Statistically Significant COVID-19 VAE Results based on VAERS Data Analysis (using data as of Dec. 31, 2021)
Here we provide the results of statistically signficant COVID-19 vaccine adverse events (VAEs) obtained by analyzing the VAERS data (collected up to the end of 2021) using our statistical data analysis pipeline. In our study, the statistically signficant VAEs are identified using three criteria: (i) the minimal number of case reports > 0.2% of the total reports for the vaccine, (ii) proportional reporting ratio (PRR) >2, and (iii) the Chi-square score >4. See references: our Cov19VaxKB paper and the previous paper: Sarntivijai et al, 2012. The Cov19VaxKB tutorial web page also provides related information.
DISCLAIMER: Before using this website, please ensure that you have read, understand, and agree on the VAERS disclaimer shown at: https://vaers.hhs.gov/data.html. As described in the indicated CDC/FDA VAERS Disclaimer, the VAERS data largely came from voluntary reporting. It has the advantage of nation-wide reporting and can provide some early warning of potential safety issue(s) with a vaccine. However, the VAERS "Reports may include incomplete, inaccurate, coincidental and unverified information". In addition, the VAERS data alone cannot be used to determine the causality of the identified VAE. Instead of being causal, it only shows statistical association.
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PFIZER-BIONTECH COVID-19 vaccine-associated AEs from VAERS data analysis:(The total number of AE case reports with the vaccine is: 323186.)
| Adverse event |
Case No. |
AE case occurrency (%) |
PRR value |
Chi squared |
Significance |
| Acute kidney injury |
744 |
0.23 |
3.95 |
772.94 |
Yes |
| Acute respiratory failure |
840 |
0.26 |
3.68 |
801.76 |
Yes |
| Ageusia |
2381 |
0.74 |
3.26 |
1944.28 |
Yes |
| Anosmia |
2007 |
0.62 |
3.92 |
2070.08 |
Yes |
| Anticoagulant therapy |
969 |
0.3 |
2.74 |
602.32 |
Yes |
| Anxiety |
4279 |
1.32 |
2.21 |
1763.72 |
Yes |
| Atrial fibrillation |
1251 |
0.39 |
2.5 |
660.61 |
Yes |
| Axillary pain |
3002 |
0.93 |
2.68 |
1802.05 |
Yes |
| Bell\'s palsy |
1728 |
0.53 |
3.36 |
1467.31 |
Yes |
| Blood pressure increased |
3327 |
1.03 |
2.49 |
1754.28 |
Yes |
| Blood pressure measurement |
2219 |
0.69 |
4.2 |
2475.37 |
Yes |
| Blood test |
7909 |
2.45 |
2.42 |
3972.87 |
Yes |
| Body temperature |
5655 |
1.75 |
3.65 |
5383.87 |
Yes |
| Breast pain |
1017 |
0.31 |
2.95 |
716.01 |
Yes |
| Cerebrovascular accident |
1391 |
0.43 |
2.11 |
511.72 |
Yes |
| Chest discomfort |
8180 |
2.53 |
2.59 |
4673.06 |
Yes |
| Chest pain |
11968 |
3.7 |
2.52 |
6524.1 |
Yes |
| Chest X-ray |
3132 |
0.97 |
2.38 |
1502.52 |
Yes |
| Computerised tomogram |
3845 |
1.19 |
2.26 |
1652.31 |
Yes |
