Safety outcomes associated with the moderna COVID-19 vaccine (mRNA-1273): a literature review

Figures & data

Figure 1. PRISMA flow chart depicting study screening and selection process.

Table 1. Qualitative summary of included RCTs (randomized control trial studies).

Reference	Intervention	Study Design	Participants/ Setting	Mean age (years)	Study duration or Follow-up	Relevant Results	Limitations
Baden LR, et al. [16]	2 doses of mRNA-1273 (100μg) 28 days apart.	Observer-blinded, placebo-controlled trial	n = 30420 from 99 US sites Males: 52.7% Females: 47.3%	51.4	63 days	Injection site events: 84.2% after 1^st dose and 88.6% after 2^nd dose. Systemic events: 54.9% after 1^st dose and 79.4% after 2^nd dose. The frequency of grade 3 AEs in the placebo group (1.3%) was similar in the vaccine group (1.5%), as were the frequencies of medically attended AEs (9.7% vs 9.0%) and serious AEs (0.6% in both groups). The severity of systemic events increased after the 2^nd dose of mRNA-1273.	Short follow-up period, exclusion of pregnant women and children.
Anderson EJ, et al. [19]	2 doses of mRNA-1273 (25-μg) or placebo.	Observer-blinded, placebo-controlled trial	n = 6,388 from 79 sites in the US and 8 sites in Canada Male: 50.9% Female: 49.1%	2-5years: 3 6-23months: 1.32	71 days	Systemic events: fatigue, irritability or crying, sleepiness, and loss of appetite. The incidence of local and systemic AEs was higher in the mRNA-1273 group than in the placebo group. The overall incidence of AEs that occurred within 28 days after the injection was similar in the mRNA-1273 and the placebo groups, with the incidence slightly higher in the vaccine group. Observed AEs were generally low-grade and transient.	Healthy children and the underrepresentation of the Black population.
Creech CB, et al. [20]	2 doses of mRNA-1273 (50μg) or placebo.	Observer-blinded, placebo-controlled phase 3 trial	n = 4,016 from 79 sites in the US and 8 sites in Canada Male: 50.8% Female: 49.2%	8.5	82 days	Local AEs were more common in the mRNA-1273 group after the 1^st and 2^nd dose. The most common local AE was pain at the injection site (93% after dose 1 and 95% after dose 2). Others included erythema (12% after 1^st dose and 19% after 2^nd dose), swelling (12% after 1^st dose and 17% after 2^nd dose) and lymphadenopathy (16% after 1^st dose and 18% after 2^nd dose) Systemic AEs were more common in the mRNA-1273 group only after the 2^nd dose. The most common systemic events reported in the mRNA-1273 group were headache (31% after 1^st dose and 54% after 2^nd dose) and fatigue (43% after 1^st dose and 65% after 2^nd dose). Majority of AEs within the vaccine group occurred within 1–2 days after either dose. AEs were largely low-grade and transient.	Short follow-up and included healthy children.
Ali K,et al. [22]	2 doses of mRNA-1273 vaccine (100μg) or placebo	Phase 3 placebo-controlled trial.	n = 3,732 participants from across 26 sites in the US. Male: 51% Female: 49%	14.3	83 days	Injection site events: pain after the 1^st dose (93.1%; grade 3, 5.4%) and the 2^nd dose (92.4%; grade 3, 5.1%). Systemic events: headaches (44.6% after the 1^st dose and 70.2% after the 2^nd dose) and fatigue (47.9% after the 1^st dose and 67.8% after the 2^nd dose). No serious AEs related to mRNA-1273 were identified.	Short follow-up period, and the majority of participants were White (84%).
Masuda T, et al. [25]	2 doses of mRNA-1273 (100μg) or placebo.	Observer blind placebo-controlled trial.	n = 200 The study was conducted at 2 centres in Japan. Male: 56% Female: 44%	mRNA-1273 cohort: 53.3 Placebo cohort: 52.4	4 weeks	Induration and swelling after the 1^st and 2^nd dose was more common within the older participants (12.0% and 16.0% respectively) than in younger participants (3.0% and 8.0% respectively). Erythema, induration, and swelling were also reported more frequently in older participants (26.5%, 24.5% and 28.6%, respectively) than in younger participants (13.3%, 7.1%, and 10.2, respectively). Common systemic AEs: Myalgia (61.2%), fatigue (59.2%), fever and headache (both, 34.7%).	Limited sample size, the inclusion of healthy adults.
Anderson EJ, et al. [28]	2 doses of mRNA-1273 (25μg or 100μg).	Expansion of a phase 1 dose-escalation, open-label trial.	n = 40 Conducted across 3 research institutes within the US. Male: 48% Female: 52%	68.7	13 months	The most common local AEs observed was injection-site pain. Common systemic AEs: headache, fatigue, myalgia and chills. Three participants (7.5%) experienced mild erythema lasting 5–7 days. The incidence of local and systemic events was more common and predominately moderate in severity after the administration of the 2^nd dose of the vaccine.	A large percentage of the study population was White (98%).

