| Prospective (N = 210) a | Retrospective (N = 29) b | |||||
|---|---|---|---|---|---|---|
| n | % | 95% CI | n | % | 95% CI | |
| Asthenia | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Chest discomfort | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Cough | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Dizziness | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Dry Throat | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Dyspnoea | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Expired product administered | 8 | 3.81 | 1.82, 7.46 | 1 | 3.45 | 0.37, 15.00 c |
| Extra dose administered | 7 | 3.33 | 1.49, 6.85 | 1 | 3.45 | 0.37, 15.00 c |
| Eye pruritus | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Facial pain | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Fatigue | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Fibromyalgia | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Pain (general) | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Gingival pain | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Guillain–Barré syndrome | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| H1N1 influenza infection | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Headache | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Hypersensitivity | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Hypaesthesia | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Hypoglycaemia | 1 | 0.48 | 0.05, 2.20 c | 1 | 3.45 | 0.37, 15.00 c |
| Inappropriate concomitant administration of additional vaccine | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Injection site inflammation | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Influenza infection | 2 | 0.95 | 0.04, 3.63 | 1 | 3.45 | 0.37, 15.00 c |
| Influenza‐like illness | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Injection site bruising | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Injection site mass | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Injection site pain | 7 | 3.34 | 1.17, 6.24 | 1 | 3.45 | 0.37, 15.00 c |
| Injection site reaction | 3 | 1.43 | 0.29, 4.31 | — | — | — |
| Injection site scar | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Lupus enteritis | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Malaise | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Myalgia | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Nasal congestion | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Nasopharyngitis | 1 | 0.48 | 0.05, 2.20 c | 1 | 3.45 | 0.37, 15.00 c |
| Pain in extremities | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Presyncope | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Product storage error | 3 | 1.43 | 0.29, 4.31 | 1 | 3.45 | 0.37, 15.00 c |
| Pruritus | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Pyrexia | 2 | 0.95 | 0.04, 3.63 | 1 | 3.45 | 0.37, 15.00 c |
| Rash | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Rash maculopapular | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Rash papular | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Rash pruritic | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Rhinorrhoea | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Secondary infection | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Seizure | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Shock | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Sinusitis | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Skin discoloration | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Sneezing | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Thrombocytopenia | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Underdose | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Upper respiratory tract infection | — | — | — | 1 | 3.45 | 0.37, 15.00 c |
| Urticaria | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Vaccination failure | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Vaccination site erythema | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Vaccination site Inflammation | 2 | 0.95 | 0.04, 3.63 | — | — | — |
| Vaccination site pruritus | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Vaccination site swelling | — | — | — | 1 | 3.45 | 0.37, 15.00 c |
| Vomiting | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
| Wheezing | 1 | 0.48 | 0.05, 2.20 c | — | — | — |
a
Among cases with exposure reported prior to prenatal testing (N = 210).
b
Among cases with exposure reported following prenatal testing (N = 29).
c
Jefferies method used to ensure attained intervals fell between 0,1 in accordance with the binomial distribution.