| Computerised tomogram thorax |
712 |
0.22 |
2.86 |
476.83 |
Yes |
| Computerised tomogram thorax abnormal |
674 |
0.21 |
2.55 |
368.19 |
Yes |
| COVID-19 |
17749 |
5.49 |
4.75 |
22849.23 |
Yes |
| COVID-19 pneumonia |
1412 |
0.44 |
4.06 |
1517.44 |
Yes |
| Deafness |
809 |
0.25 |
2.03 |
269.64 |
Yes |
| Deep vein thrombosis |
943 |
0.29 |
2.15 |
361.52 |
Yes |
| Dysgeusia |
2390 |
0.74 |
2.52 |
1287.09 |
Yes |
| Dysmenorrhoea |
1090 |
0.34 |
4.25 |
1230.3 |
Yes |
| Ear discomfort |
1362 |
0.42 |
3 |
982.3 |
Yes |
| Echocardiogram |
2314 |
0.72 |
3.07 |
1729.27 |
Yes |
| Echocardiogram abnormal |
682 |
0.21 |
2.26 |
291.1 |
Yes |
| Echocardiogram normal |
984 |
0.3 |
2.35 |
458.02 |
Yes |
| Electrocardiogram |
5863 |
1.81 |
2.83 |
3890.12 |
Yes |
| Electrocardiogram abnormal |
1394 |
0.43 |
2.22 |
573.13 |
Yes |
| Electrocardiogram normal |
2807 |
0.87 |
2.15 |
1078.63 |
Yes |
| Exposure to SARS-CoV-2 |
1048 |
0.32 |
6.32 |
1682.11 |
Yes |
| Facial paralysis |
1333 |
0.41 |
2.61 |
761.59 |
Yes |
| Fibrin D dimer |
776 |
0.24 |
2.74 |
483.55 |
Yes |
| Fibrin D dimer increased |
725 |
0.22 |
2.75 |
454.63 |
Yes |
| Flushing |
4879 |
1.51 |
2.32 |
2225.6 |
Yes |
| Gait inability |
1011 |
0.31 |
2.1 |
367.29 |
Yes |
| Head discomfort |
1531 |
0.47 |
2.83 |
1008.73 |
Yes |
| Heart rate |
2077 |
0.64 |
4.38 |
2423.69 |
Yes |
| Heart rate increased |
6946 |
2.15 |
2.27 |
3050.09 |
Yes |
| Heart rate irregular |
943 |
0.29 |
2.63 |
548 |
Yes |
| Heavy menstrual bleeding |
2508 |
0.78 |
4.77 |
3183.13 |
Yes |
| Hot flush |
1792 |
0.55 |
2.16 |
694.2 |
Yes |
| Hypoacusis |
781 |
0.24 |
2.5 |
411.39 |
Yes |
| Hypoaesthesia oral |
2604 |
0.81 |
2.79 |
1679.2 |
Yes |
| Illness |
2271 |
0.7 |
2.15 |
875.69 |
Yes |
| Immunisation |
2627 |
0.81 |
27.14 |
7614.68 |
Yes |
| Incorrect product formulation administered |
663 |
0.21 |
4.08 |
714.22 |
Yes |
| Interchange of vaccine products |
5701 |
1.76 |
5.72 |
8521.63 |
Yes |
| Intermenstrual bleeding |
780 |
0.24 |
5.29 |
1086.6 |
Yes |
| Investigation |
974 |
0.3 |
45.75 |
3050.56 |
Yes |
| Loss of personal independence in daily activities |
2232 |
0.69 |
2.11 |
818.35 |
Yes |
| Lymph node pain |
2702 |
0.84 |
3.02 |
1977.53 |
Yes |
| Lymphadenopathy |
11810 |
3.65 |
2.29 |
5303.36 |
Yes |
| Magnetic resonance imaging |
2666 |
0.82 |
3.12 |
2045.06 |
Yes |
| Magnetic resonance imaging head |
844 |
0.26 |
3.22 |
675.15 |
Yes |
| Menstrual disorder |
1436 |
0.44 |
4.18 |
1592.2 |
Yes |
| Menstruation irregular |
1875 |
0.58 |
4.05 |
2009.78 |
Yes |
| Metabolic function test |
2745 |
0.85 |
2.16 |
1067.15 |
Yes |
| Migraine |
4132 |
1.28 |
2.04 |
1396.64 |
Yes |
| Myocardial infarction |
740 |
0.23 |
2.35 |
345.59 |
Yes |
| Myocarditis |
1542 |
0.48 |
4.09 |
1669.49 |
Yes |
| Nervousness |
