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.
3/13/21 ER HPI -> transferred to hospital 88 y.o. female who presents to the Hospital Emergency Department by private auto with her daughter. Apparently, the patient has a 2 day history of intractable nausea and vomiting. She states she has vomited more than 5 times over the last 2 days. She has become more and more weak. She states she has been having coffee-ground emesis. No definite fever. The patient had a similar episode to this a few months ago. The patient does take nightly ibuprofen. She also take iron on a daily basis because of chronic anemia. She is not on any blood thinners. When the patient did get to the ER she had an episode of vomiting and it did appear coffee-ground. She is having a little bit of epigastric abdominal pain. No history of GI bleed in the past 3/16 note from Hospital Hospital Course: 88 y.o. female with a past history significant for hypertension, renal artery stenosis, arthritis, skin cancer presented to hospital with nausea/vomiting and transferred to another hospital on 3/13/2021 for GI evaluation. Patient developed coffee ground emesis and had NG tube placed, yielding 1800 cc of coffee-ground emesis. She was also noted to be hypertensive. A CT done at the outside hospital revealed a large hiatal hernia with a significantly distended herniated portion of the stomach and a portion in the left upper quadrant compatible with a gastric outlet obstruction. Transferred to another hospital and GI consulted. Underwent EGD on 3/14 with results as noted below. Recommended to continue PPI, avoid NSAIDs if possible and repeat EGD in 8 weeks as outpatient. NG-tube removed and tolerated diet. No further bleeding noted. Hgb remained stable. Medically stable for discharge. Counseled on medication use and diet. Patient or daughter had no further questions or concerns on discharge.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | 031M20A | IM |
| RECVDATE: | 03-16-2021 | RPT_DATE: |
| CAGE_YR: | 88 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 4 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Pertinent Data/Imaging: Lab Results Component Value Date WBC 9.9 03/15/2021 HGB 10.8 (L) 03/16/2021 HCT 33.6 (L) 03/15/2021 MCV 98.5 (H) 03/15/2021 PLT 223 03/15/2021 Lab Results Component Value Date CREATININE 2.4 (H) 03/13/2021 BUN 47 (H) 03/13/2021 NA 144 03/13/2021 K 3.8 03/13/2021 CL 97 (L) 03/13/2021 CO2 36 (H) 03/13/2021 Lab Results Component Value Date INR 1.1 01/25/2020 PROTIME 11.1 01/25/2020 XR CHEST PORTABLE Result Date: 3/14/2021 AP chest HISTORY: Infection. COMPARISON: 1/25/2020 FINDINGS: Mild atelectasis or infiltrate at the left lung base. Left lung base is not well evaluated due to cardiomegaly. No pleural effusion or pneumothorax was seen. Nasogastric tube tip terminates over the cardiac silhouette, probably within a large hiatal hernia. The visualized osseous structures appear intact. XR CHEST PORTABLE Result Date: 3/13/2021 EXAM DESCRIPTION: XR CHEST PORTABLE CLINICAL HISTORY: 88 years Female, nausea and vomiting COMPARISON: 10/25/2019 TECHNIQUE: Upright AP view FINDINGS: There is no focal consolidation, pleural effusion or pneumothorax. The cardiac silhouette and pulmonary vascularity are within normal limits. Degenerative changes are seen in the thoracic spine. A large hiatal hernia is seen. IMPRESSION: No acute cardiopulmonary pathology. Large hiatal hernia. CT ABDOMEN PELVIS WO CONTRAST Result Date: 3/13/2021 The EXAMINATION: CT ABDOMEN PELVIS WO CONTRAST CLINICAL HISTORY: 88 years Female,Intractable nausea/vomiting COMPARISON: 11/29/2018 TECHNIQUE: Axial imaging and 2-D reformatting performed from the level of the lung bases through the pelvis without IV and without oral contrast. This exam was performed according to our departmental dose-optimization program, which includes automated exposure control, adjustment of the mA and/or kV according to patient size and/or use of iterative reconstruction technique. FINDINGS: Degenerative changes are seen in the visualized spine. The visualized osseous structures are osteopenic. The patient is status post left total hip arthroplasty. Mild atelectasis is seen at the lung bases. There is a large hiatal hernia which is not fully visualized at its proximal aspect. The distal esophagus appears fluid-filled. The GE junction is not well visualized. On the prior examination, the GE junction appears to be in normal location. This is suggestive of a paraesophageal hiatal hernia. There is significant distention of the herniated portion of the hernia in the lower thorax and a portion in the left upper quadrant. The gastric outlet tract is not fully delineated but could be located in the hiatus. The duodenum is normal in caliber. The small bowel is not dilated. Large amount of fecal matter is seen throughout the colon with the largest amount in the rectum. There is no abdominal or pelvic ascites. The noncontrast appearance of the liver, biliary tree, gallbladder, spleen, pancreas and adrenal glands are unremarkable. Nonobstructive bilateral renal calculi are seen. Right renal cysts are also visualized. The abdominal aorta is normal in caliber. The fetus vascular calcifications are seen along the abdominal aorta and common iliac arteries. There is no retroperitoneal lymphadenopathy. The urinary bladder, uterus and adnexa appear unremarkable. IMPRESSION: 1. Large hiatal hernia whose superior aspect is not visualized. Significantly distended herniated portion of the stomach and the portion in the left upper quadrant compatible with gastric outlet obstruction. Gastroduodenal junction not well seen and may be located at the hiatus. An underlying volvulus cannot be excluded. 2. Large fecal retention in the colon and rectum. Fecal impaction cannot be excluded. No small bowel obstruction. |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | Current Outpatient Medications: ? amLODIPine (NORVASC) 5 MG tablet, Take 1 tablet (5 mg) by mouth daily, Disp: 90 tablet, Rfl: 1 ? Apoaequorin (PREVAGEN EXTRA STRENGTH) 20 MG CAPS, Take 1 capsule by mouth daily, Disp: , Rfl: ? cephALEX |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 03-16-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | nka |
| V_FUNDBY: |
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