Adverse event reports following vaccination for XXXX : December 1998-July 2000.

@entity1 @entity3001 @entity625 @entity4040 @entity3541 @entity158 @entity4841 @entity925 @entity204 @entity309
CONTEXT: The vaccine adverse event reporting system (VAERS) monitors vaccine safety post-licensure. Although events reported to VAERS are not necessarily causally associated with vaccination, VAERS reports can be used to identify possible safety concerns that occur at too low a rate to have been identified prior to licensure. OBJECTIVE: To evaluate adverse events following @entity3001 vaccination reported to VAERS during the first 19 months of the vaccine's licensure. DESIGN, SETTING, AND @entity1 : Analysis of all VAERS reports of adverse events following vaccination for @entity3001 in the US from 28 December 1998 to 31 July 2000. MAIN OUTCOME MEASURE: We evaluated reported adverse events for unexpected patterns in age, gender, time to onset, dose number, and clinical characteristics and compared them to adverse events observed in clinical trials of this vaccine. RESULTS: Over 1,400,000 doses were distributed and 905 adverse events were reported to VAERS, 440 in @entity1 and 404 in @entity1 , with ages ranging from 10 to 82 years. The majority (56%) of adverse events occurred after administration of the first dose. The most frequently reported adverse events were @entity4841 (250), @entity925 (195), and @entity158 (157). There were 59 reports coded as @entity625 , 34 as @entity4040 , 9 as @entity309 , and 12 as @entity3541 . Sixty-six (7.4%) events were classified as serious, involving life-threatening illness, hospitalization, prolongation of hospitalization, persistent or significant disability/incapacity, or @entity204 . Twenty-two hypersensitivity reactions were reported. CONCLUSION: Based on reporting to VAERS, we did not detect unexpected or unusual patterns of reported adverse events following @entity3001 vaccine administration, other than hypersensitivity reactions, compared with adverse events observed in clinical trials.