1212 |
0.38 |
2.05 |
411.43 |
Yes |
| Off label use |
1204 |
0.37 |
4.43 |
1419.3 |
Yes |
| Oropharyngeal discomfort |
781 |
0.24 |
3.41 |
675.46 |
Yes |
| Oropharyngeal pain |
6060 |
1.88 |
2.07 |
2141.31 |
Yes |
| Oxygen saturation decreased |
942 |
0.29 |
2.1 |
340.84 |
Yes |
| Palpitations |
7385 |
2.29 |
2.67 |
4427.81 |
Yes |
| Panic attack |
672 |
0.21 |
2.64 |
391.61 |
Yes |
| Paraesthesia oral |
3627 |
1.12 |
2.94 |
2550.65 |
Yes |
| Parosmia |
704 |
0.22 |
3.19 |
556.56 |
Yes |
| Pericarditis |
975 |
0.3 |
2.93 |
676.2 |
Yes |
| Pharyngeal swelling |
2313 |
0.72 |
3.49 |
2071.88 |
Yes |
| Product preparation error |
739 |
0.23 |
3.43 |
646.47 |
Yes |
| Product preparation issue |
3341 |
1.03 |
13.14 |
7945.18 |
Yes |
| Pulmonary embolism |
1339 |
0.41 |
2.3 |
599.16 |
Yes |
| Respiratory tract congestion |
1916 |
0.59 |
2.33 |
879.76 |
Yes |
| SARS-CoV-2 antibody test |
961 |
0.3 |
5.18 |
1312.93 |
Yes |
| SARS-CoV-2 test |
10910 |
3.38 |
8.34 |
21154.03 |
Yes |
| SARS-CoV-2 test negative |
4496 |
1.39 |
3.38 |
3875.6 |
Yes |
| SARS-CoV-2 test positive |
13160 |
4.07 |
4.63 |
16437.87 |
Yes |
| Seizure |
2373 |
0.73 |
2.1 |
860.96 |
Yes |
| Swollen tongue |
2421 |
0.75 |
2.38 |
1159.44 |
Yes |
| Taste disorder |
1001 |
0.31 |
2.98 |
713.95 |
Yes |
| Throat irritation |
3323 |
1.03 |
2.57 |
1854.53 |
Yes |
| Throat tightness |
3708 |
1.15 |
2.28 |
1625.47 |
Yes |
| Thrombosis |
1737 |
0.54 |
2.38 |
830.8 |
Yes |
| Tinnitus |
6933 |
2.15 |
2.92 |
4844.67 |
Yes |
| Troponin |
1025 |
0.32 |
3.25 |
831.84 |
Yes |
| Troponin increased |
1411 |
0.44 |
4.32 |
1621.04 |
Yes |
| Ultrasound Doppler |
673 |
0.21 |
2.12 |
250.21 |
Yes |
| Vaccination site pain |
6436 |
1.99 |
2.23 |
2708.1 |
Yes |
| Vaccine breakthrough infection |
1143 |
0.35 |
3.75 |
1118.04 |
Yes |
| Vaginal haemorrhage |
870 |
0.27 |
2.95 |
612.07 |
Yes |
| Vertigo |
3859 |
1.19 |
2.13 |
1450.75 |
Yes |
MODERNA COVID-19 vaccine-associated AEs from VAERS data analysis:(The total number of AE case reports with the vaccine is: 329057.)
| Adverse event |
Case No. |
AE case occurrency (%) |
PRR value |
Chi squared |
Significance |
| Ageusia |
1866 |
0.57 |
2.08 |
654.59 |
Yes |
| Anticoagulant therapy |
839 |
0.25 |
2.1 |
299.81 |
Yes |
| Atrial fibrillation |
1145 |
0.35 |
2.11 |
415.38 |
Yes |
| Bell\'s palsy |
1384 |
0.42 |
2.21 |
558.43 |
Yes |
| Chills |
44223 |
13.44 |
2.02 |
15573.07 |
Yes |
| Expired product administered |
9136 |
2.78 |
3.16 |
7115.98 |
Yes |
| Illness |
2491 |
0.76 |
2.45 |
1258.89 |
Yes |
| Impaired work ability |
2714 |
0.82 |
2.09 |
964.26 |
Yes |
| Inappropriate schedule of product administration |
4727 |
1.44 |
2.81 |
3059.5 |
Yes |
| Injection site pruritus |
16757 |
5.09 |
4.23 |
18954.42 |
Yes |
| Injection site rash |
9455 |
