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.
Cardio-respiratory arrest; the patient found submerged in the bathtub; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. A 13-year and 6-month-old male patient received second single dose of bnt162b2 (COMIRNATY: Solution for injection; Batch/Lot Number: FK0108; Expiration Date: 30Apr2022), via an unspecified route of administration on 30Oct2021 16:55 (the day of vaccination, at the age of 13-year old) as dose 2, single for covid-19 immunisation. Medical history included bronchial asthma from an unknown date and unknown if ongoing. The patient had no allergies to medications, food, or other products. It was unknown if the patient received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FJ1763, Expiration date 30Apr2022) via an unspecified route of administration on an unspecified date in Oct2021 as dose 1 ,single for COVID-19 immunization. The onset date/time of the event was reported as 30Oct2021 at 21:20. On 30Oct 2021 at 21:20, (day of vaccination), the patient developed cardio-respiratory arrest and died. An autopsy was performed, but the cause of death confirmed by the autopsy was unknown. The event required emergency room visit. On 30Oct2021 at around 21:00, about 4 hours after the second dose of the vaccination, the patient found submerged in the bathtub. The course of the events was as follows: On 30Oct2021, after receiving the second dose of the vaccination, the patient returned home. At around 19:00, the patient had a meal. At 20:30, he took a bath, but he did not get out of the bathroom. At around 21:20, his parents found that he was in cardio-respiratory arrest. They called an ambulance and at 21:34, an emergency team arrived. At 21:40, they arrived at the reporting hospital where cardiopulmonary resuscitation was performed, but his death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. From the findings from the macroscopic anatomy, no possible cause of the event was found. The reporting pharmacist commented as follows: The fatal case of COVID-19 vaccine was reported from the emergency medical care center. The patient had past medical history of bronchial asthma, however, considering that he was a healthy child and suddenly died, the possibility of BNT162b2 being related to the adverse event was considered to be high. After his death was confirmed, an autopsy was performed by the police. The reporting physician commented as follows: On 02Nov2021, judicial autopsy was performed. From the results, the cause of drowning could not be macroscopically detected. No follow-up attempts are needed; No further information is expected.; Reported Cause(s) of Death: Drowning; Cardio-respiratory arrest
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||11 November 2021|
|DATEDIED:||29 October 2021|
|HISTORY:||Medical History/Concurrent Conditions: Bronchial asthma|
|TODAYS_DATE:||10 November 2021|