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.
Pneumonia; Eosinophil count high; allergic reaction; This is a spontaneous report from a contactable consumer (patient's wife). An 81-year-old male patient received the first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on 04Jan2021 at single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient had his first vaccine dose on 04Jan, then 7 days later he was in the hospital with a really high eosinophils count and infiltrate in his lungs, they did a CAT scan, and he had pneumonia in there. Patient's wife said that he was in the hospital for three days for Pneumonia, and now he was out of the hospital and he was supposed to get his second dose of the vaccine on the 25th. She would like to know if her husband should have the second dose, since she didn't know if the pneumonia was caused from the vaccine for sure, it could be an allergic reaction for the vaccine since his count was 22.2 for absolute eosinophils and that was down now to 2.4. She would like to know if it was safe for him get the second dose. She said her husband was still coughing and she didn't know, she was afraid for him to get it. The patient underwent lab tests and procedures which included a CAT scan in Jan2021 and he had pneumonia in there , absolute eosinophils: 22.2 (Eosinophil count high) in Jan2021, absolute eosinophils: 2.4 in Jan2021. The outcome of the events was unknown. Information about lot/batch number has been requested.
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