Table 2. Qualitative summary of included observational studies.

Reference	Intervention	Study design	Participants/ Setting	Mean age (years)	Study duration or Follow-up	Relevant Results	Limitations
Kadali RAK, et al [14]	A dose of the mRNA-1273 vaccine.	Cross-sectional study	n = 432 from healthcare communities in the US. Male: 10.42% Female: 89.35% No response: 0.23%	43.76	1 month	Localized symptom/s (96.06%) Generalized symptom/s (67.59%) Musculoskeletal symptom/s (62.5%); Gastrointestinal symptom/s (35.4%) Psychological/psychiatric symptom/s (24.3%) Endocrine symptom/s (21.99%) Head/ear/eyes/nose/throat symptom/s (20.37%); Neurological symptom/s (16.67%) Cardiovascular symptom/s (12.04%) Respiratory symptom/s (6.01%) Allergic (other than localized/generalized rash) (4.63%) Urinary symptom/s (2.55%)	Self-reported symptoms were not verified clinically, most of the study population was female, data from minority ethnic groups, the initial onset of symptoms and underlying medical conditions were not considered.
Lee DS, et al. [15]	A dose of AZD1222 (AstraZeneca), BNT162b2 (Pfizer), JNJ-78436735 (Janssen), or mRNA-1273.	Retrospective study	n = 36299,704 n = 2,343,396 received the mRNA-1273 vaccine (6.5%). Data was collected from the Korean Disease Control and Prevention Agency. Within mRNA-1273 recipients: Male: 48.3% Female: 51.7%	Notreported.	6 months	Common mild AEs: myalgia (1,717), headache (1,544), gastrointestinal symptoms (1398), skin-related symptoms (989), fever (911) and arthritis (523). These usually occurred within a day after vaccine administration. Common severe AEs: severe skin reactions (167), acute paralysis (144), anaphylaxis (26), acute respiratory distress syndrome (18) and lymphadenitis (18). Both severities of AEs were more common with the 2nd dose. The frequency and severity of AEs in participants who received mRNA-1273: Mild: 7990 Major severe: 120 Anaphylaxis event: 26 Mortality event: 2	No data on the ethnicity of participants and blood test data was not used to confirm disease severity.
Moro PL, et al. [29]	1 or 2 doses of COVID-19 vaccine	Post-authorization surveillance using VAERS.	n = 3,462 reports from VAERS Female: 100% Male: 0%	33	10 months	The most common non-pregnancy specific AEs were headache (19.8%), fatigue(19.2%), pyrexia(18.8%), pain(17.9%) and chills(17.2%). Most common pregnancy-specific outcomes included; spontaneous abortion(SAB) (25.3% of reports), vaginal bleeding(2.7%) and preterm delivery (1.9%). Of 3,462 AEs reported 1,350 (38.9%) occurred after receiving mRNA-1273.	Underreporting, stimulated reporting and the lack of denominator data are limitations of VAERS.
Sadarangani M, et al. [31]	COVID-19 vaccine in previous 7 days.	Cohort study	n = 265,896 non-pregnant n = 8,705 pregnant Recruited from 7 Canadian provinces. Female: 99% Other: 1%	Not reported	7 days	Local AE: among pregnant persons was injection site reactions (86.3% after the 1^st dose and 83.1% after the 2^nd dose). Significant health events after the 2^nd dose in pregnant females; feeling unwell or malaise or myalgia (11·4%), headache or migraine (8·5%), and respiratory tract infection (5·6%). Miscarriage or stillbirth were the most frequently reported adverse pregnancy outcomes. These were similar within the control (2·1%) and vaccinated groups after the 1^st dose of any mRNA vaccine. Significant health events occurred less commonly within the pregnant population than the non-pregnant after both doses (4.1% vs 6.6% after 1st dose and 12.1% vs 16.1% after 2nd dose). Regression analysis showed an increased risk of significant health events within 7 days after the 2^nd dose of mRNA-1273 (aOR 4·4 [CI 2 ·4–8·3]) among pregnant vaccinated individuals, compared with pregnant unvaccinated controls.	Short follow-up, subject to recall bias and relied on individuals having an email address and actively enrolling.
