This study found a significantly increased risk of narcolepsy in adults following Pandemrix vaccination in England.

PMID: 

Sleep. 2016 05 1 ;39(5):1051-7. Epub 2016 May 1. PMID: 26856903

Abstract Title: 

Risk of Narcolepsy after AS03 Adjuvanted Pandemic A/H1N1 2009 Influenza Vaccine in Adults: A Case-Coverage Study in England.

Abstract: 

STUDY OBJECTIVES: An increased risk of narcolepsy has been observed in children following ASO3-adjuvanted pandemic A/H1N1 2009 (Pandemrix) vaccine. We investigated whether this risk extends to adults in England.METHODS: Six adult sleep centers in England were visited between November 2012 and February 2014 and vaccination/clinical histories obtained from general practitioners. Suspected narcolepsy cases aged older than 17 y were selected. The risk of narcolepsy following Pandemrix was calculated using cases diagnosed by the time of the center visits and those with a diagnosis by November 30, 2011 after which there was increased awareness of the risk in children. The odds of vaccination in cases and in matched population data were compared using a case-coverage design.RESULTS: Of 1,446 possible cases identified, most had onset before 2009 or were clearly not narcolepsy. Of the 60 remaining cases, 20 were excluded after expert review, leaving 40 cases with narcolepsy; 5 had received Pandemrix between 3 and 18 mo before onset. All the vaccinated cases had cataplexy, two received a diagnosis by November 2011 and two were aged 40 y or older. The odds ratio for vaccination in cases compared to the population was 4.24 (95% confidence interval 1.45-12.38) using all cases and 9.06 (1.90-43.17) using cases with a diagnosis by November 2011, giving an attributable risk of 0.59 cases per 100,000 doses.CONCLUSIONS: We found a significantly increased risk of narcolepsy in adults following Pandemrix vaccination in England. The risk was lower than that seen in children using a similar study design.

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This study confirms an increased hazard ratio of narcolepsy following the H1N1 vaccination.

PMID: 

Vaccine. 2017 04 4 ;35(15):1879-1885. Epub 2017 Mar 13. PMID: 28302408

Abstract Title: 

Narcolepsy and hypersomnia in Norwegian children and young adults following the influenza A(H1N1) 2009 pandemic.

Abstract: 

BACKGROUND: Associations between influenza infection and sleep disorders are poorly studied. We investigated if pandemic influenza infection or vaccination with Pandemrix in 2009/2010 was associated with narcolepsy or hypersomnia in children and young adults.METHODS: We followed the Norwegian population under age 30 from January 2008 through December 2012 by linking national health registry data. Narcolepsy diagnoses were validated using hospital records. Risks of narcolepsy or hypersomnia were estimated as adjusted hazard ratios (HRs) in Cox regression models with influenza infection and vaccination as time-dependent exposures.RESULTS: Among the 1,638,526 persons under age 30 in Norway in 2009, 3.6% received a physician diagnosis of influenza during the pandemic, while 41.9% were vaccinated against pandemic influenza. Between October 1st 2009 and December 31st 2012, 72 persons had onset of narcolepsy and 305 were diagnosed with hypersomnia. The risk of a sleep disorder was associated with infection during the first six months, adjusted HR 3.31 with 95% confidence interval [CI], 1.01-10.79 for narcolepsy and adjusted HR 3.13 (95% CI, 1.12-8.76) for hypersomnia. The risk of narcolepsy was strongly associated with vaccination during the first six months adjusted HR 17.21 (95% CI, 6.28-47.14), while the adjusted HR for hypersomnia was 1.54 (95% CI, 0.81-2.93).CONCLUSIONS: The study confirms an increased HR of narcolepsy following pandemic vaccination. Slightly increased HRs of narcolepsy and hypersomnia are also seen after influenza infection. However, the role of infection should be viewed with caution due to underreporting of influenza.

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This study found a small, but statistically significant association between early thimerosal exposure and the presence of tics in boys.

