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.
At 5:16pm the patient received 0.2mL of the Pediatric Pfizer vaccine. At 5:20pm the patient lost consciousness. The father grabbed the patient as he was falling to the ground and gently laid him on the ground. The father carried the patient to the cot. The patient reported feeling dizzy and nauseous. The patient denied any pain. The head of the bed was elevated. The patient denied any trouble breathing. At 5:24pm the patient's BP was 90/62 and HR was 110. At 5:24pm the patient vomited. At 5:24pm EMS was called. At 5:29pm the patient reported that he no longer felt dizzy. The patient was asked if he was itchy anywhere and he reported that his back was itchy. The back was assessed and hives were present across his back. The patient's parents reported that the patient has a history of breaking out in hives. The patient reported that his back was itchy before receiving the vaccine. At 5:31pm BP was 102/72 and RR 13. The fire department arrived at 5:35pm and assumed care of the patient. At 5:40pm BP was 118/77, HR 74, and O2 Sat 95%. At 5:41pm paramedics arrived on site and assumed care of the patient. At 5:43pm the patient was transported by the paramedics to the emergency room.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FK5127 | IM | AR |
| RECVDATE: | 11-11-2021 | RPT_DATE: |
| CAGE_YR: | 10 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | PUB |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 11-11-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | no known allergies according to patient's mom |
| V_FUNDBY: |
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