Adverse Reactions Following Immunisation with the Comirnaty (Pfizer–BioNTech) COVID-19 Vaccine

Adverse Reactions Following Immunisation with the Comirnaty (Pfizer–BioNTech) COVID-19 Vaccine

+ Very common reactions (≥10%): headache, arthralgia, myalgia, injection site pain, fatigue, chills, pyrexia (higher frequency observed after the second dose), and injection site swelling.
+ Common reactions (1/100 to <1/10): nausea and injection site erythema.
+ Uncommon reactions (≥1/1,000 to <1/100): lymphadenopathy, insomnia, pain in extremity, malaise, and injection site pruritus.
+ Rare reactions (≥1/10,000 to <1/1,000): Bell's palsy (acute peripheral facial paralysis).
+ The manufacturer has not issued specific recommendations regarding anaphylaxis, myocarditis, or thrombosis with thrombocytopenia syndrome (TTS). However, these adverse events have been reported internationally at very rare frequencies.

Seek Immediate Medical Attention at a Hospital or Healthcare Facility if Any of the Following Signs Occur:
- Oral symptoms: numbness around the lips or tongue;
- Skin symptoms: rash, erythema, cyanosis, skin redness, bleeding, or petechiae/subcutaneous haemorrhage;
- Throat symptoms: pruritus, tightness, choking sensation, or difficulty speaking;
- Neurological symptoms: persistent or severe headache, lethargy, somnolence, confusion, coma, or seizures;
- Cardiovascular symptoms: chest pain, persistent palpitations, or syncope;
- Gastrointestinal symptoms: vomiting, cramping abdominal pain, or diarrhoea;
- Respiratory symptoms: dyspnoea, stridor, wheezing, or cyanosis;
- Systemic symptoms:
+ Dizziness, lightheadedness, vertigo, feeling faint, or unusual fatigue.
+ Unusual and severe pain at one or multiple sites not caused by trauma or injury. Persistent high fever exceeding 39°C that is unresponsive to antipyretics.

Important Notes:
- Ensure 24/7 assistance by a caregiver, particularly during the first 3 days following COVID-19 vaccination.
- Avoid alcohol and other stimulants for at least the first 3 days post-vaccination.
- Maintain adequate nutrition.
- If swelling, redness, pain, or a small nodule appears at the injection site: Continue monitoring; seek immediate medical evaluation if the swelling rapidly expands. Do not apply ointments, compresses, or any substances to the swollen or painful area.
- Regularly monitor body temperature. If:
+ Fever is below 38.5°C: Remove or loosen clothing, apply warm compresses to the forehead, armpits, and groin, and ensure adequate fluid intake. Avoid chilling. Recheck temperature after 30 minutes.
+ Fever is 38.5°C or higher: Administer antipyretics as instructed by healthcare personnel. If the fever does not subside or recurs within 2 hours, notify medical personnel immediately and report to the nearest healthcare facility.

Source: COVID-19 Vaccination Practice Guidelines Manual, National Immunisation Programme