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.
Due to patient's complex PMH, provider asked that patient be monitored overnight after administration of COVID vaccine. Patient was moved from PICU to general peds floor due to improvement in condition on Thursday. Vaccine was administered that evening. Patient did well. Remained on room air. Was discharged home on Saturday. On Monday morning, father checked on patient and she was found pulseless and not breathing. It is unclear whether or not patient was placed on home CPAP during the night. EMS called. Patient arrived to ED as a CPR in progress. Patient presented with a pH of <6. Last known well 9pm the evening prior. Patient expired at 11/22/21 at 11:05 CST.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||fk5127||IM||RA|
|LAB_DATA:||Blood gas was done indicating pH<6, high CO2.|
|OTHER_MEDS:||albuterol nebs, baclofen, vitamin D, flonase, glycopyrrolate, levetiracetam, nystatin topical, phenobarbital, Miralax, azithromycin, PRN tylenol and ibuprofen|
|CUR_ILL:||Recent admission for rhino/enterovirus, mycoplasma pneumoniae ab+ for acute respiratory failure.|
|HISTORY:||PMH of twin to twin transfusion born at erm, neuroimaging showed significant loss of gray-white matter, hydrocephalus s/p VP shunt, spastic CP, seizure disorder. Use CPAP at home at night.|