Tree-Based Data Mining for Safety Assessment of First COVID-19 Booster Doses in the Vaccine Safety Datalink

Details

• Personal Author:
  Daley, Matthew F. ; Duffy, Jonathan ; Fireman, Bruce ; Maro, Judith C. ; McClure, David ; Nelson, Jennifer ; Qian, Lei ; Smith, Ning ; Vazquez-Benitez, Gabriela ; Weintraub, Eric ; Williams, Joshua T. B. ; Xu, Stanley ; Yih, W. Katherine
• Description:
  Background: The Centers for Disease Control and Prevention's Vaccine Safety Datalink (VSD) has been performing safety surveillance for COVID-19 vaccines since their earliest authorization in the United States. Complementing its real-time surveillance for pre-specified health outcomes using pre-specified risk intervals, the VSD conducts tree-based data-mining to look for clustering of a broad range of health outcomes after COVID-19 vaccination. This study's objective was to use this untargeted, hypothesis-generating approach to assess the safety of first booster doses of Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Ad26.COV2.S) COVID-19 vaccines. Methods: VSD enrollees receiving a first booster of COVID-19 vaccine through April 2, 2022 were followed for 56 days. Incident diagnoses in inpatient or emergency department settings were analyzed for clustering within both the hierarchical ICD-10-CM code structure and the follow-up period. The self-controlled tree-temporal scan statistic was used, conditioning on the total number of cases for each diagnosis. P-values were estimated by Monte Carlo simulation; p = 0.01 was pre-specified as the cut-off for statistical significance of clusters. Results: More than 2.4 and 1.8 million subjects received Pfizer-BioNTech and Moderna boosters after an mRNA primary series, respectively. Clusters of urticaria/allergy/rash were found during Days 10-15 after the Moderna booster (p = 0.0001). Other outcomes that clustered after mRNA boosters, mostly with p = 0.0001, included unspecified adverse effects, common vaccine-associated reactions like fever and myalgia, and COVID-19. COVID-19 clusters were in Days 1-10 after booster receipt, before boosters would have become effective. There were no noteworthy clusters after boosters following primary Janssen vaccination. Conclusions: In this untargeted data-mining study of COVID-19 booster vaccination, a cluster of delayed-onset urticaria/allergy/rash was detected after the Moderna booster, as has been reported after Moderna vaccination previously. Other clusters after mRNA boosters were of unspecified or common adverse effects and COVID-19, the latter evidently reflecting immunity to COVID-19 after 10 days. [Description provided by NIOSH]
• Subjects:
  Communicable Diseases Emergency Responders Health Care Facilities Workforce And Services Occupational Health Safety
• Keywords:
  Author Keywords: COVID-19 COVID-19 Data-mining Emergency Care Epidemiologic Research Design Health Effects Medical Facilities Surveillance Vaccination Vaccines
• ISSN:
  0264-410X
• Document Type:
  Text
• Funding:
  Contract
• Genre:
  Journal Article
• Place as Subject:
  California ; Colorado ; Georgia ; Massachusetts ; Minnesota ; Oregon ; OSHA Region 1 ; OSHA Region 10 ; OSHA Region 4 ; OSHA Region 5 ; OSHA Region 8 ; OSHA Region 9 ; Washington ; Wisconsin
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  7 pdf pages
• Volume:
  41
• NIOSHTIC Number:
  nn:20066656
• Citation:
  Vaccine 2023 Jan; 41(2):460-466
• Contact Point Address:
  W. Katherine Yih, Harvard Pilgrim Health Care Institute and Department of Population Medicine, Harvard Medical School, Boston, MA
• Federal Fiscal Year:
  2023
• Peer Reviewed:
  True
• Source Full Name:
  Vaccine
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:bd5df9587d1328d45225b9f9419261de4a8a39bf2f810015468894d8fc97a7a07bc24475dc69880d16079d8705a6150a47d3f0a94abad7ecfd66f78693f9a7f3
• Download URL:
  https://stacks.cdc.gov/view/cdc/230663/cdc_230663_DS1.pdf
• File Type:
  [PDF - 274.35 KB ]