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.
Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 011J20A | IM | RA |
| RECVDATE: | 01-13-2021 | RPT_DATE: |
| CAGE_YR: | 84 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 11 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | 1/7/21: XR chest 1 view: IMPRESSION: No acute cardiopulmonary disease RIGHT UPPER QUADRANT ULTRASOUND: IMPRESSION: Limited evaluation of pancreatic tail due to overlying bowel gas. The remainder of the pancreatic parenchyma is difficult to differentiate from surrounding retroperitoneal fat. The pancreatic duct is top normal caliber at 3 mm. Unremarkable liver. Slightly distended gallbladder containing thickened partially congealed bile. No calcified stones. No sonographic evidence of cholecystitis. The extrahepatic ducts measure up to 8 mm, normal for patient's age. Stable septated right side renal cyst compared to 2018. Troponin I: 0.08 Bilirubin Direct: 0.91 Blood Culture: Salmonella Gram Stain: gram negative Rods LDH: 292 WBC: 19.24 1/8/21: lower limb venous duplex study, complete bilateral: CONCLUSION: Impression: RIGHT LOWER LIMB: No evidence of acute or chronic deep vein thrombosis. No evidence of superficial thrombophlebitis noted. LEFT LOWER LIMB: No evidence of acute or chronic deep vein thrombosis. No evidence of superficial thrombophlebitis noted. CT ABDOMEN AND PELVIS WITHOUT IV CONTRAST: IMPRESSION: 1. No definite acute intra-abdominal abnormality. 2. Distended gallbladder with cholelithiasis but no discernible pericholecystic inflammatory changes. There is a tiny calcification in the porta hepatis near the base of the gallbladder, relationship to ductal structures cannot be determined on noncontrast imaging although could potentially be vascular. There does not appear to be intrahepatic duct dilatation. 3. 1 cm indeterminate right renal nodule. 4. Possible small pancreatic cysts. 5. Colonic diverticulosis without focal diverticulitis. 6. Mild splenomegaly. 7. Trace abdominal ascites. Although contrast imaging is preferential to evaluate the parenchymal organs, patient has impaired renal function, and noncontrast MRCP may still provide additional information regarding parenchymal organs and ductal structure findings as described. Limited study without IV contrast. 1/9/21 XR knee 1 or 2 vw right IMPRESSION: No acute osseous abnormality. Degenerative changes as described 1/11/21 XR chest portable IMPRESSION: Mild pulmonary vascular congestion. 1/12/21 MRI OF THE ABDOMEN WITHOUT CONTRAST WITH MRCP IMPRESSION: Dominant 2.2 cm stone in the gallbladder neck with prominent distention of the gallbladder but without gallbladder wall thickening. Trace nonspecific pericholecystic fluid in this patient with trace perihepatic and upper abdominal ascites as well as mesenteric and retroperitoneal edema. No choledocholithiasis. Borderline common duct. Minor prominence of central intrahepatic biliary tree. Multiple cystic pancreatic lesions most consistent with intraductal papillary mucinous pancreatic neoplasm. The largest these measures up to 21 mm in the pancreatic head. No main pancreatic ductal enlargement. Based on institutional consensus and recent literature gastroenterology consult and/or surgical oncology consult is recommended. By these criteria, endoscopic ultrasound is likely warranted. Considerations related to the patient's age and/or comorbidities may be used to alter these recommendations. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Medication List As of 1/6/2021 11:25 AM amLODIPine Besylate 5 mg Oral Apixaban 5 mg Oral 2 times daily Aspirin 81 mg Oral Daily Cholecalciferol 10,000 Units Oral 2 times weekly cloNIDine HCl 0.1 mg/day Transdermal Weekly Clopidogrel B |
| CUR_ILL: | |
| HISTORY: | ? Atrial fibrillation (HCC) ? Cancer (HCC) prostate cancer ? Cardiac disease ? CHF (congestive heart failure) (HCC) ? Diabetes mellitus (HCC) ? GERD (gastroesophageal reflux disease) ? Hyperlipidemia ? Hypertension ? Renal disorder end stage renal |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 01-13-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Atorvastatin Iodinated Diagnostic Agents Metrizamide Nsaids All statins Tolmetin |
| V_FUNDBY: |
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