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 was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines. She does report a history of similar reaction that occurs fairly regularly after drinking beverages containing alcohol. 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 flushed, warm face and ears. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, lip swelling and tongue swelling. This APP was notified of patient reaction and she was then assessed in the emergency bay area. Vitals Vitals: 12/17/20 1450 12/17/20 1500 12/17/20 1515 BP: (!) 153/73 120/60 138/70 BP Location: Right arm Right arm Right arm Patient Position: Sitting Semi-fowlers Sitting Pulse: 84 79 78 Resp: 14 14 14 SpO2: 100% 98% 98% Physical Exam Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished. No distress. HENT: Nose: Nose normal. Mouth/Throat: Oropharynx is clear and moist. Neck: No tracheal deviation present. Cardiovascular: Normal rate, regular rhythm and normal heart sounds. Pulmonary/Chest: Effort normal and breath sounds normal. No stridor. No respiratory distress. She has no wheezes. She has no rales. Musculoskeletal: General: No edema. Neurological: She is alert and oriented to person, place, and time. Skin: Skin is warm and dry. No rash noted. She is not diaphoretic. No erythema. Psychiatric: She has a normal mood and affect. Her behavior is normal. Thought content normal. Patient was observed x 35 minutes after receiving vaccination. All symptoms resolved within 20 minutes. No treatment was required. She reports some mild history of anxiety and questions if perhaps she was having a panic attack. She has medication to treat this at home if needed. She was observed x 35 minutes and then released.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | IM | LA |
| RECVDATE: | 12-18-2020 | RPT_DATE: |
| CAGE_YR: | 57 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | |
| V_ADMINBY: | PUB |
| OTHER_MEDS: | Medication List As of 12/17/2020 2:46 PM Cetirizine HCl 10 mg Oral PRN Cyclobenzaprine HCl 10 mg Oral 3 TIMES DAILY PRN Levothyroxine Sodium 50 MCG Take 1/2 tablet (25 mcg total) by mouth every morning before breakfast. LORazepam 0.5 M |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-18-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Lisinopril |
| V_FUNDBY: |
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