Evidence map›Paper›PMID 34656181›Full record

ArticleAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology2021

Anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines: a systematic review and meta-analysis.

Saad Alhumaid, Abbas Al Mutair, Zainab Al Alawi, Ali A Rabaan, Raghavendra Tirupathi, Mohammed A Alomari, Aqeel S Alshakhes, Abeer M Alshawi, Gasmelseed Y Ahmed, Hassan M Almusabeh and 11 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05648110 (A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study), which is not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 5% 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.

NCT05648110 phase2 / phase3completednot on this mapstarted 2022, after this paper: background citation

A Phase I/III Randomized, Double-blind Study to Evaluate the Safety, Efficacy and Neutralizing Activity of AZD5156/AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants With Conditions Causing Immune Impairment. Sub-study: Phase II Open Label Sub-study to Evaluate the Safety, PK, and Neutralizing Activity of AZD3152 for Pre-exposure Prophylaxis of COVID-19

TypeinterventionalSponsorAstraZenecaRan2022 to 2025Enrolled3,882ConditionsCOVID-19, SARS-CoV-2ArmsAZD5156 (Parent study Sentinel Safety Cohort), Placebo (Parent study Sentinel Safety Cohort), EVUSHELD™ (Parent study Main Cohort), AZD3152 (Parent study Main Cohort), Placebo (Parent study Main Cohort)
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  6. Outcomes of pediatric patients with suspected allergies to COVID-19 vaccines.The journal of allergy and clinical immunology. Global · 2025
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  19. The conundrum of COVID-19 mRNA vaccine-induced anaphylaxis.The journal of allergy and clinical immunology. Global · 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

21 authors at 16 institutions in 7 countries.

Saad AlhumaidAdministration of Pharmaceutical Care, Al-Ahsa Health Cluster, Ministry of Health, Rashdiah Street, P. O. Box 12944, Al-Ahsa, 31982, Saudi Arabia. saalhumaid@moh.gov.sa.ORCID http://orcid.org/0000-0003-4552-4513
Abbas Al MutairResearch Center, Almoosa Specialist Hospital, Al-Ahsa, Saudi Arabia.ORCID http://orcid.org/0000-0002-9471-2767
Zainab Al AlawiDivision of Allergy and Immunology, College of Medicine, King Faisal University, Al-Ahsa, Saudi Arabia.
Ali A RabaanMolecular Diagnostic Laboratory, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia.
Raghavendra TirupathiDepartment of Medicine Keystone Health, Penn State University School of Medicine, Hershey, PA, USA.
Mohammed A AlomariPalliative Care Department, King Fahad Medical City, Riyadh, Saudi Arabia.
Aqeel S AlshakhesDepartment of Psychiatry, Prince Saud Bin Jalawi Hospital, Al-Ahsa, Saudi Arabia.
Abeer M AlshawiDepartment of Pharmacy, King Fahad Hofuf Hospital, Al-Ahsa, Saudi Arabia.
Gasmelseed Y AhmedResearch Center, Almoosa Specialist Hospital, Al-Ahsa, Saudi Arabia.
Hassan M AlmusabehAdministration of Pharmaceutical Care, Al-Ahsa Health Cluster, Ministry of Health, Rashdiah Street, P. O. Box 12944, Al-Ahsa, 31982, Saudi Arabia.
Tariq T AlghareebAdministration of Pharmaceutical Care, Al-Ahsa Health Cluster, Ministry of Health, Rashdiah Street, P. O. Box 12944, Al-Ahsa, 31982, Saudi Arabia.
Abdulaziz A AlghuwainemAdministration of Compliance, Al-Ahsa Health Affairs, Ministry of Health, Al-Ahsa, Saudi Arabia.
Zainab A AlsulaimanDepartment of Pharmacy, Hereditary Blood Diseases Centre, Al-Ahsa, Saudi Arabia.
Mohammed A AlabdulmuhsinDepartment of Pharmacy, Maternity and Children Hospital, Al-Ahsa, Saudi Arabia.
Emad A AlBuwaidiPrimary Care Medicine, Al-Ahsa Health Cluster, Ministry of Health, Al-Ahsa, Saudi Arabia.
Amjad K Bu DukhiDepartment of Pharmacy, Prince Saud Bin Jalawi Hospital, Al-Ahsa, Saudi Arabia.
Hani N MuftiDepartment of Cardiac Sciences, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, Jeddah, Saudi Arabia.
Manaf Al-QahtaniDepartment of Medicine, Royal College of Surgeons in Ireland, Bahrain, Kingdom of Bahrain.
Kuldeep DhamaDivision of Pathology, ICAR-Indian Veterinary Research Institute, Izatnagar, Bareilly, Uttar Pradesh, 243122, India.
Jaffar A Al-TawfiqInfectious Disease Unit, Specialty Internal Medicine, Johns Hopkins Aramco Healthcare, Dhahran, Saudi Arabia.
Awad Al-OmariCollege of Medicine, Alfaisal University, Riyadh, Saudi Arabia.
Ministry of Health · MMPrince Mohammed bin Abdulaziz Hospital · SAAlfaisal University · SAIndian Veterinary Research Institute · INJohns Hopkins University · USKing Fahad Hospital Hufūf · SAKing Fahd Medical City · SAKing Faisal University · SAKing Saud bin Abdulaziz University for Health Sciences · SAMaternity and Children's Hospital · SAMinistry of Health · SAPrincess Nourah bint Abdulrahman University · SASaad Specialist Hospital · SASaudi Aramco Medical Services Organization · SAUniversity of Bahrain · BHWellSpan Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently there is no systematic review and meta-analysis of the global incidence rates of anaphylactic and nonanaphylactic reactions to SARS-CoV-2 vaccines in the general adult population.

