Table 3.
Frequencies of all adverse reactions (ARs) reported for IIV4 during the 2017/18 EPSS and comparison with the frequency categories listed in the SmPC.
| 18–65 y (N = 276) |
>65 y (N = 671) |
|||||||
|---|---|---|---|---|---|---|---|---|
| 2017/18 |
2017/18 |
|||||||
| n | % (95% CI) | Category | SmPCd category | n | % (95% CI) | Category | SmPCd category | |
| Participants reporting ≥1 suspected AR | 5 | 1.8 (0.6, 4.2) | 15 | 2.2 (1.1, 3.4) | ||||
| Participants reporting ≥1 AEI | 4 | 1.4 (0.4, 3.7) | 12 | 1.8 (0.8, 2.8) | ||||
| Suspected ARsa | 13 | 4.7 | 43 | 6.4 | ||||
| AEIsa, b | 7 | 2.5 | 18 | 2.7 | ||||
| Feverc | 1 | 0.4 (0.0, 2.0) | Uncommon | Common | 2 | 0.3 (0.0, 1.1) | Uncommon | Uncommon |
| Headache | 2 | 0.7 (0.1, 2.6) | Uncommon | Very common | 5 | 0.7 (0.2, 1.7) | Uncommon | Very common |
| Vaccination site inflammation | 1 | 0.4 (0.0, 2.0) | Uncommon | Mixede | 2 | 0.3 (0.0, 1.1) | Uncommon | Mixede |
| Malaise | 1 | 0.4 (0.0, 2.0) | Uncommon | Very common | 1 | 0.1 (0.0, 0.8) | Uncommon | Common |
| Myalgia | 0 | 0.0 (−) | − | Very common | 2 | 0.3 (0.0, 1.1) | Uncommon | Very common |
| Other ARsb | ||||||||
| Fatigue | 1 | 0.4 (0.0, 2.0) | Uncommon | Uncommon | 2 | 0.3 (0.0, 1.1) | Uncommon | Uncommon |
| Feeling hot | 0 | 0.0 (−) | − | − | 2 | 0.3 (0.0, 1.1) | Uncommon | − |
| Pain | 1 | 0.4 (0.0, 2.0) | Uncommon | − | 1 | 0.1 (0.0, 0.8) | Uncommon | − |
| Nasopharyngitis | 0 | 0.0 (−) | − | − | 2 | 0.3 (0.0, 1.1) | Uncommon | − |
| Pain in extremity | 1 | 0.4 (0.0, 2.0) | Uncommon | − | 1 | 0.1 (0.0, 0.8) | Uncommon | − |
| Dizziness | 0 | 0.0 (−) | − | Rare | 2 | 0.3 (0.0, 1.1) | Uncommon | Uncommon |
| Lethargy | 0 | 0.0 (−) | − | Rare | 2 | 0.3 (0.0, 1.1) | Uncommon | Rare |
| Oropharyngeal pain | 0 | 0.0 (−) | − | − | 3 | 0.4 (0.1, 1.3) | Uncommon | − |
| Rhinorrhea | 0 | 0.0 (−) | − | − | 2 | 0.3 (0.0, 1.1) | Uncommon | − |
Abbreviations: AEI, adverse event of interest; CI, confidence interval; IIV4, quadrivalent split-virion inactivated influenza vaccine; PRAC, Pharmacovigilance Risk Assessment Committee; SmPC, Summary of Product Characteristics; −, not reported
a Since the proportion of total reported ARs and AEIs could theoretically be >100%, 95% CIs were not calculated
b Only ARs reported in ≥2 participants in NH Season 2017/18 are shown
c Includes feeling of body temperature change or pyrexia
d Frequencies: very common (≥10%); common (≥1% to <10%); uncommon (≥0.1% to <1%); rare (≥0.01% to <0.1%); very rare (<0.01%)
e Pain (very common; ≥10%), erythema and swelling (common; ≥1% to <10%), warmth (uncommon; ≥0.1% to <1%)