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.
Notes 12/18/2020 Subjective No chief complaint on file. Patient is a 25 y.o. female who had no chief complaint listed for this encounter. History of Present Illness Patient is at the Covid vaccination clinic Received her vaccination and approx 5 min following administration notified staff that she was feeling a little lightheaded Was also c/o feeling hot at time Patient admits that she did not have breakfast this AM and has not had anything to drink Denies throat discomfort or tingling No shortness of breath or headaches Patient brought to the bay for evaluation History Review / Additional history Review of Systems Patient's medications, allergies, past medical, surgical, social and family histories were reviewed and updated as appropriate. Objective Blood pressure 126/74, pulse 88, SpO2 98 %, not currently breastfeeding. Physical Exam HENT: Head: Normocephalic. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: Normal range of motion. Skin: Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: She is alert. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment / Plan VSS on arrival to evaluation bay Following laying down for 10 min, drinking water, and eating a granola bar patient reports feeling much better. Sat at the bedside for an additional 5 min with no recurrence of symptoms. Repeat VSS Instructions given to go to the ED if worsening symptoms, lightheaded, throat swelling or shortness of breath. Encouraged to eat and drink prior to next immunization.
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | IM | RA |
| RECVDATE: | 12-18-2020 | RPT_DATE: |
| CAGE_YR: | 25 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-18-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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