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.
had a dull pain in my bilateral upper arms since receiving the vaccine; My right arm has significant less strength; had an episode approximately 2 weeks after receiving it where I had severe itching; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 1, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "had an episode approximately 2 weeks after receiving it where I had severe itching." (unspecified if ongoing), notes: No rash but had to take Benadryl to be able to sleep. The patient's concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious) with onset Feb2022, outcome "not recovered", described as "My right arm has significant less strength"; ARTHRALGIA (non-serious) with onset Feb2022, outcome "not recovered", described as "had a dull pain in my bilateral upper arms since receiving the vaccine"; PRURITUS (non-serious) with onset 2022, outcome "unknown", described as "had an episode approximately 2 weeks after receiving it where I had severe itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of arthralgia, asthenia. Therapeutic measures were taken as a result of pruritus. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 May 2022|
|LAB_DATA:||Test Date: 202205; Test Name: Nasal Swab; Test Result: Negative|
|HISTORY:||Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes); Itching (No rash but had to take Benadryl to be able to sleep.)|
|TODAYS_DATE:||11 May 2022|