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.
8yo previously healthy boy. Mom had COVID around 1/5/22. As far as we know the boy did not have symptomatic covid during or after her illness. He was not seen in the clinic for covid, nor was his 12 yo brother. There was no communication with them about this other than mom called to reschedule their appt for the 2nd COVID vaccine on 1/5 b/c she herself had covid. (Both of the kids got the first dose of the vaccine on 12/17/22) Both of the boys got the 2nd dose of Pfizer Covid vaccine at our clinic on 2/3/22. Mom called in on 2/9 with what sounded like a gastroenteritis over the phone and Zofran was called in. Our nurse documented well his GI bug history and that his UOP was good and to call back PRN any problems. The nurse remembers talking to this mom and that she did not seem worried at all?.just needed an antiemetic called in for nausea and vomiting. Patient was not having fever or abdominal pain. That call was at 8:53 on Wednesday AM. We did not hear from them again about this. The details now get incredibly hazy due to the trauma of the whole event. Sometime during the night on Thursday night 2/10/2022 (40 hours or so after their phone call) one of the parents found him blue and lifeless in his bed. (Do not know details of what made them go check on him). Was taken to the Hospital with a full code in process. They were able to get a pulse back a few times for a brief time, but then lost him in the ICU. This family goes to church at the same church that one of our doctors attends,. This doctor got a notification on the morning of 2/11/2022 that a member in the church had died. The word that she received was that the boy had died of MIS-C (we do not know what exactly they were basing that on or who made that determination/speculation). My partner called me 2/11/2022 AM about it since the boy is my patient. I looked through the chart and talked with my nurse who specifically remembered the call and how completely unworried and normal the mother seemed about the boys illness?.not in an unusual way but in a normal ?my kid has a GI bug, can you call in some zofran? kind of way. I called mom to reach out to her, but had to leave a voice mail (not surprisingly under the circumstances). There are obviously lots of details about the history/presentation/treatment that I don?t know. They may have sought medical care somewhere else other than our clinic before he became so significantly ill. I just don?t know since the family is in crisis mode and not returning calls or text messages. At present we don?t even know burial arrangements.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 February 2022|
|DATEDIED:||10 February 2022|
|LAB_DATA:||None by me, but plenty at ER/ICU?..I know they are doing an autopsy.|
|CUR_ILL:||Mom had Covid around 1/2/2022?.no evidence that the patient had it from our records|
|TODAYS_DATE:||12 February 2022|