The DOI matches its Crossref record; 17 of the 17 references it cites were found in a registry or an index.
Maintaining Safety with SARS-CoV-2 Vaccines
Open accessAbstract
The following table lists substances, other than active ingredients (i.e., antigens), shown in the manufacturers' package insert (PI) as being contained in the final formulation of each vaccine.Substances used in the manufacture of a vaccine but not listed as contained in the final product (e.g., culture media) can be found in each PI, but are not shown on this table.Each PI, which can be found on the FDA's website (see below) contains a description of that vaccine's manufacturing process, including the amount and purpose of each substance.In most PIs, this information is found in Section 11: "Description." Please refer to the PI for a complete list of ingredients or excipients.
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
Polack, F. P., Thomas, S. J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J. L., Pérez Marc, G., Moreira, E. D., Zerbini, C., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2034577 · Cited by 14,592
mRNA vaccines — a new era in vaccinology
Pardi, N., Hogan, M. J., Porter, F. W., & Weissman, D. (2018) · Nature Reviews Drug Discovery · doi:10.1038/nrd.2017.243 · Cited by 4,667
An mRNA Vaccine against SARS-CoV-2 — Preliminary Report
Jackson, L. A., Anderson, E. J., Rouphael, N. G., Roberts, P. C., Makhene, M., Coler, R. N., McCullough, M. P., Chappell, J. D., Denison, M. R., Stevens, L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2022483 · Cited by 3,237
A global survey of potential acceptance of a COVID-19 vaccine
Lazarus, J. V., Ratzan, S. C., Palayew, A., Gostin, L. O., Larson, H. J., Rabin, K., Kimball, S., & El-Mohandes, A. (2021) · Nature Medicine · doi:10.1038/s41591-020-1124-9 · Cited by 2,904
SARS-CoV-2 vaccines in development
Krammer, F. (2020) · Nature · doi:10.1038/s41586-020-2798-3 · Cited by 2,098
Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
Chung, C. H., Mirakhur, B., Chan, E., Le, Q.-T., Berlin, J., Morse, M., Murphy, B. A., Satinover, S. M., Hosen, J., Mauro, D., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa074943 · Cited by 1,521
Freeman, D. H., Loe, B. S., Chadwick, A., Vaccari, C., Waite, F., Rosebrock, L. E., Jenner, L., Petit, A., Lewandowsky, S., Vanderslott, S., et al. (2020) · Psychological Medicine · doi:10.1017/s0033291720005188 · Cited by 802
Chanan-Khan, A., Szebeni, J., Savay, S., Liebes, L., Rafique, N. M., Alving, C. R., & Muggia, F. M. (2003) · Annals of Oncology · doi:10.1093/annonc/mdg374 · Cited by 479
Stone, C. A., Liu, Y., Relling, M. V., Krantz, M. S., Pratt, A. L., Abreo, A. M., Hemler, J. A., & Phillips, E. J. (2018) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2018.12.003 · Cited by 349
Bochner, B. S., & Lichtenstein, L. M. (1991) · New England Journal of Medicine · doi:10.1056/nejm199106203242506 · Cited by 324
Cited by
Sorted by citations
Unlocking the promise of mRNA therapeutics
Rohner, E., Yang, R., Foo, K. S., Goedel, A., & Chien, K. R. (2022) · Nature Biotechnology · doi:10.1038/s41587-022-01491-z · Cited by 612
Nanomaterial Delivery Systems for mRNA Vaccines
Buschmann, M. D., Carrasco, M. J., Alishetty, S., Paige, M., Alameh, M. G., & Weissman, D. (2021) · Vaccines · doi:10.3390/vaccines9010065 · Cited by 582
“Since the emergency use approval of the Pfizer/BioNTech vaccine, there has been several observed incidences of acute anaphylaxis corresponding to 1 case in 100,000 vaccinations, which is about 10-fold the rate seen with other vaccines [170].”
