McMurry et al. assess the real-world safety of the BNT162b2 and mRNA-1273 COVID-19 vaccines. Using natural language processing, they compare the rates of specified adverse effects between 68,266 vaccinated individuals and 68,266 matched unvaccinated individuals. They find that both vaccines are safe and tolerated in clinical practice.

As the COVID-19 vaccination campaign unfolds as one of the most rapid and widespread in history, it is important to continuously assess the real world safety of the FDA-authorized vaccines. Curation from large-scale electronic health records (EHRs) allows for near real-time safety evaluations that were not previously possible. Here, we advance context- and sentiment-aware deep neural networks over the multi-state Mayo Clinic enterprise (Minnesota, Arizona, Florida, Wisconsin) for automatically curating the adverse effects mentioned by physicians in over 108,000 EHR clinical notes between December 1st 2020 to February 8th 2021. We retrospectively compared the clinical notes of 31,069 individuals who received at least one dose of the Pfizer/BioNTech or Moderna vaccine to those of 31,069 unvaccinated individuals who were propensity matched by demographics, residential location, and history of prior SARS-CoV-2 testing. We find that vaccinated and unvaccinated individuals were seen in the the clinic at similar rates within 21 days of the first or second actual or assigned vaccination dose (first dose Odds Ratio = 1.13, 95% CI: 1.09-1.16; second dose Odds Ratio = 0.89, 95% CI: 0.84-0.93). Further, the incidence rates of all surveyed adverse effects were similar or lower in vaccinated individuals compared to unvaccinated individuals after either vaccine dose. Finally, the most frequently documented adverse effects within 7 days of each vaccine dose were fatigue (Dose 1: 1.77%, Dose 2: 1.2%),nausea (Dose 1: 1.05%, Dose 2: 0.84%), myalgia (Dose 1: 0.67%; Dose 2: 0.66%), diarrhea (Dose 1: 0.67%; Dose 2: 0.46%), arthralgia (Dose 1: 0.64%; Dose 2: 0.57%), erythema (Dose 1: 0.59%; Dose 2: 0.46%), vomiting (Dose 1: 0.45%, Dose 2: 0.29%) and fever (Dose 1: 0.29%; Dose 2: 0.23%). These remarkably low frequencies of adverse effects recorded in EHRs versus those derived from active solicitation during clinical trials (arthralgia: 24-46%; erythema: 9.5-14.7%; myalgia: 38-62%; fever: 14.2-15.5%) emphasize the rarity of vaccine-associated adverse effects requiring clinical attention. This rapid and timely analysis of vaccine-related adverse effects from contextually rich EHR notes of 62,138 individuals, which was enabled through a large scale Artificial Intelligence (AI)-powered platform, reaffirms the safety and tolerability of the FDA-authorized COVID-19 vaccines in practice.

Patients rehospitalized after SARS-CoV-2 clearance have distinct laboratory test profiles Rehospitalized patients have lower hemoglobin before and during SARS-CoV-2 infection Rehospitalized patients are more likely to experience anemia during active infection

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SummaryBackgroundAs the number of new and recovering COVID-19 cases continues to rise, it has become evident that patients can experience symptoms and complications after viral clearance. Clinical biomarkers characterizing patients who are likely to experience these prolonged effects are unknown.MethodsWe conducted a retrospective study to compare longitudinal lab test measurements (hemoglobin, hematocrit, estimated glomerular filtration rate, serum creatinine, and blood urea nitrogen) in patients rehospitalized after PCR-confirmed SARS-CoV-2 clearance (n=104) versus patients not rehospitalized after viral clearance (n=278).FindingsCompared to patients who were not rehospitalized after PCR-confirmed viral clearance, those who were rehospitalized had lower median hemoglobin levels in the year prior to COVID-19 diagnosis (cohen’s D = -0.50; p=1.2×10−3) and during the active infection window (cohen’s D = -0.71; p=4.6×10−8). Patients hospitalized after viral clearance were also more likely to be diagnosed with moderate or severe anemia during the active infection window (OR = 2.18; p = 4.99×10−9).ConclusionsThe occurrence of moderate or severe anemia in hospitalized COVID-19 patients is strongly associated with rehospitalization after viral clearance. Whether interventions to mitigate anemia can improve long term outcomes of COVID-19 patients should be further investigated.FundingThis study was funded by nference.