objectivesTo estimate the incidence rates of anaphylactic and nonanaphylactic reactions after COVID-19 vaccines and describe the demographic and clinical characteristics, triggers, presenting signs and symptoms, treatment and clinical course of confirmed cases.

designA systematic review and meta-analysis. Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] statement was followed.

methodsElectronic databases (Proquest, Medline, Embase, Pubmed, CINAHL, Wiley online library, and Nature) were searched from 1 December 2020 to 31 May 2021 in the English language using the following keywords alone or in combination: anaphylaxis, non-anaphylaxis, anaphylactic reaction, nonanaphylactic reaction, anaphylactic/anaphylactoid shock, hypersensitivity, allergy reaction, allergic reaction, immunology reaction, immunologic reaction, angioedema, loss of consciousness, generalized erythema, urticaria, urticarial rash, cyanosis, grunting, stridor, tachypnoea, wheezing, tachycardia, abdominal pain, diarrhea, nausea, vomiting and tryptase. We included studies in adults of all ages in all healthcare settings. Effect sizes of prevalence were pooled with 95% confidence intervals (CIs). To minimize heterogeneity, we performed sub-group analyses.

resultsOf the 1,734 papers that were identified, 26 articles were included in the systematic review (8 case report, 5 cohort, 4 case series, 2 randomized controlled trial and 1 randomized cross-sectional studies) and 14 articles (1 cohort, 2 case series, 1 randomized controlled trial and 1 randomized cross-sectional studies) were included in meta-analysis. Studies involving 26,337,421 vaccine recipients [Pfizer-BioNTech (n = 14,505,399) and Moderna (n = 11,831,488)] were analyzed. The overall pooled prevalence estimate of anaphylaxis to both vaccines was 5.0 (95% CI 2.9 to 7.2, I

conclusionThe prevalence of COVID-19 mRNA vaccine-associated anaphylaxis is very low; and nonanaphylactic reactions occur at higher rate, however, cutaneous reactions are largely self-limited. Both anaphylactic and nonanaphylactic reactions should not discourage vaccination.

Indexed as

AllergicCOVID-19ImmunologicIncidenceReactionsSARS-Cov-2Systematic reviewVaccines

Identifiers

PMID34656181
PMCPMC8520206
OpenAlexW3207837666

What OpenQuestion holds

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Registered trials

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.