BackgroundDrug allergy: A 2022 practice parameter update
Khan, D. A., Banerji, A., Blumenthal, K. G., Phillips, E. J., Solensky, R., White, A. A., Bernstein, J. A., Chu, D. K., Ellis, A. K., Golden, D. B. K., et al. (2022) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2022.08.028 · Cited by 607
Chen, B., Cheng, T., & Roffler, S. R. (2021) · ACS Nano · doi:10.1021/acsnano.1c05922 · Cited by 587
The Limitless Future of RNA Therapeutics
Damase, T. R., Sukhovershin, R. A., Boada, C., Taraballi, F., Pettigrew, R. I., & Cooke, J. P. (2021) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2021.628137 · Cited by 577
Shi, D., Beasock, D., Fessler, A., Szebeni, J., Ljubimova, J. Y., Afonin, K. A., & Dobrovolskaia, M. A. (2022) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.114079 · Cited by 535
The dawn of mRNA vaccines: the COVID-19 case
Verbeke, R., Lentacker, I., De Smedt, S. C., & Dewitte, H. (2021) · Journal of Controlled Release · doi:10.1016/j.jconrel.2021.03.043 · Cited by 504
Watad, ., Marco, G. D., Mahajna, H., Druyan, A., Eltity, M., Hijazi, N., Haddad, A., Elias, M., Zisman, D., Naffaa, M. E., et al. (2021) · Vaccines · doi:10.3390/vaccines9050435 · Cited by 364
COVID-19 in early 2021: current status and looking forward
Wang, C., Wang, Z., Wang, G., Lau, J. Y., Zhang, K., & Li, W. (2021) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-021-00527-1 · Cited by 358
STING agonist delivery by tumour-penetrating PEG-lipid nanodiscs primes robust anticancer immunity
Dane, E. L., Belessiotis‐Richards, A., Backlund, C. M., Wang, J., Hidaka, K., Milling, L. E., Bhagchandani, S. H., Melo, M. B., Wu, S., Li, N., et al. (2022) · Nature Materials · doi:10.1038/s41563-022-01251-z · Cited by 342
McDonald, I., Murray, S. M., Reynolds, C. J., Altmann, D. M., & Boyton, R. J. (2021) · npj Vaccines · doi:10.1038/s41541-021-00336-1 · Cited by 253
The safety of Covid-19 mRNA vaccines: a review
Anand, P., & Stahel, V. P. (2021) · Patient Safety in Surgery · doi:10.1186/s13037-021-00291-9 · Cited by 239
Greenhawt, M., Abrams, E. M., Shaker, M. S., Chu, D. K., Khan, D. A., Akin, C., Alqurashi, W., Arkwright, P. D., Baldwin, J. L., Ben‐Shoshan, M., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.06.006 · Cited by 206
“14,18,88,121 Of note, skin testing to the vaccines is not approved under any of the EUAs.”
Anti-PEG antibodies compromise the integrity of PEGylated lipid-based nanoparticles via complement
Sentí, M. E., de Jongh, C. A., Dijkxhoorn, K., Verhoef, J. J. F., Szebeni, J., Storm, G., Hack, C. E., Schiffelers, R. M., Fens, M. H. A. M., & Boross, P. (2021) · Journal of Controlled Release · doi:10.1016/j.jconrel.2021.11.042 · Cited by 207
Kounis, N. G., Koniari, I. C., GREGORIO, C. D., Velissaris, D., Petalas, K., Brinia, A., Assimakopoulos, S. F., Gogos, C., Kouni, S. N., Kounis, G. N., et al. (2021) · Vaccines · doi:10.3390/vaccines9030221 · Cited by 192
“Vaccinated subjects with very high IgE concentrations thereby respond poorly to the vaccine [69].”
BackgroundNanotechnology-based mRNA vaccines
Chen, S., Huang, X., Xue, Y., Álvarez‐Benedicto, E., Shi, Y., Chen, W., Koo, S., Siegwart, D. J., Dong, Y., & Tao, W. (2023) · Nature Reviews Methods Primers · doi:10.1038/s43586-023-00246-7 · Cited by 177
Szebeni, J., Storm, G., Ljubimova, J. Y., Castells, M., Phillips, E. J., Turjeman, K., Barenholz, Y., Crommelin, D. J. A., & Dobrovolskaia, M. A. (2022) · Nature Nanotechnology · doi:10.1038/s41565-022-01071-x · Cited by 170
Fix, O. K., Blumberg, E. A., Chang, K., Chu, J., Chung, R. T., Goacher, E. K., Hameed, B., Kaul, D. R., Kulik, L., Kwok, R. M., et al. (2021) · Hepatology · doi:10.1002/hep.31751 · Cited by 157
mRNA vaccine in cancer therapy: Current advance and future outlook
Li, Y., Wang, M., Peng, X., Yang, Y., Chen, Q., Liu, J., She, Q., Tan, J., Lou, C., Liao, Z., et al. (2023) · Clinical and Translational Medicine · doi:10.1002/ctm2.1384 · Cited by 158
Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials
Chen, M., Yuan, Y., Zhou, Y., Deng, Z., Zhao, J., Feng, F., Zou, H., & Sun, C. (2021) · Infectious Diseases of Poverty · doi:10.1186/s40249-021-00878-5 · Cited by 143
“Severe adverse events (SAEs) were rare, and only were reported in some volunteers as hypersensitivity, facioplegia, urticaria and anaphylactic shock [11].”
