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.
headache; Asthenia/adynamia; myalgia; chills; malaise in general; Asthenia/fatigue; arthralgia in the elbows; Decreased strength and sensation of the left pelvic limb; Decreased strength and sensation of the left pelvic limb; This is a spontaneous report from a non-contactable other healthcare professional (HCP). A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ3002, expiration date 30Apr2021) intramuscular in the left arm on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies. Concomitant medications were not reported. On 14Jan2021, the patient experienced headache, asthenia/fatigue, adynamia, chills, myalgia- timeframe between vaccination and starting of symptoms was noted as 8 hrs. The patient also experienced arthralgia, and decreased strength and sensation of the left pelvic limb on 14Jan2021. The patient was hospitalized due to the events on Jan2021. The clinical course noted that the condition began with chills, malaise in general, fatigue, so she decided to fall asleep for 2 hours and 30 minutes, upon waking she referred to arthralgia in the elbows, later she loses strength in the left pelvic limb. She was evaluated and hospitalized to carry out laboratories and cabinet. The outcome of the events was unknown. Events supposedly attributable to vaccination or immunization (ESAVI) type was noted as serious. No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. 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.
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EJ3002 | OT | LA |
RECVDATE: | 02-04-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | U |
LAB_DATA: | |
V_ADMINBY: | OTH |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | Medical History/Concurrent Conditions: Allergy |
PRIOR_VAX: | |
SPLTTYPE: | MXPFIZER INC2021069216 |
FORM_VERS: | |
TODAYS_DATE: | 02-02-2021 |
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.