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.
22lb weight loss concerning for malignancy vs progressive autoimmune process; progressively worsening hyperkeratotic lesions on feet and penis; progressively worsening hyperkeratotic lesions on feet and penis; pain/stiffness of hands, shoulders, and feet; pain/stiffness of hands, shoulders, and feet; pain/stiffness of hands, shoulders, and feet; 22lb weight loss concerning for malignancy vs progressive autoimmune process; 22lb weight loss concerning for malignancy vs progressive autoimmune process; dermatopathology from punch biopsy of L foot is consistent with reactive arthritis; This is a spontaneous report from a contactable physician. A 49-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 09Jun2021 (Batch/Lot number was not reported) at the age of 49 years old as dose 1, single for COVID-19 immunisation. Medical history included current tobacco user and known allergies to penicillins. There were no concomitant medications (other medications in two weeks: none). It was unknown if other vaccine was received in four weeks. The patient presented with progressively worsening hyperkeratotic lesions on feet and penis, pain/stiffness of hands, shoulders, and feet, and 22lb weight loss concerning for malignancy vs progressive autoimmune process. Symptom onset was 4 days after receiving 1st dose of Pfizer COVID19 vaccine (13Jun2021). PET scan was negative for malignancy, and dermatopathology from punch biopsy of L foot is consistent with reactive arthritis on 13Jun2021. Given negative work up for typical causes of reactive arthritis (no GI symptoms, negative gonorrhea/chlamydia and STD screening) based on timeline of events and discussion with rheumatology, dermatology and dermatopathology thought to be triggered by covid vaccination (COVID received on 09Jun2021). Adverse events start date was 13Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 7 days. Treatment for the adverse events was prednisone course. It was unknown if patient has history of COVID-19 prior to vaccination. The patient underwent SARS-CoV-2 test (nasal swab) with result of negative on 13Aug2021. The patient was recovering from all the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hyperkeratosis, Penis disorder , Musculoskeletal stiffness, Pain in extremity , Arthralgia, Neoplasm malignant, Autoimmune disorder, Weight decreased, Arthritis reactive cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||OT||Unknown|
|LAB_DATA:||Test Date: 20210613; Test Name: dermatopathology; Result Unstructured Data: Test Result:dermatopathology; Comments: dermatopathology from punch biopsy of L foot is consistent with reactive arthritis.; Test Name: PET scan; Test Result: Negative ; Comments: PET scan was negative for malignancy; Test Date: 20210813; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab|
|HISTORY:||Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: Penicillins); Tobacco user (Other medical history: Current Tobacco Smoker)|