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.
CHEST PAIN; CHEST DISCOMFORT; OVERDOSE; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech SE) and Regulatory Authority. Regulatory number: TW-TFDA-TVS-1100011021 (Center for Disease Control). Other Case identifier(s): TW-Fosun-2021FOS005443 (Regulatory Authority). This is a spontaneous report received from a non-contactable HCP received via Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100011021. A 15-year-old female patient received first dose of BNT162B2 (COMIRNATY) (batch number was not reported) on 18Oct2021 via Intramuscular as dose 1, 0.5 ml single (at the age of 15-year-old) for COVID-19 immunization (overdose). Medical history, concomitant medication and past product were not reported. On 19Oct2021, the patient experienced chest tightness, chest pain, chest discomfort. On 21Oct2021, the patient went to emergency for examination: 1. Cr: 0.6 mg/dL (eGFR: 143.6); 2.S-GOT: 14 U/L; 3.S-GPT: 5 U/L; 4.tro-I: 33.9. On an unspecified date, the patient discharged. Chest tightness, chest pain, chest discomfort met the seriousness criterion of Caused Hospitalisation. At the time of the report, the outcomes of the events were unknown. Initial report was received on 24Nov2021. Drug: Comirnaty Causality Assessments: Chest pain, Chest discomfort, Overdose Per Reporter= Possible Per Company (BioNTech SE) = Possible Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||08 December 2021|
|LAB_DATA:||Test Date: 20211021; Test Name: SGPT; Result Unstructured Data: Test Result:14 IU/l; Test Date: 20211021; Test Name: Serum glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:14 IU/l; Test Date: 20211021; Test Name: Creatinine; Test Result: 0.6 mg/dl; Test Date: 20211021; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:143.6; Test Date: 20211021; Test Name: Troponin I; Result Unstructured Data: Test Result:33.9|
|TODAYS_DATE:||07 December 2021|