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 with progressive hypoxemia throughout the day despite multiple changes in ventilator settings/modes. HFOV discussed with family, but functional oscillator not available and was awaiting arrival of donor oscillator. She is not a candidate for ECMO due to pulmonary hemorrhage and thrombocytopenia with recent chemotherapy as well as BMI (morbidly obese). Trial on nitric oxide performed with minimal improvement (sats increased from 60% to 65-68%). She was noted to have increasing peaked T waves as well as development of Q waves concerning for hyperkalemia and worsening cardiac function consistent with multiorgan failure; perfusion was quite poor with mottled extremities and difficult to palpate central pulse
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 3 | COVID19 | PFIZER\BIONTECH | FF2590 | IM | LA |
RECVDATE: | 11-12-2021 | RPT_DATE: |
CAGE_YR: | 16 |
CAGE_MO: | |
DIED: | Y |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Pt expired 11/11/21 (Continued) despite vasopressor support. She was given a dose of bicarbonate with some brief improvement in saturations to 70s and increased heart rate but subsequently became asystolic and CPR was started. She was given epi x 2 doses as well as a dose of bicarbonate and was hand ventilated; there was significant blood backing up into her ETT. Parents at the bedside requested cessation of resuscitation efforts at that point and the patient was pronounced dead at 2036 on 11/11/21. The doctor of the heme/onc service made aware of the patient's death; she had been at the bedside earlier in the day and involved with the conversations regarding the patient's decline. |
V_ADMINBY: | PVT |
OTHER_MEDS: | Bactrim, dexamethasone, Ketorolac, Vanc, sodium chloride |
CUR_ILL: | ALL, hypertension, obesity, Type 2 Diabetes, Cdiff |
HISTORY: | ALL phase DI of treatment, hypertension, Diabetes, obesity |
PRIOR_VAX: | |
SPLTTYPE: | |
FORM_VERS: | |
TODAYS_DATE: | 11-12-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | NKA |
V_FUNDBY: |
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