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.
Grandfather died within a week and a half after his vaccination; This is a spontaneous report from a contactable consumer. This the first case out of six cases. Patients grandson reported for the patient (reporters grandfather) that a 97-year-old male (same age during vaccination) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021, as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. Reporter stated that So, he doesnt exactly know. His grandfather was the first phase to get the Pfizer vaccination (Confirmed as Pfizer Covid 19 vaccine) back in March (Further not clarified). He was in a residential home with 5 other elderly residents with him. They all got vaccinated with the first Pfizer shot (Confirmed as Covid 19 vaccine) and they all died within the 5 weeks after their first shot. Honestly the only thing that he can pinpoint with my aunt and other people and loved ones we have talked to come together because only two of the residents were on hospice and the other people were not on hospice. They should not have died they just died. he doesnt know if it was a side effect, he knows if it was a reaction but all of the six residents that got vaccinated died within their first vaccination shot. Within the 5 weeks after the first vaccination. He was not sure other residents got the second vaccination, but his grandfather died 09Feb2021. Reporter stated he only have detail for his grandfather and other residents, and they died in their sleep supposedly. They died in their sleep. Both of them died in their sleep (Further not clarified hence not captured in tab). He just feels, his grandfather was not on hospice he was healthy considering the underlying problem that they had but they were supposed to get vaccinated with the Moderna and the day that we got there they changed the vaccination to Pfizer. So, they had the on-duty nurse there to answer any of the questions that we had. We asked then all the questions we had. We felt ok with it, everybody got vaccinated that day. My grandfather died within a week and a half after his after vaccination. So, he didnt get the second and by the middle of march their resident also died. The only thing I can tie to it is the first dose of Pfizer vaccination. Regarding Height and weight reporter stated he do not know exact. he wont say he was 5 (feet) 8 (inches) when he passed away, he believed either between 115 (pounds) and 120 (pounds) when he passed away. Outcome of the event was fatal. Information related Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021618004 same reporter/SD/AE, different patients;US-PFIZER INC-2021616779 same reporter/SD/AE, different patients;US-PFIZER INC-2021617301 same reporter/drug/AE, different patients;US-PFIZER INC-2021616796 same reporter/SD/AE, different patients;US-PFIZER INC-2021616788 same reporter/SD/AE, different patients; Reported Cause(s) of Death: Grandfather died within a week and a half after his vaccination
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Test Date: 20210209; Test Name: weight; Result Unstructured Data: Test Result:115 (pounds) and 120 (pounds)|