Adverse Events Reported by Patients With Cancer After Administration of a 2-Dose mRNA COVID-19 Vaccine.

BACKGROUND: Most safety and efficacy trials of the SARS-CoV-2 vaccines excluded patients with cancer, yet these patients are more likely than healthy individuals to contract SARS-CoV-2 and more likely to become seriously ill after infection. Our objective was to record short-term adverse reactions to the COVID-19 vaccine in patients with cancer, to compare the magnitude and duration of these reactions with those of patients without cancer, and to determine whether adverse reactions are related to active cancer therapy. PATIENTS AND METHODS: A prospective, single-institution observational study was performed at an NCI-designated Comprehensive Cancer Center. All study participants received 2 doses of the Pfizer BNT162b2 vaccine separated by approximately 3 weeks. A report of adverse reactions to dose 1 of the vaccine was completed upon return to the clinic for dose 2. Participants completed an identical survey either online or by telephone 2 weeks after the second vaccine dose. RESULTS: The cohort of 1,753 patients included 67.5% who had a history of cancer and 12.0% who were receiving active cancer treatment. Local pain at the injection site was the most frequently reported symptom for all respondents and did not distinguish patients with cancer from those without cancer after either dose 1 (39.3% vs 43.9%; P=.07) or dose 2 (42.5% vs 40.3%; P=.45). Among patients with cancer, those receiving active treatment were less likely to report pain at the injection site after dose 1 compared with those not receiving active treatment (30.0% vs 41.4%; P=.002). The onset and duration of adverse events was otherwise unrelated to active cancer treatment. CONCLUSIONS: When patients with cancer were compared with those without cancer, few differences in reported adverse events were noted. Active cancer treatment had little impact on adverse event profiles.

Using a resident-led patient safety quality council to educate future QI leaders.

Resident-led councils represent an important initiative to involve trainees in patient safety, but little is known about how to create and sustain one of these councils. We evaluated the impact of a resident-led patient safety council in an internal medicine residency program. We assessed change in resident perception of safety issues over 3 years, scholarship activities, and behavioral choices to participate or lead patient safety activities after residency.The Stony Brook Internal Medicine Residency Program formed the Patient Safety and Quality Council (PSQC) in 2014, consisting of fifteen peer-nominated residents serving a three-year term. Surveys were distributed annually from 2014 to 2017 to measure resident council members' perception of patient safety. The number of safety-related abstract/publications were tracked during and one year after graduation. Additionally, graduates from the council were surveyed to assess the influence of the council on post residency involvement and leadership in safety activities.A total of 18 residents have participated in the council from 2014 to 2017. Overall, resident perception of safety culture improved. A total of 17/18 (94%) PSQC resident members demonstrated scholarship activities in safety during residency: 8/18 (44%) were engaged in an independent Quality Improvement (QI) project, 5/18 (27%) achieved a quality improvement leadership role post residency. A total of 15 of 18 (83%) recent graduates suggest that involvement with the safety council during residency fostered future involvement in patient safety.Implementation of a resident-led safety council can help to improve the safety culture, generate scholarly activities, and encourage continued participation in patient safety after graduation.