In this study 203 subjects participated who had received at least 1st dose of ChAdOx1 nCoV-19 vaccine. We found significantly high AEFI among females vis-à-vis males for both the doses of Covishield vaccine (p = 0.001, 0.000). We found significant association between Occupation and AEFI after 1st dose (p = 0.015). ASHAs (Accredited Social Health Activist) showed highest incidence of AEFI after 1st dose of Covishield vaccine among different occupations. We found statistically significant association between substance use and AEFI (p = 0.002) after 1st dose as participants not abusing any substance reported a smaller number of AEFI compared to abusers. We found statistically significant association between diet and AEFI after 1st dose (p = 0.016) as subjects consuming vegetarian diet reported more AEFI compared to non-vegetarians. We found statistically significant association between Allergy and AEFI after 1st dose and subjects having allergy reported more AEFI compared to non-allergic subjects (p = 0.027). We found no significant association between AEFI and Age, Education status, Marital status, residential area inside hospital campus, Religion, Physical activity, comorbidity and prior COVID-19 infection [Table 1].
Table 1
Association of socio-demographic, behavioral, comorbid condition and covid status of subjects with AEFI after 1st and 2nd dose of Covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
Yes (150) | No (53) | p-value | Yes (91) | No (96) | p-value |
Age | | | | | | |
< 40 | 99(76.2) | 31 (23.8) | 0.327 | 55 (47.4) | 61 (52.6) | 0.662 |
≥ 40 | 51 (69.9) | 22 (30.1) | 36 (50.7) | 35 (49.3) |
Gender | | | | | | |
Male | 72 (64.9) | 39 (35.1) | 0.001 | 36 (36.0) | 64 (64.0) | 0.000 |
Female | 78 (84.8) | 14 (15.2) | 55 (63.2) | 32 (36.8) |
Education | | | | | | |
Post-Graduation | 21 (67.7) | 10 (32.3) | 0.295 | 16 (51.6) | 15 (48.4) | 0.953 |
Graduation | 63 (80.8) | 15 (19.2) | 37 (50.0) | 37 (50.0) |
Intermediate | 21 (65.6) | 11 (34.4) | 13 (46.4) | 15 (53.6) |
Up to 10th | 45 (72.6) | 17 (27.4) | 25 (46.3) | 29 (53.7) |
Occupation | | | | | | |
Doctor | 23 (62.2) | 14 (37.8) | 0.015 | 16 (44.4) | 20 (55.6) | 0.712 |
Nursing Officer | 22 (88.0) | 3 (12.0) | 11 (45.8) | 13 (54.2) |
Paramedical Staff | 45 (80.4) | 11(19.6) | 24 (51.1) | 23 (48.9) |
House Keeping Staff | 28 (80.0) | 7 (20.0) | 17 (50.0) | 17 (50.0) |
Supporting Staff | 23 (57.5) | 17 (42.5) | 17 (44.7) | 21 (55.3) |
ASHA | 9 (90.0) | 1 (10.0) | 6 (75.0) | 2 (25.0) |
Marital Status | | | | | | |
Ever Married | 125 (74.0) | 44 (26.0) | 0.958 | 81 (50.9) | 78 (49.1) | 0.137 |
