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.
Vaccination failure; COVID-19 respiratory infection; RESPIRATORY FAILURE; Pulmonary thromboembolism; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Authority-WEB. Regulatory number: ES-AEMPS-1196910 (RA). A 39-year-old male patient received BNT162b2 (COMIRNATY), on 12May2021 as dose 1, single (Lot number: FA4598), on 02Jun2021 as dose 2, single (Lot number: FD0785) and on 25Nov2021 as dose 3 (booster), single (Lot number: 1F1015A) for covid-19 immunisation. The patient's relevant medical history included: "Lung carcinoma stage IV" (unspecified if ongoing); "Lithiasis" (unspecified if ongoing); "Colitis ulcerative" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Afat. The following information was reported: COVID-19 (death, hospitalization, medically significant) with onset 26May2022, outcome "fatal", described as "COVID-19 respiratory infection"; PULMONARY EMBOLISM (death, hospitalization, medically significant) with onset 26May2022, outcome "fatal", described as "Pulmonary thromboembolism"; RESPIRATORY FAILURE (death, hospitalization, medically significant) with onset 26May2022, outcome "fatal"; VACCINATION FAILURE (death, hospitalization, medically significant) with onset 26May2022, outcome "fatal". The patient underwent the following laboratory tests and procedures: Auscultation: (unspecified date) Cardiopulmonary auscultation tachycardia without a, notes: Cardiopulmonary auscultation tachycardia without added sounds. No dyspnea or chest pain; Blood fibrinogen: (unspecified date) 778, notes: Fibrinogen 778; Blood glucose: (unspecified date) 117, notes: glucose 117; Blood iron: (unspecified date) 32, notes: Iron 32; Blood pressure measurement: (unspecified date) 120/84, notes: BP 120/84; C-reactive protein: (unspecified date) 97, notes: CRP 97; Full blood count: (unspecified date) Normal, notes: normal blood count and coagulation; Heart rate: (unspecified date) 115, notes: HR 115; Interleukin level: (unspecified date) IL 6 21.8, notes: IL 6 21.8; Oxygen saturation: (unspecified date) 99%, notes: Sat 99% with O2 at 4 bpm; (unspecified date) 97%, notes: 97% with O2 at 3 bpm; Renal function test: (unspecified date) Normal renal function, notes: Normal renal function; SARS-CoV-2 test positive: (24May2022) Positive, notes: Positive; Transaminases: (unspecified date) normal, notes: normal transaminases. The patient date of death was 29May2022. Reported cause of death: "COVID-19 respiratory infection", "Lung carcinoma stage IV", "Pulmonary thromboembolism". It was not reported if an autopsy was performed. Clinical course: Patient admitted due to intensified progressive dyspnea, tachycardia and general discomfort. High suspicion of PTE associated with covid + and prothrombotic state due to progressive lung neoplasm + Inflammatory bowel disease. Great improvement since admission, on treatment with remdeivir, clexane at anticoagulant doses and dexamethasone. Exploration: Afebrile. BP 120/84 HR 115 Sat 99% with O2 at 4 bpm. Maintains 97% with O2 at 3 bpm. Good general condition. Cardiopulmonary auscultation tachycardia without added sounds. No dyspnea or chest pain. Laboratory tests had normal blood count and coagulation. Fibrinogen 778, glucose 117 Normal renal function. Iron 32 normal transaminases. CRP 97 IL 6 21.8 Admitted due to RESPIRATORY FAILURE IN THE CONTEXT OF COVID-19(+) + PTE (PARANOOPLASTIC + COVID + ANTIANGIOGENIC TREATMENT WITH BEVACIZUMAB, as risk factors).Respiratory worsening with desaturation that did not recover despite O2 in Mass Airflow Sensor, actocortin, seguril and morphine. He denies chest pain. Exitus(death).Causality assessment has not been provided. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory infection; Lung carcinoma stage IV; Pulmonary thromboembolism
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | 1F1015A | Unknown | Unknown |
| RECVDATE: | 06-24-2022 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 05-29-2022 |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:Cardiopulmonary auscultation tachycardia without a; Comments: Cardiopulmonary auscultation tachycardia without added sounds. No dyspnea or chest pain.; Test Name: Fibrinogen; Result Unstructured Data: Test Result:778; Comments: Fibrinogen 778; Test Name: glucose; Result Unstructured Data: Test Result:117; Comments: glucose 117; Test Name: Iron; Result Unstructured Data: Test Result:32; Comments: Iron 32; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/84; Comments: BP 120/84; Test Name: CRP; Result Unstructured Data: Test Result:97; Comments: CRP 97; Test Name: blood count; Result Unstructured Data: Test Result:Normal; Comments: normal blood count and coagulation; Test Name: Heart rate; Result Unstructured Data: Test Result:115; Comments: HR 115; Test Name: IL; Result Unstructured Data: Test Result:IL 6 21.8; Comments: IL 6 21.8; Test Name: Saturation; Result Unstructured Data: Test Result:99%; Comments: Sat 99% with O2 at 4 bpm; Test Name: Saturation; Result Unstructured Data: Test Result:97%; Comments: 97% with O2 at 3 bpm; Test Name: renal function; Result Unstructured Data: Test Result:Normal renal function; Comments: Normal renal function; Test Date: 20220524; Test Name: COVID-19 antigen test positive; Result Unstructured Data: Test Result:Positive; Comments: Positive; Test Name: transaminases; Result Unstructured Data: Test Result:normal; Comments: normal transaminases |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Colitis ulcerative; Lithiasis; Lung carcinoma stage IV |
| PRIOR_VAX: | |
| SPLTTYPE: | ESPFIZER INC202200864621 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 06-23-2022 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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