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.
Severe coughing; SOB; Fever 102; malaise; weakness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 17-year-old male patient received BNT162b2 (BNT162B2), on 06May2022 at 17:45 as dose 3 (booster), single (Lot number: FK9893) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Single; Manufacturer Unknown, Batch/Lot No: EW0185), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Single; Manufacturer Unknown, Batch/Lot No: Unknown/Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Fever 102"; DYSPNOEA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "SOB"; COUGH (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "Severe coughing"; MALAISE (non-serious) with onset 07May2022 at 05:00, outcome "unknown"; ASTHENIA (non-serious) with onset 07May2022 at 05:00, outcome "unknown", described as "weakness". The events "severe coughing", "sob", "fever 102", "malaise" and "weakness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, dyspnoea, pyrexia, malaise, asthenia. Additional information: If other vaccine in four weeks: No. If Covid prior vaccination: Yes. If Covid tested post vaccination: No. No follow-up attempts are possible. No further information is expected.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 May 2022|
|LAB_DATA:||Test Date: 20220507; Test Name: Fever; Result Unstructured Data: Test Result:Fever 102; Comments: Fever 102 at 05:00; Test Name: Covid-19; Test Result: Positive ; Comments: If Covid prior vaccination: Yes|
|HISTORY:||Medical History/Concurrent Conditions: COVID-19 (If Covid prior vaccination: Yes.)|
|TODAYS_DATE:||11 May 2022|