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.
Palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if I was given IV contrast Dye; Thirst; Hunger; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), via intramuscular at left arm on 17Dec2020 04:30 PM at single dose for COVID-19 immunization. The facility type of vaccine was hospital. Medical history included diabetes, HTN, vertigo, sleep apnea, colonic diverticulitis, fibroid uterus, left cystic breast; pulmonary valve prolapse. No known allergies. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medication included atorvastatin; metformin; eplerenone; HCTZ; levonorgestrel (MIRENA); ascorbic acid, biotin, calcium carbonate, calcium pantothenate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride (BEROCCA) for supplement; montelukast sodium (SINGULAIR); loratadine (CLARITIN). No other vaccine in four weeks. On 17Dec2020, patient experienced palpitation; flashed face; warm feeling under the sternum; rush to both lower extremities to the toes as if being given IV contrast dye; thirst; hunger. No treatment for events. It was reported as non-serious. Outcome of events was recovered.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EJ1685 | OT | LA |
| RECVDATE: | 01-05-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | ; ; ; HCTZ; MIRENA; BEROCCA [ASCORBIC ACID;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYR; SINGULAIR; CLARITIN [LORATADINE] |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Breast cyst; Colon diverticulitis; Diabetes; Hypertension; Pulmonary valve disorders; Sleep apnea; Uterine fibroids; Vertigo |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2020520130 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-05-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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