Jiménez Ortega AF, et al. [35]	3 doses of mRNA-1273 vaccine.	Cross-sectional study	n = 93 patients with solid malignancies receiving active treatment Madrid, Spain. Males: 33% Females: 66%	61	8 months	Common systemic reactions were fever, followed by malaise and myalgia. No grade 4 or 5 AEs occurred. A higher ECOG score was associated with a lower proportion of patients suffering from systemic AEs (p = 0.012). Increasing age was also associated with a decreased likelihood of exhibiting AEs (p = 0.016). Logistic regression showed females had 5.79 times higher odds of systemic AEs after the third dose (p = 0.01) than males.	Small sample size and uneven distribution of genders and ages.
Oosting SF, et al [36]	2 doses of mRNA-1273 (100μg).	Prospective, multicentre, non-inferiority trial.	n = 743 Research was conducted across 3 centres in the Netherlands. Male: 49.7% Female: 50.3%	63	122 days	The most common local AE was pain at the injection site and the most reported systemic AE was fatigue after the 1^st and 2^nd vaccination. Incidence of systemic events was greater after the 2^nd dose within all cohorts. 2 cases of thromboembolism and Stevens-Johnson syndrome related to the vaccine were also reported. Immune-related AEs occurred in 4% treated with immunotherapy and 4% of treated with chemoimmunotherapy Grade 3 or worse reactions were more common among cohorts of cancer patients than participants without cancer (1.8% and 0%, respectively).	Not powered to study AEs within patients with different tumour types or chemotherapy regimens.
Wong KK, et al. [41]	Any COVID-19 vaccine	Cohort study	n = 5,975,363 v-safe respondents Female: 100% Male: 0%	. 37	4 weeks	From 63,815 (1%) respondents reporting irregularities or vaginal bleeding 26,741 [41·9%] respondents received the mRNA-1273 vaccine. Irregularities in menstrual timing: 42% were from mRNA-1273 recipients. Increase in severity of menstrual symptoms: 41.9% Menopausal bleeding: 44.7% Resumption of menses in persons whose menstrual cycles were suppressed by medication, conception, or breastfeeding: 42.5% Majority of responses across all themes occurred within 7 days after each dose and at the 3-month and 6-month surveys after the 2^nd dose.	Baseline incidence rates and menstruation irregularities within younger age groups (under 18) not taken. Stimulated responses due to increased awareness of symptoms.
Edelman A, et al. [45]	Any COVID-19 vaccine.	Cohort study	n = 3,959 US residents Data collected from digital fertility awareness application Natural Cycles. Female: 100% Male: 0%	Not reported	Cycle data collected over 11 months.	35% of the vaccinated cohort received mRNA-1273. Vaccinated individuals experienced a less than 1-day unadjusted increase in the length of their menstrual cycle during the first vaccine cycle compared with their three pre-vaccination cycles (0.71-day increase, 98.75% CI 0.47–0.94). After adjusting for confounders, the difference in the change in cycle length by vaccination status was 0.64 days (98.75% CI 0.27–1.01) No significant changes in cycle length were observed within the unvaccinated cohort. Sensitivity analyses comparing changes in cycle and menses length did not alter these results.	Restricted to Natural Cycles users and lack of long-term follow-up of subsequent cycles.
