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.
acute pyelonephritis and c-diff; acute pyelonephritis and c-diff; Kidney infection; having these kidney problems; UTIs and has had reoccurring UTIs; 103.5F chronic fevers; back spasms; dizziness; vomiting; constipation; loss of bladder control; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. A 12 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 13Aug2021 (Lot number: FC3181) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, injection in the left arm), administration date: 23Jul2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: CLOSTRIDIUM DIFFICILE INFECTION (hospitalization, medically significant), PYELONEPHRITIS ACUTE (hospitalization, medically significant) all with onset 13Aug2021, outcome "unknown" and all described as "acute pyelonephritis and c-diff"; KIDNEY INFECTION (medically significant) with onset 13Aug2021, outcome "unknown", described as "Kidney infection"; RENAL DISORDER (non-serious) with onset 13Aug2021, outcome "unknown", described as "having these kidney problems"; URINARY TRACT INFECTION (non-serious) with onset 13Aug2021, outcome "unknown", described as "UTIs and has had reoccurring UTIs"; PYREXIA (non-serious) with onset 13Aug2021, outcome "unknown", described as "103.5F chronic fevers"; MUSCLE SPASMS (non-serious) with onset 13Aug2021, outcome "unknown", described as "back spasms"; DIZZINESS (non-serious) with onset 13Aug2021, outcome "unknown", described as "dizziness"; VOMITING (non-serious) with onset 13Aug2021, outcome "unknown", described as "vomiting"; CONSTIPATION (non-serious) with onset 13Aug2021, outcome "unknown", described as "constipation"; URINARY INCONTINENCE (non-serious) with onset 13Aug2021, outcome "unknown", described as "loss of bladder control". The patient underwent the following laboratory tests and procedures: computerised tomogram: unknown, notes: She has had a Kidney CT; ultrasound kidney: unknown, notes: several ultrasounds they are focusing on her right kidney. Therapeutic measures were taken as a result of clostridium difficile infection, pyelonephritis acute. Clinical course: Cons calling about the PBCV (purple cap formula) and he and his wife (Name) are calling on behalf of their 12 y/o daughter who received her 1st PBCV dose in Jul2021 and her 2nd PBCV dose in Aug2021. The parents state that 13 days after her 2nd dose she began "having these kidney problems, UTIs and has had reoccurring UTIs since August. She has had 103.5F chronic fevers, back spasms, dizziness, vomiting, constipation, and loss of bladder control. She has been hospitalized x3 and she was dx with acute pyelonephritis and c-diff during her 2nd hospitalization." She has been treated with 10 days of antibiotics then followed by prophylaxis antibiotics and probiotics for 10 days. Her Mother states "10 days after we stop the the 10 days of regular antibiotics, she gets another UTI/ Kidney infection and we start all over again." This has been continuous since 13 days after her second vaccine dose. She has been treated with vancomycin, Augmentin, sulfa meth/Trimenthoprim (which she had an allergic reaction, rash) Cefinir, and Nitrofurantoin followed by 10 days prophylaxis and probiotics, and it keeps returning. She has had a Kidney CT and several ultrasounds they are focusing on her right kidney. He said that she took the vaccine in Jun2021 and about 2.5 months afterwards she developed a urinary tract infection and that was the first urinary tract infection she has had. She has had reoccurring urinary tract infections ever since. She has seen OBGYN's, immunologist, nephrologist, gastroenterologists, and infection disease doctors. They all say the same thing, and that is that they are puzzled and don't know what is causing it. Caller said that none of this existed prior to her getting the vaccine. She said that she saw a article that was about multisystem inflammatory syndrome in children. The article said that they could experience it if they came down with Covid-19. He said that his daughter has never tested positive for Covid before and has only had the vaccine. Caller said that he would like to know if there is a tie with the vaccine? Caller said that his daughter has had chronic fevers of 103.5 or higher, back spasms, dizziness, vomiting, loss of bladder control. She has been hospitalized 3 times from 7-10 days each time. 1 visit in the PICU and 2 in the ICU. She was diagnosed with Acute polynephritis and C-diff. They said that the C-diff came from constipation. He reported that the doctors said that her UTI caused the Acute polynephritis. She has had multiple CT scans, Ultrasounds, and cultures. She has been on antibiotics for 4 months, the antibiotics are prescribed for 10 days. She then goes on probiotics after 10 days, but within 5 days of being off the antibiotics she gets the urinary tract infection again.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||18 February 2022|
|LAB_DATA:||Test Name: Kidney CT; Result Unstructured Data: Test Result:unknown results; Comments: She has had a Kidney CT; Test Name: Ultrasound; Result Unstructured Data: Test Result:unknown results; Comments: several ultrasounds they are focusing on her right kidney.|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None|
|TODAYS_DATE:||17 February 2022|