2.87 |
3.18 |
7460.95 |
Yes |
| Limb discomfort |
2380 |
0.72 |
2.17 |
929.03 |
Yes |
| Maternal exposure during pregnancy |
810 |
0.25 |
3.34 |
673.44 |
Yes |
| Peripheral swelling |
10143 |
3.08 |
2.26 |
4365.3 |
Yes |
| Pharyngeal swelling |
1810 |
0.55 |
2.2 |
722.26 |
Yes |
| Poor quality product administered |
1580 |
0.48 |
7.89 |
2893.06 |
Yes |
| Product administered to patient of inappropriate age |
6386 |
1.94 |
3.43 |
5553.13 |
Yes |
| Product dose omission issue |
2243 |
0.68 |
46.8 |
6899.4 |
Yes |
| Product temperature excursion issue |
929 |
0.28 |
6.59 |
1513.56 |
Yes |
| Rash pruritic |
5336 |
1.62 |
2.08 |
1877.15 |
Yes |
| SARS-CoV-2 test negative |
3490 |
1.06 |
2.11 |
1275.12 |
Yes |
| Taste disorder |
940 |
0.29 |
2.6 |
527.72 |
Yes |
| Vaccination complication |
3481 |
1.06 |
3.05 |
2557.83 |
Yes |
| Vaccination site erythema |
5670 |
1.72 |
11.31 |
12500.15 |
Yes |
| Vaccination site induration |
1205 |
0.37 |
10.47 |
2557.19 |
Yes |
| Vaccination site mass |
838 |
0.25 |
5.08 |
1109.98 |
Yes |
| Vaccination site pain |
9006 |
2.74 |
4.08 |
9701.66 |
Yes |
| Vaccination site pruritus |
3716 |
1.13 |
15.7 |
9225.29 |
Yes |
| Vaccination site rash |
2350 |
0.71 |
10.83 |
5067.77 |
Yes |
| Vaccination site reaction |
1160 |
0.35 |
8.68 |
2240.94 |
Yes |
| Vaccination site swelling |
4312 |
1.31 |
5.54 |
6180.23 |
Yes |
| Vaccination site warmth |
3011 |
0.92 |
8.62 |
5805.98 |
Yes |
JANSSEN COVID-19 vaccine-associated AEs from VAERS data analysis:(The total number of AE case reports with the vaccine is: 63741.)
| Adverse event |
Case No. |
AE case occurrency (%) |
PRR value |
Chi squared |
Significance |
| Acute kidney injury |
137 |
0.21 |
2.36 |
97.44 |
Yes |
| Acute respiratory failure |
204 |
0.32 |
3.11 |
255.31 |
Yes |
| Adverse drug reaction |
197 |
0.31 |
5.07 |
523.37 |
Yes |
| Adverse event |
271 |
0.43 |
4.22 |
558.76 |
Yes |
| Ageusia |
439 |
0.69 |
2.13 |
241.48 |
Yes |
| Angiogram |
176 |
0.28 |
2.92 |
196.86 |
Yes |
| Angiogram pulmonary abnormal |
167 |
0.26 |
5.74 |
518.5 |
Yes |
| Anosmia |
344 |
0.54 |
2.18 |
199.33 |
Yes |
| Antibody test |
184 |
0.29 |
5.55 |
548.24 |
Yes |
| Anticoagulant therapy |
331 |
0.52 |
3.85 |
595.29 |
Yes |
| Blood glucose |
158 |
0.25 |
2.31 |
106.87 |
Yes |
| Blood pressure measurement |
434 |
0.68 |
2.61 |
386.52 |
Yes |
| Blood test |
1865 |
2.93 |
2.33 |
1300.34 |
Yes |
| Body temperature |
1515 |
2.38 |
3.46 |
2308.15 |
Yes |
| Cerebrovascular accident |
439 |
0.69 |
2.94 |
498.29 |
Yes |
| Chest X-ray |
719 |
1.13 |
2.24 |
448.46 |
Yes |
| Chills |
11387 |
17.86 |
2.31 |
8299.78 |
Yes |
| Cold sweat |
659 |
1.03 |
2.5 |
535.31 |
Yes |
| Computerised tomogram |
1108 |
1.74 |
2.78 |
1129.32 |
Yes |
| Computerised tomogram head |
335 |
0.53 |