Foltran D, et al. [46]	2 doses of an mRNA vaccine.	Post-authorization surveillance using VigiBase.	n = 4942 reports from VigiBase® Of 242 reports of pericarditis and/or myocarditis: Male: 85% Female: 15%	Among cases: 15.8	9 months	From 283 adolescents who received mRNA-1273, 3.2% reported pericarditis and/or myocarditis. Among cases, 85% were reported by males. Risk of reporting pericarditis and/or myocarditis was 10 times higher in boys compared to girls for the 1^st (ROR 10.1; 95% CI 4.26, 29.6) and 2^nd dose (ROR 10.2; 95% CI 4.88, 25.0). The second dose was associated with a 5-fold increase in the reporting odds of myocarditis and/or pericarditis compared with the first dose of vaccine ((ROR 4.95; 95% CI 3.14, 7.89).	Lack of data on dose information and subject to reporting bias.
Massari M, et al. [47]	A dose of an mRNA vaccine.	Self-controlled case series design post marketing surveillance.	n = 10769,025 received mRNA vaccines from a dynamic multiregional observational cohort. From 441 reports of myocarditis/pericarditis: Male: 68.5% Female: 31.5%	26	9 months 93 days.	From 441 cases of myocarditis/pericarditis, 95 (21.5%) received mRNA-1273. During a 21-day risk period, there were a total of 40 cases in those who received mRNA-1273. RI (relative incidence) 2.22 (95% CI 1.00 to 4.91) and 2.63 (95% CI 1.21 to 5.71) after the 1^st and 2^nd doses of mRNA-1273, respectively. There was an increased risk of myocarditis/pericarditis after 0–7 days following the 1^st dose and 2^nd of mRNA-1273 (RI = 6.55, 95% CI: 2.73 to 15.72 and RI = 7.59, 95% CI: 3.26 to 17.65, respectively) A higher risk of myocarditis/pericarditis was observed in males at 0–7 days after the 1^st (RI of 12.28 (4.09 to 36.83)) and 2^nd (RI of 11.91 (3.88 to 36.53)) dose of mRNA-1273. Among those aged 18 to 29 years, the RIs were 7.58 (2.62 to 21.94) after the 1^st dose of mRNA-1273 and 4.02 (1.81 to 8.91) and 9.58 (3.32 to 27.58) after the 2^nd dose of BNT162b2 and mRNA-1273.	Outcomes were not validated using clinical records and severity of cases could not be determined.
Husby A, et al. [48]	1 or 2 doses of a COVID-19 vaccine	Cohort study.	n = 4,931,775 Danish residents. Within the mRNA-1273 vaccine recipients: Male: 50.1% Female: 49.9%	Not reported	1 year	Of 498,814 mRNA-1273 vaccine recipients, 21 developed myocarditis or myopericarditis within 28 days from the vaccination date. Individuals vaccinated with mRNA-1273 had a significantly increased rate of myocarditis or myopericarditis compared with unvaccinated individuals (adjusted hazard ratio 3.92 (2.30 to 6.68)). The rates of myocarditis or myopericarditis were significantly higher within individuals aged 12–39 years compared with unvaccinated follow-up. The absolute rate was 4.2 per 100,000 vaccinated individuals within 28 days of vaccination (2.6 to 6.4). The tests for proportional hazards for the adjusted analysis yielded P=0.14 for mRNA-1273.	A potential confounder within results is that vaccination is a personal choice which can be affected by different health behaviours.
