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.
Myelitis (Anti-AQP4 Antibody Positive); This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21129680. A 76-year-old female patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 06Jul2021 17:15 (at the age of 76 years old) (Lot Number: FA7812; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.8 degrees centigrade. On 09Jul2021 (3 days after the vaccination), the patient experienced myelitis (Anti-AQP4 Antibody Positive). On 03Sep2021 (1 month and 28 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 06Jul2021 (the day of vaccination), at 17:15, the patient received the first dose of BNT162b2 vaccination. On 09Jul2021 (3 days after the vaccination), the patient had weakness of both lower extremities. On 11Jul2021 (5 days after the vaccination), the patient was admitted to the previous hospital. On 14Jul2021 (8 days after the vaccination), the patient was transferred to the reporting hospital. The spinal cord MRI and the spinal fluid examination were performed. Steroid pulse therapy and treatment with immune globulin were performed. On 03Sep2021 (1 month, 28 days after vaccination), the patient died. An autopsy was performed. The reporting physician classified the event as serious (hospitalization and death) and assessed the event as related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had myelitis with anti-AQP4 antibody positive which occurred in association with the vaccination. The patient died on 03Sep2021. An autopsy was performed and results were not provided. The outcome of the event was fatal.; Reported Cause(s) of Death: Myelitis (Anti-AQP4 Antibody Positive)
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FA7812 |
| RECVDATE: | 10-28-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | Y |
| DATEDIED: | 09-03-2021 |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210709; Test Name: Anti-AQP4 Antibody; Test Result: Positive ; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210714; Test Name: spinal fluid examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210714; Test Name: spinal cord MRI; Result Unstructured Data: Test Result:unknown results |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101404345 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-27-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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