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.
RESPIRATORY ARREST; REDUCED GENERAL CONDITION; DYSPNEA; health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; This is a spontaneous report from a contactable Other Health Professional downloaded from the Agency Agency-WEB NO-NOMAADVRE-FHI-2021-Uedw5, Sender's (Case) Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014102. A 94-years-old male patient received his first dose bnt162b2 (COMIRNATY), lot number: EM0477, intramuscular on left arm on 14Jan2021 12:25 at single dose for covid-19 immunisation. Medical history included wheelchair user, respiratory arrest, reduced general condition, possible dyspnea, generalised pain and started morfine (subcutanous) 01Jan2021 for generalised pain, he was not completely clear and oriented afterwards and was more drowsy/confused; urinary tract infection (Per oral antibiotics 30Dec2020 to 06Jan2021 for possible urinary tract infection), all from an unknown date. Concomitant medication included morfin [morphine] subcutaneous from 01Jan2021 for generalised aching. The patient experienced dyspnea and reduced general condition the same day as vaccination with covid-19 vaccine bnt162b2 on 14Jan2021, and experienced respiratory arrest and death the day after on 15Jan2021. His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination on 14Jan2021. He could not either eat/drink or take his medicines and was bedridden to the day after the vaccination when he died (15Jan2021). It was reported "Start-up with oxygen 0.5-1 L on spectacle catheters after clearly reduced breathing pattern." He was independent in meal situations from an unspecified date. The patient underwent lab tests and procedures which included c-reactive protein: 20 on 07Jan2021, c-reactive protein: 30 on 15Jan2021. The patient died on 15Jan2021. It was not reported if an autopsy was performed. Sender Comment: A 94-year-old man with dyspnoea and reduced general condition same day as vaccination with covid-19 vaccine (Comirnaty). Respiratory arrest and death the next day. His health was already reduced from before the vaccination, but the situation worsened after the vaccination. When vaccinating marginal patients who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. It cannot be ruled out that the vaccine has contributed to the worsening of the patient's underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient's underlying disease or some other random incident, happening at the same time but that has nothing to do with the vaccination in question. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the message is classified as serious, even though no causal link between the vaccine and the death has been established. Reporter's comment: 21Jan2021: Received additional information from reporter (phone call): date of death, date of adverse events, other details. No follow-up attempts possible. No further information expected.; Reporter's Comments: 21Jan2021: Received additional information from reporter (phonecall): date of death, date of adverse events, other details; Reported Cause(s) of Death: reduced general condition; RESPIRATORY ARREST; His health condition was already reduced (reduced general condition and possible dyspnea) from before, and it got worse the same day as the vaccination; dyspnea
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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.