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.
vomit with secretion; started to present severe symptoms of the disease / COVID-19/ fever / weakness / the reporter believes that the patient's fever and weakness were related to COVID-19; started to present severe symptoms of the disease / COVID-19/ fever / weakness / the reporter believes that the patient's fever and weakness were related to COVID-19; blood pressure low; weakness; septic shock; pulmonary sepsis; unspecified pneumonia; respiratory failure; This is a spontaneous report from two contactable consumers (patient's father and patient's aunt) received through portal. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via Intramuscular, administered in right arm on 23Aug2021 12:00 AM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing Down's syndrome (He was born with it). He did not have any medical history, only Down's Syndrome. Concomitant medication included alprazolam taken for sedative therapy, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergic to any medications, food or other products. The patient did not receive any other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. 13 days after taking the vaccine, the patient started to present severe symptoms of the disease and died in 7 days. The patient after taking the vaccine got sick and as result of the disease he died. The causes were written on the death certificate as follows bellow: Septic shock, Pulmonary sepsis, Unspecified pneumonia and Covid-19. The patient did not leave the house, did not receive visitors and his health was very good. The house members did the tests and as per the results, they were not infected. Reporter said that the patient was a very healthy boy and refused to take any vaccine, but he received the Pfizer vaccine against covid-19 on 23Aug2021. He started to show symptoms of fever on 06Sep2021 at 01:00 AM and as the fever did not go away and because he presented weakness (in Sep2021) and vomiting with secretions on 10Sep2021, he was taken to the emergency care unit on 11Sep2021. His condition was considered serious and, on that same day, he was taken to the ICU of the hospital. The patient underwent a PCR test on 11Sep2021 and on 14Sep2021 he received a positive result (the reporter believes that the patient's fever and weakness were related to COVID-19). On 11Sep2021, he also performed a chest tomography and the result showed major pulmonary impairment, therefore, the patient was intubated from 11Sep2021 on with oxygen supplementation. Oxygen flow was decided according to the patient's health status and the patient received supplemental oxygen during the 7 days of hospitalization. On the day of intubation, the patient had low blood pressure (in Sep2021) and received norepinephrine. The reporter does not know how the patient's blood pressure was during hospitalization. During intubation, the reporter had no contact with the patient and did not talk to the medical team, so she was unable to say if there was a worsening of the Down Syndrome and was unable to say any exams and/or treatments performed. The physician only commented that all the patient's organs were normal, with only the respiratory system being compromised. On 18Sep2021 (date of death), the patient suffered a respiratory arrest, respiratory failure, but the reporter was unable to give further details. The reporter commented that she did not know that the patient had pneumonia during hospitalization, she only found out when she saw the investigation. She reported that the patient used alprazolam as a concomitant medication and was unable to say whether the patient used it in the hospital until the date of death. The patient was hospitalized from 11Sep2021 to 18Sep2021. The patient died on 18Sep2021. In case of death, an autopsy was performed. Autopsy results: the medical report indicated the cause of death as pulmonary sepsis, nonspecific pneumonia and covid-19. The reporter said that the result of covid-19 in the final medical report had a question mark, indicating it as inconclusive, but she believed that the patient had COVID-19 due to the exam done on 11Sep2021, which was positive. An autopsy was performed that revealed pulmonary sepsis, unspecified pneumonia, covid-19, septic shock. The outcome of events COVID-19, drug ineffective, septic shock, pulmonary sepsis, unspecified pneumonia and respiratory failure was fatal, vomit with secretion was recovered on 10Sep2021, blood pressure low and weakness was unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: COVID-19; respiratory failure; Autopsy-determined Cause(s) of Death: COVID-19; pulmonary sepsis; unspecified pneumonia; septic shock
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||26 September 2021|
|DATEDIED:||17 September 2021|
|LAB_DATA:||Test Date: 20210911; Test Name: chest tomography; Result Unstructured Data: Test Result:major pulmonary impairment; Test Date: 20210911; Test Name: COVID-19 PCR test; Test Result: Positive|
|OTHER_MEDS:||Pfizer, Inc. EUA 027034|
|TODAYS_DATE:||25 September 2021|