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.
44M with no significant PMH who presented with acute ICH 2/2 sagittal sinus thrombosis complicated by seizures requiring intubation for airway protection, and aspiration pneumonia. Patient successfully extubated on 12/6. Subsequent head CT head scans have shown stability. Patient started on heparin drip then transition to lovenox on 12/7. Started on 3% NS therapy due to cerebral edema and that has since improved too as well. Keppra 500 mg BID initiated for seizures. CT chest/abdomen/pelvis negative for malignancy, but consolidation present suspicious for pneumonia, Zosyn started on 12/7. Vanco added on 12/8. Would recommend a 7 day course for pneumonia. Hypercoag workup revealing as well, other than patient is heterozygous for prothrombin mutation. He will need anticoagulation for 3 months with repeat CTV at that time, econsult to neurology needed upon discharge to manage seizure medication (keppra 500 mg BID). Currently he is on lovenox cause his swallowing recently has been an issue, once his swallowing is more reliable he can be switched to pradaxa. He was started on decadron on 12/8 for headaches. That can be tapered off over the next 1-2 weeks. The etiology of his cerebral venous sinus thrombosis remains unclear but perhaps related to his vaccine which he received 5 days before his onset of headaches.
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