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.
Neck pain; Headache; trapped nerve; her neck was stiff; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202101201534520460, Safety Report Unique Identifier GB-MHRA-ADR 24621472. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1688) via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history included osteoporosis. The patient's concomitant medications were not reported. It reported that the patient took pyroxine, naxapine, pepersol, texdadine, iron (unknown if took concomitantly). The patient had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. The patient noticed her neck was stiff in Jan2021 4 hours after vaccination. By the morning on 15Jan2021 the pain (neck) was so intense she phoned 111 and she was admitted to hospital. The patient also experienced headache in Jan2021. The patient thought it was a trapped nerve but her doctor thought it was an ADR. The events neck pain and headache were also assessed as medically significant. The patient underwent COVID-19 test with result of negative on 18Jan2021.The outcome of event neck pain was not recovered, outcome of headache was recovered in Jan2021, outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||Unknown||COVID19||PFIZER\BIONTECH||EJ1688||Unknown||Unknown|
|LAB_DATA:||Test Date: 20210118; Test Name: COVID-19 virus test; Test Result: Negative|
|HISTORY:||Medical History/Concurrent Conditions: Osteoporosis|