Never Married | 25 (73.5) | 9(26.5) | 10 (35.7) | 18 (64.3) |
Residence | | | | | | |
Inside Hospital Campus | 7 (58.3) | 5 (41.7) | 0.206 | 6 (50.0) | 6 (50.0) | 0.924 |
Outside Hospital Campus | 143 (74.9) | 48 (25.1) | 85 (48.6) | 90 (51.4) |
Religion | | | | | | |
Hindu | 142 (73.6) | 51(26.4) | 0.652 | 85 (47.5) | 94 (52.5) | 0.128 |
Others | 8 (80.0) | 2 (20.0) | 6 (75.0) | 2 (25.0) |
Substance Use | | | | | | |
Yes | 24 (55.8) | 19 (44.2) | 0.002 | 17 (44.7) | 21 (55.3) | 0.587 |
No | 126 (78.8) | 34 (21.3) | 74 (49.7) | 75 (50.3) |
Diet | | | | | | |
Vegetarian | 77 (81.9) | 17 (18.1) | 0.016 | 46 (54.8) | 38 (45.2) | 0.132 |
Non-vegetarian | 73 (67.0) | 36 (33.0) | 45 (43.7) | 58 (56.3) |
Physical Activity | | | | | | |
Regular | 45 (73.8) | 16 (26.2) | 0.987 | 28 (50.0) | 28 (50.0) | 0.064 |
Occasional | 47 (74.6) | 16 (25.4) | 36 (59.0) | 25 (41) |
Not at all | 58 (73.4) | 21 (26.6) | 27 (38.6) | 43 (61.4) |
Comorbidity | | | | | | |
Yes | 39 (83.0) | 8 (17.0) | 0.106 | 22 (52.4) | 20 (47.6) | 0.584 |
No | 111 (71.2) | 45 (28.8) | 69 (47.6) | 76 (52.4) |
Allergy | | | | | | |
Yes | 13 (100.0) | 0 (0.0) | 0.027 | 7 (63.6) | 4 (36.4) | 0.306 |
No | 137 (72.1) | 53 (27.9) | 84 (47.7) | 92 (52.3) |
COVID 19 Infection | | | | | | |
COVID Group | 58 (80.6) | 14 (19.4) | 0.109 | 33 (50.0) | 33 (50.0) | 0.787 |
Non COVID Group | 92 (70.2) | 39 (29.8) | 58 (47.9) | 63 (52.1) |
Females reported higher AEFIs than males after both the doses (p = 0.001, 0.000). Less number of males reported AEFI after the second dose. Systemic AEFIs were reported higher among females after both the doses (p = 0.000, 0.000). AEFIs like tiredness (p = 0.001, 0.000), fever (p = 0.001, 0.002), feeling unwell (p = 0.001, 0.012) and headache (p = 0.000, 0.008) were higher among females after both the doses. Joint pain after the second dose was higher among females (8%) compared to males (1%) (p = 0.018). Nausea or vomiting was higher among females (8.7%) compared to males (0.9%) after the first dose (p = 0.007) [Table 2].
Table 2
Association of self-reported AEFI with gender after 1st and 2nd dose of covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
Male (111) | Female (92) | p-value | Male (100) | Female (87) | p-value |
Any AEFI | | | | | | |
Yes | 72 (64.9) | 78 (84.8) | 0.001 | 36 (36.0) | 55 (63.2) | 0.000 |
No | 39 (35.1) | 14 (15.2) | 64 (64.0) | 32 (36.8) |
Local AEFI | | | | | | |
Yes | 55 (49.5) | 52 (56.5) | 0.332 | 26 (26.0) | 34 (39.1) | 0.056 |
No | 56 (50.5) | 40 (43.5) | 74 (74.0) | 53 (60.9) |
Systemic AEFI | | | | | | |
