Evidence map›Paper›PMID 34230920›Full record

ArticleMed (New York, N.Y.)2021

Real-time analysis of a mass vaccination effort confirms the safety of FDA-authorized mRNA COVID-19 vaccines.

Reid McMurry, Patrick Lenehan, Samir Awasthi, Eli Silvert, Arjun Puranik, Colin Pawlowski, A J Venkatakrishnan, Praveen Anand, Vineet Agarwal, John C O'Horo and 16 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Med (New York, N.Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  4. Facial Nerve Palsy Amid the SARS-CoV-2 Pandemic: A Pooled Analysis.Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale
    Pooled it
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  13. Data Mining Pipeline for COVID-19 Vaccine Safety Analysis Using a Large Electronic Health Record.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Reid McMurrynference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Patrick Lenehannference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Samir Awasthinference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Eli Silvertnference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Arjun Puraniknference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Colin Pawlowskinference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
A J Venkatakrishnannference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Praveen Anandnference Labs, 2nd Floor, 22 3rd Cross Rd, Murgesh Pallya, Bengaluru, Karnataka 560017, India.
Vineet Agarwalnference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
John C O'HoroMayo Clinic, Rochester, MN 55902, USA.
Gregory J GoresMayo Clinic, Rochester, MN 55902, USA.
Amy W WilliamsMayo Clinic, Rochester, MN 55902, USA.
Andrew D BadleyMayo Clinic, Rochester, MN 55902, USA.
John HalamkaMayo Clinic, Rochester, MN 55902, USA.
Abinash VirkMayo Clinic, Rochester, MN 55902, USA.
Melanie D SwiftMayo Clinic, Rochester, MN 55902, USA.
Katie Carlsonnference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Deeksha Doddahonnaiahnference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Anna Metzgernference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Nikhil Kayalnference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Gabi Bernernference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Eshwan Ramudunference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Corinne Carpenternference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Tyler Wagnernference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Ajit Rajasekharannference, One Main Street, East Arcade, Cambridge, MA 02142, USA.
Venky Soundararajannference, One Main Street, East Arcade, Cambridge, MA 02142, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs the coronavirus disease 2019 (COVID-19) vaccination campaign unfolds, it is important to continuously assess the real-world safety of Food and Drug Administration (FDA)-authorized vaccines. Curation of large-scale electronic health records (EHRs) enables near-real-time safety evaluations that were not previously possible.

methodsIn this retrospective study, we deployed deep neural networks over a large EHR system to automatically curate the adverse effects mentioned by physicians in over 1.2 million clinical notes between December 1, 2020 and April 20, 2021. We compared notes from 68,266 individuals who received at least one dose of BNT162b2 (n = 51,795) or mRNA-1273 (n = 16,471) to notes from 68,266 unvaccinated individuals who were matched by demographic, geographic, and clinical features.

findingsIndividuals vaccinated with BNT162b2 or mRNA-1273 had a higher rate of return to the clinic, but not the emergency department, after both doses compared to unvaccinated controls. The most frequently documented adverse effects within 7 days of each vaccine dose included myalgia, headache, and fatigue, but the rates of EHR documentation for each side effect were remarkably low compared to those derived from active solicitation during clinical trials. Severe events, including anaphylaxis, facial paralysis, and cerebral venous sinus thrombosis, were rare and occurred at similar frequencies in vaccinated and unvaccinated individuals.

conclusionsThis analysis of vaccine-related adverse effects from over 1.2 million EHR notes of more than 130,000 individuals reaffirms the safety and tolerability of the FDA-authorized mRNA COVID-19 vaccines in practice.

fundingThis study was funded by nference.

Indexed as

COVID-19Drug-Related Side Effects and Adverse ReactionsBNT162 VaccineCOVID-19 VaccinesHumansMass VaccinationRetrospective StudiesRNA, MessengerSARS-CoV-2United StatesUnited States Food and Drug AdministrationBNT162 VaccineCOVID-19 VaccinesRNA, MessengerBNT162b2COVID-19COVID-19 vaccinesmRNA-1273propensity score matchingreal world analysisvaccine safety

Identifiers

PMID34230920
PMCPMC8248717

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.