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.
Sudden death; This case was reported by a physician via regulatory authority and described the occurrence of sudden death in a 25-year-old male patient who received HAB (Twinrix adult) (batch number AHABB418AC, expiry date unknown) for prophylaxis. Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis and HUMAN PAPILLOMAVIRUS 9-VALENT-VACCINE (GARDASIL 9) (batch number S035693, expiry date unknown) for prophylaxis. On 28th October 2020 11:41, the patient received the 3rd dose of Twinrix adult (intramuscular). On 28th October 2020, the patient started hepatitis A and hepatitis B vaccine pre-filled syringe device. On 28th October 2020 11:41, the patient received the 3rd dose of GARDASIL 9 (intramuscular). On 28th October 2020, less than a day after receiving Twinrix adult and hepatitis A and hepatitis B vaccine pre-filled syringe device, the patient experienced sudden death (serious criteria death and GSK medically significant). On 28th October 2020, the outcome of the sudden death was fatal. The patient died on 28th October 2020. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the sudden death to be related to Twinrix adult and hepatitis A and hepatitis B vaccine pre-filled syringe device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details : The patient was vaccinated with Twinrix adult and GARDASIL 9 on an left arm. The Regulatory Authority causality assessment was reported as not assessed in association with reported suspect vaccine and events. The time to onset was reported as 1 day in drug event mapping, however based on vaccination date and event onset date it was captured as less than a day. The time to onset for events sudden death with Gardasil 9 was reported as 1 day however based on vaccination date and event onset date it was captured as less than a day. The duration for event sudden death was reported as 1 day, However looking of the nature of event the duration was not captured in duration field. It was unknown if the reporter considered the sudden death to be related to gardasil 9. Initial information was received from a physician via regulatory authority on 1st February 2021: Sudden death Reporter's comment: 26.01.2021 Regulatory Authority has requested additional information, This is a preliminary report Sender's comment: Reported Cause(s) of Death: Unknown cause of death
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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.