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.
The baby's heart stopped beating; The baby's heart stopped beating; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority FR-AFSSAPS-LL20216048. This consumer reported information for both mother and fetus/baby. This is the fetus/baby report. A fetus patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 transplacental on 12Aug2021 (Lot Number: FE7C1BSA) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother pregnant in her 1st trimester, vaccinated on 12Aug2021 at 6 weeks pregnant. On 19Aug2021 the parent had a miscarriage (metrorrhagia presenting symptom). The baby's heart stopped beating. Though on her follow-up visit on 10Aug2021 the heart was beating. Ultrasound on 19Aug2021: interrupted pregnancy at 9 weeks. The baby died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : FR-PFIZER INC-202101166496 Maternal/baby case; Reported Cause(s) of Death: The baby's heart stopped beating; The baby's heart stopped beating
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|RECVDATE:||21 September 2021|
|TODAYS_DATE:||20 September 2021|