Yellow Fever Vaccine Deaths

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PRO/EDR> Yellow fever vaccine-associated deaths - Peru (Ica): susp., RFI

YELLOW FEVER VACCINE-ASSOCIATED DEATH - PERU

(ICA): SUSPECTED, REQUEST FOR INFORMATION

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[1]

Date: Fri 12 Oct 2007

Source: RPP Peru [in Spanish, trans. CopyEd.MJ, edited]

<http://www.rpp.com.pe/portada/nacional/100036_1.php>

A 73-year-old man from Nazca is the 3rd presumed

fatality as a result of the application of yellow

fever vaccine. An autopsy will be performed in

Lima in order to confirm that the cause of death

is the same as that of the young woman, a

university student, who died a few days ago.

Meanwhile, there are other 3 people under medical

observation at Ica Regional Hospital. They

present the same symptoms as the 2 victims:

diarrhea and fever.

--

Communicated by:

ProMED-PORT

<promed@...>

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[2]

Date: Sat 13 Oct 2007

Source: El Comercio [in Spanish, trans. CopyEd.MJ, edited]

<http://www.elcomercio.com.pe/edicionimpresa/Html/2007-10-13/Muere_otra_pers

ona_vacunada_co.html>

A 79-year-old man [73 years old according to

other media reports] is the 3rd victim of the

alleged adverse reaction to yellow fever vaccine

that has been reported over the past 5 days in

Ica. According to the Regional Hospital in Ica,

the cause of death was " multiorgan dysfunction. "

Clarens Campos, attending physician and head of

the Epidemiology Department of the hospital said,

" The patient was rushed to the hospital from

Nazca, with irregular hearth rhythm and acute

renal failure added to a severe pulmonary

problem, which resulted in his death given his

old age. "

However, the patient's children maintained the

man was in good health before he and his wife,

66, were vaccinated by nurses who setup an

ambulatory post in Nazca's Central Market. " They

vaccinated them without asking their age. " they

added.

The regional health director, Donayre,

indicated that the person responsible for the

vaccination campaign is preparing a report to

justify the vaccination of elderly people given

that it is indicated for people between 15 and 59

years of age.

The Ministry of Health, Vallejos, said

only that the cause of the deaths would be

revealed when the results of tests on samples

sent to Brazil and the United States become

available.

There are 13 persons that remain under

observation in Ica's regional hospital (8) and

San de Chincha Hospital (5), after reporting

adverse reactions to the yellow fever vaccine.

According to the Pan American World Health

Organization (PAHO), during 2007, there have been

11 deaths attributed to yellow fever vaccine

associated viscerotropic (YFV-AVD) disease and 26

cases of encephalitis [neurotropic (YFV-AND)

disease.]

The vaccine used in Ica is produced by

Biomanguinhos, a laboratory that undergoes strict

quality control evaluations.

PAHO performs tests on the vaccines.

--

Communicated by:

ProMED-mail

<promed@...>

******

[3]

Date: Fri 12 Oct 2007

Source: Correo [in Spanish, trans. CopyEd.MJ, edited]

<http://www.correoperu.com.pe/paginas_nota.php?nota_id=57030 & seccion_nota=5>

A 6th-year medical student was hospitalized in

the city of Ica after an adverse reaction to the

yellow fever vaccine. Coincidentally, he is a

classmate of the woman who died last weekend [5-6

Oct 2007] after receiving the same vaccine.

The case was reported to RPP yesterday afternoon

[11 Oct 2007] by a friend of the patient's. He

requested that the patient be transferred to a

hospital in Lima in an effort to save his life.

He also reported that between 85 and 90 percent

of the medical students in Ica were vaccinated

against yellow fever.

--

Communicated by:

ProMED-PORT

<promed@...>

[This is worrisome. Adverse side effects of the

yellow fever vaccine have been known for a long

time, but not with this incidence. Apparently

something else is involved in these cases. -

Mod.LJS]

******

[4]

Date: Sun 14 Oct 2007

Source: PRESS PERU [in Spanish, trans. CopyEd.MJ, edited]

<http://pressperu.com/index.php?option=com_content & task=view & id=258 & Itemid=1>

The Ministry of Health's (MINSA) Committee for

the Review of Events Presumably Attributed to

Vaccination has been investigating the reports of

alleged adverse effects of the yellow fever (YF)

vaccine in the area of Ica. The results of the

investigation are expected within the next few

days.

In the meantime, the head of said committee, Dr

Herminio , has ruled out the possibility

that the vaccines administered in the country,

and particularly in Ica Region, came from an

expired vaccine lot.

