Post-licensure surveillance of quadrivalent live attenuated XXXX vaccine United States, Vaccine Adverse Event Reporting System (VAERS), July 2013-June 2014.

@entity1 @entity410 @entity66 @entity565 @entity2319 @entity683 @entity5011 @entity17692 @entity10 @entity204 @entity221
BACKGROUND: Quadrivalent live attenuated @entity683 vaccine (LAIV4) was approved in 2012 for healthy @entity1 aged 2-49 years. Beginning with the 2013-2014 @entity683 season, LAIV4 replaced trivalent live attenuated @entity683 vaccine (LAIV3). METHODS: We analyzed LAIV4 reports to VAERS, a national spontaneous reporting system. LAIV4 reports in 2013-2014 were compared to LAIV3 reports from the previous three @entity683 seasons. Medical records were reviewed for non-manufacturer serious reports (i.e., @entity204 , hospitalization, prolonged hospitalization, life-threatening illness, @entity2319 ) and reports of selected conditions of interest. We conducted Empirical Bayesian data mining to identify disproportional reporting for LAIV4. RESULTS: In 2013-2014, 12.7 million doses of LAIV4 were distributed and VAERS received 779 reports in individuals aged 2-49 years; 95% were non-serious. Expired drug administered (42%), @entity221 (13%) and cough (8%) were most commonly reported in @entity1 aged 2-17 years when LAIV4 was administered alone, while @entity10 (18%), expired drug administered (15%) and exposure during pregnancy (12%) were most common in adults aged 18-49 years. We identified one @entity204 report in a @entity1 who died from complications of @entity17692 . Among non- @entity204 serious reports, neurologic conditions were common in @entity1 and adults. In @entity1 , @entity410 (3) and @entity5011 (2) were the most common serious neurologic outcomes. We identified three serious reports of @entity565 /wheezing following LAIV4 in @entity1 . Data mining detected disproportional reporting for vaccine administration errors and for @entity683 in @entity1 . CONCLUSIONS: Our analysis of VAERS reports for LAIV4 did not identify any concerning patterns. The data mining finding for reports of @entity683 is consistent with low LAIV4 vaccine effectiveness observed for @entity66 in @entity1 in 2013-2014. Reports of LAIV4 administration to @entity1 in whom the vaccine is not recommended (e.g., pregnant @entity1 ) indicate the need for education, training and screening regarding indications.
