2011
DOI: 10.1016/j.vaccine.2011.08.093
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Causality assessment of serious neurologic adverse events following 2009 H1N1 vaccination

Abstract: Background-Adverse events occurring after vaccination are routinely reported to the Vaccine Adverse Event Reporting System (VAERS). We studied serious adverse events (SAEs) of a neurologic nature reported after receipt of influenza A (H1N1) 2009 monovalent vaccine during the 2009-10 influenza season. Investigators in the Clinical Immunization Safety Assessment (CISA) Network sought to characterize these SAEs and to assess their possible causal relationship to vaccination.

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Cited by 51 publications
(37 citation statements)
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“…According to a flow diagram depicting modified WHO causality assessment, her neurological event was considered to be "possibly" related to influenza vaccination (6). Among the reports of the neurological adverse effects associated with H1N1 vaccines occurring between October 1, 2009 and March 31, 2010 (6), Guillain-Barré syndrome (GBS) was the most frequent (79 cases; 37.3% of the total neurological adverse effects).…”
Section: Discussionmentioning
confidence: 99%
“…According to a flow diagram depicting modified WHO causality assessment, her neurological event was considered to be "possibly" related to influenza vaccination (6). Among the reports of the neurological adverse effects associated with H1N1 vaccines occurring between October 1, 2009 and March 31, 2010 (6), Guillain-Barré syndrome (GBS) was the most frequent (79 cases; 37.3% of the total neurological adverse effects).…”
Section: Discussionmentioning
confidence: 99%
“…Williams et al 14 assessed the causality of adverse events following influenza H1N1 vaccination. Their review 14 included a single case of cranial VI palsy 13 d after influenza H1N1 vaccine and trivalent seasonal influenza vaccine, in a 15-yold male who also had a history of headaches and sports-related concussions. Based on the time course and concomitant exposures, the authors 14 concluded that cranial neuropathy-including Bell's palsy and optic neuritis, as well as the case of abducens palsy-had a "possible" causal relationship with vaccination, according to modified World Health Organization criteria.…”
Section: Introductionmentioning
confidence: 99%
“…ADEM has been reported following measles, mumps, rubella, smallpox, hepatitis B, and IIV (6) . Severe neurological complications including ADEM associated with influenza vaccination have been sporadically reported from countries with a good surveillance system (7)(8) . Here, we report a case of ADEM following infl uenza vaccination that occurred in the western Brazilian Amazon.…”
mentioning
confidence: 99%