Evidence map›Paper›PMID 40821247›Full record

ReviewCureus2025

Side Effects Associated With Respiratory Syncytial Virus Prefusion F (RSVpreF) Maternal Vaccination: A Scoping Review.

Mabel Palmero, Roberto A Martin, Benjamin Olson, Lindsey Millares, Macey Melinek, Delaney Waggoner, Caitlin Higginbotham, Alia E Gali, Sophia M Kershner, Joseph S De Gaetano

Abstract readReview
In one paragraph

Review in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

10 authors.

Mabel PalmeroFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Roberto A MartinFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Benjamin OlsonFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Lindsey MillaresFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Macey MelinekFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Delaney WaggonerFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Caitlin HigginbothamFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Alia E GaliFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Sophia M KershnerFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.
Joseph S De GaetanoFamily Medicine, Nova Southeastern University Dr. Kiran C. Patel College of Osteopathic Medicine, Fort Lauderdale, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRTIs), with significant morbidity and mortality in infants. In August 2023, the Pfizer RSVpreF (respiratory syncytial virus prefusion F) vaccine was approved in the United States for maternal immunization, aiming to reduce RSV-related illness in neonates. The vaccine has proven efficacy in preventing severe LRTI in infants. However, limited research exists on its potential side effects, particularly on maternal health outcomes. This scoping review aimed to assess the extent and type of evidence available regarding safety and maternal side effects of the Pfizer RSVpreF vaccine when administered during pregnancy. A systematic search was conducted across six databases, including Ovid MEDLINE, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Cochrane Central, Web of Science, and ClinicalTrials.gov, for peer-reviewed studies published between January 2020 and September 2024. Studies focusing on maternal outcomes following RSVpreF vaccine administration in pregnancy were included. Data extraction and analysis were performed following the Joanna Briggs Institute (JBI) methodology for scoping reviews. Of 1,259 initially identified studies, five met the inclusion criteria. The studies, spanning 2020-2024, included randomized controlled trials and a retrospective cohort study, primarily regarding high-income populations. Across the studies, findings indicate that the RSVpreF vaccine is generally well tolerated, with the most common side effects being mild-to-moderate local injection site reactions. Adverse events, including preeclampsia and gestational hypertension, were reported inconsistently across studies. A recent cohort study suggested a possible association between vaccine administration and hypertensive disorders of pregnancy (HDP), though findings remain inconclusive. Overall, the Pfizer RSVpreF vaccine appears to be well tolerated in pregnant women, but gaps in maternal safety data warrant further research. Future studies should prioritize high-risk patients and underrepresented populations, long-term maternal health outcomes, and potential associations with hypertensive disorders to ensure comprehensive vaccine safety and equitable access.

Indexed as

adverse effectsfemaleinfantpregnancyrespiratory syncytial virus vaccinationrsvpreftreatment outcome

Identifiers

PMID40821247
PMCPMC12357593

What OpenQuestion holds

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LicenceCC BY
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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.