authorized or approved mRNA COVID-19

pain, shortness of breath, or palpitations

vaccines. Although postmarketing data

following vaccination.

following a booster dose of mRNA vaccines

Healthcare professionals should consult

are limited, available evidence suggests a

guidance and/or specialists to diagnose and

lower myocarditis risk following a booster

treat this condition.

dose relative to the risk following the primary

The risk of myocarditis after a third dose (0.5

series second dose.

mL, 100 micrograms) or booster dose (0.25

The CDC has published considerations related

mL, 50 micrograms) of Spikevax has not yet

to myocarditis and pericarditis after

been characterised.

vaccination, including for vaccination of
individuals with a history of myocarditis or
pericarditis
(https://www.cdc.gov/vaccines/covid19/clinical-considerations/myocarditis.html).

6 OVERALL SAFETY SUMMARY

4.8 Undesirable effects

4.8 Undesirable effects

Anaphylaxis and other severe allergic

Table 1 Adverse reactions from Spikevax

Table 1: Adverse reactions from Spikevax

reactions, myocarditis, pericarditis, and

clinical trials and post-authorisation

clinical trials and post authorisation

syncope have been reported following

experience in individuals 12 years of age

experience in individuals 12 years of age

administration of the Moderna COVID-19

and older

and older

Vaccine outside of clinical trials..

Cardiac disorders

Cardiac disorders

18