Vaccination and unexplained sudden death risk in Taiwanese infants

Huang, Wan‐Ting; Chen, Robert T.; Hsu, Yu‐Chen; Glasser, John W.; Rhodes, Philip

doi:10.1002/pds.4141

Cited by 14 publications

(7 citation statements)

References 40 publications

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“…Similarly, SIDS was the second leading cause of death among children aged 0–18 months in the VSD [37]. A recent study in Taiwan assessed the risk of sudden unexplained infant death (SUID) following DTaP which was introduced in that country in 2010 [38] and found DTaP did not increase the risk of SUID. SIDS deaths in the US have been declining since the early 1990s for a variety of factors that include recommended changes in sleeping position and environment, clarification of the case definition, and diagnostic coding shifts [39–41].…”

Section: Discussionmentioning

confidence: 99%

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines

Moro¹,

Perez‐Vilar

Lewis³

et al. 2018

Pediatrics

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Section: Discussionmentioning

confidence: 99%

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines

Moro¹,

Perez‐Vilar

Lewis³

et al. 2018

Pediatrics

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“…Vaccinations are usually well tolerated. In some previous studies, sudden death following vaccination has been considered [7,8,[15][16][17]; however, myocarditis following vaccination has been reported as a rare AEFI and cause of death [18][19][20]. Majorly, myocarditis has been reported as a rare adverse effect following DTwP and polio vaccination [18][19][20].…”

Section: Discussionmentioning

confidence: 99%

Sudden Infant Death Due to Postvaccinal Myocarditis: A Case Report

Salahshour

Sadeghi

Sajadianfar

et al. 2021

IJMTFM

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Background: Vaccination is a fundamental strategy in public health for controlling and eradicating infectious diseases. However, the undesirable Adverse Events Following Immunization (AEFI) should be effectively monitored, prevented, and managed in societies. Previously, Sudden Infant Death (SID) has been reported as a serious AEFI. We present a rare case of SID in an 18-month-old girl due to severe myocarditis following vaccination. Case Presentation: An 18-month-old girl presented to the Emergency Department (ED) with a history of the injection of Diphtheria-Tetanus-Whole Cell Pertussis (DTwP); Measles, Mumps, and Rubella (MMR), and oral poliovirus vaccines. She expired one-hour post ED admission after the episodes of vomiting and cardiopulmonary arrest. Postmortem histopathological examination signified marked congestion and the destruction of muscle fibers in the myocardium with inflammatory cells infiltration predominantly eosinophils. Given the postmortem histopathological findings, the cause of death was concluded as severe myocarditis following vaccination. Finally, the causality assessment was performed according to the Naranjo scale; the relevant data revealed a probable association in this regard (Naranjo score 6). Conclusion: Myocarditis is a rare and probable AEFI; thus, cardiac monitoring should be recommended as a diagnostic measure in managing postvaccinal adverse effects.

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“…Considering the large exposure of the world population to vaccines and the rate of infant death, it is expected that deaths occur also closely after vaccine administration, without it being caused by the vaccine. Various studies have investigated death following immunization using observational data, especially in the pediatric population [56][57][58][59][60][61]. These studies have all ruled out a causal association with vaccine administration and death, both in cases of SIDS and also unspecified death [56][57][58][59][60][61][62][63][64].…”

Section: Discussionmentioning

confidence: 99%

Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

Hoeve

Gadroen

Kwa

et al. 2020

Vaccine

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Background: Serious adverse reactions after immunization are rare but do occur. In very rare instances, cases with fatal outcome have been reported. These reports can have a huge impact and even more so when due to an immunization error. The aim of this study is to systematically review immunization errors with fatal outcomes in EudraVigilance. Methods: This was a case-series analysis of Individual Case Safety Reports (ICSRs) reporting immunization errors and a fatal outcome. To determine the level of certainty of a causal association between the immunization errors and fatal outcomes two independent reviewers assessed all ICSRs using the WHO tool ''Causality assessment of an Adverse Event Following Immunization (AEFI)". In accordance with the tool, the ICSRs were classified as consistent, indeterminate, inconsistent/coincidental, or unclassifiable. In addition, we estimated the contribution of reported errors to the fatal outcomes as large, moderate, small, none, or unclassifiable using a classification developed for this study. Results: A total of 154 ICSRs met the inclusion criteria. Vaccines reported most frequently were pneumococcal (33), rabies (27) and influenza vaccines (24). Most frequently reported errors were noncompliance with recommended schedules of immunization (63). The most frequently reported vaccine-error combination was rabies vaccines and non-compliance with a recommended schedule of immunization (23). Twelve cases were classified as consistent with causal association and had a large error contribution. These cases concerned a cluster of six cases reporting incorrect handling of multidose vials containing measles vaccine and six cases reporting administration of live-attenuated vaccines to immunocompromised patients. Discussion: In this study, we showed that fatal outcomes following immunization errors are very rare. Four key issues were the importance of: (1) quality control of multi-dose vaccines, (2) screening patients for immunocompromising factors, (3) education on the importance of adherence, and (4) measures to improve distinction between vaccines and medicines.

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Vaccination and unexplained sudden death risk in Taiwanese infants

Cited by 14 publications

References 40 publications

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines

Safety Surveillance of Diphtheria and Tetanus Toxoids and Acellular Pertussis (DTaP) Vaccines

Sudden Infant Death Due to Postvaccinal Myocarditis: A Case Report

Fatal outcomes following immunization errors as reported to the EudraVigilance: A case series

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