claus D, Kunesch E, Yaretskyy G, Spieker S, Jung S, Spitzer C, Busch A, Schneider H, Machetanz J, Grehl H, Nolden-Koch M, Wilmsen H, Lehmann H, Seitz R, Griese M, Schmitt HM, Dietze C, Holz J, Leinisch E, Derfuß T, Linker R, Reinhardt FM, Krämer M, Koeppen S, Gerhard H, Bauer H, Stolze H, Jost V, Steinmetz H, Schütz H, Böhm J, Rauer S, Klotz JM, Schneider A, Biemann M, Blaes F, Krämer H, Guthke K, Schmidt H, Krumpolt H, Schiess D, Roth M, Fuchs HH, Schneider E, Wohlfarth K, Müller T, Sick W, Schwandt D, Wellach I, Töpper RF, Koehler J, Rosenkranz T, Knepel S, Duwe T, Stiller M, Rieke K, Baas H, Brunotte P, Tümmler J, Heidenreich F, Stangel M, Stift T, Ringleb P, Kaendler S, Humbroich K, Plöger H, Sitzer M, Dieter J, Dietz M, Eicke M, Ochs G, Güldenring A, Hagemann G, Zinke J, Fetter M, Herath H, Escheu G, Stingele R, Berthold A, Schmitt E, Haupt WF, Petereit HF, Limmroth V, von Giesen HJ, Kirsch B, Heckmann JG, Beuche W, Schattenfroh C, Tampier-Pohl C, Friedl R, Oberwittler C, Schlenker M, Trillenberg P, Abushammala A, Schabet M, Eßer M, Thümen A, Lins H, Vielhaber S, Bayerl J, Tackenberg B, Hachgenei A, Meisenheim GK, Philipps J, Tings T, Franz O, Jauß M, Berthele A, München TU, Hupfer W, Nagi M, Dziewas R, Kusch W, Lobenstein S, Fischer V, Syed N, Bitsch A, Jahnke U, Allendörfer J, Dietrich W, Görtzen A, Stark E, Wenning W, Neumann F, Petrick M, Kaiser R, Niehoff T, Deymann R, Hartmann R, Christe W, Görlitz C, Hotz M, Buchner H, Balzer K, Braune HJ, Kindl HJ, Leschnik O, Lohner H, Zettl U, Kiefer R, Krauth S, Hansberg T, Matrisch H, Vetter T, Schepelmann K, Schade B, Nguento A, Fortwängler T, Hartnack F, Neuhaus O, Wennrich M, Leopold HC, Tebben J, Polzer U, Sieb P, Huss GP, Kuhl V, Gawlitza M, Freudenberger T, Rieder G, Schröder K, Bös M, Krüger T, Rechlin M, Bufler J, Angerer M, Möller P, Eppinger B, Dömges F, Albrecht P, Kotterba S, Stolz E, Schmidt N, Trottenberg T, Feige P, Hufschmidt A, Svrakova L, Haensch CA, Kastrau F, Schmidt P, Reiners K, Weinmann E, Merkelbach S, Bachhuber A, Hermann W, Häusler M, Toth M, Weiß BM, Stein D, Klepper J, Hirsch T, von Moers A, Brandes H, Botsch M, Köhler C, Franke I, Kössel H, Kauffmann B, Schwalm H, Kirschstein M, Tribukait U, Mandl M, Böhmann H, Schaetz K, Hebing B, Steinert M, Eichholz S, von Lilien-Waldau T, Karenfort M, Kretzschmar B, Trollmann R, Schmiedel G, Dördelmann M, Kieslich M, Mause U, Grüber C, Korinthenberg R, Heubner G, Mattes J, Radlow U, Repp R, Klinge J, Genseke R, Gsinn S, Gebhardt B, Papsch M, Mutlak S, Brockmann K, Koch G, Mandelkow F, v Blanckenburg P, Bertram U, Vieker S, Peltner HU, Sander M, Shamdeen MG, Nowka S, Koch W, Walkenhorst H, Rubens T, Westerbeck K, Rübo J, Wiater A, Pflumm K, Bensch J, Engelhardt H, Deja M, Borte M, Tibussek D, Bosse H, Rinschen K, Härtel C, Gaude-Wagener M, Beyer U, Pädiatrie A, Peters H, Kowalzik F, Seipelt P, Zippel S, Pargac KN, Schobeß A, Müller W, Baethmann M, Leiz S, Gehrmann A, Makowski C, Fiedler B, Böswald M, Weisbrod T, Kintzel K, Franz C, Feickert HJ, Kühl PG, Schneider M, Raab K, Beyer P, Kauther KD, Reiter HL, Heubner G, Behl ES, Trefz FK, Hoffmann HG, Buss M, Olbertz DM, Hempel L, Agricola G, Horneff G, Augustin KS, Mihatsch W, Kurre A, Colling S, Burghard R, Soditt V, Feierfeil K, Hornbrook D, Kellner L, Pernice W, Schirmer D, Alber M, Geerken S, Kratz M, Köhler A, Knuf M, Repinska T, Buller M, Becker JC, Niesytto C, Skopnik H, Borusiak P, Verbeek T, Gabler I, Winkelmann T.

Author information

1
Division of Safety of Medicinal Products and Medical Devices, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany.

Abstract

PURPOSE:

A prospective, epidemiologic study was conducted to assess whether the 2009 pandemic influenza A(H1N1) vaccination in Germany almost exclusively using an AS03-adjuvanted vaccine (Pandemrix) impacts the risk of Guillain-Barré syndrome (GBS) and its variant Fisher syndrome (FS).

METHODS:

Potential cases of GBS/FS were reported by 351 participating hospitals throughout Germany. The self-controlled case series methodology was applied to all GBS/FS cases fulfilling the Brighton Collaboration (BC) case definition (levels 1-3 of diagnostic certainty) with symptom onset between 1 November 2009 and 30 September 2010 reported until end of December 2010.

RESULTS:

Out of 676 GBS/FS reports, in 30 cases, GBS/FS (BC levels 1-3) occurred within 150 days following influenza A(H1N1) vaccination. The relative incidence of GBS/FS within the primary risk period (days 5-42 post-vaccination) compared with the control period (days 43-150 post-vaccination) was 4.65 (95%CI [2.17, 9.98]). Similar results were found when stratifying for infections within 3 weeks prior to onset of GBS/FS and when excluding cases with additional seasonal influenza vaccination. The overall result of temporally adjusted analyses supported the primary finding of an increased relative incidence of GBS/FS following influenza A(H1N1) vaccination.

CONCLUSIONS:

The results indicate an increased risk of GBS/FS in temporal association with pandemic influenza A(H1N1) vaccination in Germany.

KEYWORDS:

Guillain-Barré syndrome; pandemic influenza vaccination; pharmacoepidemiology; self-controlled case series

PMID:
24817531
PMCID:
PMC4282476
DOI:
10.1002/pds.3638
[Indexed for MEDLINE]
Free PMC Article

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