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.
First Pfizer COVID 19 given IM 6/3/21 ,second dose 6/28/21 lot no EW0168. Patient reports that he was well until 08/01/2021. He presented to the Emergency Room on 08/03/2021 with concerns of chest pain, shortness of breath, which had been ongoing for the last 2 days. He initially started with a history of diarrhea, abdominal pain, and low-grade fever. Both he and his brother had the same symptoms at the same time On 08/01/2021, he had gone swimming in the lake at that time and thought it was due to exertion, but he developed chest pain and shortness of breath and his heart beating fast(palpable tachycardia). Over the next 24 hours, his diarrhea resolved and his fever discontinued, but he continued to have chest pain intermittently throughout the day and shortness of breath. He went to Hospital on 08/03/2021 and they transferred him, as they noted that he had an elevated troponin at 30 and EKG changes with ST-segment elevation and depression. He was actually feeling much better. He had no headache, no history of seizures, no dizziness, no fainting, and a little lightheadedness. Occasionally his pain would extend to the jaw, but no radiation to the back. The upper abdominal pain he had was in the epigastrium. His appetite has now come back to normal. He is able to drink, able to keep fluids down, and his chest pain has almost resolved in the last 36 hours. He also has no diarrhea, and does not have any joint pains. No skin rash. Initially, he felt the heart rate going fast, but now he does not feel any tachycardia. He has had no chills. Admitted 8/3/21 -8/7/21
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | EW0168 | IM | RA |
RECVDATE: | 08-17-2021 | RPT_DATE: |
CAGE_YR: | 14 |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | Y |
HOSPDAYS: | 4 |
X_STAY: | U |
DISABLE: | U |
RECOVD: | Y |
LAB_DATA: | his troponin was 4.6, and 0.48 on discharge BNP was 84. Sedimentation rate was 14. WBC was 5400, hemoglobin 15.6, monocytes 12%, 19% lymphocytes, neutrophils 69%, and ferritin 218. Mycoplasma antibody was positive for IgG and IgM, IFA negative. Adenovirus PCR- Plasma Result- ADVPP 8/3/2021 22:44 CDT Negative & CMV DNA Detection PCR, Blood CMV DNA Detection P... 8/3/2021 22:44 CDT Undetected IU/mL & Enterovirus PCR- Plasma Negative Epstein Barr Virus by ... 8/3/2021 Undetected IU/mL & Parvovirus B19 PCR- Plasma 8/3/2021 Negative & HHV6 negative PCR SARS-CoV-2 IgG antibody was negative 8/4/2`1. Epstein-Barr virus undetected. RV panel negative. COVID PCR negative. Chest x-ray with no focal consolidation, normal cardiothymic shadow. Sodium was 139, procalcitonin 0.16, CRP 11.05, magnesium 1.9, albumin 4.1, ALT 31, and AST 111. SARS COV 2 spike ab semi Quant (Clinic) >250U/ml 8/5/21 |
V_ADMINBY: | PVT |
OTHER_MEDS: | none |
CUR_ILL: | Ill with anosmia ,chills and low grade fever, malaise in December 2020 4 members in family ill in December Dad tested positive for Coronavirus PCR ,others not tested |
HISTORY: | None |
PRIOR_VAX: | |
SPLTTYPE: | |
FORM_VERS: | |
TODAYS_DATE: | 08-17-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | None |
V_FUNDBY: |
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