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.
Suspected COVID-19; SUSPECTED COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: el9262), in left arm, on 25Feb2021 as dose 2, single (Lot number: el9266), in left arm, on 26Aug2021 as dose 3 (booster), single (Lot number: fc3181), in left arm and on 31Mar2022 at 11:30 as dose 4 (booster), single (Lot number: fk9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Mastocytosis emphysema" (unspecified if ongoing), notes: Mastocytosis emphysema; "Mastocytosis emphysema" (unspecified if ongoing), notes: Mastocytosis emphysema. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "Suspected COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. No follow-up attempts are possible. No further information is expected.
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 4 | COVID19 | PFIZER\BIONTECH | FK9895 | LA |
| RECVDATE: | 05-13-2022 | 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: | Medical History/Concurrent Conditions: Emphysema (Mastocytosis emphysema); Mastocytosis (Mastocytosis emphysema) |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC202200696695 |
| FORM_VERS: | |
| TODAYS_DATE: | 05-12-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.