Table 2.
SIRs (95% CIs) of prespecified AESIs in the 21 days following the first and second dose of the BNT162b2 vaccine, 19 February 2021–10 February 2022, New Zealand
| AESI | No. of participants | Person days | Observed events | Expected eventsa | SIR (95% CI) | Risk difference (95% CI) [per 100,000 persons] |
|---|---|---|---|---|---|---|
| Acute kidney injury | ||||||
| First dose | 4,177,045 | 90,510,885 | 1301 | 1409.4 | 0.9 (0.9–1.0) | −2.5 (−4.2 to −0.8) |
| Second dose | 3,902,566 | 85,517,178 | 1381 | 1387.6 | 1.0 (0.9–1.0) | −0.2 (−2.0 to 1.7) |
| Acute liver injury | ||||||
| First dose | 4,253,935 | 92,193,987 | 38 | 62.3 | 0.6 (0.4–0.8) | −0.6 (−0.8 to −0.3) |
| Second dose | 3,978,292 | 87,174,602 | 42 | 61.1 | 0.7 (0.5–0.9) | −0.5 (−0.8 to −0.1) |
| Guillain–Barré syndrome | ||||||
| First dose | 4,255,028 | 92,217,837 | 7 | ≤6 | 1.2 (0.4–2.2) | 0.0 (−0.1 to 0.2) |
| Second dose | 3,979,345 | 87,197,601 | ≤6b | ≤6 | 0.7 (0.2–1.5) | −0.0 (−0.1 to 0.1) |
| Erythema multiforme | ||||||
| First dose | 4,255,144 | 92,220,852 | ≤6 | ≤6 | 1.1 (0.2–2.3) | 0.0 (−0.1 to 0.1) |
| Second dose | 3,979,553 | 87,202,175 | – | ≤6 | 0.0 (0.0–0.0) | −0.1 (−0.1 to −0.1) |
| Herpes zoster | ||||||
| First dose | 4,253,208 | 92,177,972 | 36 | 50.5 | 0.7 (0.5–1.0) | −0.3 (−0.6 to −0.0) |
| Second dose | 3,977,535 | 87,157,976 | 45 | 49.8 | 0.9 (0.6–1.2) | −0.1 (−0.4 to 0.2) |
| Single organ cutaneous vasculitis | ||||||
| First dose | 4,254,584 | 92,209,508 | 11 | 12.7 | 0.9 (0.4–1.4) | −0.0 (−0.2 to 0.1) |
| Second dose | 3,979,172 | 87,193,853 | 8 | 11.3 | 0.7 (0.3–1.3) | −0.1 (−0.2 to 0.1) |
| Myo/pericarditis | ||||||
| First dose | 4,255,128 | 92,219,981 | 101 | 44.2 | 2.3 (1.8–2.7) | 1.3 (0.9 to 1.8) |
| Second dose | 3,979,436 | 87,199,638 | 172 | 43.4 | 4.0 (3.4–4.6) | 3.1 (2.5 to 3.7) |
| Arterial thrombosis | ||||||
| First dose | 4,254,942 | 92,215,906 | 27 | 34.3 | 0.8 (0.5–1.1) | −0.2 (−0.4 to 0.1) |
| Second dose | 3,979,255 | 87,195,623 | 20 | 34 | 0.6 (0.3–0.9) | −0.3 (−0.5 to −0.1) |
| Cerebral venous thrombosis | ||||||
| First dose | 4,072,973 | 88,220,151 | ≤6 | ≤6 | 2.3 (0.0–6.3) | 0.0 (−0.0 to 0.1) |
| Second dose | 3,797,778 | 83,213,165 | ≤6 | ≤6 | 0.8 (0.0–3.1) | −0.0 (−0.0 to 0.1) |
| Splanchnic thrombosis | ||||||
| First dose | 4,255,225 | 92,222,114 | 10 | 10 | 1.0 (0.4–1.7) | 0.0 (−0.1 to 0.2) |
| Second dose | 3,979,539 | 87,201,855 | 14 | 9.8 | 1.4 (0.7–2.3) | 0.1 (−0.1 to 0.3) |
| Venous thromboembolism | ||||||
| First dose | 4,247,045 | 92,042,382 | 236 | 239 | 1.0 (0.9–1.1) | −0.1 (−0.7 to 0.6) |
| Second dose | 3,971,331 | 87,021,595 | 246 | 236.7 | 1.0 (0.9–1.2) | 0.2 (−0.5 to 1.0) |
| Thrombocytopenia | ||||||
| First dose | 4,250,921 | 92,129,171 | 93 | 126.8 | 0.7 (0.6–0.9) | −0.8 (−1.2 to −0.3) |
| Second dose | 3,975,534 | 87,114,061 | 109 | 123.4 | 0.9 (0.7–1.1) | −0.3 (−0.8 to 0.2) |
AESIs adverse events of special interest, COVID-19 coronavirus disease 2019, SIR standardised incidence ratio, CI confidence interval
aExpected events were calculated using background incidence rates from the SAFE background rate study of COVID-19 AESI in New Zealand (2014–2019) [27] and person time at risk
bEvents with fewer than six occurrences have been suppressed for privacy reasons