Yes | 48 (43.2) | 69 (75.0) | 0.000 | 18 (18.0) | 38 (43.7) | 0.000 |
No | 63 (56.8) | 23 (25.0) | 82 (82.0) | 49 (56.3) |
Tiredness | | | | | | |
Yes | 27 (24.3) | 43 (46.7) | 0.001 | 6 (6.0) | 22 (25.3) | 0.000 |
No | 84 (75.7) | 49 (53.3) | 94 (94.0) | 65 (74.7) |
Fever | | | | | | |
Yes | 22 (19.8) | 37 (40.2) | 0.001 | 6 (6.0) | 19 (21.8) | 0 .002 |
No | 89 (80.2) | 55 (59.8) | 94 (94.0) | 68 (78.2) |
Feeling Unwell | | | | | | |
Yes | 19 (17.1) | 34 (37.0) | 0.001 | 3 (3.0) | 11 (12.6) | 0.012 |
No | 92 (82.9) | 58 (63.0) | 97(97.0) | 76 (87.4) |
Headache | | | | | | |
Yes | 5 (4.5) | 20 (21.7) | 0.000 | 2 (2.0) | 10 (11.5) | 0 .008 |
No | 106 (95.5) | 72 (78.3) | 98 (98.0) | 77 (88.5) |
Joint Pain | | | | | | |
Yes | 4 (3.6) | 7 (7.6) | 0.210 | 1 (1.0) | 7 (8.0) | 0 .018 |
No | 107 (96.4) | 85 (92.4) | 99 (99.0) | 80 (92.0) |
Breathing Difficulty | | | | | | |
Yes | 1 (0.9) | 3 (3.3) | 0.228 | 0 (0.0) | 1 (1.1) | 0 .282 |
No | 110 (99.1) | 89 (96.7) | 100 (100.0) | 86 (98.9) |
Sore Throat | | | | | | |
Yes | 2 (1.8) | 1 (1.1) | 0.674 | 1 (1.0) | 1 (1.1) | 0 .921 |
No | 109 (98.2) | 91 (98.9) | 99 (99.0) | 86 (98.9) |
Loss of Appetite | | | | | | |
Yes | 0 (0.0) | 3 (3.3) | 0.055 | 1 (1.0) | 1 (1.1) | 0 .921 |
No | 111 (100.0) | 89 (96.7) | 99 (99.0) | 86 (98.9) |
Abdominal Pain | | | | | | |
Yes | 1 (0.9) | 2 (2.2) | 0.454 | 1 (1.0) | 1 (1.1) | 0.921 |
No | 110 (99.1) | 90 (97.8) | 99 (99.0) | 86 (98.9) |
Rashes | | | | | | |
Yes | 1 (0.9) | 2 (2.2) | 0.454 | 2 (2.0) | 1 (1.1) | 0.644 |
No | 110 (99.1) | 90 (97.8) | 98 (98.0) | 86 (98.9) |
Excessive Sweating | | | | | | |
Yes | 0 (0.0) | 3 (3.3) | 0.055 | 0 (0.0) | 2 (2.3) | 0.127 |
No | 111 (100) | 89 (96.7) | 100 (100.0) | 85 (97.7) |
Nausea or vomiting | | | | | | |
Yes | 1 (0.9) | 8 (8.7) | 0.007 | 1 (1.0) | 1 (1.1) | 0.921 |
No | 110 (99.1) | 84 (91.3) | 99 (99.0) | 86 (98.9) |
Headache after the second dose was higher among participants of ≥ 40 years of age (11.3%) compared to participants of < 40 years of age (3.4%) (p = 0.034) [Table 3].
Table 3
Association of self-reported AEFI with age after 1st and 2nd dose of covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
< 40 Years Old (130) | ≥ 40 Years Old (73) | p-value | < 40 Years Old (116) | ≥ 40 Years Old (71) | p-value |
Any AEFI | | | | | | |
Yes | 99 (76.2) | 51 (69.9) | 0.327 | 55 (47.4) | 36 (50.7) | 0.662 |
No | 31 (23.8) | 22 (30.1) | 61 (52.6) | 35 (49.3) |
Local AEFI | | | | | | |
Yes | 73 (56.2) | 34 (46.6) | 0.190 | 38 (32.8) | 22 (31.0) | 0.801 |
No | 57 (43.8) | 39 (53.4) | 78 (67.2) | 49 (69.0) |
Systemic AEFI | | | | | | |
