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.
VACCINATION FAILURE; This solicited report received from a health care professional (PT-INFARMED-M202108-3714) on 30-SEP-2021 and concerned a 42-year-old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05, and expiry: unknown) 0.5 ml, 1 total was administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 24-JUL-2021, the patient had vaccination failure. The patient diagnostic data was not available. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure on 04-AUG-2021. The reporter provided no causality assessment. Company causality between Covid-19 vaccine ad26.cov2.s, and vaccination failure was not related. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192362. The suspected product quality complaint has been confirmed to be voided (did not meet product quality complaint criteria) based on the product quality complaint evaluation/investigation performed. This case, involving the same patient is linked to 20210908642. Following receipt of additional information on (30-SEP-2021). It was determined that nullification and deletion was required for Manufacturer Report Number (20210908642) as it was duplicate of Manufacturer Case Number (20211020509). All relevant information regarding Manufacturer Report Number (20210908642) will be submitted under Manufacturer Case Number (20211020509).
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|