US Pharm. 2024;49(10):39-46,

ABSTRACT: The adverse effect (AE) profile of the two mRNA COVID-19 vaccines (Pfizer and Moderna) and the recombinant protein COVID-19 vaccine (Novavax) that are currently available differ widely. Myocarditis/pericarditis are widely recognized AEs of the mRNA vaccines. There are conflicting data on the relationship between mRNA COVID-19 vaccines and Bell’s palsy. Guillain-Barré syndrome does not appear to be an AE of mRNA COVID-19 vaccines. Anaphylaxis and lymphadenopathy are systemic immunological AEs associated with the mRNA COVID-19 vaccines. Novavax COVID-19 vaccine–related symptoms involve more traditional systemic reactions. Pharmacists can play a major role in promoting public health by dispelling misinformation about COVID-19 vaccine safety, fulfilling their role as mandatory reporters of AEs, and educating the public about the proven benefits of vaccination.

As of September 5, 2024, three COVID-19 vaccines were available in the United States.1 Two mRNA COVID-19 vaccines were available: Moderna COVID-19 Vaccine (2024-2025 Formula) and Spikevax. Moderna COVID-19 Vaccine (2024–2025 Formula) is authorized for children aged 6 months to 11 years; SPIKEVAX is the licensed Moderna product for people aged 12 years and older. The FDA refers to these vaccines as 2024–2025 Moderna COVID-19 Vaccine.

Pfizer-BioNTech COVID-19 Vaccine (2024–2025 Formula) is authorized for children aged 6 months to 11 years; COMIRNATY is the licensed Pfizer-BioNTech product for people aged 12 years and older. The FDA refers to these vaccines as 2024–2025 Pfizer-BioNTech COVID-19 Vaccine.

Novavax COVID-19 Vaccine, Adjuvanted (2024–2025 Formula), a protein subunit vaccine, is authorized for people aged 12 years and older. It is hereafter referred to as 2024–2025 Novavax COVID-19 Vaccine. (The 2023-2024 Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines are no longer recommended and should not be used.)

Information discussed in this article is based on the
prescribing information/emergency use authorization (EUA) for the 2023-2024 COVID-19 vaccines.2-4 Janssen’s COVID-19 vaccine, which was an adenovirus vector vaccine, had its EUA revoked on June 1, 2023, and is not discussed.5 This article will provide an update on safety data for the COVID-19 vaccines, excluding Janssen’s. The latest recommendations of the Advisory Committee on Immunization Practices in the U.S. for 2024-25 were published in the September 10, 2024, early release issue of Morbidity and Mortality Weekly Report.

CDC Vaccine Safety and Monitoring Website

The CDC’s website provides information on COVID-19 vaccine safety, healthcare provider and parent/caregiver information on vaccine safety, and facts about vaccine safety. The website also contains links to the U.S. Vaccine Adverse Event Reporting System (VAERS), the Vaccine Safety Datalink, V-safe, the Clinical Immunization Safety Assessment project, and the COVID-19 Vaccine Pregnancy Registry. 

VAERS serves as the nation’s early warning system to monitor for potential vaccine safety problems. Pharmacists have a professional obligation to file a report if an adverse event (AE) to a vaccination is suspected (see SIDEBAR 1).6,7

The 2023-2024 updated COVID-19 vaccines are monitored by V-safe, the safety monitoring system for vaccine recipient reporting. The COVID-19 Vaccine Pregnancy Registry is for individuals who enrolled in V-safe and reported receiving a COVID-19 vaccine during pregnancy or within 30 days before their last menstrual period before the pregnancy.

VAERS data and deidentified reports are available to the public on the VAERS and CDC Wide-ranging ONline Data for Epidemiologic Research (WONDER) websites. It is an easy-to-use online system that makes the information resources of the CDC available to public health professionals and the public.8 However, it is important that pharmacists understand the limitations of the VAERS data available through WONDER. VAERS has issued several caveats, including that its data cannot be used to determine if a vaccine caused or contributed to an AE or illness. It warns that the number of reports alone cannot be interpreted as evidence of a causal association between a vaccine and an AE. The VAERS data may be incomplete, inaccurate, coincidental, unverifiable, or in some cases, deliberately biased or misleading despite being subject to a fine and imprisonment under federal law. Follow-up information is not obtained for every report, and additional information, if obtained, is not included in the WONDER database as it only allows for initial event reporting. VAERS data do not represent all known safety information.