Yes | 76 (58.5) | 41 (56.2) | 0.751 | 34 (29.3) | 22 (31.0) | 0.808 |
No | 54 (41.5) | 32 (16.7) | 82 (70.7) | 49 (69.0) |
Tiredness | | | | | | |
Yes | 45 (34.6) | 25 (34.2) | 0.958 | 15 (44.4) | 13 (18.3) | 0.317 |
No | 85 (65.4) | 48 (65.8) | 101 (87.1) | 58 (81.7) |
Fever | | | | | | |
Yes | 42 (32.3) | 17 (23.3) | 0.174 | 15 (12.9) | 10 (14.1) | 0.822 |
No | 88 (76.5) | 56 (76.7) | 101 (87.1) | 61 (85.9) |
Feeling Unwell | | | | | | |
Yes | 38 (29.2) | 15 (20.5) | 0.176 | 8 (6.9) | 6 (8.5) | 0.695 |
No | 92 (70.8) | 58 (79.5) | 108 (93.1) | 65 (91.5) |
Headache | | | | | | |
Yes | 15 (11.5) | 10 (13.7) | 0.653 | 4 (3.4) | 8 (11.3) | 0.034 |
No | 115 (88.5) | 63 (86.3) | 112 (96.6) | 63 (88.7) |
Joint Pain | | | | | | |
Yes | 8 (6.2) | 3 (4.1) | 0.537 | 5 (4.3) | 3 (4.2) | 0.978 |
No | 122 (93.8) | 70 (95.9) | 111 (95.7) | 68 (95.8) |
Breathing Difficulty | | | | | | |
Yes | 4 (3.1) | 0 (0.0) | 0.130 | 1 (0.9) | 0 (0.0) | 0.433 |
No | 126 (96.9) | 73 (100.0) | 115 (99.1) | 71 (100.0) |
Sore Throat | | | | | | |
Yes | 2 (1.5) | 1 (1.4) | 0.924 | 1 (0.9) | 1 (1.4) | 0.724 |
No | 128 (98.5) | 72 (98.6) | 115 (99.1) | 70 (98.6) |
Loss of Appetite | | | | | | |
Yes | 2 (1.5) | 1 (1.4) | 0.924 | 1 (0.9) | 1 (1.4) | 0.724 |
No | 128 (98.5) | 72 (98.6) | 115 (99.1) | 70 (98.6) |
Abdominal Pain | | | | | | |
Yes | 3 (2.3) | 0 (0.0) | 0.191 | 1 (0.9) | 1 (1.4) | 0.724 |
No | 127 (97.7) | 73 (100.0) | 115 (99.1) | 70 (98.6) |
Rashes | | | | | | |
Yes | 3 (2.3) | 0 (0.0) | 0.191 | 3 (2.6) | 0 (0.0) | 0.172 |
No | 127 (97.7) | 73 (100.0) | 113 (97.4) | 71 (100.0) |
Excessive Sweating | | | | | | |
Yes | 1 (0.8) | 2 (2.7) | 0 .264 | 0 (0.0) | 2 (2.8) | 0.069 |
No | 129 (99.2) | 71 (97.3) | 116 (100.0) | 69 (97.2) |
Nausea or Vomiting | | | | | | |
Yes | 8 (6.2) | 1 (1.4) | 0 .112 | 1 (0.9) | 1 (1.4) | 0.724 |
No | 122 (93.8) | 72 (98.6) | 115 (99.1) | 70 (98.6) |
Participants not abusing any substance (78.8%) reported significant incidence of AEFI after 1st dose compared to abusers. (p = 0.002). Local(p = 0.003) and systemic(p = 0.002) AEFI after 1st dose were statistically significant among participants not abusing any substance compared to abusers. Among systemic AEFI, tiredness was significantly more after 2nd dose than 1st dose (p = 0.017). Among systemic AEFI, tiredness was significantly associated with AEFI after 2nd dose (p = 0.017) and subjects not abusing any substance reported more incidence of tiredness. AEFI like fever (p = 0.005) and feeling unwell(p = 0.005) were reportedly significant in participants after 1st dose [Table 4].
