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.
Arrhythmia; Unusual bleeding (ovulation bleeding for two days) and from the third month, it was not regular at all; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2022274251 (RA). Other Case identifier(s): DE-CADRPEI-2022274251 (RA Webportal), DE-PEI-202200074898 (RA). A 36-year-old female patient received BNT162b2 (COMIRNATY), on 27Nov2021 as dose 3 (booster), single (Lot number: SCVY8) for covid-19 immunisation. The patient's relevant medical history included: "Iodine allergy" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1., Strength: 0.3ml, Lot/Batch no: EX8680), administration date: 11May2021, for covid-19 immunisation; comirnaty (Dose 2, Strength: 0.3ml, Lot/Batch no: FD7958), administration date: 22Jun2021, for covid-19 immunisation. The following information was reported: ARRHYTHMIA (medically significant) with onset 23Dec2021, outcome "not recovered"; INTERMENSTRUAL BLEEDING (non-serious) with onset 23Dec2021, outcome "not recovered", described as "Unusual bleeding (ovulation bleeding for two days) and from the third month, it was not regular at all". Clinical course: So far none, it had to be monitored, cycle was previously always consistent and the patient never had bleeding at ovulation time. The causality assessment for suspect drug to event Arrhythmia was reported as follows: Source of assessment RA Result of Assessment B. Indeterminate. The causality assessment for suspect drug to event Intermenstrual bleeding was reported as follows: Source of assessment RA Result of Assessment D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200875330 same patient, drug, reporter but dose '2' was administered beyond 42 days of dose '1'.;
|COVID19 (COVID19 (PFIZER-BIONTECH))||3||COVID19||PFIZER\BIONTECH||SCVY8||Unknown||Unknown|
|HISTORY:||Medical History/Concurrent Conditions: Hyperthyroidism; Iodine allergy|