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.
Motor paralysis; Altered deep tendon reflex; Fall; weakness in four limbs/weakness in legs; could not walk; Acute disseminated encephalomyelitis; headache; queasy; malaise; Mild low-grade fever/pyrexia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128736. A 12-year and 9-month-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021) via an unspecified route of administration on 15Sep2021 at 09:29 (at the age of 12-year-old) as a single dose for COVID-19 immunization. The patient had no family history. The patient had a history of Heat illness before a week. Body temperature before vaccination was 36.7 degrees Centigrade. On 21Sep2021 at 22 :00 (6 days after the vaccination), the patient experienced Acute disseminated encephalomyelitis. On 22Sep2021 (7 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 15Sep2021, the patient received the second Comirnaty vaccination. The following night, mild low-grade fever from 37.5 to 37.9 degrees centigrade occurred. The low-grade fever continued until 20Sep2021. In the morning of 21Sep2021, the low-grade fever disappeared, and then the patient went to school. After coming back from school, headache, queasy, malaise and pyrexia of 37 degrees centigrade existed. Around 22:00, because of queasy, the patient went to the toilet, but fell on the way because of weakness in four limbs. Since the patient could not walk, the patient was emergency transported to hospital. The next morning, the patient's grasping power seemed like it was recovering, but the weakness in legs did not improve. Therefore, the patient was introduced to reporter's hospital and hospitalized on 22Sep2021. After that, the symptoms were spontaneously recovering and became able to walk a bit. On 30Sep2021, the patient was discharged from the hospital. On 30Sep2021 (15 days after the vaccination), the outcome of the event was recovering The questionnaire for acute disseminated encephalomyelitis (ADEM) form stated that there was no histopathological diagnosis. Clinical symptoms included: Estimated caused by Inflammatory demyelinating; This was the first episode in the patient (irrespective of preceding vaccination); From 22Sep2021, Motor paralysis (diffuse, or more frequently localized) and Altered deep tendon reflex (hyporeflexia or hyperreflexia, asymmetrical reflex) can be attributable to central nervous system diseases. Imaging examination (Magnetic resonance imaging (MRI)) included: 21Sep2021 and 22Sep2021 and 24Sep2021, Not applicable to at least one of the following MRI criteria for multiple sclerosis:Demonstration of dissemination in space on MRI: At least one lesion observed on T2-weighted images in at least 2 areas among 4 areas of the central nervous system (around the cerebral ventricle, right below the cortex, below the tentorium, and in the spinal cord) (not necessarily to be enhanced lesions, and lesions responsible to these symptoms should be excluded in patients with brain stem or spinal symptoms); Dissemination in time on MRI: Asymptomatic gadolinium-enhanced lesions and asymptomatic non-enhanced lesions existing simultaneously at any time, or symptomatic or asymptomatic lesions on T2-weighted images and/or gadolinium-enhanced lesions, newly emerging after MRI at any reference point of time. Course of disease:Time from onset to the final observation (0 Month). Observation period insufficient to indicate the monophasic pattern of disease: Observation period of less than 3 months after onset. Differential diagnosis included: MRI findings or histopathological data not consistent with the diagnostic criteria of ADEM. Cerebrospinal fluid test performed on 24Sep2021: Cell count (2)/uL, Glucose (67) mg/dL, Protein (24) mg/dL; Oligoclonal bands was in submitting and result not come out (On 06Oct2021), no IgG index increase, MBP negative. Autoantibody test not performed. The reporting physician classified the event as serious (hospitalized form 22Sep2021 to 30Sep2021) and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: During the hospital stay from 22Sep2021 to 30Sep2021, MRI, spinal fluid examination and so on were conducted. However, there was not any obvious abnormal finding. And also, any evident relationships between his symptoms and the vaccination were not conclusively diagnosed.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FF9944 |
| RECVDATE: | 10-20-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 8 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20210924; Test Name: Glucose; Test Result: 67 mg/dl; Test Date: 20210924; Test Name: IgG index; Result Unstructured Data: Test Result:no IgG index increase; Test Date: 20210915; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210915; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 to 37.9 Centigrade; Test Date: 20210921; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Name: spinal fluid examination; Result Unstructured Data: Test Result:there was not any obvious abnormal finding; Test Date: 20210924; Test Name: MBP; Test Result: Negative ; Test Date: 20210924; Test Name: Cell count; Result Unstructured Data: Test Result:2; Comments: /uL; Test Name: MRI; Result Unstructured Data: Test Result:there was not any obvious abnormal finding; Test Date: 20210924; Test Name: Protein; Test Result: 24 mg/dl |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | Medical History/Concurrent Conditions: Heat illness (before a week) |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101319453 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-19-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | Y |
| ALLERGIES: | |
| V_FUNDBY: |
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