Table 4
Association of self-reported AEFI with substance use after 1st and 2nd dose of Covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
Substance Use | p-value | Substance Use | p-value | |
Yes (43) | No (160) | Yes (38) | No (149) |
Any AEFI | | | | | | |
Yes | 24 (55.8) | 126 (78.8) | 0.002 | 17 (44.7) | 74 (49.7) | 0.587 |
No | 19 (44.2) | 34 (21.3) | 21 (55.3) | 75 (50.3) |
Local AEFI | | | | | | |
Yes | 14 (32.6) | 93 (58.1) | 0.003 | 9 (23.7) | 51 (34.2) | 0.214 |
No | 29 (67.4) | 67 (41.9) | 29 (76.3) | 98 (65.8) |
Systemic AEFI | | | | | | |
Yes | 16 (37.2) | 101 (63.1) | 0.002 | 9 (23.7) | 47 (31.5) | 0.345 |
No | 27 (62.8) | 59 (36.9) | 29 (76.3) | 102 (68.5) |
Tiredness | | | | | | |
Yes | 10 (23.3) | 60 (37.5) | 0.081 | 1 (2.6) | 27 (18.1) | 0.017 |
No | 33 (76.7) | 100 (62.5) | 37 (97.4) | 122 (81.9) |
Fever | | | | | | |
Yes | 5 (11.6) | 54 (33.8) | 0.005 | 3 (7.9) | 22 (14.8) | 0.267 |
No | 38 (88.4) | 106(66.3) | 35 (92.1) | 127 (85.2) |
Feeling unwell | | | | | | |
Yes | 4 (9.3) | 49 (30.6) | 0.005 | 1 (2.6) | 13 (8.7) | 0.203 |
No | 39 (90.7) | 111 (69.4) | 37 (97.4) | 136 (91.3) |
Headache | | | | | | |
Yes | 2 (4.7) | 23(14.4) | 0.085 | 2 (5.3) | 10 (6.7) | 0.745 |
No | 41 (95.3) | 137 (85.6) | 36 (94.7) | 139 (93.3) |
Joint pain | | | | | | |
Yes | 3 (7.0) | 8 (5.0) | 0.611 | 1 (2.6) | 7 (4.7) | 0.574 |
No | 40 (93.0) | 152 (95.0) | 37 (97.4) | 142 (95.3) |
Breathing difficulty | | | | | | |
Yes | 1 (2.3) | 3 (1.9) | 0.850 | 0 (0.0) | 1 (0.7) | 0.613 |
No | 42 (97.7) | 157 (98.1) | 38 (100.0) | 148 (99.3) |
Sore throat | | | | | | |
yes | 1 (2.3) | 2 (1.3) | 0.604 | 1 (2.6) | 1 (0.7) | 0.294 |
No | 42 (97.7) | 158 (98.8) | 37 (97.4) | 148 (99.3) |
Loss of appetite | | | | | | |
Yes | 0 (0.0) | 3 (1.9) | 0.366 | 0 (0.0) | 2 (1.3) | 0.473 |
No | 43 (100.0) | 157 (98.1) | 38 (100.0) | 147 (98.7) |
Abdominal pain | | | | | | |
Yes | 1 (2.3) | 2 (1.3) | 0.604 | 0 (0.0) | 2 (1.3) | 0.473 |
No | 42 (97.7) | 158 (98.8) | 38 (100.0) | 147 (98.7) |
Rashes | | | | | | |
Yes | 1 (2.3) | 2 (1.3) | 0.604 | 2 (5.3) | 1 (0.7) | 0.044 |
No | 42 (97.7) | 158 (98.8) | 36 (94.7) | 148 (99.3) |
Excessive sweating | | | | | | |
Yes | 0 (0.0) | 3 (1.9) | 0.366 | 0 (0.0) | 2 (1.3) | 0.473 |
No | 43 (100.0) | 157 (98.1) | 38 (100.0) | 147 (98.7) |
Vomiting nausea | | | | | | |
Yes | 1 (2.3) | 8 (5.0) | 0.449 | 0 (0.0) | 2 (1.3) | 0.473 |
No | 42 (97.7) | 152 (95.0) | 38 (100.0) | 147 (98.7) |
Systemic AEFI after 1st dose were significant in participants with comorbidity (p = 0.020). Among participants with comorbidity AEFI like headache were significant after 1st dose (p = 0.008). AEFI like loss of appetite were reported significantly in the participants of both the doses (p = 0.001, 0.008). AEFI like abdominal pain(p = 0.008) and excessive sweating(p = 0.008) were reported significantly after 2nd dose [Table 5]. We found no significant association between prior COVID-19 infection and Systemic AEFI after both the doses (p = 0.881, 0.280) [Table 6].
