Source: VAERS.HHS.GOV
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.
medication error; Anaphylactic reaction; Pulmonary edema; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-EYC 00237518, Safety Report Unique Identifier: GB-MHRA-ADR 24581820. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/Batch: EE8493), parenteral on 11Jan2021 at single dose for COVID-19 vaccination. Medical history included ongoing multiple allergies. Concomitant medication included fexofenadine hydrochloride (unknown manufacturer). The patient experienced anaphylactic reaction on 11Jan2021 and medication error (Contraindicated product administered) on an unspecified date. The patient reported that she was advised to have the jab even though she carried epi pen and had multiple allergies. This was stated on patient forms. Upon recent follow-up, the patient had been seen by the general practitioner (GP) again and had prescribed antibiotics and more steroids as she had pulmonary edema described as fluid on her left lung (same side of vaccination) (started in Jan2021) and still suffering symptoms of anaphylaxis. The outcome of event anaphylactic reaction was not recovered; and outcome of the event pulmonary edema was unknown. The reported events were considered serious requiring hospitalization. No follow-up attempts are possible. No further information is expected. Follow-up (21Jan2021): New information received from the same contactable consumer (patient) included: event details (outcome of the event anaphylactic reaction updated from recovered with sequelae to 'not recovered'; new event: pulmonary edema). No follow-up attempts are possible. No further information is expected.
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.