2.62 |
301.19 |
Yes |
| Computerised tomogram head abnormal |
180 |
0.28 |
4.99 |
468.29 |
Yes |
| Computerised tomogram head normal |
147 |
0.23 |
2.07 |
74.19 |
Yes |
| Computerised tomogram thorax |
188 |
0.29 |
2.95 |
213.19 |
Yes |
| Computerised tomogram thorax abnormal |
237 |
0.37 |
3.8 |
416.72 |
Yes |
| Contusion |
644 |
1.01 |
2.03 |
311.33 |
Yes |
| COVID-19 |
2867 |
4.5 |
2.24 |
1827.43 |
Yes |
| COVID-19 pneumonia |
385 |
0.6 |
3.75 |
664.63 |
Yes |
| Death |
919 |
1.44 |
2.02 |
439.26 |
Yes |
| Deep vein thrombosis |
524 |
0.82 |
5.85 |
1667.82 |
Yes |
| Disorientation |
308 |
0.48 |
2.08 |
157.98 |
Yes |
| Dysmenorrhoea |
173 |
0.27 |
2.08 |
89.31 |
Yes |
| Dyspnoea exertional |
173 |
0.27 |
2.87 |
186.62 |
Yes |
| Electrocardiogram |
1173 |
1.84 |
2.15 |
661.09 |
Yes |
| Endotracheal intubation |
171 |
0.27 |
2.09 |
88.67 |
Yes |
| Epistaxis |
309 |
0.48 |
2.17 |
178.72 |
Yes |
| Eye pain |
425 |
0.67 |
2.11 |
227.26 |
Yes |
| Facial paralysis |
274 |
0.43 |
2.1 |
144.77 |
Yes |
| Fatigue |
10913 |
17.12 |
2.01 |
5538.44 |
Yes |
| Feeling abnormal |
2474 |
3.88 |
2.11 |
1340.27 |
Yes |
| Feeling cold |
1125 |
1.76 |
2.97 |
1303.14 |
Yes |
| Feeling of body temperature change |
217 |
0.34 |
2.87 |
234.21 |
Yes |
| Fibrin D dimer |
354 |
0.56 |
5.47 |
1036.64 |
Yes |
| Fibrin D dimer increased |
268 |
0.42 |
4.24 |
557.46 |
Yes |
| Gait inability |
263 |
0.41 |
2.36 |
187.03 |
Yes |
| Head discomfort |
362 |
0.57 |
2.58 |
315.13 |
Yes |
| Head injury |
310 |
0.49 |
2.07 |
156.62 |
Yes |
| Headache |
15890 |
24.93 |
2.24 |
11188.04 |
Yes |
| Heart rate |
320 |
0.5 |
2.05 |
157.5 |
Yes |
| Heart rate decreased |
144 |
0.23 |
2.02 |
67.81 |
Yes |
| Heavy menstrual bleeding |
444 |
0.7 |
2.49 |
355.35 |
Yes |
| Hot flush |
462 |
0.72 |
2.38 |
335.43 |
Yes |
| Hyperhidrosis |
3612 |
5.67 |
2.71 |
3554.09 |
Yes |
| Hypoxia |
291 |
0.46 |
2.12 |
157.46 |
Yes |
| Impaired work ability |
656 |
1.03 |
2.2 |
393.88 |
Yes |
| Laboratory test |
943 |
1.48 |
2.14 |
525 |
Yes |
| Loss of consciousness |
1831 |
2.87 |
2.26 |
1177.78 |
Yes |
| Lung opacity |
145 |
0.23 |
3.12 |
182.79 |
Yes |
| Magnetic resonance imaging |
647 |
1.02 |
2.82 |
676.87 |
Yes |
| Magnetic resonance imaging head |
238 |
0.37 |
3.41 |
351.58 |
Yes |
| Magnetic resonance imaging head abnormal |
207 |
0.32 |
4.73 |
501.88 |
Yes |
| Magnetic resonance imaging head normal |
145 |
0.23 |
3.33 |
205.04 |
Yes |
| Magnetic resonance imaging normal |
149 |
0.23 |
2.82 |
155.19 |
Yes |
| Menstrual disorder |
231 |
0.36 |
2.1 |
121.37 |
Yes |
| Menstruation irregular |
316 |
0.5 |
2.17 |
182.57 |
Yes |
| Migraine |
1239 |
1.94 |
2.71 |
1198.08 |
Yes |
| Muscle spasms |
1298 |
2.04 |
2.62 |
1168.26 |
Yes |
| Muscle tightness |
272 |
0.43 |
2.27 |
176.34 |
