Table 4.
Reported adverse events following vaccination and common treatment modalities
| Author, year | Mean onset time of first AE post vaccination (days) ± SD | Presenting AE (n) | Total number of thromboembolic eventsa | Thromboembolic events (n) | ER admission (n) | ICU admission (n) | Hospitalization (n) | Mean time to hospitalization post vaccination (days) ± SD | Mortality |
| Aladdin et al., 2021 | 14.00 | Fever (1), headache (1), limb weakness (1), seizures (1), vomiting (1) | 1 | CVST (1) | 1 | 1 | 1 | NR | 1 |
| Al-mayhani et al., 2021 | 13.00 ± 7.55 | headache (2), speech/mouth-related issues (1), limb weakness (2), visual impairment (2), drowsiness (1), facial weakness (1), confusion (1) | 9 | Carotid artery thrombosis (1), cerebral artery thrombosis (2), CVST (1), iliac or femoral vein thrombosis (1), jugular vein thrombosis (1), PE (1), splanchnic vein thrombosis (2) | NR | NR | NR | NR | 1 |
| Al rawahi et al., 2021 | 7.00 | Fever (1), lethargy (1), malaise (1), abdominal pain (1), altered mental status (1), somnolence (1) | 3 | Aortic thrombosis (1), PE (1), renal vein thrombosis (1) | 1 | NR | 1 | 7.00 | 0 |
| Althaus et al., 2021 | 10.40 ± 5.24 | Ecchymosis/bruising/petechiae/erythema (3) | 13 | CVST (5), DVT (1), PE (4), thrombosis in other unspecified organs (3) | NR | NR | 8 | NR | 3 |
| Bano et al., 2021 | 10.67 ± 2.52 | Dyspnea (1), pain in extremities (1), headache (2), facial weakness (1), hemiparesis (1), speech/mouth-related issues (1) | 4 | CVST (2), PE (1), jugular vein thrombosis (1) | 3 | NR | 3 | 13.33 ± 3.05 | 2 |
| Bayas et al., 2021 | 1.00 | Fever (1), DIPLOPIA (1) | 1 | SOVT (1) | 0 | NR | 1 | 10.00 | 0 |
| Bersinger et al., 2021 | 9.00 | Headache (1), seizure (1) | 5 | CVST (1), iliac or femoral vein thrombosis (1), jugular vein thrombosis (1), PE (1), splanchnic vein Thrombosis (1) | 1 | 1 | 1 | 14.00 | NA |
| Bjornstad-tuveng et al., 2021 | 7.00 | Headache (1), lethargic (1), speech/mouth-related issues (1), unstable walking (1) | 2 | CVST (1), PE (1) | 0 | 1 | 1 | 10.00 | 1 |
| Blauenfeldt et al., 2021 | NR | Headache (1), abdominal pain (1), adrenal hemorrhage (1), subcapsular renal hematoma (1) | 1 | Carotid artery thrombosis (1) | 1 | 1 | 1 | 7.00 | 1 |
| Bourguignon et al., 2021 | 12.33 ± 5.51 | Pain in extremities (2), cramping (1), dyspnea (1), headache (1), confusion (1), weakness (1) | 12 | Aortic thrombus (1), carotid artery thrombosis (1), celiac artery thrombus (1), CVST (1), DVT (2), jugular vein thrombosis (1), peripheral artery thrombosis (2), PE (2), splanchnic vein thrombosis (1) | 3 | 1 | 3 | 14.67 ± 8.33 | 0 |
| Castelli et al., 2021 | 7.00 | Headache (1), speech/mouth-related issues (1), loss of lower limb strength (1), unstable walking (1), visual impairment (1) | 1 | CVST (1) | 1 | 1 | 1 | 11.00 | 1 |
| Casucci et al., 2021 | 0 | Headache (1), photophobia (1), nausea (1), chills (1), fever (1), myalgia (1), arthralgia (1), fatigue (1) | 1 | Disseminated intravascular coagulation (1) | 0 | 0 | 1 | 15.00 | 0 |
| Choi et al., 2021 | NR | Headache (1), tingling (1), vomiting (1), altered mental status (1), fever (1) | 1 | CVST (1) | 1 | 1 | 1 | 12.00 | 1 |
| Cliff-patel et al., 2021 | 13.00 ± 5.72 | Back pain (2), hematuria (1), headache (1), pain in extremities (1) loss of lower limb strength (1), dyspnea (1), chest pain (1) | 5 | DVT (1), PE (3), renal vein thrombosis (1) | NR | NR | 3 | 15.33 ± 9.00 | NA |
| Costentin et al., 2021 | 3.00 | Nausea (1), muscle ache (1), body ache (1), fatigue (1), headache (1) | 2 | PE (1), splanchnic vein thrombosis (1) | 1 | 1 | 1 | 7.00 | NR |
| D’agostino et al., 2021 | NR | Acute cerebrovascular accident (1) | 4 | Aortic arch (1), carotid artery thrombosis (1), CVST (1), Splanchnic vein thrombosis (1) | 1 | 1 | 1 | 12.00 | 1 |
