Table 1.
Demographic and clinical data of individuals with liver injury after vaccination.
| Results, mean ± SD | All SARS-CoV-2 vaccines | Pfizer | Moderna | J&J | Influenza vaccine |
|---|---|---|---|---|---|
| Total vaccinated individuals, n | 3,546,047 | 2,062,837 | 1,230,887 | 252,323 | 130,067 |
| Vaccine-exposed cohort, n | 470,274 | 257,254 | 188,097 | 24,923 | 21,784 |
| Total individuals with liver injury, n | 177 | 87 | 84 | 6 | 15 |
| Individuals with liver injury, % | 0.038% | 0.034% | 0.045% | 0.024% | 0.069% |
| Age, years, mean ± SD | 70 ± 14 | 71 ± 14 | 70 ± 14 | 52 ± 16 | 56 ± 19 |
| Females (%) | 60 | 60 | 59.5 | n/a | 60 |
| Whites (%) | 90 | 88.5 | 92 | n/a | 80 |
| Liver injury after 1st dose, % | 14 | 9 | 12 | 100 | 100 |
| Time from 1st vaccine dose to 1st abnormal liver test | 29 ± 21 | 26 ± 24 | 24 ± 16 | 43 ± 19 | 12 ± 24 |
| Liver injury after 2nd dose, % | 86 | 91 | 88 | n.a. | n.a. |
| Time from 2nd vaccine dose to 1st abnormal liver test | 45 ± 25 | 46 ± 26 | 45 ± 24 | n.a. | n.a. |
| Baseline labs | |||||
| AST (U/L), mean ± SD | 20 ± 7 | 20 ± 6 | 21 ± 8 | 19 ± 6 | 21 ± 8 |
| ALT (U/L), mean ± SD | 18 ± 9 | 17 ± 8 | 18 ± 9 | 19 ± 7 | 23 ± 10 |
| ALP (U/L), mean ± SD | 83 ± 25 | 85 ± 25 | 81 ± 25 | 77 ± 21 | 78 ± 26 |
| TB (mg/dl), mean ± SD | .5 ± .22 | .51 ± .22 | .49 ± .23 | .45 ± .14 | .52 ± .23 |
| Pattern of liver injury | |||||
| R ≥5 (hepatocellular), % | 45 | 39 | 54 | 0 | n.a. |
| R <2 (cholestatic), % | 35 | 38 | 31 | 50 | n.a. |
| 2 ≤R < 5 (mixed), % | 20 | 23 | 15 | 50 | n.a. |
| Peak liver tests after vaccination | |||||
| AST (U/L), mean ± SD | 800 ± 1757 | 657 ± 1454 | 983 ± 2058 | 313 ±147 | 443 ± 731 |
| ALT (U/L), mean ± SD | 553 ± 721 | 477 ± 578 | 650 ± 855 | 313 ± 176 | 494 ± 626 |
| Alkaline phosphatase (U/L), mean ± SD | 405 ± 429 | 345 ± 266 | 465±1015 | 443 ± 477 | 251 ± 199 |
| Total bilirubin at peak (mg/dl), mean ± SD | 3.1 ± 4.2 | 3.3 ± 4.4 | 3 ± 4 | 2.8 ± 4 | 2.9 ± 2.2 |
| Cases ever with TB >2.5 mg/dl, % | 29 | 34 | 23 | 33 | 47 |
| Follow-up | |||||
| Cases with follow-up labs, n | 42 | 21 | 20 | 1 | n.a. |
| Cases with normalization, n | 20 | 10 | 10 | 0 | n.a. |
| Time to normalization from first abnormal to first normal lab value (days) | |||||
| AST | 43 ± 39 | 36 ± 30 | 49 ± 46 | n.a. | n.a. |
| ALT | 50 ± 35 | 42 ± 30 | 56 ± 40 | n.a. | n.a. |
| ALP | 30 ± 40 | 15±11 | 44 ± 47 | n.a. | n.a. |
| TB | 8 ± 14 | 7 ± 11 | 8 ± 16 | n.a. | n.a. |
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; TB, total bilirubin. Frequencies of liver injury after vaccination compared using the Chi-Square test.