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.
Allergic reaction to vaccine +1 more Dx Referred by MD Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Physician Assistant Cosign Needed 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 was given the Pfizer-Biontech (lot: EH9899) vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience oral tingling (upper lip and then into the lower lib) It then progressed to the tongue and she reported tingling to the tip of the tongue and further back to the middle of tongue. She thought there might be some mild swelling to the tip of the tongue. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling and lip swelling. This Staff member was notified of patient reaction and she was then assessed in the emergency bay area. PMH: Hx hypertension but did not take her medication today. Patient had recovered from the COVID-19 virus about 2 weeks ago. Vitals Time 1130 BP 170/90 HR 86 s/r RR 14 nl O2 97 % Physical Exam Constitutional: She is oriented to person, place, and time. She appears well-developed and well-nourished. No distress. HENT: Head: Normocephalic and atraumatic. Right Ear: Hearing and external ear normal. Left Ear: Hearing and external ear normal. Eyes: Conjunctivae are normal. Right eye exhibits no discharge. Left eye exhibits no discharge. No scleral icterus. Neck: Normal range of motion. 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: Normal range of motion. Neurological: She is alert and oriented to person, place, and time. No sensory deficit. Gait normal. Skin: Skin is warm and dry. She is not diaphoretic. Psychiatric: She has a normal mood and affect. Her behavior is normal. Judgment and thought content normal. Cognition and memory are normal. Vitals reviewed. Treatment included antihistamines. Patient was given 50 mg of benadryl at 1138. Vitals Time 1147 BP 160/100 HR 90 S/R RR 14 nl O2 98% Response to care: Patient states the upper lip resolved but the lower lip and tongue sensations remained but did not worsen. Patient was recommended to go to the hospital given her sudden response with concern of tongue swelling. Patient did agree to this. COVID staff was made aware that the patient would be leaving her SUV in the parking lot. Patient was transfer by Response team to the hospital at 11:53 AM.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | EH9899 | IM | LA |
| RECVDATE: | 12-17-2020 | RPT_DATE: |
| CAGE_YR: | 51 |
| 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: | Acyclovir 800 mg Oral 2 TIMES DAILY Patient taking differently: Take 800 mg by mouth as needed. amLODIPine Besylate 2.5 mg Oral DAILY Atenolol 25 MG TAKE ONE TABLET BY MOUTH EVERY DAY prn Calcium Carbonate-Vitamin D 500-400 MG-UNIT Or |
| CUR_ILL: | unknown |
| HISTORY: | unknown |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-17-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | Allergies as of 12/17/2020 Reviewed by RN on 12/15/2020 Updated Reaction Type Reactions Bactrim [sulfamethoxazole-trimethoprim] 10/17/2018 1:14 PM Other (See Comments) Causes Acute Kidney Injury Covid-19 (mrna) Vaccine 12/17/2020 12:21 PM Allergy Other (See Comments) Tingling of lips and tongue Decadron [dexamethasone] 01/11/2020 11:28 AM Palpitations Multiple PVCs |
| V_FUNDBY: |
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