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.
Cardiac arrest; cardiopulmonary arrest; NOMI(Non-occlusive mesenteric ischaemia); ventricular fibrillation; This is a spontaneous report from a contactable physician received from the Reglatory Agency. Regulatory authority report number is v21126302. A 16-year-old (also reported as 16-year and 6-month-old) male patient received bnt162b2 (COMIRNATY, Lot Number: FF0843; Expiration Date: 31Oct2021), dose 1 via an unspecified route of administration on 10Aug2021 13:00 as single dose for covid-19 immunisation. Medical history was none. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient's concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees Centigrade. On 10Aug2021 at 13:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 16Aug2021 at 16:40 (6 days, 3 hours and 40 minutes after the vaccination), the patient experienced cardiac arrest. The patient was immediately transported and admitted to the reporting hospital. On 01Sep2021 (22 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Aug2021 at 16:40 (6 days, 3 hours and 40 minutes after the vaccination), the patient was immediately transported the reporting hospital because of cardiopulmonary arrest (CPA). Before arrival to the hospital, automatic external defibrillator (AED) was conducted once. After the arrival, asystole, then VF(ventricular fibrillation) were noted. And return of spontaneous circulation (ROSC) was achieved after the one attempt of direct-current defibrillator (DC). The patient was hospitalized after resuscitated from the CPA. An obvious cause of cardiac arrest was unknown on computerised tomogram (CT), the blood test and electrocardiogram. The patient underwent tracheal intubation, and was managed by artificial respiration under hospitalization. Although targeted temperature management (TTM) was performed, there was no recovery of consciousness. On 31Aug2021 (21 days after the vaccination), blood pressure decreased. NOMI(Non-occlusive mesenteric ischaemia) was diagnosed through CT. On 01Sep2021 (22 days after the vaccination), the death was confirmed. The reporting physician classified the event as serious (Hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not reported. The patient died on 01Sep2021. It was not reported if an autopsy was performed. The outcome of event ventricular fibrillation was recovered on 16Aug2021, the rest of events was fatal.; Reported Cause(s) of Death: Cardiac arrest; cardiopulmonary arrest; Non-occlusive mesenteric ischaemia
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||15 September 2021|
|DATEDIED:||31 August 2021|
|LAB_DATA:||Test Date: 20210831; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210816; Test Name: blood test; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown; Test Date: 20210810; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210816; Test Name: CT; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown; Test Date: 20210831; Test Name: CT; Result Unstructured Data: Test Result:NOMI(Non-occlusive mesenteric ischaemia); Test Date: 20210816; Test Name: electrocardiogram; Result Unstructured Data: Test Result:An obvious cause of cardiac arrest was unknown; Comments: An obvious cause of cardiac arrest was unknown|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none|
|TODAYS_DATE:||14 September 2021|