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.
pot syndrome; blood pressure was high; heart beat was too fast; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 26-year-old female patient received BNT162b2 (COMIRNATY), on 09Dec2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 11Dec2021, outcome "not recovered", described as "blood pressure was high"; HEART RATE INCREASED (non-serious) with onset 11Dec2021, outcome "not recovered", described as "heart beat was too fast"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (medically significant) with onset 11Dec2021, outcome "not recovered", described as "pot syndrome". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: High; Heart rate: Increased. Additional information: Reporter called on behalf of her daughter who is 26 years old. Last year December on the 9th she took her 1st and on the 11Dec2021 she started experiencing side effect, her blood pressure was high, her heart beat was too fast and she developed a pot syndrome. Still to date this is happening. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
| Vaccine Type | Manufacturer | Vaccine Name | Dose | Route | Site | Lot |
|---|---|---|---|---|---|---|
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| RECVDATE: | 05 May 2022 |
| CAGE_YR: | |
| CAGE_MO: | |
| RPT_DATE: | |
| DIED: | |
| DATEDIED: | |
| L_THREAT: | |
| ER_VISIT: | |
| HOSPITAL: | |
| HOSPDAYS: | |
| X_STAY: | |
| DISABLE: | |
| RECOVD: | N |
| LAB_DATA: | Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Name: heart beat was too fast; Result Unstructured Data: Test Result:Increased |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | ZAPFIZER INC202200654828 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 04 May 2022 |
| BIRTH_DEFECT: | |
| OFC_VISIT: | |
| ER_ED_VISIT: | |
| ALLERGIES: | |
| V_FUNDBY: | |
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