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.
Patient is a 18 y.o. male patient with a past medical history significant for lupus who presents with Pulmonary hemorrhage. About 2 days ago, pt developed fevers and worsening shortness of breath. T max 102 F at home. He did not note anything that relieved or exacerbated his difficulty breathing. He also reported fatigue, abdominal pain and several episodes of NBNB emesis the week prior to admission. No recently chest pain, diarrhea, hematuria, dysuria, headache or neck stiffness. Pt presented to ED yesterday and was treated with antibiotics and discharged, he came back today due to worsening shortness of breath. Of note, pt was had 2 hospital admissions in the last 2 months, most recently for febrile neutropenia. Completed 2 doses of COVID vaccine. At ED, pt arrived with temp of 39.1, HR 143, RR 28, BP 117/67, SpO2 98% EKG with sinus tachycardia, no ST elevations/depressions or other acute ischemic changes. CXR revealed diffuse bilateral airspace opacities without pneumothorax. CBC 10.6>8.1/27.4<203, CMP 137/3.9/110/22/18/0.58<99, Ca 7, Alb 1.5, AST 15, ALT 86. UA negative for infection, no protein. CXR with progressive diffuse bilateral airspace opacity with air bronchograms, no pneumothorax. Cultures obtained. Pt was treated with vancomycin, cefepime and levofloxacin for sepsis and concern for pneumonia and given IV fluids per ED sepsis protocol. He was also given Solumedrol 1g. Less likely COVID given vaccination status and negative COVID swab. Due to worsening tachycardia and hypoxia on oxygen, pt was intubated and bleeding in airway was noted. Pt was admitted to the ICU, and pulm crit care performed a bronchoscopy that revealed diffuse alveolar hemorrhage. Repeat CXR in ICU revealed almost complete white out of both lungs. Pt was bagged for almost an hour due to persistent hypoxia. Pt was subsequently transferred to CW due to concern for requiring VV ECMO. On arrival to CW CICU, pt satting low 70s, vent settings titrated and sats improved to 90s. He was continued on Epi, Norepi, Dexmed and Fentanyl. Rheum history: Lupus diagnosed on renal biopsy 7/21/21, on bactrim prophylaxis recently, recent treatment with rituximab, on daily prednisone 30 mg BID Parents spanish speaking. Patient is a 18 y.o. male patient with a past medical history significant for lupus who presents with acute hypoxic respiratory failure requiring mechanical ventilation, septic shock and pulmonary hemorrhage. It is unclear at this time if his pulmonary hemorrhage is related to lupus vs idiopathic process. COVID negative and fully vaccinated, making COVID pneumonia less likely. He is maintaining his MAPs on epinephrine and arterial sats in the 90s on SIMV PC PS. He is candidate for VV ECMO but does not require it at this time due to decreasing vent settings. Rheumatology consulted and large lab workup is underway. Plan to continue broad spectrum antibiotics, close monitoring of hemodynamics and to continue to watch for signs of recurrent pulmonary hemorrhage. Pt requires CICU due to risk of acute cardiopulmonary decompensation. Patient was an 18 yo man with Dx of lupus who presented to hospital (transferred from outside hospital) in respiratory failure due to pulmonary hemorrhage. Due to worsening hypoxemia in spite of mechanical ventilation he was started on VV ECMO. While on VV ECMO, he had a cardiac arrest due to right ventricular failure and was converted to VA ECMO. He also developed acute renal failure and was on CRRT. On 9/14, while on VA ECMO, he developed a massive MI due to occlusion of his LAD and circumflex coronaries. This heart injury was assessed as non recoverable and all further care was considered futile. After given time to the family to say their goodbyes, patient was removed from VA ECMO support and pronounced dead with his family at the bedside on 9/15/2021 at 7:30 am
