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.
Patient received Pfizer vaccine in 8/2021. In 9/2021 she began to have some vague complaints of upper back pain. Patient ultimately diagnosed with epitheliod sarcoma. Parents requested that this information be sent to VAERS in case her cancer was related to Vaccine. Physicians caring for the child do not feel her death or her cancer was related to the covid vaccine. Presented to the local Medical Center on 10/30/21 after having received care closer to home. Pt is a 13 y.o. female with no past medical history who presents with fever, chest pain, and diarrhea. About two weeks PTA, she began complaining of sternal chest pain. She had fatigue and sore throat so was taken to an urgent care where she was negative for strep, flu, and COVID. She was prescribed bromfed. She then progressed to a dry mild that started about 10 days PTA. On Tuesday, 10/26, she was seen at an outside ER and was diagnosed with pneumonia. She was started on azithromycin and augmentin. She has continued to have chest pain, SOB, and fatigue. The day of presentation, she stayed home from school. She developed nonbloody diarrhea, tachycardia, and weakness so she was taken back to the ER for evaluation. Found to have a pericardial friction rub. Admitted to hospitalist service.
| Vaccine Type | Manufacturer | Vaccine Name | Dose | Route | Site | Lot |
|---|---|---|---|---|---|---|
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| RECVDATE: | 30 November 2021 |
| CAGE_YR: | 13 |
| CAGE_MO: | |
| RPT_DATE: | |
| DIED: | Y |
| DATEDIED: | 30 November 2021 |
| L_THREAT: | |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 30 |
| X_STAY: | |
| DISABLE: | |
| RECOVD: | N |
| LAB_DATA: | Admitted to local HCF 10/30/21. See the following from her death note summary related to hospital course: Pt is a 13 y.o. female admitted for Left atrial mass and has been hospitalized for 30 days. she had her left atrial mass resection on 11/11/21, pericardial window creation, and mediastinal exploration with debridement. Her mass continued to grow and increase in size and Rhee invading the left atrium and possibly the right atrium along with creation of tamponade physiology on the ventricles. She was started on chemotherapy by hematology team, Nephrology team started her her on CRRT since she developed acute kidney injury along was multi organ failure and severe lactic acidosis. Patient was on multiple inotropics support with progressively increasing inotropics support epinephrine up to 0.3 micrograms/kilogram per minute, norepinephrine up to 0.3 micrograms/kilogram per minute along with 2 milliunits per kg per minute vasopressin. Over the past 48 hours prior to patient staff she was getting multiple fluid boluses and she was few L positive every day with severe 3rd spacing and progressively worsening cardiac output. She has had evidence of progressive tamponade physiology despite aggressive chemotherapy. she remained intubated and sedated with extremely high lung peak pressures and very poor compliance with severe pulmonary edema. On 12/1/2021 family expressed the wishes of stop giving fluids to her since she looks very edematous, parents understand that this will lead to cardiac arrest and ending her life within the next few hours, father expressed he is willing to do everything for her but he wants to end her suffering, mom and dad were at the bedside, IV fluid replacement was stopped. Patient vasopressin was weaned along with other inotropic support, family agreed on extubating the patient so that they can spend some time with her prior to the off. Patient continue to progressively having low cardiac output, hypotension and bradycardia, time of death was 7:00 a.m.. |
| V_ADMINBY: | UNK |
| OTHER_MEDS: | None known |
| CUR_ILL: | unknown |
| HISTORY: | none |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 30 November 2021 |
| BIRTH_DEFECT: | |
| OFC_VISIT: | |
| ER_ED_VISIT: | |
| ALLERGIES: | No known 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.