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.
Death unexplained; This is a spontaneous report from a contactable Pharmacist downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RN20210166 This is a report received from the Regulatory Authority. A 93-year-old male patient received first dose bnt162b2 (COMIRNATY, lot/batch: EM0477) , intramuscular on 15Jan2021 at single dose for covid-19 vaccination. Medical history included complete tachyarrhythmia by atrial fibrillation and mitral insufficiency with a large leak which were treated with cimetidine, movicol, fumafer, furosemide, bisoprolol, paracetamol if needed and zopiclone, He was hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction at 40 percent with moderate left ventricular dysfunction (NT pro Brain Natriuretic Peptide: 17 965pg / ml) on arrhythmia complete by atrial fibrillation + pneumopathy and functional renal failure under furosemide (LASILIX), severe hyponatremia, digestive haemorrhage due to probable ulcerative erosive gastritis, severe neurocognitive troubles and difficult home maintenance, repeated falls in the service. Sensation of discomfort without loss of consciousness on 08Jan2021 then on 14Jan2021. Cardiac decompensation table since 12Jan2021 with an increase in diuretics. Cardiac stabilized although fragile. Concomitant medication included cimetidine, macrogol 3350/ potassium chloride/ sodium bicarbonate/ sodium chloride (MOVICOL), ferrous fumarate (FUMAFER), furosemide, bisoprolol , paracetamol, zopiclone. The patient previously took furosemide (LASILIX) for functional renal failure. The patient experienced death unexplained on 19Jan2021, it was reported that he suddenly dead on 19Jan2021 in the evening, he was found dead reactive around 10 p.m(19Jan2021 22:00). An autopsy was not performed. The relaunched clinicians do not put forward any hypothesis on the cause of death. Lab data included an electrocardiogram was performed on 08Jan2021, it was unchanged. Lonogram on 15Jan2021 in the morning, stable: Na 136 mM, K 4.6 mM, Urea 15 mM, creatinine 129 uM, Albumin 29 g / l, Haemoglobin 10.6 g / dl Leukocytes at 6.9 and C-reactive protein (CRP) 64 mg / L. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EM0477 | OT | Unknown |
| RECVDATE: | 02-04-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 01-19-2021 |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210115; Test Name: Albumin; Result Unstructured Data: Test Result:29 g/l; Test Date: 20210115; Test Name: creatinine; Result Unstructured Data: Test Result:129 M; Test Date: 20210115; Test Name: K; Result Unstructured Data: Test Result:4.6 mM; Test Date: 20210115; Test Name: Na; Result Unstructured Data: Test Result:136 mM; Test Date: 20210115; Test Name: Urea; Result Unstructured Data: Test Result:15 mM; Test Date: 20210115; Test Name: CRP; Result Unstructured Data: Test Result:64 mg/l; Test Date: 20210108; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unchanged; Test Date: 20210115; Test Name: Hb; Result Unstructured Data: Test Result:10.6 g/dl; Test Date: 20210115; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.9 |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | CIMETIDINE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FUMAFER; FUROSEMIDE; BISOPROLOL; PARACETAMOL; ZOPICLONE |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Decompensation cardiac (hospitalized on 18Dec2020 for global cardiac decompensation on mitral insufficiency and left ventricular ejection fraction); Fall; Functional renal failure; General discomfort (then on 14Jan2021); Haemorrhage of digestive tract; Hyponatremia; Left ventricular dysfunction (moderate); Left ventricular ejection fraction; Mitral insufficiency; Neurocognitive deficit; Pneumopathy; Tachyarrhythmia absoluta; Ulcerative gastritis |
| PRIOR_VAX: | |
| SPLTTYPE: | FRPFIZER INC2021088340 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 02-02-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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