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. 2022 Jun 20;11:2021-12-3. doi: 10.7573/dic.2021-12-3

Table 1.

Vaccine-associated adverse events of special interest.

Vaccine Doses administered (country; data cut-off date) Cases reported Estimated cases per million doses Groups at higher risk (impact of sex, age or ethnicity)
Anaphylaxis/anaphylactoid reactions
Ad26.COV2.S 7.98 million doses (US; April 12, 2021)58 79 Estimate of 9.9 cases per million doses58
4 confirmed, 4 under review58
AZD1222 24.9 million first doses; 24.2 million second doses; 64,000 third doses (UK; March 02, 2022)57 873 Estimate of 17.8 cases per million doses57

  • Women may be more prone; of those reporting anaphylaxis aged between 18 and 85 years, it has been shown that the majority are women (1,002/1,183 cases) (EudraVigilance; February 26, 2022)154
BNT162b2 26.1 million first doses; 23.4 million second doses; 29.3 million third doses (UK; March 02, 2022)57 654 Estimate of 8.3 cases per million doses57

  • Incidence of anaphylaxis is 2–7 times higher for recipients of mRNA vaccines with a prior history of allergies (VAERS; US)155

  • Women may be more prone (VAERS; US)155
mRNA-1273 1.6 million first doses; 1.5 million second doses; 90 million third doses (UK; March 02, 2022)57 87 Estimate of 7.2 cases per million doses57

  • Incidence of anaphylaxis is 2–7 times higher for recipients of mRNA vaccines with a prior history of allergies (VAERS; US)155

  • Women may be more prone (VAERS; US)155
Thrombosis/major thromboembolic events with thrombocytopenia syndrome a
Ad26.COV2.S 12.6 million doses (US; June 30, 2021)59 38 4 deaths

  • Highest reporting rates seen in women aged 30–39 years (8.8 cases per one million doses)59
AZD1222 24.9 million first doses; 24.2 million second doses; 64,000 third doses (UK; March 02, 2022)57 437 Estimate of 8.8 cases per million doses57
78 deaths (6 following second dose)57
49/437 cases occurred following second dose57

  • Higher incidence in younger adult population following the first dose compared to the older groups (21.3 per million doses in those aged 18–49 years compared to 11.1 per million doses in those aged ≥50 years) (UK; March 02, 2022)57
BNT162b2 26.1 million first doses; 23.4 million second doses; 29.3 million third doses (UK; March 02, 2022)57 32 Estimate of 0.4 cases per million doses57
4 deaths reported57

  • The 32 events occurred in 13 women and 18 men aged 18–91 years (UK; March 02, 2022)57
mRNA-1273 1.6 million first doses; 1.5 million second doses; 90 million third doses (UK; March 02, 2022)57 5 Estimate of 0.4 cases per million doses57
No deaths reported57

  • The 5 events occurred in adult men <75 years (UK; March 02, 2022)57
Myocarditis
Ad26.COV2.S156 2.0 million doses (EU/EEA; May 31, 2021) 0 N/A N/A
AZD1222 (ref.57) 24.9 million first doses; 24.2 million second doses; 64,000 third doses (UK; March 02, 2022)57 221 Estimate of 4.5 cases per million doses57

  • Number of UK ADR reports associated with suspected myocarditis, pericarditis and other related terms was higher in those aged ≥40 years57
BNT162b2 (ref.57) 26.1 million first doses; 23.4 million second doses; 29.3 million third doses (UK; March 02, 2022)57 739 Estimate of 9.4 cases per million doses57

  • Higher case numbers in male adolescents and young adults68

  • 70.7, 105.9 and 52.4 cases per million in those aged 12–15 years, 16–17 years and 18–24 years, respectively (VAERS; US)68

  • Usually occur following the second dose and within a week of vaccination
mRNA-1273 (ref.57) 1.6 million first doses; 1.5 million second doses; 90 million third doses (UK; March 02, 2022)57 212 Estimate of 17.5 cases per million doses57

  • Higher case numbers in male adolescents and young adults68

  • 56.3 cases per million in those aged 18–24 years (VAERS; US)68

  • Usually occur following the second dose and within a week of vaccination157
Pericarditis
Ad26.COV2.S156 2.0 million doses (EU/EEA; May 31, 2021)156 1 Estimate of 0.5 cases per million doses N/A
AZD1222 (ref.57) 24.9 million first doses; 24.2 million second doses; 64,000 third doses (UK; March 02, 2022)57 216 Estimate of 4.4 cases per million doses57

  • Number of UK ADR reports associated with suspected myocarditis, pericarditis and other related terms was higher in those aged ≥40 years57
BNT162b2 (ref.57) 26.1 million first doses; 23.4 million second doses; 29.3 million third doses (UK; March 02, 2022)57 507 Estimate of 6.4 cases per million doses57

  • Higher case numbers in male adolescents and young adults157

  • Usually occur following the second dose and within a week of vaccination157
mRNA-1273 (ref.57) 1.6 million first doses; 1.5 million second doses; 90 million third doses (UK; March 02, 2022)57 119 Estimate of 9.8 cases per million doses57

  • Higher case numbers in male adolescents and young adults157

  • Usually occur following the second dose and within a week of vaccination157
a

Classed as major thromboembolic events (blood clots) with concurrent thrombocytopenia (low platelet counts).

ADR, adverse drug reaction; VAERS, Vaccine AE Reporting System.