Citation

Spyker DA, Bronstein AC, Weber JA. Clin. Toxicol. (Phila) 2021; ePub(ePub): ePub.

Copyright

(Copyright © 2021, Informa - Taylor and Francis Group)

DOI

10.1080/15563650.2021.1933510

PMID

unavailable

Abstract

OBJECTIVES: Our six goals are: 1) describe the relationship between the National Strategy for the COVID-19 Response and Pandemic Preparedness and the 55 US poison centers (PCs); 2) detail FDA emergency Use Authorization (EUA) COVID-19 vaccine-related regulatory procedures and associated acronyms; 3) list availability of specific vaccine clinical information to support PC staff COVID-19 vaccination and adverse event (AE) data collection; 4) describe required health care practitioner COVID-19 vaccine AE reporting to the Vaccine AE Reporting System (VAERS) and PC reporting options; 5) document public and health care professionals' use of PCs for COVID-19 vaccine information; and 6) propose strategy to maximize PCs contribution to the pandemic solution.

METHODS: We reviewed 13-Feb-2020 through 15-Apr-2021 National Poison Data System (NPDS) COVID-19 records for changes over time. We examined NPDS cases and VAERS COVID-19 vaccine reports 1-Nov-2020 through 2-Apr-2021 for vaccine manufacturer, patient characteristics, state, and clinical effects.

RESULTS: PCs reported 1,052,174 COVID-19 contacts; maximum (peak) contacts/day (12,163) on 16-Mar-2020. As of 5-Apr-2021 the US reported >167 million administrations of COVID-19 vaccines (Pfizer-BioNTech, Moderna or Janssen). US PCs reported 162,052 COVID-19 vaccine contacts. Most (61.1%) were medical information calls, 34.9% were drug information, and 2.58% were exposures. Over the same period VAERS reported 49,078 COVID-19 vaccine cases reporting 226,205 symptoms - headache most frequent, ranging from 20% to 40% across the 3 vaccines.

CONCLUSIONS AND RECOMMENDATIONS: Although differences exist between the intent and content of the 2 data sets, NPDS volume is compelling. The PC nationwide 800 number facilitates data collection and suggests comingling the 2 data streams has merit. PC professionals received tens of thousands of calls and can: 1) support fact-based vaccine information; 2) contribute vaccine AE follow-up information: 3) advocate for best-case coding and reporting, especially for vaccine adverse experiences.

Language: en

Keywords

COVID-19; pandemic; adverse events; NPDS; required reporting; SARS-CoV-2; vaccine; VAERS