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.
Nephrotic syndrome; oedema; protein urine; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129133. A 13-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FF9942, Expiration Date: 30Nov2021), via an unspecified route of administration on 18Sep2021 (age at vaccination was 13-year and 11-month-old) as dose 1, single for COVID-19 immunisation. Medical history included nephrotic syndrome from Jul2013, where the patient was hospitalized for the initial episode of care of nephrotic syndrome, which was recovering with steroid therapy; then, observation without additional treatment. The patient's concomitant medications were not reported. On 01Oct2021, the patient experienced nephrotic syndrome, oedema, and protein urine. The clinical course was as follows: On 01Oct2021 (13 days after the vaccination), oedema and protein urine appeared. The patient experienced nephrotic syndrome. On 02Oct2021 (14 days after the vaccination), the patient visited the hospital for persistent protein urine and was admitted to the hospital. On 07Oct2021 (19 days after the vaccination), the patient recovered from the events. On 09Oct2021 (21 days after the vaccination), the patient was discharged from the hospital. The reporting physician classified the event as serious (hospitalization from 02Oct2021 to 09Oct2021) and assessed that the causality between the events and BNT162b2 was unassessable. The reporting physician commented as follows: Whether the event was directly related to the vaccine was not clear.
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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 | FF9942 |
| RECVDATE: | 10-26-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 7 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | Y |
| LAB_DATA: | Test Date: 20211001; Test Name: protein urine; Result Unstructured Data: Test Result:appeared; Test Date: 20211002; Test Name: protein urine; Result Unstructured Data: Test Result:peristent; Comments: admitted to the hospital |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Nephrotic syndrome (hospitalized for the initial episode of care of nephrotic syndrome) |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101353214 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-25-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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