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.
33 y.o.malewith no significant past medical history except for obesity who has been working as a nurse in the emergency room department in our hospital and today he received COVID-19 vaccine and 30 minutes later patient started having increased saliva, cold hands and feet, left-sided pressure-like headache and some numbness in his legs at the same time he suddenly started talking only in first language and lost his ability to speak in second language. He understand second language but replying first language stating that he is talking in second language. On exam he was alert oriented confused by people not understanding his second language stating that his numbness and cold feeling in the hands and feet have improved. Initially patient received 10 mg of Decadron for possible allergic reaction he had a head CT scan that was negative and his labs were remarkable only for hypokalemia. Patient had no prior history of any neurological symptoms he was advised admission to the hospital for observation Patient symptoms resolved next day,he is alert oriented able to communicate in second language he had a head MRI and head neck MRA that came back negative and had an EEG that showed no seizure activities. Patient was seen in neurology consultation who felt that patient most likely had an episode of migraine headache. Patient is going to be discharged home and to have a follow-up with his primary care physician next week
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(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)) | 0 | COVID19 | PFIZER\BIONTECH | EK#5730 | IM | LA |
| RECVDATE: | 12-28-2020 | RPT_DATE: |
| CAGE_YR: | 33 |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 2 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | CMP: Recent Labs 12/23/20 1525 12/23/20 1650 NA 135* -- K 3.3* -- CL 101 -- CO2 20.3 -- GLUCOSE 124 106 BUN 11.0 -- CREATININE 1.1 -- ALBUMIN 3.8 -- ALKPHOS 67 -- ALT 37 -- AST 41* -- BILITOT 0.4 -- CBC: Recent Labs 12/23/20 1525 WBC 10.00 EOSABS 0.2 RBC 4.51 HGB 13.5 HCT 39.1 MCV 86.7 MCHC 34.6 PLT 343 MPV 7.1* Results from last 7 days Lab Units 12/23/20 1525 TROPONIN I ng/mL <0.017 Results from last 7 days Lab Units 12/23/20 1525 TROPONIN I ng/mL <0.017 Lab Results Component Value Date HGB 13.5 12/23/2020 Lab Results Component Value Date HGB 13.5 12/23/2020 |
| V_ADMINBY: | PVT |
| OTHER_MEDS: | No |
| CUR_ILL: | No |
| HISTORY: | No |
| PRIOR_VAX: | |
| SPLTTYPE: | |
| FORM_VERS: | |
| TODAYS_DATE: | 12-28-2020 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | No known allergies |
| V_FUNDBY: |
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