BackgroundResultFirst-Dose mRNA COVID-19 Vaccine Allergic Reactions: Limited Role for Excipient Skin Testing
Wolfson, A. R., Robinson, L. B., Li, L., McMahon, A. E., Cogan, A. S., Fu, X., Wickner, P. G., Samarakoon, U., Saff, R. R., Blumenthal, K. G., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.06.010 · Cited by 140
“7) History of PEG Allergy 2 (3) 2 (3) 0 (0) Reaction History (n, %) Cutaneous Symptoms ǁ 65 (81) 51 (78) 14 (93) Lower Respiratory Symptoms ¶ 18 (23) 14 (22) 4 (27) Cardiovascular Symptoms # 11 (14) 10 (15) 1 (7) Gastrointestinal Symptoms ** 9 (11) 7 (11) 2 (13) Upper Airway Symptoms †† 6 (8) 6 (9) 0 (0) Other Symptom…”
BackgroundAlthaus, K., Mӧller, P., Uzun, G., Singh, A., Beck, A., Bettag, M., Bösmüller, H. C., Guthoff, M., Dorn, F., Petzold, G. C., et al. (2021) · Haematologica · doi:10.3324/haematol.2021.279000 · Cited by 132
Reactivation of Varicella Zoster Virus after Vaccination for SARS-CoV-2
Psichοgiou, M., Samarkos, M., Mikos, N., & Hatzakis, A. E. (2021) · Vaccines · doi:10.3390/vaccines9060572 · Cited by 135
“In addition, mRNA platform is a promising new technology and demonstration of its safety is meaningful for the development of further vaccines against viruses and tumors [41].”
BackgroundWarren, C. M., Snow, T. T., Lee, A., Shah, M. M., Heider, A., Blomkalns, A. L., Betts, B. A., Buzzanco, A. S., González, J. C., Chinthrajah, R. S., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.25524 · Cited by 135
“In pharmaceuticals, PEG is often conjugated to biological therapeutics to form a depot agent, and sensitivity to PEG has been linked to IgE-mediated anaphylaxis after administration of PEG-conjugated biological therapeutics.(9,10,14-16) Interestingly, severe allergic reactions to PEG have been associated with preexist…”
BackgroundInfluentialVaccines and allergic reactions: The past, the current COVID‐19 pandemic, and future perspectives
Sampath, V., Rabinowitz, G., Shah, M. M., Jain, S., Diamant, Z., Jeseňák, M., Rabin, R. L., Vieths, S., Agache, I. O., Akdiş, M., et al. (2021) · Allergy · doi:10.1111/all.14840 · Cited by 117
COVID-19 Vaccines: Current Understanding on Immunogenicity, Safety, and Further Considerations
He, Q., Mao, Q., Zhang, J., Bian, L., Gao, F., Wang, J., Xu, M., & Liang, Z. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.669339 · Cited by 112
“Severe allergic reactions have been reported after the administration of the two vaccines (89, 90).”
BackgroundHartwell, B. L., Melo, M. B., Xiao, P., Lemnios, A. A., Li, N., Chang, J. Y. H., Yu, J., Gebre, M. S., Chang, A., Maiorino, L., et al. (2022) · Science Translational Medicine · doi:10.1126/scitranslmed.abn1413 · Cited by 112
“Recently, some concerns have arisen from clinical studies of the SARS-CoV-2 mRNA vaccines regarding the possibility of antibody responses against PEG included in vaccine formulations, which might induce allergic reactions in human volunteers (50, 51).”
SARS-CoV-2 vaccines: a triumph of science and collaboration
Golob, J. L., Lugogo, N. L., Lauring, A. S., & Lok, A. S.-F. (2021) · JCI Insight · doi:10.1172/jci.insight.149187 · Cited by 113
“rare observed incidence of anaphylaxis remains unclear, as does the possible underlying etiology (49).”
BackgroundA COVID-19 Vaccine: Big Strides Come with Big Challenges
Mellet, J., & Pepper, M. S. (2021) · Vaccines · doi:10.3390/vaccines9010039 · Cited by 103
“Scientists speculate that these allergic reactions might be related to either the lipid or the PEG component of these vaccines [46].”
BackgroundRecent Advances in Site-Specific Lipid Nanoparticles for mRNA Delivery
Xu, X., & Xia, T. (2023) · ACS Nanoscience Au · doi:10.1021/acsnanoscienceau.2c00062 · Cited by 106
Multisystem inflammatory syndrome in an adult following the SARS-CoV-2 vaccine (MIS-V)
Nune, A., Iyengar, K. P., Goddard, C., & Ahmed, A. E. (2021) · BMJ Case Reports · doi:10.1136/bcr-2021-243888 · Cited by 99
Adverse events following COVID-19 vaccination: A systematic review and meta-analysis
Kouhpayeh, H., & Ansari, H. (2022) · International Immunopharmacology · doi:10.1016/j.intimp.2022.108906 · Cited by 102
“Severe adverse events (SAEs) are rare, and usually were reported in some cases as hypersensitivity, acute allergic reactions, urticaria and anaphylactic shock [41].”
InfluentialKrantz, M. S., Kwah, J. H., Stone, C. A., Phillips, E. J., Ortega, G., Banerji, A., & Blumenthal, K. G. (2021) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2021.3779 · Cited by 98
Current and future nanoparticle vaccines for COVID-19
Vu, M. N., Kelly, H. G., Kent, S. J., & Wheatley, A. K. (2021) · EBioMedicine · doi:10.1016/j.ebiom.2021.103699 · Cited by 101
“This phenomenon also raises safety concerns to other PEG derivatives such as polysorbates which are formulated with other nanoparticle vaccines, for examples S protein-micelle vaccines manufactured by Novavax [82].”
