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.
Low grade fever; Headache; Weakness; Nauseous; Difficulty breathing; Dizziness; and the stomach ache; real tired; had the normal arm soreness; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 13-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 23Jul2021 (at the age of 13-year-old) as dose 1, single for COVID-19 immunisation. No medical history and concomitant medications were reported. Report is not related to a study or programme. No investigation assessment was reported. Historical vaccine given to patient previously was HPV vaccine in Jun2021 for Immunisation. On 24Jul2021, the patient experienced real tired, had the normal arm soreness. On 27Jul2021, the patient experienced low grade fever. On 26Jul2021, the patient experienced headache, weakness, nauseous, difficulty breathing, dizziness, and the stomach ache. It was reported that the caller said that she just wanted to report that her daughter had the vaccine on Friday, and she was just real tired and had the normal arm soreness and then by Monday, 48 hours after, she was short of breath and was dizzy and felt like she was going to vomit, but she never vomited. But for this whole week she has been dizzy and weak and today was Thursday, so the caller wanted to be sure that she called and reported everything. Her daughter just turned 13 and the caller wanted to make sure that Pfizer was aware of this. The tiredness and the normal arm soreness began Saturday, the day after, confirmed to 24Jul2021, she was just real tired for probably a few hours after her shot and then she was really tied on Saturday, like lethargic, and then Sunday she felt fine. By Monday was when she went downhill, and she has been in bed ever since Monday. The arm soreness ended on 25Jul2021. She was still tired, but it was getting better, it was not as bad as the first three days on Monday, Tuesday, and Wednesday but the biggest was her being dizzy and the stomach ache and being nauseous from the stomach ache. Caller was looking at the sheet that she has from the vaccine that the side effects that her daughter does not have are the chills, the joint pain, she did have a fever on Tuesday, but it was just a low-grade fever, she has no itching, hives or swelling in the face. She just has a headache, tiredness, weakness and nauseous. She had difficulty breathing on Monday and dizziness and weakness. Caller confirmed that these all began on Monday, confirmed to 26Jul2021 and the being dizzy and weak are still there and she still has a headache that has been there but everything else seems to be better and she has not had any more shortness of breath. She confirmed 27Jul2021 for when her daughter had a fever, it was a very low-grade fever, it was not spiked high it was just low grade and that was gone. Reporter gave consent to contact and did not gave consent to contact healthcare professional. The outcome of the event real tired was reported as resolving. The outcome of the events Headache, Weakness, and Dizziness was not resolved. The outcome of the events Nauseous and the stomach ache was unknown. The outcome of the event the normal arm soreness was reported as resolved on 25Jul2021 and outcome of the event Low grade fever reported as resolved on 27Jul2021 and outcome of the event Difficulty breathing was reported as resolved on 26Jul2021.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||16 September 2021|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None|
|TODAYS_DATE:||15 September 2021|