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.
20 min after vaccine shot I had very dry mouth; difficult to swallow saliva; Back of tongue seemed swollen; feeling of swelling in the back of my throat 6 hours after vaccine; This is a spontaneous report from a contactable other health care professional (patient). A 48-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8736), via an unspecified route of administration, administered in right arm on 26Apr2021 14:45 (at the age of 48 years) as dose 2, single for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 (at the age of 47 years) as dose 1, single for COVID-19 immunization and experienced normal soreness around injection site, tenderness, soreness in the entire arm developed, 5-6 days post injection a small rash. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. On 26Apr2021 15:05 (20 min after vaccine shot) the patient had very dry mouth and she had trouble swallowing. Back of tongue seemed swollen and it was difficult to swallow saliva. A few hours after shot swallowing got better. She still had a slight problem with a feeling of swelling in the back of her throat 6 hours after vaccine. This is very concerning and scary to feel like she cannot swallow easily and constantly having to swallow saliva. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The outcome of the events was unknown. No Follow-up attempts are possible. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | ER8736 | RA |
| RECVDATE: | 11-18-2021 | RPT_DATE: |
| CAGE_YR: | |
| 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: | USPFIZER INC2021481669 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-17-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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