The VAERS program advises that its data be considered in the context of other scientific information, as the VAERS program is designed to rapidly detect “safety signals” or unusual or unexpected patterns of AEs associated with a particular vaccine.8

COVID-19 Vaccine Safety Updates

Vaccines are often available and/or used in combination, making association between AEs and a particular vaccine component difficult to assess. Further, the literature sometimes does not indicate the trade name of a vaccine, nor may it indicate its availability in the U.S. Additional difficulties in reviewing statistics on AEs to COVID-19 vaccines include that they have been developed using various platforms and with several names for the same vaccine. Patients may have received different brands for their original vaccine and subsequent boosters, which makes data collection and establishing correlation complicated.9

Based on prescribing information (PI), adverse reactions that are most commonly associated with Pfizer’s mRNA COVID-19 vaccine (PmRNACV) include pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection-site swelling (up to 11.8%), and injection-site redness (up to 10.4%).2

The AEs most often seen with Moderna’s mRNA COVID-19 vaccine (MmRNVACV) are reported by age in the PI. The PI for Spikevax includes data on AEs for those aged 12 to 17 years, 18 to 64 years, and >65 years. Pain at the injection site, axillary swelling/tenderness, and nausea/vomiting were reported as most common in those aged 12 to 17 years, whereas fatigue, headache, myalgia, arthralgia, and chills were seen more often in those aged 18 to 64 years. The most common AEs for those aged 65 years and older were pain at t injection site, fatigue, myalgia,  headache, and arthralgia.3

Novavax’s COVID-19 vaccine AE profile includes injection-site pain/tenderness, fatigue/malaise, muscle pain, headache, joint pain, nausea/vomiting, and injection-site reactions.4

The number of COVID-19 vaccinations administered in the U.S. differ based on manufacturer. According to the website Our World in Data, as of March 22, 2023, the last date for which data are available for the U.S., 401.69 million, 251.85 million, 18.99 million, and 83,047 doses of PmRNACV, MmRNVACV, Johnson & Johnson, and Novavax’s COVID-19 vaccines, respectively, had been administered.10

The CDC has a webpage highlighting selected AEs reported after COVID-19 vaccination, which include anaphylaxis, death, Guillain-Barré syndrome (GBS), myocarditis, pericarditis, and thrombosis with thrombocytopenia syndrome.11

Due to the global nature of the COVID-19 pandemic, the International Network of Special Immunization Services was formed to monitor for AEs of special interest (AESIs), to identify the pathogenesis of AESIs, and to assist with future vaccine development.12

The following is an update of selected serious reactions that have been associated with COVID-19 vaccines. It is important to point out that causality has not been established. The following is based on a review of the literature using Medical Subject Headings.

Serious Cardiovascular/Hematological Reactions

Myocarditis or Pericarditis: Myocarditis is defined as inflammation of the myocardium with or without necrosis, whereas pericarditis is inflammation of the pericardium. The presence of both acute myocarditis and pericarditis is called myopericarditis or perimyocarditis.9

A definitive diagnosis of myocarditis requires that an endomyocardial biopsy be performed, which was not typically done during the pandemic. A diagnosis is based on clinical presentation and laboratory data, but there is controversy regarding the appropriateness of using troponin levels in diagnosing myocarditis as they are unreliable biomarkers for myocarditis and may only identify severe or persistent cases.9,13 Therefore, most cases of vaccine-induced myocarditis are considered clinically suspected or probable cases.9

Numerous studies have reported on the development of myocarditis or pericarditis in relation to the use of COVID-19 mRNA vaccines.9,14-80

The mRNA vaccines’ PI postmarketing data for authorized or approved mRNA COVID-19 vaccines cite increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. Although some cases required intensive-care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae.2,3

