Evidence map›Paper›PMID 35891231›Full record

ReviewVaccines2022

Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies.

Shin-Jie Yong, Alice Halim, Michael Halim, Abbas Al Mutair, Saad Alhumaid, Jehad Al-Sihati, Hawra Albayat, Mohammed Alsaeed, Mohammed Garout, Reyouf Al Azmi and 5 more

Open access · goldAbstract readReview
In one paragraph

Review in Vaccines, 2022. 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
1.6field-weighted citation impact, top 15% 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

6 citing papers in PubMed, 16 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. No evidence of an increased risk for cardiac complications following mRNA COVID-19 vaccines.Enfermedades infecciosas y microbiologia clinica (English ed.) · 2023
    Article
  6. The New Era of mRNA Vaccines: The Success of the COVID-19 Vaccines and the Safety Concerns in Adolescents.Indian journal of community medicine : official publication of Indian Association of Preventive & Social Medicine
    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

15 authors at 12 institutions in 7 countries.

Shin-Jie YongDepartment of Biological Sciences, School of Medical and Life Sciences, Sunway University, Selangor 47500, Malaysia.
Alice HalimShanghai Medical College, Fudan University, Shanghai 200032, China.
Michael HalimDepartment of Biomedical Science, School of Science, Engineering and Environment, University of Salford, Greater Manchester, Salford M5 4WT, UK.
Abbas Al MutairResearch Center, Almoosa Specialist Hospital, Al-Ahsa 36342, Saudi Arabia.
Saad AlhumaidAdministration of Pharmaceutical Care, Al-Ahsa Health Cluster, Ministry of Health, Al-Ahsa 31982, Saudi Arabia.ORCID 0000-0003-4552-4513
Jehad Al-SihatiGastroenterology Section, Internal Medicine Department, King Fahad Specialist Hospital, Dammam 31311, Saudi Arabia.
Hawra AlbayatInfectious Disease Department, King Saud Medical City, Riyadh 7790, Saudi Arabia.
Mohammed AlsaeedInfectious Disease Division, Department of Medicine, Prince Sultan Military Medical City, Riyadh 7790, Saudi Arabia.ORCID 0000-0002-0503-2154
Mohammed GaroutDepartment of Community Medicine and Health Care for Pilgrims, Faculty of Medicine, Umm Al-Qura University, Makkah 21955, Saudi Arabia.
Reyouf Al AzmiInfection Prevention and Control, Eastern Health Cluster, Dammam 32253, Saudi Arabia.
Noor AldakheelMicrobiology Laboratory, Dammam Regional Laboratory and Blood Bank, Dammam 31411, Saudi Arabia.
Abeer N AlshukairiDepartment of Medicine, King Faisal Specialist Hospital and Research Center, Jeddah 21499, Saudi Arabia.
Hani A Al AliPediatrics Department, Maternity & Children Hospital, Dammam 32253, Saudi Arabia.
Adel A AlmoumenPediatrics Department, Maternity & Children Hospital, Dammam 32253, Saudi Arabia.
Ali A RabaanCollege of Medicine, Alfaisal University, Riyadh 11533, Saudi Arabia.ORCID 0000-0002-6774-9847
Alfaisal University · SAMaternity and Children's Hospital · SADammam Central Hospital · SAKing Fahad Specialist Hospital · SAKing Saud Medical City · SAMinistry of Health · MMPrincess Nourah bint Abdulrahman University · SARiyadh Armed Forces Hospital · SAShanghai Medical College of Fudan University · CNSunway University · MYUmm al-Qura University · SAUniversity of Salford · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Given the increasing anti-vaccine movements erroneously touting vaccine danger, this review has investigated the rare adverse events potentially associated with BNT162b2 (Pfizer-BioNTech), an mRNA vaccine against the severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Only real-world surveillance studies with at least 0.1 million BNT162b2-vaccinated participants and one unvaccinated control group were selected for review. A total of 21 studies examining the potential association of BNT162b2 with cardiovascular, herpetic, thrombotic or thrombocytopenic, neurological, mortality, and other miscellaneous rare adverse events were described in this review. Only myocarditis is consistently associated with BNT162b2. An unclear direction of association was seen with stroke (hemorrhagic and ischemic), herpes zoster, and paresthesia from BNT162b2, which may require more studies to resolve. Fortunately, most surveillance studies detected no increased risks of the remaining rare adverse events reviewed herein, further reassuring the safety of BNT162b2. In conclusion, this review has concisely summarized the current rare adverse events related and unrelated to BNT162b2, arguably for the first time in sufficient depth, to better communicate vaccine safety to the public.

Indexed as

adverse eventBNT162b2COVID-19mRNA vaccinereal-world surveillanceSARS-CoV-2vaccine safety

Identifiers

PMID35891231
PMCPMC9319660
OpenAlexW4283820581

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.