Troelnikov, A., Perkins, G. B., Yuson, C., Ahamdie, A., Balouch, S., Hurtado, P. R., & Hissaria, P. (2021) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2021.04.032 · Cited by 95
Krzywicka, K., Heldner, M. R., van Kammen, M. S., van Haaps, T. F., Hiltunen, S., Silvis, S. M., Levi, M. M., Hovinga, J. A. K., Jood, K., Lindgren, E., et al. (2021) · European Journal of Neurology · doi:10.1111/ene.15029 · Cited by 95
“Using the EMA pharmacovigilance database and pre-COVID-19 CVST cases as a historical control group, we found that CVST reported after ChAdOx1 nCov-19 vaccination: (1) was notified more frequently than after the BNT162b2 and mRNA-1273 vaccines; (2) was associated in approximately half of patients with thrombocytopenia,…”
Chen, W.-A., Chang, D.-Y., Chen, B., Lin, Y., Barenholz, Y., & Roffler, S. R. (2023) · ACS Nano · doi:10.1021/acsnano.2c12193 · Cited by 100
Shavit, R., Segal, R. M., Kidon, M. I., Offengenden, I., Yahia, S. H., Machnes‐Maayan, D., Lifshitz, Y., Niznik, S., Frizinsky, S., Deutch, M., et al. (2021) · JAMA Network Open · doi:10.1001/jamanetworkopen.2021.22255 · Cited by 93
Carreño, J. M., Singh, G., Tcheou, J., Srivastava, K., Gleason, C., Muramatsu, H., Desai, P., Aberg, J. A., Miller, R. L., PARIS study group, et al. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.08.024 · Cited by 95
“Furthermore, it has been suggested that certain components of the mRNA 82 vaccine formulations might be involved in the development of some of the adverse reactions 83 observed, including anaphylaxis (2, 9).”
BackgroundCaballero, M. L., Krantz, M. S., Quirce, S., Phillips, E. J., & Stone, C. A. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.03.002 · Cited by 94
Allergy to COVID-19 vaccines: A current update
Cabanillas, B., & Novak, N. (2021) · Allergology International · doi:10.1016/j.alit.2021.04.003 · Cited by 90
Factors Associated With COVID‐19 Disease Severity in US Children and Adolescents
Antoon, J. W., Grijalva, C. G., Thurm, C. W., Richardson, T., Spaulding, A. B., Teufel, R. J., Reyes, M. A., Shah, S. S., Burns, J. E., Kenyon, C. C., et al. (2021) · Journal of Hospital Medicine · doi:10.12788/jhm.3689 · Cited by 91
Cutaneous Adverse Reactions Associated with SARS-CoV-2 Vaccines
Bellinato, F., Maurelli, M., Gisondi, P., & Girolomoni, G. (2021) · Journal of Clinical Medicine · doi:10.3390/jcm10225344 · Cited by 88
“Control for vaccine safety requires a proactive approach, involving vigilance, response, documentation, and characterization of the events [4].”
BackgroundAllergies and COVID‐19 vaccines: An ENDA/EAACI Position paper
Barbaud, A. M., Garvey, L. H., Arcolacı, A., Brockow, K., Mori, F., Mayorga, C., Bonadonna, P., Atanasković‐Marković, M., Moral, L., Zanoni, G., et al. (2022) · Allergy · doi:10.1111/all.15241 · Cited by 88
“2022;77:2292–2312.wileyonlinelibrary.com/journal/all Received: 13 September 2021 | Revised: 17 December 2021 | Accepted: 3 January 2022 DOI: 10.1111/all.15241 E A A C I P O S I T I O N P A P E R Allergies and COVID- 19 vaccines: An ENDA/EAACI Position paper Annick Barbaud1 | Lene Heise Garvey2,3 | Alessandra Arcolaci4…”
BackgroundInfluentialEfficacy and Safety of COVID-19 Vaccines in Phase III Trials: A Meta-Analysis
Cheng, H., Peng, Z., Luo, W., Si, S., Mo, M., Zhou, H., Xin, X., Liu, H., & Yu, Y. (2021) · Vaccines · doi:10.3390/vaccines9060582 · Cited by 85
“Only the COVID-19 vaccine has been approved for marketing, so more studies are still needed to evaluate its safety [38].”
BackgroundPEG That Reaction: A Case Series of Allergy to Polyethylene Glycol
Cox, F., Khalib, K., & Conlon, N. P. (2021) · The Journal of Clinical Pharmacology · doi:10.1002/jcph.1824 · Cited by 84
A case of Graves' disease and type 1 diabetes mellitus following SARS-CoV-2 vaccination
Patrizio, A., Ferrari, S. M., Antonelli, A., & Fallahi, P. (2021) · Journal of Autoimmunity · doi:10.1016/j.jaut.2021.102738 · Cited by 83
“The widespread use of mRNA vaccines against SARS-CoV-2 has quickly revealed their possible side effects such as fever, fatigue, headache, muscle and joint pain or anaphylaxis [1].”
