Adverse events following immunization associated with coronavirus disease 2019 (COVID-19) vaccines: A descriptive analysis from VigiAccess

Figures & data

Table 1. Age group distribution of AEFIs reported in VigiAccess.

Age group	Frequency	Percentage
Below 12 years	3,585	0.1
12–17 years	39,049	1.6
18–44 years	974,453	39.7
45–64 years	758,305	30.9
65–74 years	155,930	6.3
≥75 years	232,113	9.4
Unknown	293,951	12.0
Total	2,457,386	100

Table 2. Sex distribution of AEFIs reported in VigiAccess.

Sex	Frequency	Percentage
Female	1,684,497	68.5
Male	742,323	30.2
Unknown	30,566	1.3
Total	2,457,386	100

Table 3. Continental distribution of AEFI.

Continent	Frequency	Percentage
Africa	69,441	3.0
Americas	924,716	38.0
Asia	156,966	6.0
Europe	1,220,042	50.0
Oceania	86,221	4.0
Total	2,457,386	100

Table 4. Description of the top 10 AEFIs and their common manifestations.

AEFI types	AEFI manifestation	Frequency	Percentage
General disorders and administrative site conditions	Pyrexia	513,460	20.9
	Fatigue	444,751	18.1
	Chills	342,918	14.0
	Malaise	211,303	8.6
	Injection site pain	179,959	7.3
Nervous system disorders	Headache	636,476	25.9
	Dizziness	196,627	8.0
	Paraesthesia	74,004	3.0
	Hypoaesthesia	50,845	2.1
	Syncope	38,076	1.5
Musculoskeletal and connective tissue disorders	Myalgia	330,119	13.4
	Arthralgia	219,237	8.9
	Pain in extremity	175,673	7.1
	Back pain	38,907	1.6
	Limb discomfort	28,151	1.1
Gastrointestinal disorders	Nausea	279,388	11.4
	Vomiting	88,655	3.6
	Diarrhoea	84,064	3.4
	Abdominal	37,552	1.5
	Upper abdominal pain	24,849	1.0
Investigations with undesirable outcomes	Elevated blood pressure	36,019	1.5
	Elevated heart rate	23,938	1.0
	Positive COVID-19 test	20,491	0.8
	Reduced blood pressure	4,882	0.2
	Weight loss	3,395	0.1
Skin and subcutaneous tissue disorders	Rash	87,608	3.6
	Pruritus	75,647	3.1
	Hyperhidrosis	52,261	2.1
	Erythema	45,127	1.8
	Urticaria	42,127	1.7
Respiratory, thoracic and mediastinal disorders	Dyspnoea	100,081	4.1
	Cough	54,889	2.2
	Oropharyngeal pain	34,203	1.4
	Rhinorrhoea	18,204	0.7
	Pulmonary embolism	17,094	0.7
Infections and infestations	COVID-19	56,052	2.3
	Influenza	4,335	0.2
	Herpes zoster	23,144	0.9
	Nasopharyngitis	16,235	0.7
	Pneumonia	5,979	0.2
Vascular disorders	Hypertension	23,678	1.0
	Flushing	13,635	0.6
	Hot flush	3,582	0.1
	Deep vein thrombosis	12,049	0.5
	Hypotension	11,763	0.5
Injury, poisoning and procedural complications	Inappropriate schedule of product administration	15,367	0.6
	Contusion	13,081	0.5
	Fall	10,491	0.4
	Product storage error	9,488	0.4
	Product administered to patient of inappropriate age	8,944	0.4