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.
Case was hospitalized for covid 7 months after completion of vaccination series. * Pneumonia due to COVID-19 virus Assessment & Plan Symptom onset about 13 days ago with positive COVID-19 test 6 days prior to admission. Fully vaccinated February-March with Pfizer vaccine, but notable that she is on immune suppressive therapy for her renal transplant. CXR on admission consistent with viral pneumonia. Only mild hypoxia on 2L/min nasal cannula on admission. Outside time window for Remdesivir, and her renal function would preclude this in any case. - dexamethasone 6mg daily. - continue supplemental oxygen as needed. -not needing supplemental O2 at discharge. Gave return precautions.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EN6204 | IM | RA |
| RECVDATE: | 11-18-2021 | RPT_DATE: |
| CAGE_YR: | 42 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Ordered Test: SARS-CoV-2 RNA Resp Ql NAA+probe Status: Final Specimen Source: SOFT TISSUE SAMPLE Specimen Site: BOTH ANTERIOR NARES Specimen Collection Date/Time: 2021-10-25 11:51:00.0 Results: Hospitalized for COVID-19 No Final * Resulted Test: SARS-CoV-2 RNA Resp Ql NAA+probe Coded Result: POSITIVE Numeric Result: Units: Text Result: Reference Range From: Negative Reference Range To: Performing Facility Details: Date/Time: 2021-10-25 12:18:34.0 Performing Facility:CLINIC Interpretation: Abnormal Result Method: LAB DEVICE: DATABASE Status: Final Result Comments: SARS-CoV-2, NAA (COVID-19) EUA This is a molecular, nucleic acid amplification (NAAT) test performed by Isothermal Amplification. |
| V_ADMINBY: | PUB |
| OTHER_MEDS: | acetaminophen (TYLENOL) 325 mg tablet Take 500 mg by mouth every 4 hours as needed for Pain (or fever >= 38.6 C (101.5 F)). 7/16/19 amLODIPine (NORVASC) 10 MG tablet Take 0.5 tablets by mouth Daily. 7/15/21 atorvaSTATin (LIPITOR) |
| CUR_ILL: | Syst Lupus Erythematosus Diffuse proliferative lupus glomerulonephritis 2/13/2013 Disorder of kidney and ureter End stage renal disease 6/3/2014 7/10/14: Left radiocephalic AV fistula (snuffbox) and right IJ permcath insertion. Stage 4/5 Chronic Kidney Disease secondary to history of diffuse proliferative lupus nephritis. Starting the referral process to Medical Center for kidney transplant. Hypertension 2/13/2013 Kidney replaced by transplant 7/15/15 8/10/2015 Status post live donor kidney transplant as part of a paired exchange. Transplant kidney from another state. July 15, 2015; primary cause of kidney disease: lupus nephritis; mismatch 0-2-2; previous transplant; CPRA: 11%; CMV negative to CMV negative; EBV positive; status post stent removal; induction therapy with 3 infusions of Thymoglobulin |
| HISTORY: | Syst Lupus Erythematosus Diffuse proliferative lupus glomerulonephritis 2/13/2013 Disorder of kidney and ureter End stage renal disease 6/3/2014 7/10/14: Left radiocephalic AV fistula (snuffbox) and right IJ permcath insertion. Stage 4/5 Chronic Kidney Disease secondary to history of diffuse proliferative lupus nephritis. Starting the referral process to Medical Center for kidney transplant. Hypertension 2/13/2013 Kidney replaced by transplant 7/15/15 8/10/2015 Status post live donor kidney transplant as part of a paired exchange. Transplant kidney from another state. July 15, 2015; primary cause of kidney disease: lupus nephritis; mismatch 0-2-2; previous transplant; CPRA: 11%; CMV negative to CMV negative; EBV positive; status post stent removal; induction therapy with 3 infusions of Thymoglobulin Diffuse proliferative lupus glomerulonephritis 2/13/2013 Disorder of kidney and ureter End stage renal disease 6/3/2014 7/10/14: Left radiocephalic AV fistula (snuffbox) and right IJ permcath insertion. Stage 4/5 Chronic Kidney Disease secondary to history of diffuse proliferative lupus nephritis. Starting the referral process to Medical Center for kidney transplant. Hypertension 2/13/2013 Kidney replaced by transplant 7/15/15 8/10/2015 Status post live donor kidney transplant as part of a paired exchange. Transplant kidney from another state. July 15, 2015; primary cause of kidney disease: lupus nephritis; mismatch 0-2-2; previous transplant; CPRA: 11%; CMV negative to CMV negative; EBV positive; status post stent removal; induction therapy with 3 infusions of Thymoglobulin |
| PRIOR_VAX: | |
| SPLTTYPE: | 810714 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-18-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Amoxicillin ? Cefuroxime Axetil ? Cefuroxime Sodium ? Dapsone ? Myfortic [Mycophenolate] ? Sulfanilamide Sulfanilamide, Sulfanilamide |
| V_FUNDBY: |
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