TABLE 1.
Studies reporting safety of SARS‐CoV‐2 vaccination in solid organ (SOT) transplant recipients a
| First author and year | Study design | SOT patients (N) | Vaccine type and schedule | Follow‐up | Local reactions | Systemic reactions | Most common AE | Donor‐specific antibodies monitoring b |
|---|---|---|---|---|---|---|---|---|
| Boyarsky 2021 | Cross‐sectional survey | 187 | mRNA (BNT162b2 or mRNA‐1273), one dose | 1 week post‐dose 1 |
Pain Erythema Swelling |
Fever Chills Fatigue Headache Vomiting Diarrhea Myalgias |
Injection‐site pain (90%) | NR |
| Cucchiari 2021 | Prospective cohort | 148 | mRNA‐1273), two doses | 48–72 h after each dose |
Pain Erythema Swelling |
Fever Fatigue Chills Nausea or vomiting Diarrhea Myalgia Arthralgias Headache |
Injection‐site pain (86% post dose 1, 75% post dose 2) Fatigue (25% post dose 1, 27% post dose 2) |
DSA tested at baseline and 2 weeks post dose 2: present in five cases at baseline (3.4% of the entire population); no cases of de‐novo DSAs observed after dose 2 of mRNA‐1273 |
| Grupper 2021 c | Retrospective cohort | 136 | BNT162b2, two doses | 7 days after each dose |
Pain Erythema Swelling Regional lymphadenopathy |
Fever Chills Headache Fatigue, Myalgia Arthralgia Nausea Vomiting Diarrhea |
Injection‐site pain (52.2%) | NR |
| Hall 2021a | Prospective cohort | 127 |
mRNA‐1273 vaccine, two doses (n = 126 patients) mRNA‐1273 vaccine, one dose (n = 1) |
Vaccine diary for 7 days after each dose, overall follow‐up > = 60 days post‐dose 1 |
Pain Erythema Swelling |
Fatigue Myalgia Headache Arthralgia Nausea or vomiting Chills Medical visit |
Injection‐site pain (>60% post dose 1, >20% post dose 2) | NR |
| Hall 2021b | Randomized controlled trial | 60 | mRNA‐1273, three doses (treatment group) | Vaccine diary for 7 days after each injection, overall follow‐up > = 4 weeks post‐dose 3 |
Pain Swelling |
Fever Chills Fatigue Myalgia Arthralgia Headache Nausea or vomiting Diarrhea |
Injection‐site pain (46/60, 76.7%) post dose 3 | NR |
| Herrera 2021 | Prospective cohort | 104 | mRNA‐1273, two doses | 48–72 h after each dose |
Pain Swelling |
Fatigue, fever | Injection‐site pain (80%) | No increase in HLA antibodies from baseline to 3 weeks post dose 2 |
| Itzhaki Ben Zadok 2021 | Prospective cohort | 42 | BNT162b2, two doses | Days 21–26 and 35–40 post‐dose 1 |
Pain Erythema |
Fatigue Myalgia Arthralgia Headache Fever |
Injection‐site pain (71%) | NR |
| Kamar 2021 | Retrospective cohort | 101 | BNT162b2, three doses | 1 month post‐dose 3 | NR | NR | NR | NR |
| Marion 2021 | Retrospective cohort | 950 | mRNA (BNT162b2 or mRNA‐1273), two doses | 4 weeks post‐dose 2 | NR | NR | NR | NR |
| Massa 2021 | Prospective cohort | 61 | BNT162b2, three doses | 72 h after each dose |
Injection‐site pain Local paresthesia |
Fatigue Headache Diarrhea Fever Myalgia Rhinorrhea Nausea and vomiting Cough Hypertension Anorexia Vertigo Abdominal pain Insomnia |
Injection‐site pain in 60.7%, 65.6%, and 67.2% (41 of 61 patients) after dose 1, 2, and 3, respectively |
Thirteen (21.3%) patients had donor‐specific antibodies before vaccination. Only one patient developed de novo donor‐specific antibodies, donor‐specific anti‐HLA class II (DQB1*06:03) antibody 28 days after the second vaccine dose |
| Mazzola 2021 | Retrospective cohort | 143 | BNT162b2, two doses | 7 days post‐dose 1, up to 1 month post‐dose 2 | Pain | Fatigue headache | Injection‐site pain (25.7%) | NR |
| Ou 2021a | Prospective cohort | 609 | BNT162b2, two doses | 7 days after each dose |
Pain Swelling Erythema |
Fatigue Headache Myalgias Chills Fever Diarrhea Vomiting |
Injection‐site pain after dose 1 (24% in the non‐belatacept group, 22% in the belatacept group). Fatigue after dose 2 (21% in the non‐belatacept group, 17% in the belatacept group) |
NR |
| Ou 2021b | Prospective cohort | 741 |
BNT162b2, two doses (n = 400) mRNA‐1273 vaccination, 2 doses (n‐341) |
7 days after each dose |
Pain Swelling Erythema |
Fatigue Headache Myalgia Chills Fever Diarrhea Vomiting |
Injection‐site pain (84% after dose 1, 77% after dose 2) | NR |
| Peled 2021 | Prospective cohort | 77 | BNT162b2, two doses | 7 days after each dose |
Pain Erythema Swelling |
Fatigue Headache Chills Vomiting Diarrhea New or worsening muscle or joint pain Use of antipyretic or pain medication |
Injection‐site pain in 56% and 49% after dose 1 and 2, respectively | NR |
| Rabinowich 2021 | Case‐control |
Liver (n = 71) Controls (n = 21) |
BNT162b2, two doses | Survey 7 days post each dose, follow up until 7–10 weeks post‐dose 2 | Pain | Fatigue headache myalgias | Injection‐site pain in each group following the dose 1 and 2: 43/71, 60.5% (LTR) versus 15/21, 71% (controls); 38/71, 53.5% (LTR) versus 15/21, 71% (controls); respectively | NR |
| Shostak 2021 | Prospective cohort | 168 | BNT162b2, two doses | Median of 68 days (IQR 65–73) post‐dose 1 | Pain | Fatigue | Injection‐site pain (108/168, 64.29%) | NR |
| Werbel 2021 | Case series | 30 |
Three‐dose schedule Initial: BNT162b2, 2 doses (n = 17); mRNA‐1273, 2 doses (n = 13) Dose 3: JNJ‐78436735 (n = 15), mRNA‐1273 (n = 9), BNT162b2 (n = 6) |
Survey 7 days post‐dose 3, follow‐up limited |
Pain Erythema Swelling |
Chills Headache Fatigue Myalgia Diarrhea |
Fatigue in 8/11 (72.73%) of J&J recipients Injection‐site pain in 12/12 (100%) of mRNA recipients |
NR |
Abbreviations: AE, adverse event; NR, not reported; URI, upper respiratory infection; UTI, urinary tract infection.
References for the table can be found on the Supplement.
The study by Sattler et al. 4 also monitored HLA‐specific antibodies with no increase from baseline seen; however no detailed safety assessment was performed.
One patient with undetectable antibody levels despite full vaccination died from severe PCR‐proven COVID‐19.