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.
Progress Notes; Nurse Practitioner Cosign Needed Expand All Collapse All COVID VACCINE CLINIC 12/22/2020 Date: 12/22/2020 Subjective Patient is a 60 y.o. female who 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 was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience Headache over the front of the head. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis. Finger stick BS 101 12:15 pm granola bar and water given Review of Systems Neurological: Positive for headaches. All other systems reviewed and are negative. Objective Vitals Vitals: 12/22/20 1203 12/22/20 1226 BP: (!) 158/81 (!) 153/75 BP Location: Left arm Left arm Patient Position: Sitting Sitting Pulse: 76 72 SpO2: 98% 98% Physical Exam Vitals signs and nursing note reviewed. HENT: Head: Normocephalic. Nose: Nose normal. Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: Pupils: Pupils are equal, round, and reactive to light. Neck: Musculoskeletal: Normal range of motion. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Normal range of motion. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP. Pt reports headache went away after she ate. No new symptoms manifested. Pt released at 12:30 pm Electronically Signed 12/22/2020 12:29 PM
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
| 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: | 60 |
| 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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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.