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.
After the second vaccine, it felt like she had bee stings all through her legs for 3 hours.; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs were stinging and burning and, it was just like when she got her second vaccination; Her legs started to have twitching, like muscle twitching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (Dose 1, Lot Number / Expiry Date: Unknown, Route of administration and Anatomical Location: not provided), administration date: 24Jun2021, when the patient was 46-year-old, for COVID-19 immunization; Tetanus shot (Her tetanus shot, like 5 or 6 years ago), for immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "not recovered", described as "After the second vaccine, it felt like she had bee stings all through her legs for 3 hours."; BURNING SENSATION (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "Her legs were stinging and burning and, it was just like when she got her second vaccination"; MUSCLE TWITCHING (non-serious), outcome "not recovered", described as "Her legs started to have twitching, like muscle twitching". Therapeutic measures were taken as a result of limb discomfort, burning sensation, pain, muscle twitching. Additional information: Reporter stated that, patient did not receive any prior vaccinations (within 4 weeks). Patient has not had any vaccinations since her tetanus shot, like 5 or 6 years ago. No family medical history reported relevant to ae(s). After the second vaccine, it felt like she had bee stings all through her legs for 3 hours, patient felt this the other day when she put her feet up. Patient legs started to have twitching, like muscle twitching. Her legs were stinging and burning and, it was just like when she got her second vaccination. It was clarified that patient experienced events the other day after the vaccination. Reporter stated that, patient was still experiencing events but, it was not as much of the deep throbbing and aching. It was her whole entire limbs of her legs. Patient tried Aleve and stated that it doesn't help. 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|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient's Medical History (including any illness at time of vaccination)? None Other Conditions: N.|
|TODAYS_DATE:||11 May 2022|