MmRNVACV’s PI provides more information on myocarditis/pericarditis and how the company is monitoring for the potential AEs.3

The Global Vaccine Data Network (GVDN) is a vaccine research network involving 31 sites in 26 countries on six continents and has included data on >300 million people. Retrospective observational data from this network of >99 million persons followed for 42 days post injection identified a statistically significant, increased prioritized signal fulfilling the safety threshold for myocarditis for the first, second, and third doses of both mRNA COVID-19 vaccines. The highest observed to expected (O/E) ratio for the occurrence of myocarditis was following the first and second dose of the MmRNVACV.81

Overall, COVID-19 mRNA vaccine–associated myocarditis accounted for 68% of all cases of vaccine-associated myocarditis or pericarditis reported to VAERS between January 1, 2021, and July 20, 2021.

AEs to the MmRNVACV from January 1, 2021, through October 27, 2022, accounted for 1,942 AEs or 0.28% of all adverse reactions reported to VAERS. These adverse reactions included myocarditis (25.18%, 489 reports); acute myocardial infarction (24.46%, 475 reports); bradycardia (14.93%, 290 reports); and pericarditis (14.47%, 281 reports).9,82

For PmRNACV, the observed risk of myocarditis is highest in males aged 12 to 17 years, whereas for MmRNVACV, the observed risk is highest in males aged 18 to 24 years.2,3

Analysis of data for adolescents aged 12 to 17 years from VigiBase, the World Health Organization’s global Individual Case Safety Report database, found a statistically significantly elevated adjusted reporting odds ratio (OR) of 19.61 (95% CI 14.05-27.39) for myocarditis/pericarditis for both COVID-19 mRNA vaccines. These accounted for over 95% of all COVID-19 vaccinations.83

The incidence of pericarditis or myocarditis after the PmRNACV in adolescent patients (median age 15 years) presenting to the emergency department with cardiovascular symptoms was found to be approximately 7%.20 Hospitalization rates for myocarditis/pericarditis vary, with reports of up to 87%.39

Risk factors for pediatric intensive unit admission for myocarditis are abnormal electrocardiographic findings and abnormal serum troponin level in the pediatric emergency department.15,20  

An increased rate of reports among individuals aged 16 to 17 years was seen when the second dose of PmRNACV was administered with a short (i.e., <30 days) interdose interval (21.3 per 100,000; 95%CI, 11.0-37.2).21 Other reports have found that males aged 15 to 24 years are at highest risk of developing myocarditis following the second COVID-19 mRNA vaccine.37

Children aged 5 to 11 years appear to be at a lower risk of developing myocarditis/pericarditis than adolescents aged 12 to 15 years.30

A compendium that reviewed world literature on COVID-19 and myocarditis/pericarditis found that the incidence of these conditions varied greatly depending on the vaccine type and how many doses were administered. The highest rates of myocarditis/pericarditis were reported for MmRNVACV, with an overall incidence of about 10/100,000 and around 50/100,000 in men aged <40 years. There was consensus among the reports that those at greatest risk of developing myocarditis were men aged between 12 and 39 years; an elevated rate of vaccine-associated myocarditis is not seen in those aged >50 years; however, pericarditis is most often seen in men in this group.9

Myocarditis is most commonly observed following the second COVID-19 mRNA vaccine, although it also can occur after the first dose.14,15,17,20,21,39  Direct head-to-head comparisons and epidemiological studies in both males and females found that rates of myocarditis and pericarditis after either dose of MmRNVACV was modestly higher than for the PmRNACV during the 0 to 7 days post vaccination.29,32,34,37,39,62 Most cases of COVID-19–related myocarditis are transient and self-limiting.25 However, cardiogenic shock requiring mechanical circulatory support has been reported.28 More patients were hospitalized and treated in the intensive care unit for vaccine-related myocarditis (95% hospitalized and 10% in the intensive care unit) than for vaccine-related pericarditis (35% hospitalized and 3% in intensive care).9

