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.
Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus; This case was reported by a physician via regulatory authority and described the occurrence of paralytic ileus in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) (batch number AFLBA511AD, expiry date unknown) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Influenza Vaccine Quadrivalent Pre-Filled Syringe Device) injection syringe for prophylaxis. On 26th October 2020, the patient received Fluarix Tetra 2020-2021 season (intramuscular) .5 ml and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. On 4th November 2020, 9 days after receiving Fluarix Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device, the patient experienced paralytic ileus (serious criteria hospitalization and GSK medically significant), dysphagia (serious criteria hospitalization), paresthesia of limbs (serious criteria hospitalization), lumbalgia (serious criteria hospitalization) and hyposthenia (serious criteria hospitalization). On an unknown date, the outcome of the paralytic ileus, dysphagia, paresthesia of limbs, lumbalgia and hyposthenia were not recovered/not resolved. It was unknown if the reporter considered the paralytic ileus, dysphagia, paresthesia of limbs, lumbalgia and hyposthenia to be related to Fluarix Tetra 2020-2021 season and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details: The age at vaccination was not reported however patient could be 58 or 59 years old at the time of vaccination. On an unknown date, CXR and Computerised axial tomogram was performed with no result. On 8th November 2020, Electrocardiogram was performed with no result. On 9th November 2020, Electromyogram normal was performed with no result. Batch number of Fluarix Tetra was reported as AFLB511AD, however upon safety data review, the batch number was corrected to AFLBA511AD Initial information was received from a physician via regulatory authority on 1st February 2021: Appearance of symmetric paresthesia in the 4 limbs. Then ingravescent hysthenia lower arts. Dysphagia for solid and liquid foods. Lumbalgia. Paralytic ileus
| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) | Unknown | FLU4 | GLAXOSMITHKLINE BIOLOGICALS | IM | Unknown |
| RECVDATE: | 02-04-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | U |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Name: CXR; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Name: Computerised axial tomogram; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201108; Test Name: Electrocardiogram; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20201109; Test Name: Electromyogram normal; Result Unstructured Data: (Test Result:No result,Unit:unknown,Normal Low:,Normal High:) |
| V_ADMINBY: | |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | ITGLAXOSMITHKLINEIT202102 |
| FORM_VERS: | 2 |
| TODAYS_DATE: | 02-03-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | U |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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