BackgroundNanomaterial-encapsulated STING agonists for immune modulation in cancer therapy
Chen, X., Xu, Z., Li, T., Thakur, A., Wen, Y., Zhang, K., Liu, Y., Liang, Q., Liu, W., Qin, J., et al. (2024) · Biomarker Research · doi:10.1186/s40364-023-00551-z · Cited by 92
“However, using PEGylated NPs raises potential concerns about preexisting anti-PEG responses, such as allergic reactions, alerting developers to the side effects of exogenous modification on nanocarriers [94].”
BackgroundSchramm, R., Costard‐Jäckle, A., Rivinius, R., Fischer, B., Muller, B. Z., Boeken, U., Haneya, A., Provazník, Z., Knabbe, C., & Gummert, J. F. (2021) · Clinical Research in Cardiology · doi:10.1007/s00392-021-01880-5 · Cited by 81
HIV mRNA Vaccines—Progress and Future Paths
Mu, Z., Haynes, B. F., & Cain, D. W. (2021) · Vaccines · doi:10.3390/vaccines9020134 · Cited by 84
Striving for Uniformity: A Review on Advances and Challenges To Achieve Uniform Polyethylene Glycol
Bento, C., Katz, M., Santos, M. M. M., & Afonso, C. A. M. (2024) · Organic Process Research & Development · doi:10.1021/acs.oprd.3c00428 · Cited by 81
Haabeth, O. A. W., Lohmeyer, J. J. K., Sallets, A., Blake, T. R., Sagiv-Barfi, I., Czerwinski, D. K., McCarthy, B., Powell, A. E., Wender, P. A., Waymouth, R. M., et al. (2021) · ACS Central Science · doi:10.1021/acscentsci.1c00361 · Cited by 74
Enhancing therapeutic performance of personalized cancer vaccine via delivery vectors
Ye, T., Li, F., Ma, G., & Wei, W. (2021) · Advanced Drug Delivery Reviews · doi:10.1016/j.addr.2021.113927 · Cited by 73
Zhang, R., Shao, S., Piao, Y., Xiang, J., Wei, X., Zhang, Z., Zhou, Z., Tang, J., Qiu, N., Xu, X., et al. (2023) · Advanced Materials · doi:10.1002/adma.202303614 · Cited by 72
Straight to the point: targeted mRNA-delivery to immune cells for improved vaccine design
Clemente, B., Denis, M., Silveira, C. P., Schiavetti, F., Brazzoli, M., & Stranges, D. (2023) · Frontiers in Immunology · doi:10.3389/fimmu.2023.1294929 · Cited by 71
“Another aspect that is highly relevant for patient compliance is the emergence of side effects, such as injection site pain, fever, fatigue, headache and diarrhea following mRNA vaccination (13).”
BackgroundBeyond Lipids: Exploring Advances in Polymeric Gene Delivery in the Lipid Nanoparticles Era
Jogdeo, C. M., Siddhanta, K., Das, A., Ding, L., Panja, S., Kumari, N., & Oupický, D. (2024) · Advanced Materials · doi:10.1002/adma.202404608 · Cited by 76
COVID ‐19: vaccination problems
Brüssow, H. (2021) · Environmental Microbiology · doi:10.1111/1462-2920.15549 · Cited by 69
“It is currently unknown whether for these subjects the adenovirus vectored vaccine which is formulated with polysorbate 80, a nonionic surfactant and emulsifier that has a structure similar to PEG, is an alternative (Castells and Phillips, 2021).”
BackgroundMcMurry, R., Lenehan, P. J., Awasthi, S., Silvert, E., Puranik, A., Pawlowski, C., Venkatakrishnan, A., Anand, P., Agarwal, V., O’Horo, J. C., et al. (2021) · Med · doi:10.1016/j.medj.2021.06.006 · Cited by 65
“Notably, these rates of adverse effects documented in EHR notes were markedly lower than the rates of adverse effects observed in clinical trials (e.g., fatigue [63%–70%], myalgia [38%–62%], arthralgia [24%–46%], fever [14%–16%], and ery-thema [10%–15”
Kim, M. S., Jung, S. Y., Ahn, J. G., Park, S.-J., Shoenfeld, Y., Kronbichler, A., Koyanagi, A., Dragioti, E., Tizaoui, K., Hong, S. H., et al. (2021) · Journal of Medical Virology · doi:10.1002/jmv.27424 · Cited by 67
“2,3,6 Although the safety profiles of mRNA vaccines have been evaluated in serial clinical trials, 4,5,7 concerns remain as the safety evaluations in clinical trials were limited to relatively healthy people, excluding vulnerable populations such as children, pregnant women, and individuals with…”
BackgroundCOVID-19 vaccination in patients with multiple myeloma: a consensus of the European Myeloma Network
Ludwig, H., Sonneveld, P., Facon, T. T. F., Miguel, J. F. S., Avet‐Loiseau, H., Mohty, M., Mateos, M.-V., Moreau, P., Cavo, M., Pawlyn, C., et al. (2021) · The Lancet Haematology · doi:10.1016/s2352-3026(21)00278-7 · Cited by 66
McSweeney, M. D., Mohan, M., Commins, S. P., & Lai, S. K. (2021) · Frontiers in Allergy · doi:10.3389/falgy.2021.715844 · Cited by 64
Alhumaid, S., Mutair, A. S. A., Alawi, Z. A., Rabaan, A. A., Tirupathi, R., Alomari, M. A., Alshakhes, A. S., Alshawi, A. M., Ahmed, G. Y., Almusabeh, H. M., et al. (2021) · Allergy Asthma and Clinical Immunology · doi:10.1186/s13223-021-00613-7 · Cited by 62
Gounant, V., Ferré, V. M., Soussi, G., Charpentier, C., Flament, H., Houhou‐Fidouh, N., Collin, G., Namour, C., Assoun, S., Bizot, A., et al. (2021) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2021.10.015 · Cited by 61
“After blood sampling and vaccine injection, patients were followed up for 15 minutes under medical surveillance.(27) This study was approved by the ParisNorth institutional review board (number 00006477, approval N CER-2021-72).”
