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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Sep2021 as dose 1, single (Lot number: FE3592), in left arm and on 08Oct2021 at 13:15 as dose 2, single (Lot number: FF8839) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "esophageal ca" (unspecified if ongoing), notes: other medical history: esophageal ca; "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 25Apr2022, stop date: 09May2022; DEXAMETHASONE, start date: 05May2022, stop date: 06May2022; OMEPRAZOLE, start date: 25Apr2022, stop date: 09May2022; FERROUS [IRON], start date: 25Apr2022, stop date: 09May2022; ZINC [ZINC SULFATE], start date: 25Apr2022, stop date: 09May2022; VITAMIN B-12, start date: 25Apr2022, stop date: 09May2022; KEYTRUDA, start date: 04May2022, stop date: 04May2022; ALOXI, start date: 04May2022, stop date: 04May2022; LEUCOVORIN [FOLINIC ACID], start date: 04May2022, stop date: 04May2022; OXALIPLATIN, start date: 04May2022, stop date: 04May2022; ADRUCIL, start date: 04May2022, stop date: 06May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Seriousness criteria-Results in death was reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 May 2022|
|OTHER_MEDS:||LEVOTHYROXINE; DEXAMETHASONE; OMEPRAZOLE; FERROUS [IRON]; ZINC [ZINC SULFATE]; VITAMIN B-12; KEYTRUDA; ALOXI; LEUCOVORIN [FOLINIC ACID]; OXALIPLATIN; ADRUCIL|
|HISTORY:||Medical History/Concurrent Conditions: Esophageal cancer (other medical history: esophageal ca); Penicillin allergy|
|TODAYS_DATE:||11 May 2022|