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.
Administered 2nd booster of Pfizer in afternoon on 4/20/22. Patient was alert and stated he felt good and no previous issues with the vaccine. He completed the 15-20 minute observation period without any adverse reactions. When the observation period concluded, the patient exited the clinic with his wife and returned to his vehicle. Shortly afterwards, the patient's wife approached some staff members in the parking lot and reported that her husband was having difficulty breathing and was not responding appropriately to her questions while sitting in the driver's seat of their car. The staff members immediately activated our clinic's emergency response procedure including a 911 notification. When the vaccine team arrived at the vehicle, they found the patient unresponsive in the driver's seat. He had a pulse, shallow breath and was diaphoretic. The team removed the patient from the vehicle, lowering him onto blankets on the ground. Patient's color was grey. Vital signs were monitored every few minutes: BP: 165/79, HR 52, O2 sat 97% on RA BP: 165/89, HR 50, O2 sat 96% on RA BP: 152/79, HR 51, O2 sat 97% on RA BP: 163/82, HR 49, O2 sat 98% on RA BP: 171/80, HR 56, O2 sat 95% on RA EMS arrived and took over management of the patient along with transport to an outside hospital. On 4/21/22 our staff was in contact with the patient's family who informed us that the patient passed away earlier this morning.
|COVID19 (COVID19 (PFIZER-BIONTECH))||4||COVID19||PFIZER\BIONTECH||FJ6369||IM||LA|
|LAB_DATA:||Unknown - patient was transferred to an outside hospital.|
|OTHER_MEDS:||Patient reported being on a blood thinner and a beta blocker. No other medications reported.|
|CUR_ILL:||No illnesses reported. Patient replied "no" to question #1 on the pre-vaccination questionnaire (Are you feeling sick today?).|
|HISTORY:||Patient's wife reports patient having a cardiac history. No other chronic or long-standing health conditions reported.|
|ALLERGIES:||No allergies reported.|