Carreno JM, et al. [54]	2 doses of an mRNA vaccine.	Longitudinal study	n = 64 Most samples were collected from the PARIS (Protection Associated with Rapid Immunity to SARS-CoV-2) study. Within the PARIS study: Male: 36.5% Female: 63.5%	43.6	18.9 days after the 1^st dose and 19.3 days after the 2^nd dose.	The sera collected after vaccination with mRNA-1273 showed increasing reactivity against the mRNA-1273 formulation. mRNA-1273 administration induced specific IgG and IgM, but not IgE antibodies against PEG (polyethylene glycol). Within the study participants who reported vaccine-associated AEs such as delayed onset reactions, including injection site rashes or severe allergic reactions, a significant association between baseline anti-PEG titres and antibody induction after vaccination with mRNA-1273 was not found..	Small sample size limits evaluation of the relationship between PEG reactive antibodies and vaccination-induced adverse reactions.
Ju Y, et al. [55]	2 doses of an mRNA vaccine	Cohort study	n = 130 Within mRNA-1273 recipients: Male: 45% Female: 55%	Within mRNA-1273 cohort:44	6-month	For BNT162b2 and mRNA-1273 cohorts, PEG-specific IgG was detectable before vaccination in 53 of the 75 subjects (71%). Mean fold change of 13.1 (range 1.0−70.9) after the 1st dose and 68.5 (range 0.9−377.1) after the 2nd dose increase in anti-PEG IgG and IgM after receiving mRNA-1273. However, within the control group (n 55), anti-PEG IgG and IgM titres slightly decreased over 6 months with a mean fold change of 0.92 and 0.98, respectively. The anti-PEG antibodies produced were shown to specifically recognize PEG in the PEG−lipid component of the mRNA-1273 vaccine The increase in anti-PEG IgG and IgM antibodies after mRNA-1273 vaccination correlated with the increase in association of Onpattro LNPs to granulocytes and monocytes. The rise in levels of anti-PEG IgG and IgM following mRNA-1273 was associated with a higher rate of systemic (and total) reactogenicity post-boost vaccination. However, the same was not observed for local reactions.	Large CI intervals and small study population.
McMahon DE, et al. [56]	1st or 2nd dose of an mRNA vaccine.	Registry-based study.	n = 414 cases reported by healthcare workers. Female: 90% Male: 10%	44	2 months	From 414 cases of cutaneous reactions reported 83% (343) of patients received mRNA-1273. 267 (77.8%) were reported after the 1^st dose of mRNA-1273 and 102 (29.7%) were reported after the 2^nd dose. Common cutaneous reactions: delayed large local reactions (n = 175 1^st; n = 31 2^nd dose), local injection site reaction (n = 117 1^st; n = 69 2^nd dose), urticaria (n = 16 1^st; n = 7 2^nd dose), morbilliform (n = 11 1^st; 7 2^nd dose), and erythromelalgia (n = 5 1^st; n = 6 2^nd dose). Of 215 patients with a recorded cutaneous reaction after the 1^st dose, 94% still planned to receive the 2^nd however, 5.6% did not plan to receive the 2^nd dose due to concerns from 1^st dose cutaneous reactions. The median time from the first vaccination to the onset of cutaneous symptoms was 7 days (IQR 2–8). 94% of delayed large local arm reactions occurred after the mRNA-1273 vaccine at a median of 7 days (IQR 7–8) after the first vaccine and lasted 4 days.	Incomplete record follow-up, unable to measure the incidence of events and 90% female study population may be due to reporting bias.

