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.
short of breath; Intense headache; tiredness; body aches; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELO124), via an unspecified route of administration on 23Dec2020 at 14:30 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Rheumatoid arthritis, lupus. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications included baricitinib (OLUMIANT), hydroxychloroquine, prednisone. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intense headache, tiredness, body aches, short of breath on 24Dec2020; events were resulted in: Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19 on 27Dec2020: Nasal Swab, result was unknown. No treatment was received for the events. The outcome of the events was not recovered.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | ELO124 | LA |
| RECVDATE: | 01-04-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20201227; Test Name: covid test type post vaccination: Nasal Swab; Result Unstructured Data: Test Result:Unknown Results; Comments: Nasal Swab |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | OLUMIANT; ; |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Lupus erythematosus systemic; Rheumatoid arthritis |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2020514088 |
| FORM_VERS: | |
| TODAYS_DATE: | 01-04-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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