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.
19 year old male presented for smallpox vaccination on 9SEP2015, also issued medication to treat current case of tinea pedis. Patient did not follow recommended follow up instructions for 7 days post vaccination and presented on day 9. Satellite lesions noted, as well as increased severity of tinea pedis, along with improper vaccination site care. The following day Patient presented to the Emergency Room for possible generalized vaccinia (10 days post vaccination), patient was febrile (104 degree oral temp), tachycardic, and had a transient blood pressure of 110/70. Treated with fluids and anti-inflammatories at ER. No labs drawn at this time due to vital signs. Patient followed up next day (day 11) to rule out meningitis and encephalitis. Asymptomatic at that time, however, later that night patient presented again to ER with 102.8 degree temperature, tachycardia and was treated for possible streptococcal pharyngitis. Rapidstrep, CBC and monospot labs taken, and later results were positive for infectious mononucleosis, which could have contributed to systemic spread by suppressing the immune system. The next day (day 12, 21SEP2015) patient presented with multiple smallpox lesions on the feet, one on the face, four on the lower back, and one on the right leg along with the same number of satellite lesions as noted on day 9. Patient referred to Dermatology same day, diagnosed with generalized vaccinia due to systemic spread and not accidental autoinoculation. Normal vital signs noted and recommended isolation precautions x14 days. Patient currently is checked twice a day to monitor for vital signs and possible development of new lesions.
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|ANTHRAX (BIOTHRAX)||1||ANTH||EMERGENT BIOSOLUTIONS||FAV427A||IM||RA|
|HEP A + HEP B (TWINRIX)||3||HEPAB||GLAXOSMITHKLINE BIOLOGICALS||3ED7N||IM||RA|
|JAPANESE ENCEPHALITIS (IXIARO)||1||JEV1||INTERCELL AG||JEV13M54E||IM||RA|
|SMALLPOX (ACAM2000)||1||SMALL||SANOFI PASTEUR||vv04003a||Unknown||Unknown|
|LAB_DATA:||Positive Heterophile Ab (Infectious Mononucleosis Screening)|
|OTHER_MEDS:||Patient was initially using hydrocortisone cream on tinea pedis, was issued clotrimazole 1%. Patient has taken ibuprofen 800 mg tabs @ ER.|
|CUR_ILL:||Tinea Pedis noted.|
|HISTORY:||Egg allergy, Seasonal Allergies, unconfirmed previous case of eczema notified by mother (not disclosed by patient at time of vaccination).|