Note: Abbreviations: aOR, adjusted odds ratio; ROR, reporting odds ratio, Ci; confidence interval; RI, relative incidence; ECOG, eastern cooperative oncology group; IQR, interquartile range.

Table A1. Summary of the set inclusion and exclusion criteria for study selection.

Inclusion Criteria	Exclusion Criteria
Studies which assessed reactogenicity or specific safety outcomes of mRNA-1273 (Moderna vaccine) as a primary or secondary outcome.	Studies assessing different outcomes such as efficacy or hesitancy.
Rates of adverse effects presented as percentages, relative rates, hazard ratios or odds ratios.	Studies where the rates of outcomes of interest are equivalent to 0.
Observational studies (cohort, case – control, test-negative case – control).	Studies assessing safety of different vaccines.
Randomized control trials (RCTs)	Review articles
Cross-sectional studies	Single case reports
Cohort studies	Systematic reviews and meta-analyses
Qualitative studies	Editorials, commentaries, and articles presenting opinions rather than original data.
	Studies which did not report data specifically for the mRNA-1273 vaccine

Table A2. Overview of the preliminary search strategy. A broad literature search of the 2 major electronic databases, Embase and PubMed, was performed. Search terms considered different abbreviations for the exposure (Moderna Vaccine) and the outcome (adverse effects) within each database. The search period was set from 2020 till 2022 within both databases.

Database	Search #	Search Terms	Results
Embase	#1	‘Moderna vaccine’ OR mRNA-1273 OR spikevax OR elasomeran	4,773
	#2	Safety* OR ‘adverse effects*’	374,354
	#3	#1 AND #2 (‘Moderna vaccine’ OR mRNA-1273 OR spikevax OR elasomeran) AND (Safety* OR ‘adverse effects*’)	1,263
Pubmed	#1	‘Moderna vaccine’ OR mRNA-1273	2,817
	#2	‘Serious adverse effects’ OR ‘serious side effects’	16,449
	#3	#1 AND #2 (‘Moderna vaccine’ OR mRNA-1273) AND (‘Serious adverse effects’ OR ‘serious side effects’)	102

Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021 Feb 4;384(5):403–416.

 PubMed Web of Science ®Google Scholar

Anderson EJ, Creech CB, Berthaud V, et al. Evaluation of mRNA-1273 vaccine in children 6 months to 5 years of age. N Engl J Med. 2022 Nov 3;387(18):1673–1687. DOI:10.1056/NEJMoa2209367

 PubMed Web of Science ®Google Scholar

Creech CB, Anderson E, Berthaud V, et al. Evaluation of mRNA-1273 covid-19 vaccine in children 6 to 11 years of age. N Engl J Med. 2022 May 26;386(21):2011–2023. DOI:10.1056/NEJMoa2203315

 PubMed Web of Science ®Google Scholar

Ali K, Berman G, Zhou H, et al. Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents. N Engl J Med. 2021 Dec 9;385(24):2241–2251. DOI:10.1056/NEJMoa2109522

 PubMed Web of Science ®Google Scholar

Masuda T, Murakami K, Sugiura K, et al. A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: an interim report. Vaccine. 2022;40(13):2044–2052. DOI:10.1016/j.vaccine.2022.02.030

 PubMed Web of Science ®Google Scholar

Anderson EJ, Rouphael NG, Widge AT, et al. Safety and immunogenicity of SARS-CoV-2 mRNA-1273 vaccine in older adults. N Engl J Med. 2020 Dec 17;383(25):2427–2438. DOI:10.1056/NEJMoa2028436

 PubMed Web of Science ®Google Scholar

Kadali RAK, Janagama R, Peruru S, et al. Non-life-threatening adverse effects with COVID-19 mRNA-1273 vaccine: a randomized, cross-sectional study on healthcare workers with detailed self-reported symptoms. J Med Virol. 2021 Jul;93(7):4420–4429.

 PubMed Web of Science ®Google Scholar

Lee DS, Kim JW, Lee KL, et al. Adverse events following COVID-19 vaccination in South Korea between February 28 and August 21, 2021: a nationwide observational study. Int J Infect Dis. 2022 May;118:173–182.