Table 5
Association of self-reported AEFI with comorbidity after 1st and 2nd dose of covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
Comorbidity | p-value | Comorbidity | p-value | |
Yes (47) | No (156) | Yes (42) | No (145) |
Any AEFI | | | | | | |
Yes | 39 (83.0) | 111(71.2) | 0.106 | 22 (52.4) | 69 (47.6) | 0.584 |
No | 8 (17.0) | 45 (28.8) | 20 (47.6) | 76 (52.4) |
Local AEFI | | | | | | |
Yes | 28 (59.6) | 79 (50.6) | 0.282 | 14 (33.3) | 46 (31.7) | 0.844 |
No | 19 (40.4) | 77 (49.4) | 28 (66.7) | 99 (68.3) |
Systemic AEFI | | | | | | |
Yes | 34 (72.3) | 83 (53.2) | 0.020 | 14 (33.3) | 42 (29.0) | 0.586 |
No | 13 (27.7) | 73 (46.8) | 28 (66.7) | 103 (71.0) |
Tiredness AEFI | | | | | | |
Yes | 20 (42.6) | 50 (32.1) | 0.184 | 10 (23.8) | 18 (12.4) | 0.068 |
No | 27 (57.4) | 106 (67.9) | 32 (76.2) | 127 (87.6) |
Fever | | | | | | |
Yes | 18 (38.3) | 41 (26.3) | 0.112 | 8 (19.0) | 17 (11.7) | 0.219 |
No | 29 (61.7) | 115(73.7) | 34 (81.0) | 128 (88.3) |
Feeling unwell | | | | | | |
Yes | 13 (27.7) | 40 (25.6) | 0.782 | 3 (7.1) | 11 (7.6) | 0.923 |
No | 34 (72.3) | 116 (74.4) | 39 (92.9) | 134 (92.4) |
Headache | | | | | | |
Yes | 11 (23.4) | 14 (9.0) | 0.008 | 3 (7.1) | 9 (6.2) | 0.827 |
No | 36 (76.6) | 142 (91.0) | 39 (92.9) | 136 (93.8) |
Joint pain | | | | | | |
Yes | 4 (8.5) | 7 (4.5) | 0.285 | 2 (4.8) | 6 (4.1) | 0.860 |
No | 43 (91.5) | 149 (95.5) | 40 (95.2) | 139 (95.9) |
Breathing difficulty | | | | | | |
Yes | 0 (0.0) | 4 (2.6) | 0.268 | 0 (0.0) | 1 (0.7) | 0.589 |
No | 47 (100.0) | 152 (97.4) | 42 (100.0) | 144 (99.3) |
Sore throat | | | | | | |
yes | 0 (0.0) | 3 (1.9) | 0.338 | 1 (2.4) | 1 (0.7) | 0.348 |
No | 47 (100.0) | 153 (98.1) | 41 (97.6) | 144 (99.3) |
Loss of appetite | | | | | | |
Yes | 3 (6.4) | 0 (0.0) | 0.001 | 2 (4.8) | 0 (0.0) | 0.008 |
No | 44 (93.6) | 156 (100.0) | 40 (95.2) | 145 (100.0) |
Abdominal pain | | | | | | |
Yes | 1 (2.1) | 2 (1.3) | 0.674 | 2 (4.8) | 0 (0.0) | 0.008 |
No | 46 (97.9) | 154 (98.7) | 40 (95.2) | 145 (100.0) |
Rashes | | | | | | |
Yes | 1 (2.1) | 2 (1.3) | 0.674 | 0 (0.0) | 3 (2.1) | 0.347 |
No | 46 (97.9) | 154 (98.7) | 42 (100.0) | 142 (97.9) |
Excessive sweating | | | | | | |
Yes | 2 (4.3) | 1 (0.6) | 0.072 | 2 (4.8) | 0 (0.0) | 0.008 |
No | 45 (95.7) | 155 (99.4) | 40 (95.2) | 145 (100.0) |
Vomiting nausea | | | | | | |
Yes | 4 (8.5) | 5 (3.2) | 0.449 | 1 (2.4) | 1 (0.7) | 0.348 |
No | 43 (91.5) | 151 (96.8) | 41 (97.6) | 144 (99.3) |
