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.
Peripheral nerve disorder NOS; Muscular weakness of limbs; Light-headed feeling; Astasia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128952. The patient was a 14-year and 0-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade on 25Sep2021. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Sep2021 at 13:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH3023, Expiration date 31Dec2021) at the age of 14-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Sep2021 at 21:00 (1 day 7 hours 30 minutes after the vaccination), the patient experienced Peripheral nerve disorder NOS, Muscular weakness of limbs. On 01Oct2021 (6 days after the vaccination), the patient was admitted to the hospital and discharged on 07Oct2021. On 07Oct2021, the outcome of the event was recovering. The course of the event was as follows: "On 26Sep2021 from night, the patient experienced Muscular weakness of both upper and lower limbs (Smartphone dropped, Light-headed feeling when walking, Astasia). After that, the symptoms worsened, and the patient went to hospital for consultation. On 01Oct2021, No abnormalities in blood test, head MRI. On 01Oct2021, for intensive investigation, the patient was introduced to this hospital. At the time of consultation, the cranial nerve system and sensory nerves were normal. The Muscular weakness was low at the level of MMT3/3, Biceps and knee tendon reflex normal. Spinal fluid check resulted in protein cells without dissociation. No decrease in nerve conduction velocity in upper and lower limbs. Judgment was Peripheral nerve disorder NOS. 2 days after hospitalization, Muscular improvement tendency. On 07Oct2021, Limbs MMT5/5, made sure it had no impact on daily life, Discharged." The outcome of events Light-headed feeling, astasia was recovering. The reporting physician classified the event as serious (hospitalization from 01Oct2021 to 07Oct2021), and 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: Only the frequency of occurrence of F wave of median nerve of both upper limbs was 30-40%, so the patient planned to revisit as outpatient.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 1 | COVID19 | PFIZER\BIONTECH | FH3023 |
| RECVDATE: | 10-22-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 6 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20211001; Test Name: blood test; Result Unstructured Data: Test Result:No abnormalities; Test Date: 20210925; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211001; Test Name: Spinal fluid check; Result Unstructured Data: Test Result:protein cells without dissociation; Test Date: 20211001; Test Name: MMT; Result Unstructured Data: Test Result:3/3; Test Date: 20211007; Test Name: MMT; Result Unstructured Data: Test Result:5/5; Test Date: 20211001; Test Name: head MRI; Result Unstructured Data: Test Result:No abnormalities; Test Name: F wave of median nerve of both upper limbs; Result Unstructured Data: Test Result:30-40 % |
| 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 INC202101335287 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-21-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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