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:
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Patient expired due to Large Bowel Obstruction. (found to be COVID positive) Attestation signed by MD at 8/7/2021 11:02 PM (Updated) General Surgery Pt seen and examined on 8/6/2021 with the surgery team, all labs, vitals, imaging and objective data reviewed. Agree with the below note with the following addendum: The patient is a 75-year-old female with multiple chronic medical comorbidities presenting to the emergency department with a complaint of abdominal pain. She states that her pain just started this morning and really worsened around noon. Has been rapidly worsening since that time. She also notes significant nausea and abdominal distention. She reportedly underwent colonoscopy several years ago which was incomplete due to inability to pass the colonoscope. She reports that for the last several months the caliber of her stools has been very small. AAOx3. Writhing in pain. No focal Neuro-deficits Non-labored respirations. Very distended, severely ttp throughout Moving all extremities A/P: 75 year old female with large bowel obstruction -large bowel obstruction: The patient's CT scan and history are consistent with a diagnosis of large bowel obstruction. She has evidence of severe dilation of all proximal colon. The etiology of her obstruction is unclear. It could be related to malignancy or, based on her history, it is more likely related to chronic diverticular inflammation. Regardless of its etiology the patient is in distress and I am concerned that she is at high risk for colon ischemia or perforation. She will need emergent operative exploration. I discussed this case with the Dr with the colorectal surgery service. Following our discussion the decision is made that the general surgery service should take the patient to the operating room. I discussed the plan for operative intervention with the patient as well as her daughter. I will plan for an exploratory laparotomy with sigmoid colectomy. Risks of the surgery are significant. We discussed the risks which include bleeding, infection, need for reoperation, need for multiple operations, cardiopulmonary complications from anesthesia, ostomy creation which may be temporary or permanent, hernia, and need for postoperative ventilator support. The patient voices understanding of these and is eager to proceed with surgery. -COVID positive: The patient has already had COVID and has since been vaccinated. She is PCR positive for COVID today. I will take respiratory precautions. Is unclear whether this is an active COVID infection or not. -Coagulopathy: The patient takes eliquis. Reverse with PCC at this time for emergent operative intervention. -hypoxia: The patient is hypoxic and requiring supplemental oxygen at this time. This is unclear whether this is related to her COVID diagnosis for her severe abdominal distention. -sepsis: The patient has evidence of sepsis with the source of ischemic colon. Administer broad-spectrum antibiotics at this time. Procedure the operating room for source control. Continue with hemodynamic support.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EN6199 | IM | UN |
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | ER2613 | IM | UN |
| RECVDATE: | 08-19-2021 | RPT_DATE: |
| CAGE_YR: | 75 |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 08-07-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | HOSPITAL COURSE: Patient presented to the hospital with a one day history of abdominal pain and nausea. Found to have a large bowel obstruction and taken to the OR urgently for subtotal colectomy. Abthera placed and patient transferred to SICU for further treatment. Patient remained intubated and on maximum vasopressor support with no improvement. Bedside laparotomy preformed and patient's remaining bowel was found to be pan-ischemic. Family updated and decision to transition to comfort care once remaining family members arrived was made. Comfort care and terminal extubation initiated with the guidance of palliative care. Asystole was noted on monitor and exam preformed. Time of death 20:41. |
| V_ADMINBY: | |
| OTHER_MEDS: | albuterol HFA (PROVENTIL HFA, VENTOLIN HFA, PROAIR HFA) 108 (90 Base) MCG/ACT inhaler allopurinol (ZYLOPRIM) 300 MG tablet amoxicillin (AMOXIL) 500 MG capsule apixaban (ELIQUIS) 5 MG tablet aspirin 81 MG enteric coated tablet atorvastatin ( |
| CUR_ILL: | on CPAP; diabetes mellitus |
| HISTORY: | Asthma OSA on CPAP Hypoxia Diastolic dysfunction CAD (coronary artery disease) Essential hypertension Anxiety Dyslipidemia Morbid obesity Hypothyroid DM type 2 (diabetes mellitus, type 2) CKD (chronic kidney disease), stage III Pulmonary hypertension Type 2 diabetes mellitus without complication Nonrheumatic aortic valve stenosis Acute bronchitis, unspecified organism Bradycardia Type 2 diabetes mellitus with both eyes affected by mild nonproliferative retinopathy without macular edema, with long-term current use of insulin Posterior vitreous detachment of right eye Regular astigmatism of both eyes Moderate persistent asthma without complication Chest pain PAF (paroxysmal atrial fibrillation) Dry eyes, bilateral Large bowel obstruction |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 08-19-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Iodine containing dye; morphine; sulfa drugs |
| V_FUNDBY: |
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