 PubMed Web of Science ®Google Scholar

Moro PL, Olson CK, Clark E, et al. Post-authorization surveillance of adverse events following COVID-19 vaccines in pregnant persons in the vaccine adverse event reporting system (VAERS), December 2020 - October 2021. Vaccine. 2022 May 26;40(24):3389–3394. DOI:10.1016/j.vaccine.2022.04.031

 PubMed Web of Science ®Google Scholar

Sadarangani M, Soe P, Shulha HP, et al. Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study. Lancet Infect Dis. 2022 Nov;22(11):1553–1564.

 PubMed Web of Science ®Google Scholar

Jiménez Ortega AF, de Luna Aguilar A, Benitez Fuentes JD, et al. Adverse drug reactions of the SARS-CoV-2 mRNA-1273 vaccine in a cohort of cancer patients of a tertiary hospital in Madrid, Spain. J Clin Oncol. 2022;40(16_suppl):e24072. DOI:10.1200/JCO.2022.40.16_suppl.e24072

 Web of Science ®Google Scholar

Oosting SF, van der Veldt AAM, GeurtsvanKessel CH, et al. mRNA-1273 COVID-19 vaccination in patients receiving chemotherapy, immunotherapy, or chemoimmunotherapy for solid tumours: a prospective, multicentre, non-inferiority trial. Lancet Oncol. 2021 Dec;22(12):1681–1691.

 PubMed Web of Science ®Google Scholar

Wong KK, Heilig CM, Hause A, et al. Menstrual irregularities and vaginal bleeding after COVID-19 vaccination reported to v-safe active surveillance, USA in December, 2020-January, 2022: an observational cohort study. Lancet Digit Health. 2022 Sep;4(9):e667–675.

 PubMedGoogle Scholar

Edelman A, Boniface ER, Benhar E, et al. Association between menstrual cycle length and coronavirus disease 2019 (COVID-19) vaccination: a U.S. Cohort Obstet Gynecol. 2022 Apr 1;139(4):481–489. DOI:10.1097/AOG.0000000000004695

 PubMed Web of Science ®Google Scholar

Foltran D, Delmas C, Flumian C, et al. Myocarditis and pericarditis in adolescents after first and second doses of mRNA COVID-19 vaccines. Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):99–103. DOI:10.1093/ehjqcco/qcab090

 PubMed Web of Science ®Google Scholar

Massari M, Spila Alegiani S, Morciano C, et al. Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: a multi-database, self-controlled case series study. PLOS Med. 2022 Jul;19(7):e1004056. DOI:10.1371/journal.pmed.1004056

 PubMed Web of Science ®Google Scholar

Husby A, Hansen JV, Fosbol E, et al. SARS-CoV-2 vaccination and myocarditis or myopericarditis: population based cohort study. BMJ. 2021 Dec 16;375:e068665. DOI:10.1136/bmj-2021-068665

 PubMedGoogle Scholar

Carreno JM, Singh G, Tcheou J, et al. mRNA-1273 but not BNT162b2 induces antibodies against polyethylene glycol (PEG) contained in mRNA-based vaccine formulations. Vaccine. 2022 Oct 6;40(42):6114–6124. DOI:10.1016/j.vaccine.2022.08.024

 PubMed Web of Science ®Google Scholar

Ju Y, Lee WS, Pilkington EH, et al. Anti-PEG antibodies boosted in humans by SARS-CoV-2 lipid nanoparticle mRNA vaccine. ACS Nano. 2022 Aug 23;16(8):11769–11780. DOI:10.1021/acsnano.2c04543

 PubMedGoogle Scholar

McMahon DE, Amerson E, Rosenbach M, et al. Cutaneous reactions reported after moderna and Pfizer COVID-19 vaccination: a registry-based study of 414 cases. J Am Acad Dermatol. 2021 Jul;85(1):46–55.

 PubMed Web of Science ®Google Scholar