Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study
Abstract
:1. Introduction
2. Material and Methods
- Local reactions (pain, redness, swelling, induration at the injection site)
- Allergic reaction (anaphylaxis, allergic/urticarial reaction)
- Gastrointestinal symptoms (nausea, vomiting, diarrhea)
- General malaise (asthenia, myalgia, malaise, drowsiness/insomnia
- Neurological symptoms (irritability, nervousness, headache)
- Fever/hyperpyrexia.
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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AEFI | n | % | Reporting Rate (95%CI) × 100 Enrolled |
---|---|---|---|
Local reaction | 378 | 87.8 | 51.0 (47.3–54.7) |
General malaise | 114 | 26.5 | 15.4 (12.9–18.2) |
Neurological symptoms | 36 | 8.4 | 4.9 (3.4–6.7) |
Fever/hyperpyrexia | 21 | 4.8 | 2.8 (1.8–4.3) |
Gastrointestinal disorder | 9 | 2.1 | 1.2 (0.6–2.3) |
Allergic reaction | 2 | 0.4 | 0.27 (0.03–0.97) |
At least one AEFI | 430 | 100.0 | 58.0 (54.4–61.6) |
AEFI (Only Local Reaction) | n | % | Reporting Rate (95%CI) × 100 Enrolled |
---|---|---|---|
Pain at injection site | 357 | 94.4 | 48.2 (44.5–51.8) |
Induration of injection site | 81 | 21.4 | 10.9 (8.8–13.4) |
Swelling | 28 | 7.4 | 5.1 (2.5–5.4) |
Redness | 21 | 5.5 | 2.8 (1.8–4.3) |
Females (n = 412) | Males (n = 369) | p-Value | |||
---|---|---|---|---|---|
AEFI | n | Reporting Rate (95%CI) × 100 Enrolled | n | Reporting Rate (95%CI) × 100 Enrolled | |
Local reaction | 240 | 58.3 (53.3–63.1) | 138 | 41.9 (36.6–47.5) | <0.0001 |
General malaise | 79 | 19.2 (15.5–23.3) | 35 | 10.6 (7.5–14.5) | 0.001 |
Neurological symptoms | 23 | 5.6 (3.6–8.3) | 13 | 4.0 (2.1–6.7) | 0.305 |
Fever/hyperpyrexia | 16 | 3.9 (2.2–6.2) | 5 | 1.5 (0.5–3.5) | 0.054 |
Gastrointestinal disorder | 6 | 1.5 (0.5–3.1) | 3 | 0.5 (0.2–2.6) | 0.501 |
Allergic reaction | 1 | 0.2 (0.0–1.3) | 1 | 0.3 (0.0–1.7) | 0.873 |
At least one AEFI | 270 | 65.5 (60.7–70.1) | 160 | 48.6 (43.1–54.2) | <0.0001 |
<40 Years Old (n = 380) | ≥40 Years Old (n = 361) | p-Value | |||
---|---|---|---|---|---|
AEFI | n | Reporting Rate (95%CI) × 100 Enrolled | n | Reporting Rate (95%CI) × 100 Enrolled | |
Local reaction | 229 | 60.2 (55.1–65.2) | 149 | 41.3 (36.1–46.5) | <0.0001 |
General malaise | 64 | 16.8 (13.2–21.0) | 50 | 13.9 (10.5–17.8) | 0.259 |
Neurological symptoms | 20 | 5.3 (3.2–8.0) | 16 | 4.4 (2.6–7.1) | 0.599 |
Fever/hyperpyrexia | 15 | 3.9 (2.2–6.4) | 6 | 1.7 (0.6–3.6) | 0.061 |
Gastrointestinal disorder | 1 | 0.3 (0.0–1.5) | 8 | 2.2 (1.0–4.3) | 0.015 |
Allergic reaction | 2 | 0.5 (0.1–1.9) | 0 | 0.0 (0.0–1.0) | 0.168 |
At least one AEFI | 251 | 66.1 (61.0–70.8) | 179 | 49.6 (44.3–54.9) | <0.0001 |
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Stefanizzi, P.; De Nitto, S.; Spinelli, G.; Lattanzio, S.; Stella, P.; Ancona, D.; Dell'Aera, M.; Padovano, M.; Soldano, S.; Tafuri, S.; et al. Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study. Vaccines 2021, 9, 456. https://doi.org/10.3390/vaccines9050456
Stefanizzi P, De Nitto S, Spinelli G, Lattanzio S, Stella P, Ancona D, Dell'Aera M, Padovano M, Soldano S, Tafuri S, et al. Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study. Vaccines. 2021; 9(5):456. https://doi.org/10.3390/vaccines9050456
Chicago/Turabian StyleStefanizzi, Pasquale, Sara De Nitto, Giuseppe Spinelli, Sabrina Lattanzio, Paolo Stella, Domenica Ancona, Maria Dell'Aera, Margherita Padovano, Savino Soldano, Silvio Tafuri, and et al. 2021. "Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study" Vaccines 9, no. 5: 456. https://doi.org/10.3390/vaccines9050456
APA StyleStefanizzi, P., De Nitto, S., Spinelli, G., Lattanzio, S., Stella, P., Ancona, D., Dell'Aera, M., Padovano, M., Soldano, S., Tafuri, S., & Bianchi, F. P. (2021). Post-Marketing Active Surveillance of Adverse Reactions Following Influenza Cell-Based Quadrivalent Vaccine: An Italian Prospective Observational Study. Vaccines, 9(5), 456. https://doi.org/10.3390/vaccines9050456