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.
High blood pressure; Hearing loss, at about 50%. Supervision by an ear, nose, throat doctor and multiple checks using an audiogram; Tender pain in the lymph node area below the left ear; Sensation of heat in the head area, also externally visible, red head, feeling of pressure in the front area of the skull; Sensation of heat in the head area, also externally visible, red head, feeling of pressure in the front area of the skull; Sensation of heat in the head area, also externally visible, red head, feeling of pressure in the front area of the skull; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2022282918 (RA). Other Case identifier(s): DE-CADRPEI-2022282918 (RA Webportal), DE-PEI-202200087609 (RA). A 56-year-old male patient received BNT162b2 (COMIRNATY), on 20Dec2021 as dose 2, single (Lot number: Ch.-B.: ACB4694) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: ERYTHEMA (non-serious), FEELING HOT (non-serious), HEAD DISCOMFORT (non-serious) all with onset 04Jan2022, outcome "not recovered" and all described as "Sensation of heat in the head area, also externally visible, red head, feeling of pressure in the front area of the skull"; LYMPH NODE PAIN (non-serious) with onset 04Jan2022, outcome "not recovered", described as "Tender pain in the lymph node area below the left ear"; DEAFNESS (medically significant) with onset 05Jan2022, outcome "not recovered", described as "Hearing loss, at about 50%. Supervision by an ear, nose, throat doctor and multiple checks using an audiogram"; HYPERTENSION (non-serious) with onset 21Jan2022, outcome "not recovered", described as "High blood pressure". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (21Jan2022) High. Therapeutic measures were taken as a result of deafness, hypertension, lymph node pain, erythema, feeling hot, head discomfort. Clinical information: No known allergies reported. Care by an ear nose throat (ENT) doctor, cortisone therapy with 3 times injections, additional acupuncture and traditional medicine (TM). No improvement. The causality assessment of Comirnaty via RA source to the events was D Unclassifiable. No follow-up attempts are possible. No further information is expected.
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | Ch.-B.: ACB4694 | Unknown | Unknown |
| RECVDATE: | 06-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20220121; Test Name: blood pressure; Result Unstructured Data: Test Result:High |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | DEPFIZER INC202200846730 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 06-23-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
Questions? Comments? Bugs?
[email protected]
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.
OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.