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.
Pregnancy history: G2P1001. Patient had the Pfizer COVID vaccine on 8/6/21 at 33 3/7 weeks gestation (EDD 9/21/21). Presented 8/15/21 at 34 5/7 weeks gestation with preterm labor. CBC with differential found to have significant abnormalities. Twins were delivered via C-section. Twin A birth weight 5lb 2.5oz and twin B birth weight 6lb 1.4oz. Oncology consulted and bone marrow biopsy diagnosed patient with AML. Induction chemotherapy with 7+3 given 8/17-8/23/21 with resulting pancytopenia necessitating daily blood/platelet transfusions. On 9/1/21, had a catastrophic intracranial hemorrhage and patient died on 9/2/21.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EW0167||IM||LA|
|LAB_DATA:||CBC w/ diff (8/15/21): WBC 11.4, ANC 1.7, Platelets 57, Abs Blasts 8.4, %Blasts 74 Bone Marrow Biopsy (8/17/21): AML in a hypocellular marrow (30%) with decreased trilineage hematopoiesis and 75% blasts Bone Marrow Biopsy (8/31/21): results pending|
|OTHER_MEDS:||Acetaminophen PRN, aspirin 81 mg daily, docusate 100 mg BID, ferrous sulfate 325 mg daily, fluoxetine 20 mg daily, magnesium 200 mg daily, omeprazole 40 mg daily, prenatal vitamin daily|
|HISTORY:||major depression, generalized anxiety, gestational diabetes (diet controlled), gestational hypertension|