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 pancreatitis; Episode of lithiasis migration; Liver reaction with cytolysis; Cholestasis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: FR-RA-PA20220754 (RA). A 53-year-old female patient received BNT162b2 (COMIRNATY), on 09May2021 as dose 1, 0.3 ml, single (Lot number: Unknown) intramuscular for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: EBASTINE ARROW. The following information was reported: PANCREATITIS ACUTE (hospitalization, medically significant) with onset 14May2021, outcome "recovered" (14May2021), described as "Acute pancreatitis"; CHOLESTASIS (hospitalization, medically significant) with onset 14May2021, outcome "unknown"; BILE DUCT STONE (hospitalization, medically significant) with onset 14May2021, outcome "unknown", described as "Episode of lithiasis migration"; HEPATIC CYTOLYSIS (hospitalization, medically significant) with onset 14May2021, outcome "unknown", described as "Liver reaction with cytolysis". The patient was hospitalized for pancreatitis acute, bile duct stone, hepatic cytolysis, cholestasis (start date: 14May2021, discharge date: 20May2021, hospitalization duration: 6 day(s)). The events "acute pancreatitis", "episode of lithiasis migration", "liver reaction with cytolysis" and "cholestasis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerized tomogram abdomen: (19May2021) fatty infiltration of the pancreas, notes: (grade C pancreatitis). No fluid collection. Fortuitous discovery of a 22mm splenic artery aneurysm; Endoscopic ultrasound: (18May2021) Thin and clear main bile duct, notes: Gallbladder wall thickening Normal pancreas (homogeneous structure). Uncomplicated splenic artery aneurysm measuring 15x13mm; SARS-CoV-2 test: (25May2021) Negative; Ultrasound abdomen: (15May2021) Hepatomegaly, notes: due to steatosis and gallbladder sludge without biliary dilatation. Clinical information: It was reported that patient had sudden onset of acute abdominal pain in the epigastric region following a meal in the evening, without fever or intestinal peristalsis disorder. Conclusion : Episode of lithiasis migration with Balthazar score C acute biliary pancreatitis without collection, without signs of clinical seriousness. Liver reaction with cytolysis and cholestasis discharged on 20May2021 given the good clinical and biological outcome, with appointment on 26May2021 for prophylactic outpatient cholecystectomy. The patient had acute pancreatitis within 5 days of her first dose of the COMIRNATY vaccine. Arguments suggesting a probable lithiasis migration complicated by non-serious acute pancreatitis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||Unknown||OT||Unknown|
|LAB_DATA:||Test Date: 20210519; Test Name: CHEST AND PELVIC COMPUTED TOMOGRAPHY; Result Unstructured Data: Test Result:fatty infiltration of the pancreas; Comments: (grade C pancreatitis). No fluid collection. Fortuitous discovery of a 22mm splenic artery aneurysm.; Test Date: 20210518; Test Name: Endoscopic ultrasound; Result Unstructured Data: Test Result:Thin and clear main bile duct; Comments: Gallbladder wall thickening Normal pancreas (homogeneous structure). Uncomplicated splenic artery aneurysm measuring 15x13mm.; Test Date: 20210525; Test Name: TEST COVID 19; Test Result: Negative ; Test Date: 20210515; Test Name: ABDOMINAL ULTRASOUND; Result Unstructured Data: Test Result:Hepatomegaly; Comments: due to steatosis and gallbladder sludge without biliary dilatation.|