Table 3. Frequencies of medically attended adverse events of interest following COVID-19 vaccination reported at any point throughout the study period by condition and vaccine brand, England, 1 October 2020–12 September 2021 (n = 781,200 individuals).
| Condition | Comirnaty (1 or 2 doses) n = 300,641 |
Vaxzevria (1 or 2 doses) n = 368,898 |
Spikevax (1 or 2 doses) n = 12,024 |
Unvaccinated n = 99,637 |
|||
|---|---|---|---|---|---|---|---|
| n | Rate per 10,000 doses | n | Rate per 10,000 doses | n | Rate per 10,000 doses | n | |
| General non-specific | |||||||
| Asthenia | 1,064 | 19.02 | 1,494 | 21.11 | 11 | 5.33 | 505 |
| Fatigue | 34,930 | 624.36 | 40,928 | 23.47 | 1,525 | 739.50 | 11,282 |
| Fever | 8,940 | 159.80 | 12,120 | 171.26 | 270 | 130.93 | 3,578 |
| Fever with chills | 28 | 0.50 | 29 | 0.41 | 0 | 0 | 5 |
| Malaise | 8,797 | 157.25 | 10,935 | 154.52 | 173 | 83.89 | 2,252 |
| Oedema of face | 60 | 1.07 | 101 | 1.43 | 4 | 1.94 | 19 |
| Injection site | |||||||
| Bruising | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Burning | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema | 9 | 0.16 | 25 | 0.35 | 1 | 0.48 | 5a |
| Induration | 0 | 0 | 3 | 0.04 | 0 | 0 | 0 |
| Inflammation | 1 | 0.02 | 0 | 0 | 0 | 0 | 0 |
| Irritation | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pain | 16 | 0.29 | 57 | 0.81 | 2 | 0.97 | 6a |
| Pruritus | 0 | 0 | 0 | 0 | 1 | 0.48 | 0 |
| Rash | 2 | 0.04 | 5 | 0.07 | 1 | 0.48 | 1a |
| Swelling | 16 | 0.29 | 27 | 0.38 | 4 | 1.94 | 2a |
| Urticaria | 0 | 0 | 3 | 0.04 | 0 | 0 | 0 |
| Ear | |||||||
| Tinnitus | 7,972 | 142.50 | 11,901 | 168.17 | 368 | 178.45 | 2,081 |
| Gastrointestinal | |||||||
| Abdominal pain | 76,997 | 1,376.28 | 92,299 | 1,304.22 | 3,587 | 1,739.40 | 31,389 |
| Diarrhoea | 26,181 | 467.97 | 32,112 | 453.76 | 744 | 360.78 | 6,124 |
| Nausea | 9,541 | 170.54 | 10,620 | 150.07 | 288 | 139.66 | 4,060 |
| Vomiting | 10,588 | 189.26 | 12,798 | 180.84 | 378 | 183.30 | 6,096 |
| Immune | |||||||
| Anaphylaxis | 419 | 7.49 | 861 | 12.17 | 21 | 10.18 | 235 |
| Hypersensitivity reactions | 12,475 | 222.98 | 16,099 | 227.49 | 606 | 293.86 | 4,860 |
| Lymphatic | |||||||
| Lymphadenopathy | 4,290 | 76.68 | 3,986 | 56.32 | 286 | 138.69 | 1,508 |
| Metabolic/nutrition | |||||||
| Decrease in appetite | 4,746 | 84.83 | 5,899 | 83.36 | 90 | 43.64 | 1,872 |
| Musculoskeletal | |||||||
| Joint pain | 89,366 | 1,597.37 | 124,710 | 1,762.20 | 2,470 | 1,197.75 | 19,813 |
| Myalgia | 15,357 | 274.50 | 17,003 | 240.26 | 109 | 52.86 | 1,358 |
| Weakness | 1,064 | 19.02 | 1,494 | 21.11 | 11 | 5.33 | 505 |
| Neurological | |||||||
| Bell’s palsy | 1,199 | 21.43 | 1,661 | 23.47 | 50 | 24.25 | 425 |
| Dizziness | 27,802 | 496.95 | 30,702 | 433.83 | 659 | 24.25 | 6,026 |
| Drowsiness | 916 | 16.37 | 1,175 | 16.60 | 30 | 14.55 | 303 |
| Guillain–Barré syndrome | 91 | 1.63 | 221 | 3.12 | 0 | 0 | 62 |
| Headache | 60,901 | 1,088.58 | 74,663 | 1,055.02 | 3,365 | 1,631.75 | 22,855 |
| Lethargy | 1,786 | 31.92 | 2,166 | 30.61 | 53 | 25.70 | 496 |
| Paraesthesia | 6,533 | 116.77 | 9,394 | 132.74 | 223 | 108.14 | 1,865 |
| Peripheral tremor | 3,633 | 64.94 | 4,752 | 67.15 | 50 | 24.25 | 597 |
| Psychiatric | |||||||
| Insomnia | 11,723 | 209.54 | 14,714 | 207.92 | 434 | 210.45 | 4,583 |
| Respiratory | |||||||
| Cough | 67,336 | 1,203.60 | 94,675 | 1,337.80 | 1,716 | 832.12 | 17,926 |
| Influenza-like illness | 3,349 | 59.86 | 4,990 | 70.51 | 122 | 59.16 | 1,561 |
| Sneezing | 255 | 4.56 | 233 | 3.29 | 6 | 2.91 | 110 |
| Sore throat | 19,406 | 346.87 | 19,338 | 273.25 | 1,056 | 512.07 | 8,221 |
| Skin | |||||||
| Angioedema | 647 | 11.56 | 1,003 | 14.17 | 25 | 12.12 | 214 |
| Eruption of skin | 49,270 | 880.68 | 57,713 | 815.51 | 2,075 | 1,006.21 | 14,383 |
| Hyperhidrosis | 828 | 14.80 | 623 | 8.80 | 34 | 16.49 | 420 |
| Vascular | |||||||
| Capillary leak syndrome | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myocarditis | 220 | 3.93 | 258 | 3.65 | 8 | 3.88 | 46 |
| Pericarditis | 429 | 7.67 | 597 | 8.44 | 21 | 10.18 | 177 |
COVID-19: coronavirus disease.
a As the self-controlled case series design compares the occurrence of adverse events of interest in the risk period to the control period to determine whether the vaccine may be associated with a higher risk of certain adverse events, no a priori assumptions are made on whether these events are causally related, nor were there any selection process for events to include or exclude. For this reason, such events can include those that happened following administration of other vaccines, and a small number of injection site reactions were observed in the unvaccinated group.