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.
PULMONARY EMBOLISM; CARDIAC ARREST; Major brain damage; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: NO-NOMAADVRE-FHI-2022-V43egr (Agency). Other Case identifier(s): NO-NOMAADVRE-E2B_00079336 (Agency), NO-NOMAADVRE-FHI-2022-Vjrjn6 (Physician). A 78 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 31Mar2021 (Lot number: EX6564) as dose 1, single and intramuscular, administration date 12May2021 (Lot number: EX6564) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (SPIKEVAX), intramuscular, administration date 18Nov2021 (Lot number: 3004498) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (death, hospitalization, medically significant) with onset 09Feb2022, outcome "fatal", described as "PULMONARY EMBOLISM"; CARDIAC ARREST (death, hospitalization, medically significant) with onset 09Feb2022, outcome "fatal", described as "CARDIAC ARREST"; BRAIN INJURY (death, hospitalization, medically significant) with onset 09Feb2022, outcome "fatal", described as "Major brain damage ". The patient was hospitalized for pulmonary embolism, cardiac arrest, brain injury (start date: 09Feb2022). The patient underwent the following laboratory tests and procedures: computerised tomogram: (09Feb2022) ct detected large pulmonary embolies. Therapeutic measures were taken as a result of pulmonary embolism, cardiac arrest, brain injury included thrombolysis. The patient date of death was 20Feb2022. The reported cause of death was pulmonary embolism, cardiac arrest, brain injury. It was not reported if an autopsy was performed. Clinical course of events was reported as follows: The patient developed severe pulmonary embolism and cardiac arrest with return of spontaneous circulation on 09Feb2022. He was hospitalized on 09Feb2022 and died after several days of intensive care. No direct cause for pulmonary embolism was found. Circulatory unstable, received thrombolysis. Transferred to medical intensive care. Intensively treated until 20Feb2022. Detected major brain damage after cardiac arrest and treatment was terminated. The Pharmacovigilance Center assessed the casual relationship between bnt162b2 (COMIRNATY) and all the reported events as possible. Reporters comment: 25Feb Agency: additional information received by phone. The following fields have been updated: event and patient. 25Feb2022 Agency: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2022-V43egr (this report). Report NO-NOMAADVRE-FHI-2022-Vjrjn6 has been nullified. The following fields have been updated: patient, lab, event description, relevant lab tests/data and reporters comments. No follow-up attempts are possible. No further information is expected.; Reporter's Comments: 25Feb Agency: additional information received by phone. The following fields have been updated: event and patient. 25Feb2022 Agency: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2022-V43egr (this report). Report NO-NOMAADVRE-FHI-2022-Vjrjn6 has been nullified. The following fields have been updated: patient, lab, event description, relevant lab tests/data and reporters comments.; Sender's Comments: Linked Report(s) : NO-PFIZER INC-202200368170 Same patient and product; different dose and events; Reported Cause(s) of Death: Pulmonary embolism; Cardiac arrest; Major brain damage
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EX6564||OT||Unknown|
|LAB_DATA:||Test Date: 20220209; Test Name: Computerized tomography; Result Unstructured Data: Test Result:CT detected large pulmonary embolies|