Table 2. Adverse events (AE) following the yellow fever (YF) vaccination reported by 341 immunocompromised persons vaccinated with the vaccine from BioManguinhos or the one from Sanofi-Pasteur at the Reference Center for Immunobiologicals (CRIE) of Hospital das Clinicas of University of Sao Paulo Medical School, from September 2017 to December 2018.
AE following vaccination | BioManguinhos (233) n (%) | Sanofi-Pasteur (108) n (%) | Total (341) n (%) |
---|---|---|---|
At least one AE | 74 (31.8) | 37 (34.3) | 111 (32.6) |
Local AE | 26 (11.2) | 18 (16.7) | 44 (12.9) |
Solicited local AE | |||
Pain | 23 (9.9) | 18 (16.7) | 41 (12.0) |
Edema | 0 | 5 (4.6) | 5 (1.5) |
Erythema | 2 (0.8) | 1 (0.9) | 3 (0.9) |
Unspecified local AE | 1 (0.4) | 0 | 1 (0.3) |
Systemic AE | 54 (23.2) | 25 (23.2) | 79 (23.2) |
Solicited systemic AE | |||
Myalgia | 24 (10.3) | 10 (9.3) | 34 (10.0) |
Fever | 17 (7.3) | 8 (7.4) | 25 (7.3) |
Headache | 7 (3.0) | 9 (8.3) | 16 (4.7) |
Unsolicited systemic AE | |||
Asthenia | 8 (3.0) | 1 (0.9) | 9 (2.6) |
Somnolence | 3 (1.3) | 0 | 3 (0.9) |
Nausea/Vomiting | 3 (1.3) | 0 | 3 (0.9) |
Malaise | 2 (0.9) | 1 (0.9) | 3 (0.9) |
Diarrhea | 0 | 2 (1.9) | 2 (0.6) |
Sore throat | 1 (0.4) | 1 (0.9) | 2 (0.6) |
Facial edema** | 1 (0.4) | 0 | |
Hoarseness | 1 (0.4) | 0 | 1 (0.3) |
Cough | 0 | 1 (0.9) | 1 (0.3) |
Jaundice | 1 (0.4) | 0 | 1 (0.3) |
Papular lesions (on the back of hands and feet) | 1 (0.4) | 0 | 1 (0.3) |
Arrhythmia | 1 (0.4) | 0 | 1 (0.3) |
Joint swelling | 0 | 1 (0.9) | 1 (0.3) |
“Neck heat” | 0 | 1 (0.9) | 1 (0.3) |
Renal colic | 0 | 1 (0.9) | 1 (0.3) |
Lower limbs paresthesia | 1 (0.4) | 0 | 1 (0.3) |
Lymphadenomegaly | 1 (0.4) | 0 | 1 (0.3) |
Abdominal pain | 1 (0.4) | 0 | 1 (0.3) |
Pruritus | 1 (0.4) | 0 | 1 (0.3) |
Chills | 1 (0.4) | 0 | 1 (0.3) |
Hypertensive episode | 1 (0.4) | 0 | 1 (0.3) |
Severe AE*** | 1 (0.4) | 3 (2.8) | 4 (1.2) |
Hospitalization | 0 | 1 (0.9) | 1 (0.3) |
Death | 1 (0.4) | 2 (1.9) | 3 (0.9) |
*12 vaccinees had both, local and systemic AE. Each vaccinee may have had ≥ 1 symptom; **A boy aged 57 months with history of egg allergy had facial edema that regressed with antiallergic drugs; ***None of the severe AEFI was considered related to the vaccination.