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.
Breakthrough COVID-19 infection; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (Breakthrough COVID-19 infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Congestive heart failure, Lung disease and Type 2 diabetes mellitus. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Breakthrough COVID-19 infection) (seriousness criteria death and hospitalization). The reported cause of death was breakthrough covid-19 infection. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered COVID-19 (Breakthrough COVID-19 infection) to be possibly related. Patient was in Intensive care unit (ICU) and critical in covid-19 severity provided with Non-invasive positive pressure ventilation support. Patient was treated with immunosuppressive agent. Company Comment: This literature-study case concerns a 65-year-old female patient with relevant medical history of congestive heart failure, lung disease and type 2 diabetes and concurrent use of immunosuppressive agents, who experienced serious unexpected event of special interest (RA) COVID-19. The event occurred after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273) however, the exact time to onset was not provided. The patient was admitted to the ICU due to critical COVID-19 with non-invasive positive pressure ventilation support. The patient passed away due to the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow up received by safety on 16-Nov-2021 included an Email with RA received from RA team and does not contain any new information; Sender's Comments: This literature-study case concerns a 65-year-old female patient with relevant medical history of congestive heart failure, lung disease and type 2 diabetes and concurrent use of immunosuppressive agents, who experienced serious unexpected event of special interest (RA) COVID-19. The event occurred after the second dose of the Moderna COVID-19 Vaccine (mRNA-1273) however, the exact time to onset was not provided. The patient was admitted to the ICU due to critical COVID-19 with non-invasive positive pressure ventilation support. The patient passed away due to the event. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Reported Cause(s) of Death: Breakthrough COVID-19 infection
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | OT | Unknown |
RECVDATE: | 11-23-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Test Name: PCR test for SARS-CoV-2; Test Result: Positive ; Result Unstructured Data: Positive |
V_ADMINBY: | |
OTHER_MEDS: | |
CUR_ILL: | Congestive heart failure; Lung disease; Type 2 diabetes mellitus |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USMODERNATX, INC.MOD20213 |
FORM_VERS: | |
TODAYS_DATE: | 11-22-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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