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.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 07:15 as dose 1, single (Lot number: EN6201), in right arm, on 26Feb2021 at 06:45 as dose 2, single (Lot number: EN6201), in right arm, on 27Sep2021 at 17:15 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 06Apr2022 at 17:15 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing); "Known Allergies: peanut Products" (unspecified if ongoing); "Known Allergies: Oil/Food" (unspecified if ongoing); "Known Allergies: Dust" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid Rebound; Positive, notes: Currently day 9 with with positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Addition information: Covid Rebound with heavy nasal congestion, sore throat and sneezing on day 8 after 5 day treatment with Paxlovid beginning on day 1 of symptoms/positive test; also nasty metallic taste in mouth days 1-5 while taking Paxlovid. Currently day 9 with positive test and heavy sinus/throat symptoms. Treatment start date was 29May2022. Treatment stop date was 02Jun2022.; Sender's Comments: The reported Covid 19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
|COVID19 (COVID19 (PFIZER-BIONTECH))||4||COVID19||PFIZER\BIONTECH||FK9895||Unknown||LA|
|LAB_DATA:||Test Name: COVID-19 Test; Test Result: Positive ; Comments: Covid Rebound; Test Name: COVID-19 Test; Test Result: Positive ; Comments: Currently day 9 with positive test|
|HISTORY:||Medical History/Concurrent Conditions: Breast cancer; Dust allergy; Food allergy; Peanut allergy; Penicillin allergy|