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.
Suicide; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122543. The 16-year and 5-month-old male patient received first dose of bnt162b2 (COMIRNATY) at 16-year-old on 15-JUL-2021 12:00 as dose 1, single (lot number: EY0583, expiration date: 31Oct2021) for COVID-19 immunisation. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included attention deficit hyperactivity disorder (ADHD) and Self injurious behaviour. Concomitant medications and family history were not provided. The course of the events was as follows: On 15Jul2021 at 12:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 23Jul2021 at 18:30 (8 days after the vaccination), the patient experienced suicide and died. The outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 23Jul2021, the patient jumped off the top floor of the apartment and died. It was assumed the he killed himself. The reporting physician classified the event as serious (fatal) and assessed that the event was not related to BNT162b2. Other possible cause of the event such as any other diseases was ADHD. The reporting physician commented as follows: The patient was prescribed oral medicines for ADHD at a psychiatry department, but recently he had stopped taking them, and self injurious behaviour had been noted.; Sender's Comments: Event suicide represents an intercurrent medical condition and unrelated to bnt162b2 . The underlying history of attention deficit hyperactivity disorder (ADHD) and Self injurious behavior may play a explanation.; Reported Cause(s) of Death: Suicide
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||16 August 2021|
|DATEDIED:||22 July 2021|
|LAB_DATA:||Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2; Comments: Before vaccination|
|HISTORY:||Medical History/Concurrent Conditions: ADHD; Self injurious behaviour|
|TODAYS_DATE:||11 August 2021|