Table 6
Association of self-reported systemic AEFI with covid status after 1st and 2nd dose of covishield vaccine
Variable | AEFI after 1st Dose | | AEFI (After 2nd dose) |
COVID Group (72) | Non COVID Group (131) | p-value | COVID Group (66) | Non COVID Group (121) | p-value |
Systemic AEFI | | | | | | |
Yes | 42 (58.3) | 75 (57.3) | 0.881 | 23 (34.8) | 33 (27.3) | 0.280 |
No | 30 (41.7) | 56 (42.7) | 43 (65.2) | 88 (72.7) |
Tiredness | | | | | | |
Yes | 28 (38.9) | 42 (32.1) | 0.327 | 12 (18.2) | 16 (13.2) | 0.364 |
No | 44 (61.1) | 89 (67.9) | 54 (81.8) | 105 (86.8) |
Fever | | | | | | |
Yes | 20 (27.8) | 39 (29.8) | 0.765 | 11 (16.7) | 14 (11.6) | 0.328 |
No | 52 (72.2) | 92 (70.2) | 55 (83.3) | 107 (88.4) |
Feeling Unwell | | | | | | |
Yes | 17 (23.6) | 36 (27.5) | 0.548 | 6 (9.1) | 8 (6.6) | 0.538 |
No | 55 (76.4) | 95 (72.5) | 60(90.9) | 113 (93.4) |
Headache | | | | | | |
Yes | 6 (8.3) | 19 (14.5) | 0.201 | 5 (7.6) | 7 (5.8) | 0.633 |
No | 66 (91.7) | 112 (85.5) | 61 (92.4) | 114 (94.2) |
Joint Pain | | | | | | |
Yes | 4 (5.6) | 7 (5.3) | 0.949 | 2 (3.0) | 6 (5.0) | 0.533 |
No | 68 (94.4) | 124 (94.7) | 64 (97.0) | 115 (95.0) |
Breathing Difficulty | | | | | | |
Yes | 0 (0.0) | 4 (3.1) | 0.134 | 0 (0.0) | 1 (0.8) | 0.459 |
No | 72 (100.0) | 127 (96.9) | 66 (100.0) | 120 (99.2) |
Sore Throat | | | | | | |
Yes | 1 (1.4) | 2 (1.5) | 0.938 | 1 (1.5) | 1 (0.8) | 0.662 |
No | 71 (98.6) | 129 (98.5) | 65 (98.5) | 120 (99.2) |
Loss of Appetite | | | | | | |
Yes | 1 (1.4) | 2 (1.5) | 0.938 | 1 (1.5) | 1 (0.8) | 0.662 |
No | 71 (98.6) | 129 (98.5) | 65 (98.5) | 120 (99.2) |
Abdominal Pain | | | | | | |
Yes | 2 (2.8) | 1 (0.8) | 0.255 | 1 (1.5) | 1 (0.8) | 0.662 |
No | 70 (97.2) | 130 (99.2) | 65 (98.5) | 120 (99.2) |
Rashes | | | | | | |
Yes | 0 (0.0) | 3 (2.3) | 0.196 | 0 (0.0) | 3 (2.5) | 0.197 |
No | 72 (100.0) | 128 (97.7) | 66 (100.0) | 118 (97.5) |
Excessive Sweating | | | | | | |
Yes | 1 (1.4) | 2 (1.5) | 0.938 | 1 (1.5) | 1 (0.8) | 0.662 |
No | 71 (98.6) | 129 (98.5) | 65 (98.5) | 120 (99.2) |
Nausea and Vomiting | | | | | | |
Yes | 1 (1.4) | 8 (6.1) | 0.118 | 0 (0.0) | 2 (1.7) | 0.294 |
No | 71 (98.6) | 123 (93.9) | 66 (100.0) | 119 (98.3) |
