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.
Patient had a large rash begin to appear on her right thigh on April 25 2021.; This is a spontaneous report from a contactable consumer (reported for himself). A 28-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in arm left on 06Apr2021 at 14:00 (at the age of 28 years old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included attention deficit hyperactivity disorder, Other medical history: Adult ADHD. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) at a dose of 60 mg, daily taken for an unspecified indication, start and stop date were not reported. The patient previously took bactrum, minocycline, formaldehyde and experienced hypersensitivity. On 25Apr2021, the patient experienced had a large rash begin to appear on her right thigh. The adverse event resulted in doctor or other healthcare professional office and clinic visit. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient scheduled second dose on 27Apr2021. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.
Open in Wayback Machine
(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)) | 1 | COVID19 | PFIZER\BIONTECH | ER8737 | LA |
| 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: | N |
| LAB_DATA: | |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | VYVANSE |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: ADHD (Other medical history: Adult ADHD) |
| PRIOR_VAX: | |
| SPLTTYPE: | USPFIZER INC2021487333 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-17-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| 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.