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.
Stroke; severe allergic reaction; This is a spontaneous report from a contactable consumer (the patient's father) from the Pfizer-sponsored program. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the Right Arm (also reported as: right shoulder) on 23Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) at 16-years-old as a single dose for COVID-19 immunisation. Medical history included heart valve operation from an unknown date and unknown if ongoing (Mechanical heart valves). Concomitant medications included an unspecified medication, taken for an unspecified indication from an unspecified date to an unspecified date, which was reported as: "Yes she is taking other medication." On 29Mar2021, the patient experienced stroke and severe allergic reaction (medically significant). The clinical course was reported as follows: On behalf of his 16-year-old daughter, the patient's father reported that she had the first dose administer in the right shoulder on 23Mar2021. On 29Mar2021, the patient had a stroke. The patient's father stated, "our lives have changed, completely." The patient's father reported that his daughter was receiving medical care ever since then; and was also being treated by a physician. The patient's father was asking about compensation from Pfizer regarding his daughter's severe adverse event (AE) that occurred after the first dose of vaccine. The patient's father reported that the case had been submitted by the (Name) healthcare team "to the FDA and to Pfizer, and I haven't heard back from either." The patient's father mentioned in passing, that he "could call (Name) and have this all over the news" but that he "wants to be responsible" and doesn't want to do that. The patient's father stated the concern, "Well my concern I am not sure that medical profession is what I really need to do, my concern is that my daughter took the Pfizer COVID vaccine on 23Mar2021 in (Name) in vaccination location. On 29Mar2021, 6 days later, she had a stroke, and that she is receiving a medical care ever since then , now my question is like I said probably for maybe for correlated relation type of person define as well as for it there is a compensation for adverse reaction to COVID vaccination being that this was only thing that was introduce in her system as far as doing that time the vaccination shot." The patient underwent lab tests and procedures which included blood test: "that's for 4/2 out of normal" on an unknown date; also reported: "Yes that's been ongoing as far as giving blood. That's for 4/2 out of normal". Therapeutic measures were not taken and was reported as "no she isn't taking anything for it." The clinical outcome of the events, stroke and severe allergic reaction, was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021411875 Pfizer
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||27 April 2021|
|LAB_DATA:||Test Name: Blood test; Result Unstructured Data: Test Result:that's for 4/2 out of normal|
|HISTORY:||Medical History/Concurrent Conditions: Heart valve operation (Mechanical heart valves)|
|TODAYS_DATE:||26 April 2021|