Evidence map›Paper›PMID 37340463›Full record

Observational studyBMC medicine2023

Reactogenicity and safety of COVID-19 primary immunisation and booster vaccination regimens: a comparative observational cohort study.

Lisette Warkentin, Felix Werner, Nikoletta Zeschick, Thomas Kühlein, Philipp Steininger, Klaus Überla, Isabelle Kaiser, Maria Sebastião, Susann Hueber

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 26% of its field
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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Inflammatory mediators of mRNA vaccine-induced adverse reactions in mice.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
    Article
  2. Article
  3. 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

9 authors at 1 institution in 1 country.

Lisette WarkentinInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany. lisette.warkentin@uk-erlangen.de.ORCID 0000-0002-6241-6082
Felix WernerInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Nikoletta ZeschickInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Thomas KühleinInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Philipp SteiningerInstitute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Schloßgarten 4, Erlangen, Germany.
Klaus ÜberlaInstitute of Clinical and Molecular Virology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Schloßgarten 4, Erlangen, Germany.
Isabelle KaiserDepartment of Medical Informatics, Biometry and Epidemiology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Waldstraße 6, Erlangen, Germany.
Maria SebastiãoInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Susann HueberInstitute of General Practice, Friedrich-Alexander-Universität Erlangen-Nürnberg, Uniklinikum Erlangen, Universitätsstraße 29, Erlangen, Germany.
Friedrich-Alexander-Universität Erlangen-Nürnberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSince the beginning of the COVID-19 vaccination campaigns, recommendations regarding the vaccination have been very dynamic. Although the safety and efficacy of different vaccines have been analysed, data were scarce for vaccine regimens combining different vaccines. We therefore aimed to evaluate and compare the perceived reactogenicity and need for medical consultation after the most frequently applied homologous and heterologous COVID-19 vaccination regimens.

methodsIn an observational cohort study, reactogenicity and safety were assessed within a maximum follow-up time of 124 days using web-based surveys. Reactogenicity was assessed for different vaccination regimens 2 weeks after a vaccination (short-term survey). The following surveys, long-term and follow-up surveys, focused on the utilisation of medical services, including those that were not suspected to be vaccine-related.

resultsData of 17,269 participants were analysed. The least local reactions were seen after a ChAdOx1 - ChAdOx1 regimen (32.6%, 95% CI [28.2, 37.2]) and the most after the first dose with mRNA-1273 (73.9%, 95% CI [70.5, 77.2]). Systemic reactions were least frequent in participants with a BNT162b2 booster after a homologous primary immunisation with ChAdOx1 (42.9%, 95% CI [32.1, 54.1]) and most frequent after a ChAdOx1 - mRNA-1273 (85.5%, 95% CI [82.9, 87.8]) and mRNA-1273/mRNA-1273 regimen (85.1%, 95% CI [83.2, 87.0]). In the short-term survey, the most common consequences were medication intake and sick leave (after local reactions 0% to 9.9%; after systemic reactions 4.5% to 37.9%). In the long-term and follow-up surveys, between 8.2 and 30.9% of participants reported consulting a doctor and between 0% and 5.4% seeking hospital care. The regression analyses 124 days after the first and after the third dose showed that the odds for reporting medical consultation were comparable between the vaccination regimens.

conclusionsOur analysis revealed differences in reactogenicity between the COVID-19 vaccines and vaccination regimens in Germany. The lowest reactogenicity as reported by participants was seen with BNT162b2, especially in homologous vaccination regimens. However, in all vaccination regimens reactogenicity rarely led to medical consultations. Small differences in seeking any medical consultation after 6 weeks diminished during the follow-up period. In the end, none of the vaccination regimens was associated with a higher risk for medical consultation.

trial registrationDRKS DRKS00025881 ( https://drks.de/search/de/trial/DRKS00025373 ). Registered on 14 October 2021. DRKS DRKS00025373 ( https://drks.de/search/de/trial/DRKS00025881 ). Registered on 21 May 2021. Registered retrospectively.

Indexed as

COVID-19COVID-19 Vaccines2019-nCoV Vaccine mRNA-1273BNT162 VaccineHumansImmunizationRetrospective StudiesVaccination2019-nCoV Vaccine mRNA-1273BNT162 VaccineCOVID-19 VaccinesAdverse drug reactionCOVID-19Medical consultationObservational studyReactogenicitySurveyVaccines

Identifiers

PMID37340463
PMCPMC10283194
OpenAlexW4381436135

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.