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.
hallucination; Level of distress; agitation; PO/IM sedation; lower respiratory tract infection; Acute delirium; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency. Other Case identifier(s): GB-MHRA-VAC-202206191545569080-YRPSJ (RA), GB-MHRA-ADR 27027624 (RA). An 88-year-old male patient received BNT162b2 (COMIRNATY), on 17May2022 as dose number unknown, 0.3ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FINASTERIDE; FUROSEMIDE; LEVETIRACETAM; LEVOTHYROXINE. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DELIRIUM (death, hospitalization, medically significant) with onset 20May2022, outcome "fatal", described as "Acute delirium"; HALLUCINATION (death, hospitalization, medically significant), outcome "fatal"; RESPIRATORY DISTRESS (death, hospitalization), outcome "fatal", described as "Level of distress"; AGITATION (death, hospitalization), outcome "fatal"; SEDATION (death, hospitalization), outcome "fatal", described as "PO/IM sedation"; LOWER RESPIRATORY TRACT INFECTION (death, hospitalization), outcome "fatal". The patient date of death was unknown. Reported cause of death: "lower respiratory tract infection", "Acute delirium", "hallucination", "Level of distress", "agitation", "PO/IM sedation". Clinical course: It was reported that after receiving Comirnarty vaccine became acutely delirious with no other obvious cause for delirium ascertained from history, examination or investigations. Level of distress, hallucination, agitation required admission to hospital and PO/IM sedation at times. Never fully recovered and then developed an lower respiratory tract infection which caused his death a few weeks later. He had a similar episode in November 5 days after receiving the comirnaty vaccine, which could also have been related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: lower respiratory tract infection; Acute delirium; hallucination; Level of distress; agitation; PO/IM sedation
|COVID19 (COVID19 (PFIZER-BIONTECH))||Unknown||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|OTHER_MEDS:||FINASTERIDE; FUROSEMIDE; LEVETIRACETAM; LEVOTHYROXINE|