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.
After 1st COVID-19 injection started with vaginal discharge spotting; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration in left arm on 14Jan2021 at single dose for covid-19 immunization at doctor's office/urgent care. Medical history included cirrhosis of liver, diabetes, there was no known drug allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not underwent for COVID-19 test. Concomitant medication included oxycodone in two weeks. There was no other vaccine in four weeks. After 1st covid-19 injection the patient started with vaginal discharge spotting on 15Jan2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the event. The outcome of the event was not resolved.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EJ1686 | LA |
| RECVDATE: | 02-10-2021 | 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: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | OXYCODONE |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Cirrhosis of liver; Diabetes |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021087056 |
| FORM_VERS: | |
| TODAYS_DATE: | 02-07-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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