Case #1225942 received by VAERS on 4/18/2021: “Patient was a 16yr female who received Pfizer [COVID-19] vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 after cardiac arrest at home. Patient placed on ECMO and imaging revealed bilateral large pulmonary embolism as likely etiology of arrest. Risk factors included oral contraceptive use. Labs have since confirmed absence of Factor V leiden or prothrombin gene mutation. Patient declared dead by neurologic criteria 3/30/21.”
Case #1386841 received by VAERS on 6/9/2021: “Prodrome of headache and gastric upset over 2 days following second dose. Then felt fine. Found the following day dead in bed. Autopsy pending” Date of COVID-19 Vaccination: 6/3/2021. Date of Death: 6/7/2021.
Case #1420630 received by VAERS on 6/23/2021: “~4 weeks after the 2nd dose of Pfizer [COVID-19 vaccine], patient presented to the hospital with chest pain; had pericardial effusion. Initially improved but then had decompensation, prolonged hospitalization. Diagnosed with hemophagocytic lymphohistocytosis (HLH) and ultimately died.”
Case #1475434 received by VAERS on 7/15/2021: “The patient died 6 days after receiving [COVID-19 vaccine] dose #2”
Established in 1990, the Vaccine Adverse Event Reporting System (VAERS) is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. VAERS is co-managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination. Anyone can report an adverse event to VAERS. Healthcare professionals are required to report certain adverse events and vaccine manufacturers are required to report all adverse events that come to their attention.
VAERS is a passive reporting system, meaning it relies on individuals to send in reports of their experiences to CDC and FDA. VAERS is not designed to determine if a vaccine caused a health problem, but is especially useful for detecting unusual or unexpected patterns of adverse event reporting that might indicate a possible safety problem with a vaccine. This way, VAERS can provide CDC and FDA with valuable information that additional work and evaluation is necessary to further assess a possible safety concern.