Referring to the 23-year-old woman who died in

Ica, said that the possibility that the

cause of death was severe paracetamol toxicity is

being investigated. According to the medical team

who treated her, the patient reported having

taken paracetamol several times a day for fever

and myalgias. suggests this could have

led to severe liver damage. Paracetamol is a

commonly used and innocuous antipyretic, but in

some cases, particularly in the presence of liver

disease, abnormal doses can have adverse health

effects. also commented that it is

strange that the woman was the only one affected

when others received vaccine from the same vial

and presented no symptoms.

" In this unfortunate case, if the vaccine had a

negative effect, the other 4 students who were

vaccinated from the same vial, the same lot, on

the same day, also should have presented with

adverse reactions but didn't. Furthermore, on the

same day and in the same hospital, 80 people were

vaccinated from the same lot and none had a

reaction. Moreover, during the days preceding

this case, more than 800 people were vaccinated

from the same lot and nothing happened. "

added that

The president of the MINSA's Consulting Committee

on Immunizations, Dr. Verne agreed with

's statement and added that it is

premature to confirm or deny a direct

relationship between the woman's death and the

yellow fever vaccine, and that the results of

tests to determine the cause of death will

probably be available by the weekend. In case

there are no concrete results, tissue samples

will be sent to a laboratory outside the country

for further analysis.

Regarding other suspected cases,

reported that one of them, a male who was

admitted to hospital, did not receive yellow

fever vaccine but diphtheria/tetanus (DT)

vaccine, which does not produce the symptoms

described by the patient. This event has been

deemed a coincidence.

The medical record of another case, a woman who

was transferred from Chincha to the Hospital Dos

de Mayo and whose condition is improving, is

still under investigation because her main

symptom --severe diarrhea -- is not consistent

with what has been described by scientists as

adverse reactions to yellow fever vaccine.

Dr. Verne reported that, as preventive measures,

MINSA has decided to stop using the yellow fever

vaccine lot and discontinue the vaccination

campaign in the area of Ica until the situation

is clear. However, he said, " So far this year

[2007] there have been 22 yellow fever deaths in

the country. It is a deathly disease and

therefore it is important to vaccinate and

protect the population. " Vaccination, using other

vaccine lots, will continue in the rest of the

country.

Dr. Verne commented that since 2004, 10 800 000

people have been vaccinated against yellow fever

in the whole country and that 32 000 doses have

been applied recently in Ica Region.

--

Communicated by:

ProMED-ESP

<promed@...>

[Locally, it has been a source of controversy

that a yellow fever immunization campaign was

implemented in an area where YF is not endemic

and where there are no known epizootics or

reservoirs of naturally infected primates. -

Mods.JT/JG]

[ica Region can be located on the map of Peru at

<http://www.peruline.com/peru/perukarte.htm>. The

cases are also documented in the

HealthMap/ProMED-mail map at

<http://healthmap.org/promed?v=-9.2,-75.9,5>. -

CopyEd.MJ]

[Yellow fever (YF) vaccine has been most commonly

associated with side effects such as fever,

headache, local erythema, and myalgias, and has

been reported to occur in up to 25 percent of

vaccinees. These side effects usually appear

within days of receiving the vaccine and last for

5-10 days. Allergic reactions have also been

reported but at a relatively low incidence of

less than 0.8 per 100 000 vaccinees. YF vaccine

had been known to cause neurological

encephalitis-type reactions in infants and as a

result, vaccination is not recommended before 9

months of age. (see Advisory Committee on

Immunizations Practices recommendation for yellow

fever vaccination in the references below). In

the USA, 10 cases of autoimmune neurological

disease were reported through the official

Vaccine Associated Events Reporting System

(VAERS), which included cases of Guillian-Barre

syndrome and an acute disseminated

encephalomyelitis.

Since 1992, there have been reports of a serious

adverse reaction following yellow fever vaccine

referred to as yellow fever vaccine associated

viscerotropic disease (YF-AVD). As of August

2006, there have been 36 cases of this syndrome

reported worldwide. The clinical picture

described, associated with this syndrome has

included fever, hypotension, respiratory failure,

elevated hepatocellular enzymes (abnormal liver

function tests), lymphocytopenia (low lymphocyte

counts), and thrombocytopenia (low platelet

counts). Of the 12 cases reported in the USA, 7

were fatal. Results of pathology studies on some

cases have demonstrated viral antigen in liver

cells and elsewhere such as lung, kidney, spleen,

lymph node, brain, and smooth muscle cells.

