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 reports that she also had a shingles and pneumonia vaccination on Monday 12/14/2020. She confirmed with both her PCP and transplant specialist that okay to receive all vaccinations. 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 tongue tingling and swelling specific to the left side of her tongue. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, dizziness and lip swelling. She reports similar reactions after receiving other vaccinations. States that those symptoms always resolved with time and never required any treatment. This APP was notified of patient reaction and she was then assessed in the emergency bay area. Vitals Vitals: 12/17/20 1545 12/17/20 1555 12/17/20 1620 BP: 128/85 116/72 126/73 BP Location: Left arm Left arm Left arm Patient Position: Sitting Sitting Sitting Pulse: (!) 109 100 99 Resp: 12 12 12 SpO2: 99% 97% 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's health history, medications and allergies were reviewed. She denied any further symptoms and the tongue numbness/swelling resolved in 30 minutes. She specifically denied any difficulty swallowing or breathing. No treatment was required. Pharmacy responded and did advise that current recommendations include no other vaccinations within two weeks of COVID. Discussed with patient. She is advised to notify staff of this reaction when receiving her 2nd dose. Patient release after 45 minutes of observation.
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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 3:24 PM Calcium Citrate-Vitamin D 315-200 MG-UNIT Oral 3 TIMES DAILY Patient taking differently: Take 1 tablet by mouth 2 (two) times daily. DULoxetine HCl 30 MG TAKE 3 CAPSULES(90 MG) BY MOUTH DAILY |
| CUR_ILL: | |
| HISTORY: | She has a past medical history of Cirrhosis of liver with ascites (2008), Depression, Diabetes mellitus type I, Double vision, GERD (gastroesophageal reflux disease), Hearing loss, History of liver transplant, History of stroke (2008), Hyperlipidemia, Obstructive sleep apnea, OSA (obstructive sleep apnea), Osteoporosis, Pain, chronic, Psoriasis (2015), Psoriatic arthropathy, and Squamous cell skin cancer (07/10/2019). She has a past surgical history that includes Liver transplant (2008); Breast reduction surgery; reduction mammoplasty; Colonoscopy (2009); pr colonoscopy w/biopsy single/multiple (2014); knee surgery; Cholecystectomy; Incisional hernia repair (2015); and Breast biopsy (Right, 2015). |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-18-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Sulfa antibiotics |
| V_FUNDBY: |
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