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.
This is the first of two spontaneous reports from a contactable consumer (patient) or other non-healthcare professional (HCP). A 38-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0151), at the age of 38, via an unspecified route of administration, in left arm, on Apr 5, 2021, at 12:00, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No known allergies. On an unspecified date in Apr 2021, patient experienced urinary tract infections, blood in urine and irregular period. Reportedly, patient had urinary tract infections after first and second shots (negative culture tests), blood in urine and also skipped period (after first shot). Therapeutic measures taken for urinary tract infection included treatment with cipro antibiotics for 10 days. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included urine culture test on an unknown date, with negative result and urine analysis revealed blood in urine on an unspecified date. The outcome of urinary tract infections, irregular period: recovering; and of blood in urine: unknown at the time of this report. No follow-up attempts needed. No further information expected.
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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)) | 1 | COVID19 | PFIZER\BIONTECH | EW0151 | Unknown | LA |
RECVDATE: | 11-18-2021 | RPT_DATE: |
CAGE_YR: | |
CAGE_MO: | |
DIED: | U |
DATEDIED: | |
L_THREAT: | U |
ER_VISIT: | |
HOSPITAL: | U |
HOSPDAYS: | |
X_STAY: | U |
DISABLE: | U |
RECOVD: | N |
LAB_DATA: | Test Name: Culture tests; Test Result: Negative; Test Name: Urine analysis; Result Unstructured Data: Test Result: Blood in Urine; Comments: Blood in Urine. |
V_ADMINBY: | PHM |
OTHER_MEDS: | |
CUR_ILL: | |
HISTORY: | |
PRIOR_VAX: | |
SPLTTYPE: | USPFIZER INC2021494231 |
FORM_VERS: | |
TODAYS_DATE: | 11-17-2021 |
BIRTH_DEFECT: | U |
OFC_VISIT: | Y |
ER_ED_VISIT: | U |
ALLERGIES: | |
V_FUNDBY: |
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