| Demichele et al., 2021 | 8.00 ± 1.41 | Hemiplegia (1), ocular-related issues (2), speech/mouth-related issues (1), abdominal Pain (1) | 9 | Cerebral artery thrombosis (1), carotid artery thrombosis (3), PE (2), splanchnic vein thrombosis (3) | 2 | NR | 2 | NR | 1 |
| Dutta et al., 2021 | 6.00 | Headache (1), visual impairment (1), vomiting (1), ocular-related issues (1) | 1 | CVST (1) | NR | 0 | 1 | 14.00 | 0 |
| Gabarin et al., 2021 | 19.50 ± 16.26 | Leg swelling (1), erythema (1), headache (1), dyspnea (1), cough (1), hemoptysis (1) | 3 | DVT (2), PE (1) | 1 | 0 | 1, NR (1) | 16.00 | 0 |
| Gangi et al., 2021 | 10.33 ± 8.38 | Myocardial Infarction (1), headache (4), visual impairment/photophobia (2), dyspnea (1), hemoptysis (1), chest pain (2), abdominal pain (1), ocular-related issues (1), nausea (1) | 10 | Coronary artery thrombosis (1), CVST (4), iliac artery thrombosis (1), PE (2), pelvic artery thrombosis (1), splanchnic vein thrombosis (1) | 6 | 1 | 6 | 16.17 ± 8.06 | 0 |
| Gattringer et al., 2021 | 7.00 ± 1.41 | Headache (2) | 2 | CVST (2) | 2 | 0 | 2 | 10.00 ± 2.83 | 0 |
| Greinacher et al., 2021 | 9.30 ± 3.35 | Chills (1), fever (1), nausea (1), epigastric discomfort (1), fatigue (1), myalgia (1), headache (1) | 21 | Aortoiliac thrombosis (1), CVST (9), PE (3), splanchnic vein thrombosis (3), iliac or femoral vein thrombosis (1), inter-ventricular thrombosis (1), IVC thrombosis (1), multiple organ thrombosis (1), widespread microvascular thrombosis (1) | NR | 1 | NR | NR | 6 |
| Guan et al., 2021 | 5 | Headache (1), nausea (1), neck pain (1) | 2 | CVST (2), Jugular vein thrombosis (1) | 1 | 0 | 1 | 10.00 | 0 |
| Haakonsen et al., 2021 | NR | Fever (2), chills (2), arthralgia (1), fatigue (1) | 2 | DVT (2) | 0 | 0 | 0 | NA | 0 |
| Ikenberg et al., 2021 | 7.00 | Headache (1), myalgia (1), chills (1) | 1 | CVST (1) | 1 | NR | 1 | 7.00 | NR |
| Jacob et al., 2021 | 7.00 | Fatigue (1), altered mental status (1), headache (1), nausea (1), hemiparesis (1) | 2 | Carotid artery thrombosis (1), cerebral artery thrombosis (1) | 1 | 1 | 1 | 9.00 | 0 |
| Jones et al., 2021 | 20.00 | Dyspnea (1), insensate (1), loss of limb strength/weakness (1), pain in extremities (1) | 3 | Aortic thrombosis (1), peripheral artery thrombosis (1), PE (1) | 1 | NR | 1 | 25.00 | 0 |
| Kotal et al., 2021 | 0 | Headache (1), loss of limb strength/weakness (1), visual impairment (1) | 1 | CVST (1) | NR | 1 | 1 | 11.00 | 0 |
| Mehta et al., 2021 | NR | Headache (2) | 2 | CVST (2) | 2 | NR | NR | NR | 2 |
| Muster et al., 2021 | 8.00 | Dyspnea (1), fatigue (1), cough (1) | 3 | Iliac or femoral vein thrombosis (1), IVC thrombosis (1), PE (1) | 1 | NR | 1 | NR | NA |
| Ocal et al., 2021 | 11.00 | Headache (1) | 2 | PE (1), Splanchnic Vein Thrombosis (1) | 1 | NR | 1 | 15.00 | NA |
| Panovska-stavridis et al., 2021 | 9.00 | Headache (1), ocular-related issues (1) | 1 | SOVT (1) | 1 | NR | 1 | 10.00 | 0 |
| Schultz et al., 2021 | 7.20 ± 0.45 | Headache (3), fever (1), comatose (including reduced consciousness) (1), back pain (1), abdominal pain (1), hemiparesis (1) | 6 | CVST (4), splanchnic vein thrombosis (1), svc including constituent draining vessels (1) | 5 | 1 | 5 | 8.40 ± 1.52 | 3 |
| Scully et al., 2021 | NR | NR | 26 | Aortic thrombosis (1), CVST (13), DVT (2), jugular vein thrombosis (1), multiple organ thrombosis (1), PE (5), splanchnic vein Thrombosis (3) | 22 | NR | NR | NR | 7 |
| Soleimani et al., 2021 | 12.33 ± 1.69 | Headache (3), hemiparesis (2), pain in extremities (1) | 7 | CVST (3), Jugular Vein Thrombosis (1), PE (2), Splanchnic Vein Thrombosis (1) | 2 | 2 | 3 | 12.67 ± 5.53 | 0 |
| Sorensen et al., 2021 | 8.00 | Headache (1), malaise (1), ecchymosis (1), | 2 | CVST (1), Splanchnic Vein Thrombosis (1) | 1 | NR | 1 | 13.00 | 0 |
