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.
MYOCARDIAL INFARCTION; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (IE-HPRA-2021-063720). A 97-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number: EM0477) intramuscularly on 22Jan2021 at 0.3 ml single in left deltoid for COVID-19 immunization. The patient's medical history included pacemaker from 2013, Road traffic accident (RTA) from Jun2016, vascular dementia, chronic kidney disease from 2018, history of faints while sitting out at commode but nil in recent months. It was reported that the patient was very unwell one year ago (2020) and had been receiving end of life care for a period but improved. In the three months prior to reporting (Oct2020), the patient tended to be in bed more often but this fluctuated. The patient had taken her meals in her bedroom in the past three months. It was outlined that the patient had been recently bright/alert and eating well. The patient's concomitant medications included ferrous fumarate (GALFER); blumea balsamifera, curcuma longa, lagerstroemia speciosa, orthosiphon aristatus (RENALIN); fats nos (CALOGEN); sennoside A+B (SENOKOT); folic acid; and memantine for dementia. The patient previously received quadrivalent influenza vaccine (split virion, inactivated), suspension for injection in pre-filled syringe. The patient experienced myocardial infarction on 25Jan2021. On 22Jan2021, the patient was well post vaccination and no side effects to vaccination had been noted. On 25Jan2021 at 7.30 am, the patient was noted to be asleep in bed when checked. At 8.15 am, the patient was found dead. The patient was not for resuscitation. It was reported that the General Practitioner (GP) certified the cause of death as myocardial infarction. The patient died on 25Jan2021. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: MYOCARDIAL INFARCTION
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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.