Safety of COVID-19 vaccination in patients with polyethylene glycol allergy: A case series
Picard, M., Drolet, J., Masse, M.-S., Filion, C. A., ALMuhizi, F., Fein, M. N., Copaescu, A. M., Isabwe, G. A. C., Blaquière, M., & Primeau, M.-N. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.11.021 · Cited by 59
Dézsi, L., Mészáros, T., Kozma, G. T., H-Velkei, M., Oláh, C. Z., Szabó, M., Patkó, Z., Fülöp, T., Hennies, M., Szebeni, M., et al. (2022) · GeroScience · doi:10.1007/s11357-021-00495-y · Cited by 58
Baki, A., Remmo, A., Löwa, N., Wiekhorst, F., & Bleul, R. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22126235 · Cited by 57
“However, it is frequently reported that PEG can lead to pseudo allergic reactions in clinical applications and can provoke IgE-mediated reactions and recurrent anaphylaxis [65,66].”
BackgroundInnovative Nanomedicine Delivery: Targeting Tumor Microenvironment to Defeat Drug Resistance
Meng, W., Huang, L., Guo, J., Xin, Q., Liu, J., & Hu, Y. (2024) · Pharmaceutics · doi:10.3390/pharmaceutics16121549 · Cited by 61
“Immune and allergic reactions triggered by nanomedicine delivery systems are another safety issue to be considered [149].”
Huang, Y., Zhang, Z., & Zhou, Y. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.1053617 · Cited by 55
“But some patients may not be suitable for vaccination due to a severe allergic reaction or may fail to mount a protective immune response through vaccines (7, 8).”
BackgroundPark, J. K., Lee, E. B., Shin, K., Sung, Y., Kim, T., Kwon, S., Lee, M. S., Hong, S., Choi, B. Y., Lee, S., et al. (2021) · Journal of Korean Medical Science · doi:10.3346/jkms.2021.36.e95 · Cited by 53
Ossato, A., Tessari, R., Trabucchi, C., Zuppini, T., Realdon, N., & Marchesini, F. (2021) · European Journal of Hospital Pharmacy · doi:10.1136/ejhpharm-2021-002933 · Cited by 57
Zakarya, K. D., Бекболатович, К. Л., Orynbayev, M. B., Abduraimov, Y. O., Sultankulova, K. T., Kassenov, M., Sarsenbayeva, G., Кулмагамбетов, И. Р., Davlyatshin, T. I., Sergeeva, M. V., et al. (2021) · EClinicalMedicine · doi:10.1016/j.eclinm.2021.101078 · Cited by 53
“Between the vaccine and placebo groups, no statistically significant difference has been shown in the level of total serum IgE antibodies which are known as specific triggers of allergic reactions [12].”
