Table 2.
Cases of viscerotropic adverse events that meet and do not meet Brighton Collaboration diagnostic and causality criteria
| Met Brighton Collaboration Viscerotropic or YEL-AVD criteria or both
| |||||
|---|---|---|---|---|---|
| Viscerotropic level | YEL-AVD classification
|
Total | |||
| Confirmed | Probable | Suspect | Did not meet any YEL-AVD criteria | ||
| Level 1 | 12 | 3 | 5 | 20 | |
| Level 2 | 3 | 1 | – | 6 | |
| Level 3 | 2 | – | – | 1 | |
| Did not meet any level criteria | 1 | – | 8 | – | |
| 62 (35 died) | |||||
| Did not meet Brighton Collaboration Viscerotropic or YEL-AVD criteria | |||||
| Cases in individual journal articles | n=28 (6 deaths) | ||||
| Australia (Lawrence 2003,58 200459) | n=1 (no deaths) | ||||
| Brazil: (For overlapping dates): (1) Martins (2010)56 for 1999–2008; reported 26 AVD cases; 21 from Brazil and5 from other Latin American countries;19 confirmed, 4 probable, 3 suspect; 24 died; For none of the Brazilian databases are clinical and laboratory details provided for individual cases (2) Brazilian Ministry of Health for 1999–200854–56 reported 28 AVD cases (3) Romano (2014)57 6 AVD (2 in the state of Rio Grande do Sul, 3 in the state of Sao Paulo, 1 in Santa Caterina), all 6 died |
n=28 (24 deaths) | ||||
| USA VAERS: (Khromava;60 n=7 AVD with 5 deaths), (Lindsey;61 n=6 AVD with2 deaths) | n=13 (7 deaths) | ||||
| Total Viscerotropic adverse events (both met and did not meet Brighton criteria) | 132 (72 deaths) | ||||
| “serious adverse events” (not further defined, which could include some viscerotropic events: Monath (2005)66 (n=34); Schumacher (2010)67 (n=3) | Unknown number of YEL-AVD cases | ||||
Notes: To avoid double counting in the different Brazilian reports for the same time, a conservative estimate is 28 cases and 24 deaths. There are three analyses of the US VAERS database with overlapping time periods. Khromava et al for 1990–2002 and Lindsey et al for 2000–2006 divided cases into neurologic or viscerotropic. Martin et al38 only presented four cases. However, Martin et al68 for the US VAERS database 1990–1998 reported 26 “systemic adverse events (multisystemic or neurologic)” but did not classify them further. His time period overlaps those of Khromava et al and Lindsey et al, and thus, only their analyses are included. Schumacher et al67 for the Swiss database reported “seven serious AEFI including four neurologic reactions” (four were assigned to the neurologic total, and the other three undefined cases are recorded as undefined SAEs). The systematic review of studies using active surveillance (Thomas et al18) did not find any SAEs. A systematic review of mortality following YF vaccination of troops and civilians during the 1930s and WWII identified an upper limit of 82 military and 24 civilian deaths, but it was difficult to assess the cause of death, and in the troops, it was most likely due to contamination by hepatitis viruses (Thomas et al69). The summary of the literature (1989–2010) by Monath et al70 estimated a world total of 113 cases of serious adverse reactions, but clinical and laboratory details of cases are not presented, and it is not possible to cross-check this estimate with the cases in this review. Cases from Monath et al’s earlier edition of their chapter are included if sufficient data were presented. Seligman’s review reported nine AVD cases already reported in the literature and already included in this review.71 Miyaji et al’s study of 906 persons 60 years or older who received YFV was able to follow-up 700, and no serious YF AEFIs were identified.72
Abbreviations: YEL-AVD, yellow fever vaccine-associated viscerotropic disease; US VAERS, US Vaccine Adverse Events Reporting System; AEFI, adverse event following immunization; SAEs, serious adverse events; WWII, World War II; YF, yellow fever; YFV, yellow fever virus.