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.
Patient complained of chest pain and was taken to ER. At the ER he complained of chest pain 6/10 and SOB. Troponin at initial hospital was 1031 and EKG showed ST depression in V1 and ST elevation in aVF and Lead II. He was transferred to hospital. Initial chest pain rated 2/10. Repeat labs showed Troponin 34000 and EKG with ST depression in V1 and ST elevation in aVF and lead II. He was admitted for COVID-19 vaccine myocarditis. On admission cardiology was consulted and requested repeat troponin, BNP and an echocardiogram in the AM of 9/28. IV meds were started at that time as well. EKG findings, and elevated cardiac biomarkers are more consistent with that of a myopericarditis. His echo on 9/30 is normal, with no evidence of dysfunction, pericardial effusion, or significant edema. On 09/27 Patient did complain of an aching chest pain at 5/10 rating, this was relieved with Toradol and no further dose of Toradol or pain was reported throughout stay. Naproxen 220 mg every 12 hours started on 9/28 and given as scheduled until 9/30 prior to discharge. We PO challenged Patient on 09/27 and he tolerated food and drink well, mom states he ate close to his home baseline. Troponins continued to down-trend, and repeat Echo and EKG were reassuring. Outpatient follow up with Dr. at discharge. Will need Halter monitoring to be set up by cardiology at follow up.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | 301358A | IM | LA |
| RECVDATE: | 10-02-2021 | RPT_DATE: |
| CAGE_YR: | 15 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 4 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Results for as of 9/30/2021 18:59 9/27/2021 02:14 9/27/2021 10:57 9/28/2021 06:48 9/28/2021 16:07 9/28/2021 21:41 9/29/2021 08:35 9/29/2021 19:25 9/30/2021 06:45 Troponin I 34,863.4 (H) 18,023.400 (H) 20,968.500 (H) 11,041.200 (H) 11,269.500 (H) 12,661.600 (H) 5,767.000 (H) 3,224.600 (H) 9/27/2021 02:14 9/29/2021 19:25 B-TYPE NATRIURETIC P 593 (H) 494 (H) SARS 2 CoV RT-PCR Result: Not detected EKGs obtained 9/28 @0819, 9/29@0834, 9/30 @1429 results as mentioned prior Echos obtained9/27 @0849, and 9/30 @1435 results no abnormalities detected |
| V_ADMINBY: | PHM |
| OTHER_MEDS: | |
| CUR_ILL: | Allergic rhinitis 2 weeks prior to vaccination |
| HISTORY: | Autism and constipation |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 10-02-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Amoxicillin, penicillin |
| V_FUNDBY: |
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