Residual effects on late gadolinium enhancement studies may indicate the presence of fibrotic changes. These changes were observed following the resolution of myocardial edema/acute inflammation. However, the significance of these findings is unclear.35,84-86

Among the proposed mechanisms for COVID-19 mRNA vaccine–induced myocarditis are hyperimmune or inflammatory response between the spike protein of SARS-CoV-2 and cardiac myosin; upregulation of inflammatory cytokines and lymphocytes resulting in tissue damage/cytokine storm from the immune response to the vaccine and bystander activation; antibodies directed against interleukin (IL)-1RA; serum sickness; eosinophilic myocarditis; hypersensitivity to vaccine vehicle components (e.g., polyethylene glycol [PEG] and tromethamine, lipid nanoparticle sheath); low residual levels of double-strand RNA; hyperviscosity; and exercise-induced secretion of proinflammatory IL-6. Differences in sex steroid hormones may also play a role.9,34

SARS-CoV-2 infection is associated with the development of ventricular arrhythmias, acute coronary syndromes with obstructive coronary artery disease such as myocardial infarction, thromboembolic syndromes including stroke, acute myocardial damage with elevated troponin levels without evidence of coronary artery disease (i.e., myocarditis), and heart failure.9

Others have also found a greater risk of myocarditis following infection with SARS-CoV-2 than with the COVID-19 mRNA vaccines.75 The risk may be ≥15-fold for developing myocarditis from SARS-CoV-2 infection compared with other causes, including the COVID-19 mRNA vaccine.9

A systematic review of AE reporting data from both Europe and the U.S., performed along with a review of the scientific literature, found a mortality rate of 0.22% (n = 30) among 13,571 myocarditis or pericarditis events reported for COVID-19 mRNA vaccines. Fatalities from myocarditis, pericarditis, and myopericarditis were more common in older adults (myocarditis, median age 60 years; pericarditis, median age 71 years; and myopericarditis, which occurred in two patients aged 55 and 83 years).38

Despite these concerns, postvaccination myocarditis is associated with a 92% lower mortality risk (adjusted hazard ratio [HR]: 0.08; 95% CI 0.01-0.57) compared with postviral myocarditis.24

A French cohort study conducted from December 27, 2020, to June 30, 2022, followed 4,635 patients who were hospitalized with myocarditis associated with the mRNA COVID-19 vaccines (i.e., vaccine administered within the previous 7 days of diagnosis, N = 558); patients with post–COVID-19 myocarditis (i.e., patient developed myocarditis within 30 days of SARS-CoV-2 infection, N = 298); and patients with conventional myocarditis (N = 3779). While the results cannot be viewed as causal, after 18 months of follow-up, investigators found that unlike those with post–COVID-19 myocarditis (weighted HR 1.04; 94% CI 0.70-1.52), those with vaccine-associated myocarditis (weighted HR 0.55; 95% CI 0.36-0.86) had fewer hospital readmissions for myopericarditis, other cardiovascular events, or all-cause death as a composite outcome compared with those who experienced conventional myocarditis.87

The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis.88

Pharmacists should counsel patients and/or parents/caregivers to monitor for chest pain, shortness of breath, or feelings of having a fast-beating, fluttering, or pounding heart, especially if these symptoms occur during the 2 weeks following a dose of the vaccine.88

Central Nervous System Reactions

Bell’s Palsy: Retrospective observational data from the GVDN, VAERS data, a self-controlled study using Medicare data on COVID-19 mRNA booster doses, and a real-world study of >200,000 vaccinated patients did not observe any significant signals for facial paralysis or Bell’s palsy (BP).81,89-91 However, others have found that the risk of BP is more frequently observed than expected based on vaccine brand, sex, and age.92 

In a systematic review and meta-analysis, the odds of developing BP were significantly greater with SARS-CoV-2 vaccines (mRNA and viral vector) in randomized, controlled studies compared with placebo. In observational studies, however, those who received mRNA COVID-19 vaccines were not at greater risk of developing BP than those who were not vaccinated.

