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.
was found unconscious; breathing difficulties; autopsy was performed on the same day at 3:40pm and found there was spontaneous bronchospasm; he was pronounced dead on the same day; injection site pain; This is a spontaneous report from an Internet Source from a non-contactable consumer via Pfizer colleague. A 15-year-old male patient received bnt162b2 (COMIRNATY) via an unknown route of administration on 23Oct2021 (at the age of 15-year-old) (Batch/Lot number: Not provided), dose 2, single for COVID-19 immunization, received at his school. The patient medical history and concomitant medications were not reported. The patient did not have any allergies to previous vaccines or medications and was not known to have any chronic illness. The patient received COVID-19 Vaccine (COVID-19 Vaccine, MANUFACTURER UNKNOWN) via an unknown route of administration on 23Oct2021 (Batch/Lot number: Not provided), dose 1, single for COVID-19 immunization. Patient also did not report any problems or complications after receiving the first dose injection. The patient experienced injection site pain (non-serious) on 23Oct2021 with outcome of unknown, breathing difficulties (hospitalization) on 24Oct2021 09:30 with outcome of unknown, was found unconscious (hospitalization) on 24Oct2021 09:30 with outcome of unknown, autopsy was performed on the same day at 3:40pm and found there was spontaneous bronchospasm (death) on 24Oct2021 10:40, he was pronounced dead on the same day (death) on 24Oct2021 10:40. The patient was hospitalized for breathing difficulties and was found unconscious from 24Oct2021 for 1 day. Therapeutic measures were taken as a result of breathing difficulties, was found unconscious. The patient died on 24Oct2021. An autopsy was performed that revealed found there was spontaneous bronchospasm. The clinical course of events was as follows: He was reported to have had injection site pain only. However a day after he received his second jab, he was found to have suffered from breathing difficulties and then was found unconscious at his home at about 9.30am. Patient was rushed to the private hospital here but he was pronounced dead on the same day (24Oct2021) at 10.40am. An autopsy was performed on the same day at 3.40pm and found there was spontaneous bronchospasm. All tissue samples in the body were sent for further examination by a hospital's pathology forensic physician. The autopsy report is categorised as still incomplete because there are still tests that have not been received. A complete autopsy report to find out the cause of his death, is awaited. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Autopsy-determined Cause(s) of Death: found there was spontaneous bronchospasm
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||04 November 2021|
|DATEDIED:||23 October 2021|
|LAB_DATA:||Test Date: 20211024; Test Name: Autopsy; Result Unstructured Data: Test Result:spontaneous bronchospasm; Comments: Incomplete, final results awaited|
|TODAYS_DATE:||03 November 2021|