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (MODERNA)) | 2 | COVID19 | MODERNA | unavailable | IM |
RECVDATE: | 09-15-2021 | RPT_DATE: |
CAGE_YR: | 18 |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | 09-15-2021 |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | 15 |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Results for patient 9/1/2021 04:10 Arterial pH: 7.35 Arterial pCO2: 31.5 (L) Arterial pO2: 71.6 Arterial HCO3: 16.8 (L) Arterial Total CO2: 17.8 (L) Arterial Base Excess/Deficit: -7.6 Arterial Measured O2 Saturation: 90.0 Sodium Blood: 136 Potassium Blood: 4.4 Chloride Blood: 114 (H) Carbon Dioxide: 17.8 (L) Glucose Blood: 241 (H) BUN: 27 (H) Creatinine Blood: 0.82 Calcium Blood: 6.8 (L) WBC: 11.3 (H) RBC: 2.33 (L) Hemoglobin: 7.2 (L) Hematocrit: 22.8 (L) MCV: 97.9 MCH: 30.9 MCHC: 31.6 (L) Platelet Count: 184 MPV: 11.4 (H) RDW: 17.9 (H) Nucleated RBC Automated: 0.2 (H) Differential Type: MANUAL DIFF % Seg: 97.5 (H) % Lymphocytes: 1.0 (L) % Monocytes: 1.0 % Meta: 0.5 (H) Absolute Neutrophils: 11.018 (H) Abs Seg: 11.02 (H) Absolute Lymphocytes: 0.11 (L) Absolute Monocytes: 0.11 Abs Meta: 0.06 (H) Total Cells Counted: 198 Anisocytosis: SLIGHT Results for patient 9/1/2021 13:38 Arterial pH: 7.11 (LL) Arterial pCO2: 62.6 (HH) Arterial pO2: 70.3 Arterial HCO3: 18.8 (L) Arterial Total CO2: 20.7 Arterial Base Excess/Deficit: -12.7 Arterial Measured O2 Saturation: 85.2 (L) Sodium Blood: 137 Potassium Blood: 4.7 Chloride Blood: 119 (H) Carbon Dioxide: 20.7 (L) Glucose Blood: 226 (H) BUN: 31 (H) Creatinine Blood: 0.89 Calcium Blood: 6.6 (L) WBC: 17.0 (H) RBC: 2.90 (L) Hemoglobin: 8.9 (L) Hematocrit: 28.7 (L) MCV: 99.0 MCH: 30.7 MCHC: 31.0 (L) Platelet Count: 187 MPV: 11.0 (H) RDW: 16.9 (H) Nucleated RBC Automated: 0.1 (H) Differential Type: AUTOMATED DIFF % Neutrophils: 94.1 (H) % Imm Gran: 1.2 (H) % Lymphocytes: 1.1 (L) % Monocytes: 3.2 % Eosinophils: 0.0 % Basophils: 0.4 Absolute Neutrophils: 15.930 (H) Abs Imm Gran: 0.21 (H) Absolute Lymphocytes: 0.19 (L) Absolute Monocytes: 0.55 (H) Absolute Eosinophils: 0.00 Absolute Basophils: 0.07 Results for patient 9/4/2021 16:04 Arterial pH: 7.40 Arterial pCO2: 47.4 (H) Arterial pO2: 60.2 (L) Arterial HCO3: 28.5 (H) Arterial Total CO2: 29.9 (H) Arterial Base Excess/Deficit: 3.7 Arterial Measured O2 Saturation: 89.7 (L) Sodium Blood: 146 (H) Potassium Blood: 3.0 (L) Chloride Blood: 106 Carbon Dioxide: 29.9 Glucose Blood: 176 (H) BUN: 67 (HH) Creatinine Blood: 2.53 (H) Calcium Blood: 8.3 (L) Ionized Calcium: 4.66 Magnesium Blood: 1.9 WBC: 8.7 RBC: 2.47 (L) Hemoglobin: 7.2 (L) Hematocrit: 21.9 (L) MCV: 88.7 MCH: 29.1 MCHC: 32.9 Platelet Count: 96 (L) MPV: 11.2 (H) RDW: 16.1 (H) Nucleated RBC Automated: 0.6 (H) Differential Type: AUTOMATED DIFF % Neutrophils: 93.0 (H) % Imm Gran: 1.6 (H) % Lymphocytes: 1.5 (L) % Monocytes: 3.7 % Eosinophils: 0.0 % Basophils: 0.2 Absolute Neutrophils: 8.120 (H) Abs Imm Gran: 0.14 (H) Absolute Lymphocytes: 0.13 (L) Absolute Monocytes: 0.32 Absolute Eosinophils: 0.00 Absolute Basophils: 0.02 PT Result: 16.1 (H) INR Result: 1.25 PTT Result: 94.3 (H) TT Result: >100.0 (H) D Dimer: 2.56 (H) Fibrinogen: 192 (L) Heparin Level.: 0.36 PREOPERATIVE DIAGNOSIS: STEMI POSTOPERATIVE DIAGNOSIS: stemi Procedure(s): Left heart catheterization with coronary angiography JL3 and SCR ANESTHESIA: General ESTIMATED BLOOD LOSS: Minimal COMPLICATIONS: None CONDITION: Critical ACCESS: 5 Fr left FA FINDINGS: Totally occluded left anterior descending & circumflex coronary arteries. Right coronary artery patent |
V_ADMINBY: | |
OTHER_MEDS: | ergocalciferol, vitamin D2, 50,000 Units capsule pimecrolimus cream (ELIDEL) 1 % cream triamcinolone ointment (KENALOG) 0.1 % ointment |
CUR_ILL: | Lupus |
HISTORY: | Lupus diagnosis on 7/21/21 |
PRIOR_VAX: | |
SPLTTYPE: | |
FORM_VERS: | |
TODAYS_DATE: | 09-15-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | Bactrim |
V_FUNDBY: |
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