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.
Sickness; Clostridium difficile infection; FACILITATED COLLECT This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4129526-00. A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Oct2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Lot number: 1154004) at citrate free for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose), administration date: 01Sep2021, when the patient was 53 years old, for COVID-19 Vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 01Sep2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 10Oct2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. No known allergies. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (medically significant) with onset 2021, outcome "recovering", described as "Clostridium difficile infection"; ILLNESS (non-serious) with onset Nov2021, outcome "unknown", described as "Sickness". The action taken for adalimumab was unknown. Clinical course: Solicited report from the USA by a consumer of a 54-year-old male with events of non-serious C-Diff and Sick with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced C-Diff. In Nov2021, the patient experienced Sick. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
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)) | 2 | COVID19 | PFIZER\BIONTECH | OT | Unknown |
RECVDATE: | 12-31-2021 | 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: | |
OTHER_MEDS: | HUMIRA |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101843934 |
FORM_VERS: | |
TODAYS_DATE: | 12-30-2021 |
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.