Summary of 2009 Monovalent H1N1 Influenza Vaccine Data – Vaccine Adverse Event Reporting System

Data through December 11, 2009
CDC and FDA provide weekly updates on our vaccine safety monitoring activities in an effort to put the data that are publicly available through the Vaccine Adverse Event Reporting System (VAERS; http://vaers.hhs.gov) and CDC’s website, WONDER (http://wonder.cdc.gov/vaers.html) in context. The following information summarizes adverse event reports to VAERS after the administration of 2009 H1N1 monovalent influenza vaccine (either nasal spray or shot).

An adverse event is a health problem that is reported after someone gets a vaccine or medicine. Note that persons may experience adverse events shortly after vaccination which may or may not be caused by the vaccine. While VAERS is an important system for helping to find potential signs, VAERS is primarily used to detect signals that may require further investigation, but is not able to determine if an adverse event was caused by vaccination.

VAERS Summary:
 As of December 11, 2009, 76.3 million doses of 2009 H1N1 vaccine had been shipped to vaccination providers in the United States, although the precise number of vaccines administered is unknown.
 As of December 11, 2009, VAERS had received 5703 adverse event reports following 2009 monovalent H1N1 vaccination.
 The vast majority (94.2%) of adverse events reported to VAERS after receiving the 2009 monovalent H1N1 vaccine are classified as “non serious” (e.g., soreness at the vaccine injection site).
 Of the 5703 reports, 333 (5.9%) were reports that were classified as “serious” health events (defined as life threatening or resulting in death, major disability, abnormal conditions at birth, hospitalization, or extension of an existing hospitalization)*.
 The percentage of reports involving what would be considered serious health events is not different between 2009 H1N1 and seasonal influenza vaccines. Additionally, no new or unusual events or pattern of adverse events have emerged.
 VAERS reports continue to be monitored as more vaccine is administered.  Among the 333 reports of serious health events, there were 21 reports of death.  As with all reports of serious adverse events and deaths, the 21 VAERS reports that
involve deaths are under review by CDC, FDA and the states where the reported deaths occurred. Preliminary findings do not indicate a common cause or pattern (such as similarities in age, gender, geographic location, illness surrounding death, or underlying medical conditions) to suggest that these deaths were associated with the vaccine. These cases are under further review pending additional medical records (e.g., autopsy reports, medical files).

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