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.
Notes APRN (Nurse Practitioner) ? ? Pediatrics Cosigned by: MD at 12/20/2020 11:30 AM Expand All Collapse All COVID VACCINE CLINIC 12/18/2020 Patient: DOB: Date: 12/18/2020 MRN: 10148412 Subjective Patient is a 48 y.o. female who was seen at Vaccine Clinic today for her first dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience tingling in hands and feet. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, lightheadedness, dizziness and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Patient with PMH of fibromyalgia and rheumatoid arthritis No history of vaccine or medication reaction previously Review of Systems Constitutional: Negative for chills and fatigue. HENT: Negative for congestion, facial swelling, rhinorrhea, sinus pain, sneezing, sore throat and trouble swallowing. Respiratory: Negative for cough and shortness of breath. Musculoskeletal: Negative for back pain, myalgias and neck stiffness. Skin: Negative for rash. Neurological: Tingling in hands and feet bilaterally Objective Vitals Vitals: 12/18/20 1255 12/18/20 1318 12/18/20 1345 BP: (!) 143/86 (!) 129/91 131/83 BP Location: Left arm Left arm Left arm Pulse: 79 72 69 SpO2: 100% 100% 100% Physical Exam Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing or diaphoretic. HENT: Head: Normocephalic. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. Musculoskeletal: Normal range of motion. Comments: C/o tinglinig to feet and hands bilaterally Normal ROM Grip strength equal bilaterally No lightheadedness or weakness Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not pale. Findings: No erythema or rash. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Assessment/Plan Treatment included antihistamines. Follow up response to treatment:good Patient discharge: Stable to go home and follow up with PCP Benadryl given at 1314 At 1330 reports significant reduction to tingling in hands and resolved in feet 1340 - tingling has resolved 1350 - Escorted by pharmacist out of building. VSS Patient provided with paperwork about immunization Strict instruction to go to the ED if shortness of breath, cough, difficulty swallowing, tingling/weakness, or other allergic symptoms occur. Patient verbalized understanding APRN Electronically Signed 12/18/2020 2:00 PM Division of Health 3 of 3
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | IM | RA |
| RECVDATE: | 12-22-2020 | RPT_DATE: |
| CAGE_YR: | 48 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-22-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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