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This is VAERS ID 840369

Case Details

VAERS ID: 840369 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Wound (1 wound)
Preexisting Conditions: Medical History/Concurrent Conditions: Dog bite (the patient was bitten in an head by probable rabid dog)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TZGLAXOSMITHKLINETZ2019GS

Write-up: Suspected vaccination failure; Rabies; Inappropriate schedule of vaccine administered; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a 3-year-old male patient who received Rabies NVS (Rabies Vaccine) for prophylaxis. Co-suspect products included Rabies NVS (Rabies Vaccine) for prophylaxis and Rabies NVS (Rabies Vaccine) for prophylaxis. Concurrent medical conditions included dog bite (the patient was bitten in an head by probable rabid dog) and wound (1 wound). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intramuscular), the 2nd dose of Rabies Vaccine (intramuscular) and the 3rd dose of Rabies Vaccine (intramuscular). On an unknown date, unknown after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant), rabies (serious criteria death and GSK medically significant) and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure and rabies were fatal and the outcome of the inappropriate schedule of vaccine administered was unknown. The reported cause of death was vaccination failure and rabies. The reporter considered the vaccination failure and rabies to be related to Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in 3-years-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis (PEP). This case corresponds to the table 2 in this literature article. The patient was the part of the study that aimed to investigate how access to post-exposure prophylaxis (PEP) can be improved to better prevent human rabies by reducing out-of-pocket costs to patients, decentralizing provision at peripheral health centers, and introducing ID vaccination. They estimated the incidence of rabies exposures and bite-injuries, and examined health seeking and health outcomes in relation to PEP access by using the two sources of data: contact tracing and mobile phone-based surveillance data. . [In this study, specifically, they conducted contact tracing in specific area 1 (2002-2017) and in 14 selected districts in specific area 2 (4 on island, and 10 in mainland, grouping urban municipalities with corresponding rural districts; 2011-2017); and implemented a rabies specific mobile phone-based surveillance system across 28 districts in 7 regions of specific area 2 (2011-2016). The patients pay for PEP in specific area 1, but in the 28 districts in specific area 2 PEP was provided for free through a WHO-coordinated rabies elimination demonstration project that began in 2010 and ended in 2015. They used surveys and qualitative interviews with stakeholders within the health system to further characterize PEP supply and triangulate these findings. They also synthesized the lessons learned from these studies relating to the rabies burden, the PEP supply chain, health seeking and compliance by persons exposed to rabies and the efficacy of PEP]. No information on patient''s family history or or concomitant condition was provided. On unspecified date, the patient was bitten in an head by probable rabid dog before the 1 day of vaccination. The patient had an 1 wound. On unspecified dates and 1 day after the bite, the patient had received 3 doses of unspecified rabies vaccine intramuscularly (administration site unspecified, batch number not provided). The age at vaccination was not provided. [In this study, the World Health Organization (WHO) recommended protocol for PEP includes immediate wound washing, administration of rabies vaccine and in severe exposures, infiltration of purified rabies immunoglobulin (RIG) into the wound(s). Throughout most of specific area 1, PEP was still administered following a 3-dose IM schedule (d0, d7, d28), despite national guidelines being updated in 2013 and 2017 to recommend the 5-dose Essen IM regimen (d0, d3, d7, d14, d28) and in the specific area 2, most patient were vaccinated with the 4-dose Updated ID regimen (d0, d3, d7, d28). Using the contact tracing data, they assessed bite patients timeliness and completion of post-exposure vaccination (hereafter referred to as PEP, as RIG was only provided to a single patient in this study). They defined ?timely'' PEP as initiated on the same day as the bite, and ?late'' PEP as initiated more than 24 hour after the bite or (a) delay between date bitten and first post-exposure vaccination for individuals bitten by probable rabid animals and (b) on delays between exposure and initiation of PEP for rabies exposed persons)]. On an unspecified date, unknown period after vaccination, the patient had clinical signs of rabies, although the patient was not laboratory confirmed. The patient had died. It was unknown, if autopsy was performed or not. The patient''s deaths were attributable to delays in PEP administration. [In this study, a biting animal was considered probable for rabies, according to WHO case definitions, if at least 2 clinical signs were evident and the animal died, was killed or disappeared within a 10 day period of the exposure. From tracing 5,168 patients who presented to health centres with bite injuries, they identified 2,367 who were exposed to bites by probable rabid animals (including 484 who did not report to a health centre). Only individuals bitten by probable rabid animals were considered (2,367). They grouped exposures according to the part of the body where the person had been bitten. For individuals with multiple bites (290), only the highest risk bite was used for this categorization, established via the following hierarchy of risk (first as head; second as arms/hands; third as legs/feet and fourth as trunk). The onset of rabies in 473 patients exposed to probable rabid dogs who all promptly received PEP (vaccination ) within 1 day of the exposure, but no RIG) and completed the course (at least 3 doses). Of 1005 individuals identified during contact tracing who received late and/or incomplete post-exposure vaccination, 14 died showing clinical signs of rabies, although none were laboratory confirmed. Nine of these deaths were attributable to delays in PEP administration, and five to initiation of post-exposure vaccination without delay but completion of only 1-2 doses]. This case has been considered as suspected vaccination failure as the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure and Death. The author commented, "Incidence of bite-injury patients was related to dog population sizes, with higher incidence in districts with lower human:dog ratios and urban centres. A substantial percentage (25 percent) of probable rabies exposures did not seek care due to costs and limited appreciation of risk. Upon seeking care a further 15 percent of probable rabies exposed persons did not obtain PEP due to shortages, cost barriers or misadvice. Of those that initiated PEP, 46 percent did not complete the course. If no PEP was administered, the risk of developing rabies following a probable rabies exposure was high (0.165), with bites to the head carrying most risk. Decentralized and free PEP increased the probability that patients received PEP and reduced delays in initiating PEP. Reactive procurement resulted in limited and unresponsive PEP supply, increasing costs and risks to bite victims. We also report the effectiveness of PEP in preventing rabies based on exposures from probable but not confirmed rabid dogs. However, we have found high correspondence between probable rabies cases identified on the basis of their clinical history and on subsequent laboratory confirmation (83-90 percent)." The author concluded, "A large number of preventable deaths from rabies occur due to poor access to PEP. We conclude that free provision of PEP at point-of-care, ring-fenced PEP procurement, switching to recommended dose-sparing ID regimens, and ensuring responsive and accountable supply chains for PEP access that should be improved and reduce the burden of human rabies and rabies deaths." Lab Comments: The patient had clinical signs of rabies, although the patient was not laboratory confirmed.; Reported Cause(s) of Death: Suspected vaccination failure; Rabies


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