BackgroundQi, Y., Li, J., Nie, Q., Gao, M., Yang, Q., Li, Z., Li, Q., Han, S., Ding, J., Li, Y., et al. (2021) · Biomaterials · doi:10.1016/j.biomaterials.2021.120952 · Cited by 54
Shin, K., Suh, H., Grundler, J., Lynn, A. Y., Pothupitiya, J. U., Moscato, Z. M., Reschke, M., Bracaglia, L. G., Piotrowski-Daspit, A. S., & Saltzman, W. M. (2022) · Biomaterials · doi:10.1016/j.biomaterials.2022.121676 · Cited by 48
Shimizu, J., Sasaki, T., Koketsu, R., Morita, R., Yoshimura, Y., Murakami, A., Saito, Y., Kusunoki, T., Samune, Y., Nakayama, E. E., et al. (2022) · Scientific Reports · doi:10.1038/s41598-022-19993-w · Cited by 50
Vaccine allergy: evidence to consider for COVID-19 vaccines
Nilsson, L. E., Csuth, Á., Storsæter, J., Garvey, L. H., & Jenmalm, M. C. (2021) · Current Opinion in Allergy and Clinical Immunology · doi:10.1097/aci.0000000000000762 · Cited by 48
Liao, Y., Li, Y., Pei, R., Fang, X. D., Zeng, P., Fan, R., Ou, Z., Deng, J., Zhou, J., Guan, W., et al. (2021) · Emerging Microbes & Infections · doi:10.1080/22221751.2021.1951126 · Cited by 47
“Recombinant protein vaccines have relatively safe profiles, because this kind of vaccines does not require lipidated PEG to form nanoparticles for delivery, or the adenovirus vectors for viral gene packaging, given that a number of AEs and SAEs present a strong correlation with lipid-PEG formulation and adenovirus vec…”
BackgroundPfizer-BioNTech COVID-19 Vaccine Tolerance in Allergic versus Non-Allergic Individuals
Nittner‐Marszalska, M., Rosiek‐Biegus, M., Kopeć, A., Pawłowicz, R., Kosińska, M., Łata, A., & Szenborn, L. (2021) · Vaccines · doi:10.3390/vaccines9060553 · Cited by 49
Duong, T. V., Lin, C.-Y., Chen, S., Huang, Y., Okan, O., Dadaczynski, K., & Lai, C.-F. (2021) · Vaccines · doi:10.3390/vaccines9090985 · Cited by 50
Özer, İ., Pitoc, G. A., Layzer, J. M., Moreno, A., Olson, L. B., Layzer, K. D., Hucknall, A., Sullenger, B. A., & Chilkoti, A. (2022) · Advanced Materials · doi:10.1002/adma.202107852 · Cited by 46
Chen, L., Qu, J., Kalyani, F. S., Zhang, Q., Fan, L., Fang, Y., Li, Y., & Xiang, C. (2022) · Cellular and Molecular Life Sciences · doi:10.1007/s00018-021-04096-y · Cited by 47
Wong, C. K. H., Lau, K. T. K., Xiong, X., Au, I. C. H., Lai, F. T. T., Wan, E. Y. F., Chui, C. S. L., Li, X., Chan, E. W., Gao, L., et al. (2022) · PLoS Medicine · doi:10.1371/journal.pmed.1004018 · Cited by 45
“Consistent with previous observations that anaphylaxis was clinically manifested more frequently after the first dose of either vaccine [57,59], it remains to be determined if these events would be considered anaphylaxis with previous sensitization to specific components of the vaccines, or anaphylactoid reactions occ…”
ResultAkache, B., Renner, T. M., Tran, A., Deschatelets, L., Dudani, R., Harrison, B. A., Duque, D., Haukenfrers, J., Rossotti, M. A., Gaudreault, F., et al. (2021) · Scientific Reports · doi:10.1038/s41598-021-01363-7 · Cited by 43
Maintaining Safety with SARS-CoV-2 Vaccines
Rolla, G., Brussino, L., & Badiu, I. (2021) · New England Journal of Medicine · doi:10.1056/nejmc2100766 · Cited by 44
Michos, A. G., Tatsi, E., Filippatos, F., Dellis, C., Koukou, D., Efthymiou, V., Kastrinelli, E., Mantzou, A., & Syriopoulou, V. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.07.067 · Cited by 41
“It is important after the emergent authorization of COVID-19 vaccines, to maintain public confidence for the safety of immunization with post-vaccination surveillance and documentation of AEs, to achieve high immunization coverage [18,19].”
Deaths associated with newly launched SARS-CoV-2 vaccination (Comirnaty®)
Edler, C., Klein, A., Schröder, A. S., Sperhake, J., & Ondruschka, B. (2021) · Legal Medicine · doi:10.1016/j.legalmed.2021.101895 · Cited by 42
“2 reactions up to anaphylactic shock were reported [6].”
Bonadonna, P., Brockow, K., Niedoszytko, M., Elberink, H. O., Akin, C., Nedoszytko, B., Butterfield, J. H., Álvarez‐Twöse, I., Sotlar, K., Schwaab, J., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.03.041 · Cited by 42
“Severe allergic reactions to the previous dose of mRNA COVID-19 vaccines, to any of its components, including polyethylene glycol and potentially cross-reacting polysorbate, are contraindications for vaccination.(24) Recent data on 2 health care workers with cutaneous and systemic mastocytosis who had a history of pri…”
Anaphylaxis associated with the mRNA COVID-19 vaccines: Approach to allergy investigation
Turk, V. E. (2021) · Clinical Immunology · doi:10.1016/j.clim.2021.108748 · Cited by 40
“Given the evidence for both IgE-mediated and non-IgE-mediated mechanisms, further research is needed to explore the possibility of their coexistence in PEG-associated anaphylaxis [29,30].”
Ferretti, F., Cannatelli, R., Benucci, M., Carmagnola, S., Clementi, E., Danelli, P., Dilillo, D., Fiorina, P., Galli, M., Gallieni, M., et al. (2021) · Frontiers in Immunology · doi:10.3389/fimmu.2021.656362 · Cited by 39
“Of course, it is recommended by FDA to have adequate medical equipment immediately available to manage a potential allergic reaction after the administration (8, 9).”
