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.
tachycardia; allergic episode; no movements; swelling of the glottis; atrophied hands and feet with no blood circulation; wheezing; breathlessness; itching on throat; swollen mouth; body completely taken by redness; This is a spontaneous report from a contactable consumer (patient) via regulatory authority. A 17-year-old female (not pregnant) patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on the left arm on 30Aug2021 at 16:45 (Batch/Lot Number: 28231BD) at the age of 17-year-old as single dose for COVID-19 immunization. Medical history included chronic asthma with medication release from Jun2020 and allergic episode from 2019. The patient didn't received other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient didn't received other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Patient presented allergic episode two years ago, and after performing over 200 tests, nothing was found. Concomitant medication was none. On 30Aug2021 at 05:00 PM, the patient was with body completely taken by redness, itching on throat, swollen mouth. At 18:00, when admitted in the hospital emergency, she was already presented wheezing and breathlessness. There were applied medications to reverse the allergic episode that momentarily worsened, letting her with atrophied hands and feet with no blood circulation, tachycardia and no movement, she stayed under observation until 2:00 am the next day. The doctor described it as swelling of the glottis, which was removed with more medications applied. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization and Life threatening illness (immediate risk of death from the event). Treatment was received included intravenous and intramuscular medications. The outcome of events was resolved with sequel.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | 28231BD | LA |
| RECVDATE: | 10-05-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 1 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: tachycardia; Result Unstructured Data: Test Result:increase |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Allergy; Asthma chronic |
| PRIOR_VAX: | |
| SPLTTYPE: | BRPFIZER INC202101288474 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-04-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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