According to data available in the CDC (US

Centers for Disease Control and Prevention)

Yellow Book, Health Information for International

Travel 2008, the crude estimate of the reported

incidence of YF-AVD in the USA is 0.3-0.5 cases

per 100 000 doses of vaccine distributed. The

reported incidence among persons older than 60

years of age is approximately 1.8 cases per 100

000 doses distributed.

(<http://wwwn.cdc.gov/travel/yellowBookCh4-YellowFever.aspx#583>)

The adverse events reported in the newswires

above do not seem to fit the previously described

serious adverse events associated with YF

vaccine. That being said, it does not preclude

the occurrence of an otherwise previously

unrecognized/undescribed serious adverse event or

more likely, a newer event that may be associated

with either a change in vaccine composition used

locally or problems associated with specific lots

of vaccine -- either production problems or

locally introduced contaminations. Hence, while

the clinical syndromes described in the newswires

above may not match those previously described as

associated with receipt of YF vaccine, that does

not preclude the events described above as being

associated with the vaccine receipt. As there is

the risk of YF in designated areas/zones in Peru,

there is an indication for YF vaccination of

those individuals living in these zones as their

risk of serious illness or death associated with

infection with the YF virus far outweighs their

risk of adverse events known to occur with the YF

vaccine.

Our ProMED-mail colleagues from Latin America

have raised a query as to whether the area where

the vaccination campaign was being conducted was

in fact an area known to be endemic for YF, or

had had reports of recent epizootic YF activity.

According to the most recent Epidemiologic

Bulletin prepared by the General Epidemiology

Office (OGE) of the Ministry of Health of Peru

(MINSA), for epidemiologic week 39 (23-29

September 2007), there were no probable cases of

jungle yellow fever reported in Peru. During

weeks one through 33, there were reports of 59

cases of which 25 were confirmed, 4 were

" probable cases " and 22 died. The departments

notifying the most number of cases were Cusco and

San (available in Spanish at

<http://www.oge.sld.pe/boletines/2007/39.pdf>;

translated and summarized by Mod.MPP).

More information on results of investigations

into these reported adverse events would be

greatly appreciated. As would more information on

the designated YF zones in Peru, and indications

for YF vaccination campaigns in Peru.

Suggested references:

1. Chan RC, Penney DJ, Little D, et al: Hepatitis

and death following vaccination with 17D-204

yellow fever vaccine. Lancet 2001; 358: 121-2.

2. M, Tsai TF, Cropp B, Chang GJ, et al:

Fever and multisystem organ failure associated

with 17D-204 yellow fever vaccination: a report

of four cases. Lancet 2001; 358: 98-104.

3. Vasconcelos PF, Luna EJ, Galler R, et al:

Serious adverse events associated with yellow

fever 17DD vaccine in Brazil: a report of two

cases. Lancet 2001; 358: 91-7.

4. Centers for Disease Control and Prevention.

Notice to readers: Fever, jaundice, and multiple

organ system failure associated with 17D-derived

yellow fever vaccination, 1996–2001. MMWR

2001;50:343-5 [available at

<http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5030a3.htm>]

5. Struchiner CJ, Luz PM, Dourado I, Sato HK,

Aguiar SG, Ribeiro JG, Soares RC, Codeco CT: Risk

of fatal adverse events associated with 17DD

yellow fever vaccine. Epidemiol Infect. 2004 Oct;

132(5): 939-46.

6. Cetron MS, Marfin AA, n KG, Gubler DJ,

Sharp DJ, Barwick RS, et al. Yellow fever

vaccine: Recommendations of the Advisory

Committee on Immunization Practices (ACIP), 2002.

MMWR Recomm. Rep. 2002;51(RR-17):1-11 [available

at

<http://www.cdc.gov/MMWR/preview/mmwrhtml/rr5117a1.htm>]

7. Yellow Fever. In: Prevention of Specific

Diseases. CDC Health Information for

International Travel 2008; Chapter 4 [available at

<http://wwwn.cdc.gov/travel/yellowBookCh4-YellowFever.aspx#583>.]

8. Kitchener S: Viscerotropic and neurotropic

disease following vaccination with the 17D yellow

fever vaccine, ARILVAX. Vaccine. 2004;22:2103-5.

- Mod.MPP]

[see also:

2002

----

Yellow fever vaccine-associated deaths - MMWR report 20021108.5756

2001

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Yellow fever vaccine-associated deaths (05) 20011201.2925

Yellow fever vaccine-associated deaths (04) 20010804.1525

Yellow fever vaccine-associated deaths (03) 20010729.1485

Yellow fever vaccine-associated deaths (02) 20010727.1467

Yellow fever vaccine-associated deaths reported 20010715.1367]

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Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

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