Thursday, November 26, 2009

VAERS Vaccine Safety Report

 

 

# 4084

 

 

From the VAERS (Vaccine Adverse Event Reporting System) we get the latest US pandemic vaccine safety report – dated November 25th, and current through November 20th.

 

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

This report paints a picture of a safe and well tolerated vaccine, one whose safety profile is comparable to the seasonal flu vaccine.

 

Follow the link to read the whole thing, but here is the summary:

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 cannot determine if an adverse event was caused by vaccination.


VAERS Summary:


•      As of November 20, 2009, 46 million doses of 2009 H1N1 vaccine had been shipped to vaccination providers in the United States.


•      As of November 20, 2009, VAERS had received 3182 adverse event reports following 2009 monovalent H1N1 vaccination. 


•      The vast majority (94%) of adverse events reported to VAERS after receiving the 2009 monovalent H1N1 vaccine have not been serious (e.g., they encompass things like soreness at the vaccine injection site).  


•      Of the 3182 reports, 177 (6%) were reports that involved what would be considered 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 177 reports of serious health events, there were 11 reports of death.

•      The 11 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).


•      VAERS has received 10 reports of Guillian-Barré syndrome (GBS), for which follow-up assessments are underway.  In the United States, about 80-160 cases of GBS are expected to occur each week, regardless of vaccination.