Evidence map›Paper›PMID 40425703›Full record

Observational studyScientific reports2025

Serious adverse drug reactions associated with anti-SARS-CoV-2 vaccines and their reporting trends in the EudraVigilance database.

Wojciech Nazar, Jan Romantowski, Grzegorz Nazar, Marek Niedoszytko, Rüdiger Braun-Dullaeus, Ludmiła Daniłowicz-Szymanowicz

Abstract readObservational Study
In one paragraph

Observational study in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Article
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

6 authors.

Wojciech NazarFaculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210, Gdańsk, Poland. wojciech.nazar@gumed.edu.pl.
Jan RomantowskiDepartment of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland.
Grzegorz NazarFaculty of Medicine, Medical University of Gdańsk, Marii Skłodowskiej-Curie 3a, 80-210, Gdańsk, Poland.
Marek NiedoszytkoDepartment of Allergology, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland.
Rüdiger Braun-DullaeusDepartment of Cardiology and Angiology, Otto Von Guericke University Magdeburg, Leipziger Street 44, 39120, Magdeburg, Germany.
Ludmiła Daniłowicz-SzymanowiczDepartment of Cardiology and Electrotherapy, Faculty of Medicine, Medical University of Gdańsk, Smoluchowskiego 17, 80-214, Gdańsk, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A serious adverse reaction (SADR) may follow a vaccination against SARS-CoV-2 infection. We aimed to explore symptoms and reporting trends of SADRs to anti-SARS-CoV-2 vaccines based on the EudraVigilance database. This retrospective observational study analysed 250,966 suspected SADRs (with 62.8% reported in females), following the administration of 733,837,251 vaccine doses against SARS-CoV-2. Pfizer BioNTech (Comirnaty-Tozinameran), Moderna (Spikevax-Elastomeran), Janssen (Jcovden) and AstraZeneca (Vaxzevria) vaccines were analysed. The assessment included 897 types of SADRs across 12 categories. The most common clinical manifestations of SADRs to anti-SARS-CoV-2 vaccines vaccines encompassed neuropsychiatric (n = 121,877), cardiovascular (n = 78,167), as well as musculoskeletal and connective tissue disorders (n = 63,994). After summarising all SADRs, vaccination with Comirnaty was associated with the lowest risk of experiencing SADRs (754/million administered doses), followed by Spikevax (785/million doses), Jcovden (1,248/million doses) and Vaxzevria (2,301/million doses; p < 0.001). Regarding the vaccine administration timelines, the reporting of SADRs tends to be delayed and occurs over a longer time (p < 0.001). SADRs associated with anti-SARS-CoV-2 vaccines seem to be relatively rare. Compared to adenovirus-based vector vaccines (Jcovden, Vaxzevria), mRNA vaccines appear to offer improved safety profiles (Comirnaty, Spikevax). The risk of SADR to any SARS-CoV-2 vaccine seems to be outweighed by the benefits of active immunization against the virus.

Indexed as

Adverse Drug Reaction Reporting SystemsCOVID-19COVID-19 VaccinesDrug-Related Side Effects and Adverse ReactionsSARS-CoV-2AdolescentAdultAgedChildDatabases, FactualFemaleHumansMaleMiddle AgedRetrospective StudiesVaccinationCOVID-19 VaccinesCOVID-19PharmacovigilanceSARS-CoV-2 infectionSerious adverse drug reactionVaccination

Identifiers

PMID40425703
PMCPMC12116907

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.