VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
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Total number of reports: 39,584
17 mon. male, received 29Oct89 MMR vaccine 1 dose. 21Dec89 received therapy w/ Promethazine HCL, HS. 22Dec89 infant found dead. Post mortem revealed acute Streptococcal tracheobronchitis.Read FULL REPORT
Pt vaccinated w/ MMVAX, developed fever, weight loss, vomiting, apena, tachycardia, bradycardia & subsequently died.Read FULL REPORT
71 yr old male w/presenile dementia, diabetes mellitus, & renal failure received Hepatitis B vaccine, recombinant, 40 mcg, IM. Dialysis shunt became infected Dx w/sepsis therapy initiated w/flucloxacillin,Read FULL REPORT
Pt given Imovax rabies on 9-JUN-90 c/o sore arm. 17-JUN-90 pt. had fever & abd tenderness. Family member states worsened. While traveling w/husband pt. began to vomit blood. Taken to ER & admittedtoRead FULL REPORT
Pt had low grade fever & fussiness within 12 hrs /p vaccination, slept well that evenig. Following moring infant was fine; taken to babysitter and was placed in crib for nap. Infant was found dead arRead FULL REPORT