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.
Anaphylaxis; Breathing difficulty; Pallor facial; BP was 90/53; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21128660. A 15-year and 6-month-old female patient received first dose of bnt162b2 (COMIRNATY) via unspecified route on 04Oct2021 18:05 (Lot Number: FJ5790; Expiration Date: 31Dec2021) single dose for covid-19 immunisation, at 15-year-old. No medical history. Body temperature before vaccination was 36.6 degrees Centigrade. The patient's concomitant medications were not reported. The patient experienced anaphylaxis, breathing difficulty, pallor facial, bp was 90/53 on 04Oct2021, 18:10, with outcome of recovered. The course of the event was as follows: Approximately 5 minutes after vaccination with the bnt162b2, breathing difficulty and pallor facial occurred. BP was 90/53, O2SAT was 97%. EPIPEN intramuscular injection, normal saline DIV started. After that, the symptoms improved. BP became 120/66. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Thought to be anaphylaxis.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FJ5790 |
| RECVDATE: | 10-21-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | Y |
| ER_VISIT: | |
| HOSPITAL: | U |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20211004; Test Name: BP; Result Unstructured Data: Test Result:90/53; Test Date: 20211004; Test Name: BP; Result Unstructured Data: Test Result:120/66; Test Date: 20211004; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20211004; Test Name: O2SAT; Test Result: 97 % |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101314147 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-20-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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