The Vaccine Adverse Event Reporting System (VAERS) Results Form -

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The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=38ECD... The Vaccine Adverse Event Reporting System (VAERS) Results Vaccine Vaccine Symptoms Age VAERS ID Adverse Event Description Type Manufacturer I do not know the exact date of the first or second Moderna COVID19 CARDIAC 6-17 Vaccine. I am the PICU attending who cared for the patient after VACCINE MODERNA 1187918-1 ARREST years her cardiac arrest which we believe was about 3-4 days after her (COVID19) second Moderna Vaccine Sore arm on 3/20/2021. No other symptoms/signs. Presented for routine heart transplant follow up visit 3/22/2021 and was found to have new decreased cardiac function by echo, new 1st degree heart block by ECG, and new gallop. Patient taken to cath lab COVID19 3/22/2021 for biopsy and hemodynamic assessment, but he had CARDIAC 6-17 VACCINE PFIZER\BIONTECH 1136945-1 V fib arrest with anesthesia induction. After initiation of CPR, ARREST years (COVID19) patient was placed on ECMO. Biopsy shows ACR 2R (moderate cellular rejection) and pAMR 2 (moderate antibody-mediated rejection). Labs show new donor specific, complement-fixing Antibody against the cardiac allograft. Patient is in ICU being treated for acute rejection. COVID19 CARDIAC 6-17 Patient reported difficulty breathing and chest pain; suffered VACCINE PFIZER\BIONTECH 1199455-1 ARREST years cardiac arrest and death (COVID19) Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 COVID19 after cardiac arrest at home. Patient placed on ECMO and imaging CARDIAC 6-17 VACCINE PFIZER\BIONTECH 1225942-1 revealed bilateral large pulmonary embolism as likely etiology of ARREST years (COVID19) 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. COVID19 CARDIAC 6-17 VACCINE PFIZER\BIONTECH 1242573-1 Heart failure FAILURE years (COVID19) Patient received second dose of Pfizer vaccine on March 17, 2020 while at work. March 18, 2020 her 5 month old breastfed infant developed a rash and within 24 hours was inconsolable, refusing COVID19 to eat, and developed a fever. Patient brought baby to local ER <6 DEATH VACCINE PFIZER\BIONTECH 1166062-1 where assessments were performed, blood analysis revealed months (COVID19) elevated liver enzymes. Infant was hospitalized but continued to decline and passed away. Diagnosis of TTP. No known allergies. No new exposures aside from the mother's vaccination the previous day. COVID19 1-2 DEATH VACCINE MODERNA 1261766-1 increased body temperature, seizure, death years (COVID19) COVID19 1-2 death by suicide Narrative: death by suicide; 12/26/20, self DEATH VACCINE PFIZER\BIONTECH 0958443-1 years inflicted gun shot wound; found deceased by family member (COVID19) she was going to die/dies after vaccine; 2-year-old patient; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A 2-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 2-years-old via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's COVID19 medical history and concomitant medications were not reported. 1-2 DEATH VACCINE PFIZER\BIONTECH 1255745-1 It was reported that the 2-year-old dies after vaccine on years (COVID19) 03Mar2021. Reported on VAERS. Look for the researchers to exclude her from the study, probably claiming her death had nothing to do with the shot, she was going to die that day, five days after vaccination anyway. That's how they roll. The patient died on 03Mar2021. The outcome of the event was fatal. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.; Reported Cause(s) of Death: she was going to die COVID19 6-17 Patient reported difficulty breathing and chest pain; suffered DEATH VACCINE PFIZER\BIONTECH 1199455-1 years cardiac arrest and death (COVID19) Patient was a 16yr female who received Pfizer vaccine 3/19/21 at vaccine clinic and presented with ongoing CPR to the ED 3/28/21 COVID19 after cardiac arrest at home. Patient placed on ECMO and imaging 6-17 DEATH VACCINE PFIZER\BIONTECH 1225942-1 revealed bilateral large pulmonary embolism as likely etiology of years (COVID19) 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. COVID19 6-17 DEATH VACCINE PFIZER\BIONTECH 1242573-1 Heart failure years (COVID19) Note: Submitting a report to VAERS does not mean that healthcare personnel or the vaccine caused or contributed to the adverse event (possible side effect). Notes: 2 of 3 13/05/2021, 11:42 The Vaccine Adverse Event Reporting System (VAERS) Results Form https://wonder.cdc.gov/controller/datarequest/D8;jsessionid=38ECD... Caveats: VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to VAERS. 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. Most 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 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: Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause. Reports may include incomplete, inaccurate, coincidental and unverified information. The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines. VAERS data are limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available. VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers, and Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100% in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to unique events is more than 100%. More information. (/wonder/help/vaers.html#Suppress) Data contains VAERS reports processed as of 4/30/2021. The VAERS data in WONDER are updated weekly, yet the VAERS system receives continuous updates including revisions and new reports for preceding time periods. Duplicate event reports and/or reports determined to be false are removed from VAERS. More information. (/wonder /help/vaers.html#Reporting) For more information on how many persons have been vaccinated in the US for COVID19 to date, see https://covid.cdc.gov/covid-data-tracker/#vaccinations/ (https://covid.cdc.gov/covid-data-tracker/#vaccinations/) Help: See The Vaccine Adverse Event Reporting System (VAERS) Documentation (/wonder/help/vaers.html) for more information. Query Date: May 13, 2021 11:42:01 AM Suggested Citation: United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - 4/30/2021, CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on May 13, 2021 11:42:01 AM Query Criteria: Age: < 6 months; 6-11 months; 1-2 years; 3-5 years; 6-17 years State / Territory: The United States/Territories/Unknown Symptoms: BRAIN DAMAGE; BRAIN DEATH; CARDIAC ARREST; CARDIAC DEATH; CARDIAC FAILURE; CARDIAC FAILURE ACUTE; CARDIAC FAILURE CHRONIC; CARDIAC FAILURE CONGESTIVE; DEATH Vaccine Products: COVID19 VACCINE (COVID19) VAERS ID: All Group By: Symptoms; Age; Vaccine Type; Vaccine Manufacturer; VAERS ID Show Totals: False Show Zero Values: Disabled 3 of 3 13/05/2021, 11:42