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.
Pacing; Talking gibberish; Temperature; highest 101 degrees; Being crazy; never acted like that before/Acting very different; Aggressive, pulling his hair; Body aches; Bad headache; Frequently waking up; Could never get comfortable; Very sick for 2 days; This is a spontaneous report from a contactable consumer (parent). A 13-years-old male (son) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FC3182, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 22Aug2021 at 10:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: FA7485, patient was 13-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient wake up and have the behaviors, then sleep for about 30 minutes or so, wake up and do it again for about 15 minutes. He could never get comfortable. States this only occurred for that night. Caller states the fever, body aches, and bad headache her son experienced lasted for about 2 days. No additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations within 4 weeks, no AE(s) following prior vaccinations. On 22Aug2021, the patient experienced pacing, talking gibberish, temperature; highest 101 degrees, being crazy; never acted like that before/acting very different, aggressive, pulling his hair, body aches, bad headache, frequently waking up, could never get comfortable, very sick for 2 days. AE(s) does not require to visit emergency Room or physician Office. The patient underwent lab tests and procedures which included body temperature: 101 degrees on 22Aug2021. The outcomes of events (Temperature; highest 101 degrees, Body aches, Bad headache, very sick for 2 days) were recovered on an unspecified date in 2021 and the outcomes of events (Pacing, Talking gibberish, Being crazy; never acted like that before/Acting very different, Aggressive, pulling his hair, Frequently waking up, Could never get comfortable) were recovered on 23Aug2021. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and 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)) | 2 | COVID19 | PFIZER\BIONTECH | FC3182 | Unknown | LA |
RECVDATE: | 09-18-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | Y |
LAB_DATA: | Test Date: 20210822; Test Name: Temperature; Result Unstructured Data: Test Result:101 degrees |
V_ADMINBY: | PHM |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC202101170470 |
FORM_VERS: | |
TODAYS_DATE: | 09-15-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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