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.
Date: 12/21/2020 Subjective Patient is a 33 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 feelings of hypoglycemia. She checked her blood glucose with her own monitor and had 77 at 1104. She chewed 1 glucose tab that she had in her purse. She noted some difficulty with swallowing it and notified clinic staff. Associated dizziness and was escorted by clinic staff to the emergency bay. This provider was notified of patient reaction and she was then assessed in the emergency bay area. She denied difficulty breathing and chest pain, history of adverse reactions with prior vaccinations or allergies to medications with the exception of spironolactone. Pateint had already been given a bottle of water by clinic staff and reported that the glucose tablet went down easier following the water. She took a second glucose tab sometime before 1113. She rechecked her sugar and had slight increase of 79. She did eat breakfast this morning about 0800 and had a protein bar right before her arrival today. Monitored patient for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea and increased work of breathing, vomiting, abdominal pain, hypotension and chest pain. Review of Systems HENT: Positive for trouble swallowing. Negative for facial swelling, hearing loss, rhinorrhea and voice change. Eyes: Negative for redness. Respiratory: Negative for cough, chest tightness and shortness of breath. Cardiovascular: Negative for chest pain. Skin: Negative for color change, pallor and rash. Neurological: Positive for dizziness. Negative for syncope and speech difficulty. Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious. Objective Vitals There were no vitals filed for this visit. Physical Exam Constitutional: General: She is not in acute distress. HENT: Head: Normocephalic and atraumatic. Nose: No rhinorrhea. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Skin: General: Skin is warm and dry. Coloration: Skin is not pale. Findings: No rash. Neurological: Motor: No weakness. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Patient is a 33-year-old female who has a 15-year history of type 2 diabetes, and experienced a hypoglycemic event without complaint of chest pain or shortness of breath. Vital signs obtained at 1105 with blood pressure within normal limits at 132/88, heart rate 83 and 98% O2 saturation on room air. Patient continued to compensate appropriately and reported feeling slightly better. Glucose checks repeated by patient at 1117 was 84, vital signs were blood pressure 116/80, heart rate 89, O2 saturation of 98% on room air. She continues to deny chest pain, shortness of breath or difficulty swallowing at this time. At 1117 a 10 mg cetirizine was administered by mouth. Patient was able to swallow this with a small sip of water without any difficulty. 1121, patient continues to deny chest pain or shortness of breath. She continues to be compensating appropriately and sitting at the edge of the bed. She states that she is feeling better. Vital signs obtained at 1123 with blood glucose per the patient's own meter, continuing to elevate at 103, blood pressure within normal limits at 116/91, heart rate at 85 and 100% O2 saturation on room air. At 1126, the patient continues to feel better. She is provided a granola bar to eat. She does note feeling sleepy though attributes this to this being the first day she has had off after working 4 days last week. She notes that she has been sleepy even prior to her arrival at the vaccine clinic today. She is able to eat the granola bar and continues conversing appropriately without difficulty. She continues taking small sips of water without issues. Continues to deny chest pain or shortness of breath. Blood sugar is rechecked at 1138 and continues to elevate to 116. She reports that her meter says her sugar is "stable." Final set of vital signs obtained at 1138 revealed blood glucose within normal limits at 116, blood pressure of 119/84, heart rate 83 and 100% O2 sats on room air. Patient denied complaints of chest pain, shortness of air, nausea, dizziness or blurred vision at this time. She felt much improved and we discussed her leaving the clinic and heading home to have lunch. She had no further complaints. She was able to rise to standing on her own without any further issues and ambulated out of the clinic without difficulty. She was advised with strict return precautions should she develop chest pain or shortness of breath to present to the ED or call 911. She expressed understanding of this. LPN, RN, PharmD present through this encounter and assisted as asked of the, by this provider. Follow up response to treatment:excellent. Patient discharge: Stable to go home and follow up with PCP. Orders Placed This Encounter Procedures ? COVID-19 MRNA LNP-S PF PA-C Electronically Signed 12/21/2020 11:17 AM
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Name | Dose # | Type | Manufacturer | Lot | Route | Site |
---|---|---|---|---|---|---|
COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | IM | LA |
RECVDATE: | 12-21-2020 | RPT_DATE: |
CAGE_YR: | 33 |
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: | 12-21-2020 |
BIRTH_DEFECT: | U |
OFC_VISIT: | U |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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