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.
On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (MODERNA)) | 1 | COVID19 | MODERNA | 037K20A | IM | LA |
| RECVDATE: | 01-12-2021 | RPT_DATE: |
| CAGE_YR: | 64 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 8 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | 12/31/2020: WBC 4.8 K/uL ; RBC 4.23 M/Ul; Hgb 12.9 g/dL; Hct 38.6%; Platelets 63 k/uL; Blood culture: No growth; Urine culture: Moderate mixed flora; Lipase 55 U/L; Procalcitonin 2.38 ng/mL; BNP 90; Lactic acid 7.2 mmo/L; CRP 110.5 mg/L; Potassium 3.4 mmol/L; INR 2.4 ; CT Angio Chest: Pulmonary embolism left and right; Moderate pachy peripheral ground glass right infiltrates Heavy triple vessel coronary calcification with heavy left main coronary calcification. Mild inflammatory stranding around the normal appearing pancreatic head suggesting pancreatitis. Moderate thickening of the wall of distal esophagus associate with small hiatal hernia: EKG on 12/31/2020: Sinus tachycardia; EKG on 1/2/2021: Atrial fibrillation with rapid RVR; On 1/3/2021: CT abdomen with contrast liver cirrhosis with portal venous hypertension, multiple splenic granulomata, recanalization of the umbilical vein. Third spacing with body wall edema and mild pericholecystic ascites. The mild stranding in the upper abdominal fat could represent mild pericholecystic ascites. Mostly liquid stool throughout colon without findings of intestinal obstruction. |
| V_ADMINBY: | SEN |
| OTHER_MEDS: | Zyprexa 15 mg tablet once daily Levothyroxine 100 mcg tablet once daily Metformin ER 500 mg tablet 2 tablets by mouth twice daily Divalproex DR 240 mg Give 3 tablets by mouth once daily Metoprolol tartrate 50 mg tablet by mouth twice daily |
| CUR_ILL: | COVID 19 (tested positive on 11/27/2020). Appeared to have recovered, but had some weight loss as well as persistent weakness, activity intolerance. |
| HISTORY: | Schizophrenia Dementia without behavioral disturbance Personal history of covid-19 (Tested positive on 11/27/2020) Type 2 diabetes mellitus Morbid Obesity Essential Hypertension BPH with LUTS Allergic rhinitis Hypothyroidism Seborrheic dermatitis Fatty liver disease Pancytopenia Glaucoma History of nicotine dependence, cigarettes |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 01-12-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | Y |
| ALLERGIES: | Ciclopirox- erythema and pruritus Naltrexone- reaction dizziness Topiramate- mood changes |
| V_FUNDBY: |
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