BackgroundRama, T. A., Moreira, A. M., & Castells, M. (2021) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2021.01.004 · Cited by 39
Yu, X., Li, H., Dong, C., Qi, S., Yang, K., Bai, B., Peng, K., Buljan, M., Lin, X., Liu, Z., et al. (2023) · ACS Nano · doi:10.1021/acsnano.3c07932 · Cited by 39
Zhang, B., Wang, C., Guo, M., Zhu, F., Yu, Z., Zhang, W., Li, W., Zhang, Y., & Tian, W. (2024) · ACS Nano · doi:10.1021/acsnano.4c07690 · Cited by 39
Alhumaid, S., Rabaan, A. A., Dhama, K., Yong, S. J., Nainu, F., Hajissa, K., Dossary, N. A., Alajmi, K. K., Saggar, A. E. A., Alharbi, F. A., et al. (2022) · Vaccines · doi:10.3390/vaccines10081289 · Cited by 39
“Maintenance of vaccine safety requires a proactive approach to maintain public confidence and reduce vaccine hesitancy [1,2].”
BackgroundPostbiotics as potential promising tools for SARS-CoV-2 disease adjuvant therapy
Khani, N., Soleimani, R. A., Noorkhajavi, G., Soleimani, A. A., Abbasi, A., & Rad, A. H. (2022) · Journal of Applied Microbiology · doi:10.1111/jam.15457 · Cited by 39
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management
Luxi, N., Giovanazzi, A., Arcolacı, A., Bonadonna, P., Crivellaro, M., Cutroneo, P. M., Ferrajolo, C., Furci, F., Guidolin, L., Moretti, U., et al. (2022) · BioDrugs · doi:10.1007/s40259-022-00536-8 · Cited by 37
“However, severe allergic reactions have been reported since the beginning of the vaccination campaign [28, 29], which suggests a higher rate of anaphylaxis due to the COVD-19 vaccine in comparison with other marketed vaccines.”
Liquid Chromatography Methods for Analysis of mRNA Poly(A) Tail Length and Heterogeneity
Gilár, M., Doneanu, C. E., & Gaye, M. M. (2023) · Analytical Chemistry · doi:10.1021/acs.analchem.3c02552 · Cited by 37
Programmable manipulation of oligonucleotide–albumin interaction for elongated circulation time
Cai, Y., Zhao, H., Sun, Y., Wang, C., Geng, X., Wang, R., Tang, L., Han, D., Liu, J., & Tan, W. (2022) · Nucleic Acids Research · doi:10.1093/nar/gkac156 · Cited by 37
“It was recently observed that the nanoparticles and polymers (polyethylene glycol, PEG) may trigger severe allergic reactions using the approved mRNA vaccine against COVID-19 (25).”
Li, Z., Liu, S., Li, F., Li, Y., Li, Y., Peng, P., Li, S., Li, H., & Liu, T. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.965971 · Cited by 40
“Theoretically, these discrepancies may be attributed to differences in the strength of the immune responses to various vaccines (86, 88, 89), as corroborated by this review’s efficacy and”
ResultAseptic meningitis after vaccination of the BNT162b2 mRNA COVID-19 vaccine
Saito, K., Shimizu, T., Suzuki‐Inoue, K., Ishida, T., & Wada, Y. (2021) · Neurological Sciences · doi:10.1007/s10072-021-05543-1 · Cited by 36
Labella, M., Céspedes, J. A., Doña, I., Shamji, M. H., Agache, I. O., Mayorga, C., & Torres, M. J. (2021) · Allergy · doi:10.1111/all.15148 · Cited by 36
A Case of Multisystem Inflammatory Syndrome in a 12-Year-old Male After COVID-19 mRNA Vaccine
Yalçınkaya, R., Öz, F. N., Polat, M., Uçan, B., Teke, T. A., Kaman, A., Özdem, S., Şen, Z. S., Cinni, R. G., & Tanir, G. (2021) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000003432 · Cited by 36
Metadata
- Authors
- Castells, M. C., & Phillips, E. J.
- Affiliations
- Brigham and Women's Hospital (US)
- Corresponding author
- Castells, Mariana C.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2021-02-18
- Volume
- 384
- Issue
- 7
- Pages
- 643-649
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC7787218
- OpenAlex
- W3115737775
- Cited by
- 395
- References
- 17
- Citations by year
- 2026: 10 · 2025: 15 · 2024: 24 · 2023: 42 · 2022: 114 · 2021: 189
- FWCI
- 11.32
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- New England Journal of Medicine (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- COVID-19 vaccines, vaccine excipients, vaccine ingredients, package inserts, vaccine safety, vaccine production
- MeSH terms
- COVID-19, COVID-19 Vaccines, mRNA Vaccines, Anaphylaxis, Humans, Vaccines, Synthetic, Viral Vaccines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