| Suresh & petchey et al., 2021 | 2.00 | Headache (1), ocular-related issues (1), vomiting (1) | 1 | CVST (1) | 1 | NR | 1 | NR | 1 |
| Tiede et al., 2021 | 8.40 ± 1.95 | Headache (4), somnolence (1), speech/mouth-related issues (2), hemiparesis (2), visual impairment (1), fatigue (1), ocular-related issues (1) | 6 | Aortic thrombosis (1), carotid artery thrombosis (1), CVST (1), peripheral artery thrombosis (1), splanchnic vein thrombosis (1), TMA (1) | 0 | 0 | 5 | 8.40 ± 1.96 | 0 |
| Tobaiqy et al., 2021 | NR | NR | 30 | Carotid artery thrombosis (1), CVST (1), DVT (16), pelvic vein thrombosis (2), peripheral artery thrombosis (2), PE (6), thrombophlebitis (2) | NR | NR | NR | NR | 3 |
| Umbrello et al., 2021 | NR | Abdominal pain (1), fever (1), fatigue (1), arthralgia (1) | 1 | Splanchnic vein thrombosis (1) | 1 | 1 | 1 | 17.00 | 0 |
| Varona et al., 2021 | NR | NR | 2 | CVST (1), PE (1) | NR | NR | 1 | 10.00 | 0 |
| Walter et al., 2021 | 8.00 | Headache (1), speech/mouth-related issues (1), hemiparesis (1), fatigue (1), myalgia (1) | 1 | Carotid artery thrombosis (1) | 1 | 1 | NR | NR | 0 |
| Weidmann et al., 2021 | 6.33 ± 0.58 | Headaches (5), weakness (2), hemiparesis (3), numbness (2), vomiting (1), altered mental status (1), fever (1), drowsiness (1), abdominal pain (1), nausea (2), ocular-related issues (2), speech/mouth-related issues (2), bruising (1) | 7 | CVST (5), PE (1), pelvic vein thrombosis (1) | 5 | 4 | 5 | 6.60 ± 3.36 | 4 |
| Wolf et al., 2021 | 5.33 ± 1.53 | Shivering (1), headaches (3), fever (2), epileptic seizure (1), speech/mouth-related issues (1), hemianopia (1), somnolent (1) | 3 | CVST (3) | NR | NR | 3 | NR | 0 |
| Zanferrari et al., 2021 | 2.00 | Fever (1), headache (1), speech/mouth-related Issues (1) | 1 | CVST (1) | NR | NR | 1 | 10.00 | NA |
| Abou-ismail et al., 2021b | 11.00 | Pain in extremities (1), chest pain (1) | 2 | DVT (1), PE (1) | 1 | 0 | 1 | 20.00 | 0 |
| Clark et al., 2021b | 5.00 | Headache (1), speech/mouth-related issues (1), photophobia (1), myalgia (1), dizziness (1), petechiae (1), sinus pressure (1) | 2 | CVST (1), PE (1) | 1 | 0 | 1 | 12.00 | 0 |
| Dhoot et al., 2021b | 11.00 | Abdominal pain (1), nausea (1), vomiting (1), decreased oral intake (1) | 3 | Splanchnic vein thrombosis (3) | 1 | 1 | 1 | 21.00 | 0 |
| Malik et al., 2021b | 7.00 | headache (1), fever (1), myalgia (1), chills (1), dyspnea (1), lightheadedness (1) | 3 | Carotid artery thrombosis (1), CVST (1), PE (1) | 1 | 0 | 1 | 10.00 | 0 |
| Muir et al., 2021b | 14.00 | Headache (1), malaise (1) | 2 | CVST (1), Splanchnic Vein Thrombosis (1) | 1 | NR | 1 | 17.00 | NR |
| See et al., 2021b | 8.00 ± 2.25 | Headache (11), visual impairment/photophobia (5), hemiplegia/hemiparesis (3), vomiting (6), comatose (1), fever (3), neck pain/stiffness (3), back pain (1), abdominal pain (2), lethargy (1), myalgia (3), chills/shivering (1), nausea (5), epileptic seizure (2), aphasia (1), chest pain (1), pain in extremities (2), malaise (1) | 26 | CVST (12), DVT (3), jugular vein thrombosis (6), PE (3), splanchnic vein thrombosis (2) | 12 | 10 | 12 | NR | 3 |
| Author, year | UFH | LMWH | Fondaparinux | Direct thrombin inhibitors | Direct factor Xa Inhibitor | IVIg | Corticosteroids | Platelet transfusion | Craniectomy |
| Aladdin et al., 2021 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Al-mayhani et al., 2021 | 0 | 0 | 2 | 0 | 0 | 3 | 1 | 1 | 1 |
| Al rawahi et al., 2021 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
| Althaus et al., 2021 | NR | NR | NR | NR | NR | 4 | NR | NR | NR |
| Bano et al., 2021 | 0 | 2 | 1 | 1 | 0 | 1 | 2 | 3 | 1 |
| Bayas et al., 2021 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Bersinger et al., 2021 | 1 | 0 | 1 | 1 | 0 | 1 | 0 | 0 | 1 |