As a result of a strong association between the SARS-CoV-2 vaccine and BP, in four randomized, controlled trials investigators concluded that the development of BP was related to vaccine exposure. However, SARS-CoV-2 infection was linked with a 3.23-fold increased risk of BP compared with SARS-CoV-2 vaccinations (relative risk 3.23; 95% CI 1.57-6.62).93

A nested case-control and self-controlled case series study found a significant increase in BP in those who received PmRNACV (adjusted OR 1.543; 95% CI 1.123-2.121), resulting in 1.112 excess events per 100,000 recipients of two doses of the vaccine. The increased risk of BP was greatest during the first 2 weeks following vaccine administration.94

Guillain-Barré Syndrome: GBS is an acute, inflammatory polyneuropathy that is due to an infection or adenoviral vector–based vaccines.95 Numerous sources did not identify a correlation between GBS and mRNA COVID-19 vaccines.81,83,96 In fact, one study found that the PmRNACV was associated with a reduced risk of developing GBS. Having had COVID-19 increases the risk of GBS.97

Systemic Immunologic Reactions

Anaphylaxis: There is no uniformly accepted definition of anaphylaxis following immunizations.98 Although anaphylaxis is mentioned in the PIs for both the PmRNACV and MmRNVACV as a contraindication for administration, no details are provided.2,3 The literature has reported the rate of anaphylaxis from the PmRNACV and MmRNVACV as 2.5 to 11 cases per million doses.1,99

In a population-based study conducted from December 16, 2020, to March 11, 2021, focusing on the frequency, severity, and risk factors associated with treated acute-onset hypersensitivity reactions from first and second-dose exposures to COVID-19 mRNA vaccines, researchers found that the calculated rate of anaphylaxis was 3.29 per million doses administered (0.00033%), with hypersensitivity reactions being approximately 2 times more likely to occur with first doses than second doses of the vaccine. This study involved over 215,000 persons who received either the PmRNACV or MmRNVAV. Risk factors for hypersensitivity reactions included female gender (86.9%), younger age, having underlying multiple drug intolerance syndrome (MDIS), and having a clinical history with known risk factors for MDIS, including a previously reported vaccine-associated adverse reaction.100

While anaphylaxis is rare, it tends to be more severe in older adults. The Allergic Rhinitis and its Impact on Asthma, European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society Working Group has published an algorithm for the management of anaphylaxis due to COVID-19 vaccines in older adults.101 Analysis of data of adolescents aged 12 to 17 years from VigiBase did not find a correlation between the COVID-19 vaccines and anaphylaxis.83

It has been postulated that COVID mRNA vaccine hypersensitivity may be secondary to PEG found in the mRNA COVID-19 vaccines, which is used as a stabilizer to maintain the colloidal stability of the nanoparticles in biological fluids and to reduce their uptake by filter organs. PEG is thought to mediate immunoglobulin E (IgE)–mediated hypersensitivity reactions. It is advisable to avoid COVID-19 mRNA vaccines in patients with severe PEG allergies, although this is not mentioned in the PI.102-105

One study involving 20 patients who experienced anaphylaxis following an mRNA COVID-19 injection, however, found that the presence of preexisting anti-PEG IgE antibodies was not a predominant mechanism behind cases of mRNA COVID-19 vaccine–related anaphylaxis, although the authors conceded that they cannot exclude typical anti–PEG IgE-mediated type 1 hypersensitivity reactions as a mechanism for mRNA COVID-19 vaccine anaphylaxis.106

Nonetheless, others have supported the possible causation between PEG allergy and anaphylaxis to the mRNA COVID-19 vaccines.103-105

A systematic review and meta-analysis were conducted to assess the risk of a severe immediate allergic reaction (i.e., anaphylaxis or requiring the need of injectable epinephrine) to a second dose of a COVID-19 mRNA vaccine in persons who had an immediate allergic reaction of any severity to the first dose of vaccine. Among 78 patients who had experienced a severe immediate allergic reaction (e.g., anaphylaxis) to the first COVID-19 mRNA injection, upon revaccination only four of these patients experienced a severe immediate allergic reaction (e.g., anaphylaxis) again.107 The CDC states, however, that giving the same type of COVID-19 vaccine is contraindicated after a severe allergic reaction (e.g., anaphylaxis) from a previous dose or to a component of the COVID-19 vaccine. It is recommended to administer an alternative COVID-19 vaccine type.108