Yes |
| Myocardial infarction |
162 |
0.25 |
2.11 |
86.12 |
Yes |
| Night sweats |
314 |
0.49 |
2.04 |
151.81 |
Yes |
| Off label use |
370 |
0.58 |
4.53 |
845.1 |
Yes |
| Oxygen saturation |
161 |
0.25 |
3.08 |
198.01 |
Yes |
| Panic attack |
139 |
0.22 |
2.13 |
76.22 |
Yes |
| Parosmia |
138 |
0.22 |
2.25 |
87.37 |
Yes |
| Platelet count |
168 |
0.26 |
5.73 |
520.44 |
Yes |
| Platelet count normal |
236 |
0.37 |
2.79 |
240.6 |
Yes |
| Poor quality product administered |
480 |
0.75 |
5.88 |
1536.94 |
Yes |
| Product administered to patient of inappropriate age |
1112 |
1.74 |
2.09 |
580.15 |
Yes |
| Pulmonary embolism |
584 |
0.92 |
4.57 |
1351.53 |
Yes |
| Pulmonary thrombosis |
139 |
0.22 |
5.76 |
433.54 |
Yes |
| SARS-CoV-2 antibody test |
231 |
0.36 |
3.66 |
383.27 |
Yes |
| SARS-CoV-2 test positive |
2376 |
3.73 |
2.51 |
1959.6 |
Yes |
| Seizure |
650 |
1.02 |
2.5 |
527.36 |
Yes |
| Sensitive skin |
179 |
0.28 |
3.27 |
246.29 |
Yes |
| Sensory disturbance |
224 |
0.35 |
2.6 |
196.94 |
Yes |
| Sinus congestion |
133 |
0.21 |
2.11 |
70.85 |
Yes |
| Sleep disorder |
1061 |
1.66 |
2.23 |
659.92 |
Yes |
| Suspected COVID-19 |
453 |
0.71 |
15.5 |
3603.14 |
Yes |
| Taste disorder |
197 |
0.31 |
2.17 |
113.73 |
Yes |
| Therapy non-responder |
300 |
0.47 |
40.37 |
4056.15 |
Yes |
| Thirst |
200 |
0.31 |
2.33 |
136.87 |
Yes |
| Thrombosis |
1004 |
1.58 |
6.66 |
3716.05 |
Yes |
| Ultrasound Doppler |
309 |
0.48 |
4.58 |
716.04 |
Yes |
| Ultrasound Doppler abnormal |
243 |
0.38 |
5.59 |
730.85 |
Yes |
| Ultrasound scan |
620 |
0.97 |
3.16 |
800.94 |
Yes |
| Ultrasound scan abnormal |
153 |
0.24 |
2.12 |
82.64 |
Yes |
| Unresponsive to stimuli |
632 |
0.99 |
2.02 |
299.13 |
Yes |
| Vaccination failure |
596 |
0.94 |
2.47 |
469.21 |
Yes |
| Vaccine breakthrough infection |
271 |
0.43 |
3.05 |
329.2 |
Yes |
| Vision blurred |
1136 |
1.78 |
2.81 |
1178.67 |
Yes |
| Visual impairment |
519 |
0.81 |
2.26 |
332.92 |
Yes |
| Vital signs measurement |
287 |
0.45 |
5.23 |
794.15 |
Yes |
Note: The total of the VAE case reports stored in the database is: 1461789
Provenance: The above statistical data analysis results were obtained using the data extracted from VAERS database on Jan 7, 2022 (Note: The data contains VAERS reports processed as of Dec. 31, 2021).
Further analysis of the results can be found in our COVID-19 VAERS data analysis publication: Wenxin Guo*, Jessica Deguise*, Yujia Tian*, Philip Chi-En Huang*, Rohit Goru*, Qiuyue Yang, Suyuan Peng, Luxia Zhang, Lili Zhao, Jiangan Xie✉, Yongqun He✉. Profiling COVID-19 vaccine adverse events by statistical and ontological analysis of VAERS case reports. Frontiers in Pharmacology. 2022. 13:870599. doi: 10.3389/fphar.2022.870599.
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