Source: VAERS.HHS.GOV
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.
Moderna #1 vaccine given at 130pm March 11th 2021. Pt had history of asthma and frequent nebulizer use and had it in car with her for drive-thru vaccine clinic we did at location, which has a large parking lot. We gave 80 doses. Pt checked off anaphylaxis on the intake form so Dr spoke to her and she changed it to no history of anaphylaxis and only has history of asthma. So we gave her the vaccine. About 5 minutes later in car parking lot she started to use her personal nebulizer. I saw her in passenger side of car using a personal nebulizer so I talked to her and her daughter to find out what was going on. They said she has exacerbations all the time and this was not out of ordinary for her. I checked pulse ox and did a lung exam, etc, and she was stable. She seemed baseline according to history by her and her daughter. As she seemed at baseline and clinically was comfortable and conversant whole time, and she felt better after her nebulizer, I told them to have a low threshold for going to ER or calling 911 if her asthma was worse or different than her usual symptoms. They agreed. According to daughter, she did well until about 24 hours the next day. The daughter said she was fine and she went to store and when she returned EMTs were intubating patient and apparently the patient used her epipen and called 911 herself. Approximate time of expiration was 230pm on March12th 2021.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 036A21A | IM | LA |
RECVDATE: | 03-18-2021 | RPT_DATE: |
CAGE_YR: | 56 |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | 03-12-2021 |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | |
V_ADMINBY: | PVT |
OTHER_MEDS: | nebulizer with medications (unknown specifics), had O2 at home, had epipen Rx already from past |
CUR_ILL: | Asthma with home O2 and regular exacerbations and nebulizer use. |
HISTORY: | severe chronic asthma with home O2 |
PRIOR_VAX: | |
SPLTTYPE: | |
FORM_VERS: | |
TODAYS_DATE: | 03-18-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | no known specific allergies to us, just history of severe asthma |
V_FUNDBY: |
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