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.
Dyspnea; Vomiting; Body pain; Fever; Muscle pain; Chills; This is a spontaneous report received from a contactable Other HCP from Regulatory Authority. Regulatory number: PH-PHFDA-300121720 Regulatory Authority. A 14 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PAA1733483202180) at the age of 14 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (death, hospitalization) with onset 23Nov2021 08:20, outcome "fatal", described as "Dyspnea"; VOMITING (death, hospitalization) with onset 19Nov2021 19:00, outcome "fatal", described as "Vomiting"; PYREXIA (non-serious) with onset 18Nov2021 20:00, outcome "recovered" (18Nov2021 21:00), described as "Fever"; MYALGIA (non-serious) with onset 18Nov2021 20:00, outcome "recovered" (18Nov2021 21:00), described as "Muscle pain"; CHILLS (non-serious) with onset 18Nov2021 20:00, outcome "recovered" (18Nov2021 21:00), described as "Chills"; PAIN (non-serious) with onset 23Nov2021 08:20, outcome "unknown", described as "Body pain". It reported 19Nov2021 night time: fever and vomiting; 20Nov2021 night time: fever and vomiting; 21Nov2021: No signs and symptoms; 22Nov2021 between 10-11:00 PM: Vomiting; 23Nov2021 8:20 AM: Difficulty of breathing, Vomiting (2x), Body pain. The patient date of death was 2021. The reported cause of death was dyspnoea, vomiting. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dyspnea; Vomiting
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||15 December 2021|
|LAB_DATA:||Test Date: 20211118; Test Name: body temperature; Result Unstructured Data: Test Result:Fever; Comments: 20:00|
|TODAYS_DATE:||13 December 2021|