Comirnaty Special Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity and anaphylaxis: Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 30 minutes is recommended following vaccination. Subsequent dose(s) of the vaccine should not be given to those who have experienced anaphylaxis to the earlier dose of COMIRNATY.
Myocarditis and pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis. These cases have primarily occurred within 14 days following vaccination, more often after the second vaccination, and more often, but not exclusively in younger males. There have been reports in females. Based on accumulating data, the reporting rates of myocarditis and pericarditis after primary series in children ages 5 through <12 years are lower than in ages 12 through 17 years. Rates of myocarditis and pericarditis in booster doses do not appear to be higher than after the second dose in the primary series. Although some cases required intensive care support and fatal cases have been observed, 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.
Local cases of myocarditis with severe outcomes have been rarely reported with strenuous physical activity following vaccination. Vaccine recipients should be advised to seek medical attention promptly if they develop chest pain, shortness of breath or abnormal heartbeats. Non-specific symptoms of myocarditis and pericarditis also include fatigue, nausea and vomiting, abdominal pain, dizziness or syncope, oedema and cough. Refer to the national vaccination guidances for local recommendations.
Anxiety-related reactions: Some individuals may have stress-related responses associated with the process of vaccination itself. Stress-related responses are temporary and resolve on their own. They may include dizziness, fainting, palpitations, increases in heart rate, alterations in blood pressure, feeling short of breath, tingling sensations, sweating and/or anxiety. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation and precautions should be in place to avoid injury from fainting.
Concurrent illness: Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection.
Thrombocytopenia and coagulation disorders: As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals: The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY may be lower in immunosuppressed individuals. Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations.
Duration of protection: The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Limitations of vaccine effectiveness: As with any vaccine, vaccination with COMIRNATY may not protect all vaccine recipients.
Effects on ability to drive and use machines: COMIRNATY has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.