AEFIs reported after the first dose, within 30 minutes were Feeling Unwell (25%), Fever or Chills (2.77%), Excessive sweating (5.55%), Local AEFIs (44.44%), Weakness (5.55%), Headache (3%), Muscle pain (8.33%) and tachycardia (2.77%). AEFIs reported after the first dose, between 30 minutes to 1 week were Feeling Unwell (12.36%), Fever or Chills (15.65%), Sore throat (0.82%), Runny Nose (0.27%), Cough (0.27%), Rashes (0.55%), Loss of Appetite (0.82%), Excessive sweating (0.55%), Breathing difficulty (1.09%), Local AEFIs (27.74%), Weakness (18.68%), Headache (6.31%), Muscle pain (8.24%), Joint pain (3.02%), Abdominal pain (0.82%), Tachycardia (0.27%) and Nausea/Vomiting (2.47%). AEFIs reported after the first dose, between 7 days to 15 days were Feeling Unwell (11.11%), Fever or Chills (14.81%), Rashes (3.7%), Loss of Appetite (3.7%), Breathing difficulty (3.7%), Local AEFIs (11.11%), Weakness (11.11%), Headache (3.7%), Muscle pain (14.81%), Joint pain (7.4%), Abdominal pain (3.7%) and Nausea/Vomiting (11.11%). AEFIs reported after the first dose, between 16 days till 1 month were Fever or Chills (11.11%), Rashes (22.22%), Local AEFIs (11.11%), Weakness (11.11%), Muscle pain (11.11%), Joint pain (22.22%) and Abdominal pain (11.11%). After 1 month from the first dose, AEFIs reported were Fever or Chills (33.33%), Rashes (33.33%) and Joint pain (33.33%) [Figure 1].
AEFIs reported after the second dose, within 30 minutes were Feeling Unwell (15.78%), Local AEFIs (63.1%), Weakness (5.26%) and Headache (15.78%). AEFIs reported after the second dose, between 30 minutes to 1 week were Feeling Unwell (7.51%), Fever or Chills (13.87%), Sore throat (1.15%), Runny Nose (0.57%), Cough (0.57%), Rashes (1.15%), Loss of Appetite (0.57%), Excessive sweating (1.15%), Breathing difficulty (0.57%), Local AEFIs (31.79%), Weakness (15.6%), Headache (5.78%), Muscle pain (12.13%), Joint pain (4.62%), Abdominal pain (0.57%) and Nausea/Vomiting (2.31%). AEFIs reported after the second dose, between 7 days to 15 days were Feeling Unwell (4.76%), Fever or Chills (23.81%), Sore throat (4.76%), Runny Nose (4.76%), Rashes (4.76%), Loss of Appetite (4.76%), Local AEFIs (4.76%), Weakness (19.05%), Muscle pain (14.28%), Joint pain (9.52%) and Abdominal pain (4.76%). AEFIs reported after the second dose, between 16 days to 1 month were Fever or Chills (11.11%), Sore throat (11.11%), Rashes (22.22%), Weakness (11.11%), Muscle pain (22.22%) and Joint pain (22.22%). After 1 month from the second dose, AEFIs reported were Sore throat (16.66%), Rashes (33.33%), Muscle pain (16.66%) and Joint pain (33.33%) [Figure 2].