Lymphadenopathy: Enlargement of cervical and axillary lymph nodes (lymphadenopathy) on the ipsilateral side of the COVID-19 mRNA injection site is a common AE associated with PmRNACV and MmRNVACV. This can lead to diagnostic confusion regarding the presence of metastases, the performance of unnecessary tests (e.g., biopsies), and patient distress.109-112

The exact mechanism for the lymphadenopathy is unknown, but it is thought to be due to an increased immune response following vaccination that results in a localized inflammatory response in the area around the injection site.109

While the PIs of both mRNA COVID-19 vaccines do not provide much detail, Novavax’s information states that the incidence of lymphadenopathy-related reactions is 0.3% among vaccine recipients versus 0.1% placebo recipients and that injection-site pruritus occurs in 0.1% vaccine recipients versus 0.0% placebo recipients. Additionally, lymphadenopathy-related reactions included lymphadenopathy, lymphadenitis, lymph node pain, and axillary pain. All lymphadenopathy-related reactions occurred in participants aged 18 to 64 years, according to Novavax’s EUA.2-4

Lymphadenopathy most commonly occurs in those aged <50 years; following an mRNA vaccine; after the first dose of the vaccine; and when administered within 4 weeks of the diagnostic ultrasound.113 Lymphadenopathy develops within 2 weeks after vaccination following the second dose of either mRNA COVID-19 vaccine. It occurs more commonly following the MmRNVACV (19%).114

In general, the mean time to resolution of lymphadenopathy on ultrasound is shorter following a booster vaccine (102 days) compared with the first dose of the initial series (129 days).115 Lymphadenopathy associated with PmRNACV resolved more quickly than that associated with MmRNVACV (117 vs. 139 days, respectively, after the first dose). Following up at least 12 weeks after vaccine-related lymphadenopathy is suspected is recommended.116

In patients with a history of cancer, guidelines recommend documenting the vaccination date and laterality and injecting into the contralateral side of the known malignancy. Imaging studies for urgent clinical indications or required-to-treat newly diagnosed breast cancer should not be postponed.117

Lymphadenopathy associated with COVID-19 vaccines is not thought to be harmful and should not be a reason to withhold future vaccinations. Imaging such as mammography should be performed before or 4 to 12 weeks following vaccination.109

Novavax COVID-19 Recombinant Protein Vaccine

On July 13, 2022, the FDA issued an EUA for the NVX-CoV2373 (Novavax) COVID-19 vaccine.118 There are limited data on AEs associated with Novavax vaccine in the literature; however, it appears to be well tolerated.119-130

One clinical trial of more than 4,400 participants found that the most common AEs associated with the vaccine for both the first and second doses were headache (20%-25%), muscle pain (17%-20%), and fatigue (12%-16%), with a duration of <3 days. Severe local AEs were uncommon and occurred most often after the second dose (4% Novavax vs. 1% placebo).120 There was a similar to slightly higher frequency of severe AEs between the vaccine and placebo groups.121,131  

Rare cases of myocarditis have been reported with Novavax.121,128,132 There are an estimated 1,805 COVID-19 cases prevented per 100,000 vaccinated, compared with 5.3 excess cases of myocarditis/pericarditis per 100,000 vaccinated.133 Despite Novavax’s better safety profile, it produces a lower antibody response to SAR-CoV-2 and is associated with a higher incidence of new COVID-19 infections.130

The American Pharmacists Association and the American Society of Health-System Pharmacists have both issued guidelines supporting the pharmacist’s role in monitoring for and reporting AEs associated with vaccinations (see SIDEBAR 2.)6,134,135

Conclusion

There is much misinformation about the safety profile of COVID-19 vaccines available online and in social media. Pharmacists can play a major role in promoting public health by dispelling misinformation about COVID-19 vaccine safety and educating the public about the proven benefits of vaccination.

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