| Bjornstad-tuveng et al., 2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Blauenfeldt et al., 2021 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Bourguignon et al., 2021 | 1 | 0 | 2 | 1 | 1 | 3 | 0 | 0 | 0 |
| Castelli et al., 2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Casucci et al., 2021 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Choi et al., 2021 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Cliff-patel et al., 2021 | 0 | 0 | 0 | 3 | 0 | 3 | 0 | 0 | 0 |
| Costentin et al., 2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| D’agostino et al., 2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Demichele et al., 2021 | 0 | 0 | 1 | 0 | 0 | 2 | 2 | 1 | 1 |
| Dutta et al., 2021 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Gabarin et al., 2021 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 0 |
| Gangi et al., 2021 | 0 | 1 | 6 | 2 | 0 | 6 | 5 | 3 | 0 |
| Gattringer et al., 2021 | 0 | 0 | 0 | 4 | 0 | 2 | 2 | 0 | 0 |
| Greinacher et al., 2021 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Guan et al., 2021 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Haakonsen et al., 2021 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Ikenberg et al., 2021 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Jacob et al., 2021 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 1 | 1 |
| Jones et al., 2021 | 1 | 1 | 1 | 0 | 0 | 1 | NR | 1 | NR |
| Kotal et al., 2021 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 |
| Mehta et al., 2021 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 |
| Muster et al., 2021 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
| Ocal et al., 2021 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Panovska-stavridis et al., 2021 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 |
| Schultz et al., 2021 | 1 | 4 | 0 | 0 | 0 | 4 | 4 | 4 | 3 |
| Scully et al., 2021 | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Soleimani et al., 2021 | 0 | 0 | 1 | 3 | 2 | 3 | 2 | 2 | 2 |
| Sorensen et al., 2021 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Suresh & petchey et al., 2021 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 1 |
| Tiede et al., 2021 | 1 | 0 | 0 | 4 | 0 | 3 | 0 | 0 | 2 |
| Tobaiqy et al., 2021 | NR | NR | NR | NR | NR | NR | NR | NR | NR |
| Umbrello et al., 2021 | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Varona et al., 2021 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Walter et al., 2021 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Weidmann et al., 2021 | 0 | 2 | 0 | 0 | 0 | 3 | 3 | 0 | 3 |
| Wolf et al., 2021 | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 0 | 0 |
| Zanferrari et al., 2021 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Abou-ismail et al., 2021b | 0 | 0 | 0 | 1 | 2 | 1 | 1 | 0 | 0 |
| Clark et al., 2021b | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 |
| Dhoot et al., 2021b | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
| Malik et al., 2021b | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 |
| Muir et al., 2021b | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| See et al., 2021b | 6 | 0 | 0 | 4 | 0 | 7 | 3 | 4 | 0 |
AE, adverse event; CVST, cerebral venous sinus thrombosis; DVT, deep vein thrombosis; ER, emergency room; IV, intravenous; IVC, inferior vena cava; IVIG, intravenous immunoglobulin; LMWH, low-molecular-weight heparin; NR, not reported; PE, pulmonary embolism; SD, standard deviation; SOVT, superior ophthalmic vein thrombosis; SVC, superior vena cava; UFH, unfractionated heparin.
a
Thromboembolic events were defined as thrombus presence upon imaging investigations or as stated by study authors. Different imaging of the same thrombus was considered a single thromboembolic event unless new findings were stated between the techniques.
b
Studies are Ad26.COV2.S reports.