Important Safety Information
Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.
Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.
Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines ().
Myocarditis and Pericarditis
Myocarditis and pericarditis have been reported following administration of the vaccine.
Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older
males. The observed risk is highest in males 12 through 17 years of age. 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. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals
with a history of myocarditis or pericarditis ().
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
Limitation of Effectiveness
The vaccine may not protect all vaccine recipients.
Primary Series Adverse Events:
In a clinical study (3 mcg modRNA) of participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%),
injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).
In a clinical study (3 mcg modRNA) of participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever
(10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).
In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection
site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).
In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%).
In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills
(41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).
In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills
(24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).
Booster Dose Adverse Events:
In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%),
injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).
In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain
(39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).
Post Authorization Experience
Severe allergic reactions, including anaphylaxis, have been reported following administration of the vaccine.
Myocarditis and pericarditis have been reported following administration of the vaccine.
Before administration of the vaccine, please click to see
Fact Sheets for individuals 6 months through 4 years of age
Fact Sheets for individuals 5 through 11 years of age
Fact Sheets and Prescribing Information for individuals 12 years of age and older