PMID: 

J Pediatr Psychol. 2012 Jan-Feb;37(1):106-18. Epub 2011 Jul 23. PMID: 21785120

Abstract Title: 

Thimerosal exposure in early life and neuropsychological outcomes 7-10 years later.

Abstract: 

OBJECTIVE: The authors used a public use data set to investigate associations between the receipt of thimerosal-containing vaccines and immune globulins early in life and neuropsychological outcomes assessed at 7-10 years.METHODS: The data were originally created by evaluating 1,047 children ages 7-10 years and their biological mothers. This study developed seven latent neuropsychological factors and regressed them on a comprehensive set of covariates and thimerosal exposure variables.RESULTS: The authors found no statistically significant associations between thimerosal exposure from vaccines early in life and six of the seven latent constructs. There was a small, but statistically significant association between early thimerosal exposure and the presence of tics in boys.CONCLUSIONS: This finding should be interpreted with caution due to limitations in the measurement of tics and the limited biological plausibility regarding a causal relationship.

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A case report of acute transverse myelitis following H1N1 vaccination.

PMID: 

Int J Clin Exp Pathol. 2011 Mar ;4(3):312-4. Epub 2011 Mar 22. PMID: 21487527

Abstract Title: 

Acute transverse myelitis following vaccination against H1N1 influenza: a case report.

Abstract: 

H1N1 vaccination is currently safe, and only rare acceptable side-effects have been reported. Here we describe for the first time a serious adverse event, i.e., acute transverse myelitis, following H1N1 vaccination in China. After the standard treatment with methylprednislone, the patient recovered completely.

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A case report of transverse myelitis after hepatitis B vaccine.

PMID: 

Rev Neurol. 2000 Sep 1-15;31(5):430-2. PMID: 11027094

Abstract Title: 

[Acute transverse myelitis secondary to hepatitis B vaccination].

Abstract: 

INTRODUCTION: Acute transverse myelitis is an inflammatory disorder. The pathogenesis is unclear, but the probable mechanism involves an autoimmune phenomenon. Possible causes included multiple sclerosis and parainfectious and postvaccinal events. Myelitis has rarely been reported secondary to vaccinations including hepatitis B. We present a case of acute myelitis, which seems secondary to the administration of the hepatitis B vaccine.CLINICAL CASE: A 15-years-old female presented with progressive numbness of the right arm and leg, with right leg weakness. Symptom began one week after receiving the first dose of the hepatitis B vaccine. Spinal cord magnetic resonance (MR) revealed a diffuse increased signal extending from C6 to D2. Cerebral MR and cerebrospinal fluid were normal. She was treated with high doses of methylprednisolone with a complete recovery of neurological functional. Repeat medullar cord MR was normal. There was no relapse during a four years follow up.CONCLUSIONS: Potential causal relationship between vaccination against hepatitis B and multiple sclerosis was brought to the attention and to public debate. However, no conclusive association could be made between vaccination and demyelination. In the clinical setting, the distinction between a first episode of multiple sclerosis or postvaccinal myelitis depends upon subsequent course.

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Live vaccines can be lethal in patients undergoing immunosuppressive therapy.

PMID: 

Vaccine. 2017 03 1 ;35(9):1216-1226. Epub 2017 Feb 3. PMID: 28162821

Abstract Title: 

Safety of live vaccinations on immunosuppressive therapy in patients with immune-mediated inflammatory diseases, solid organ transplantation or after bone-marrow transplantation

Abstract: 

BACKGROUND: Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice.OBJECTIVES: To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT).DATA SOURCES: A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches.ELIGIBILITY CRITERIA: Randomized trials, observational studies and case reports.POPULATION: Patients with IMID or SOT on immunosuppressive treatment and BMT patients

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A case report of sudden death in a male taking pseudoephedrine following typhoid and Japanese encephalitis vaccine.

PMID: 

Mil Med. 1999 Feb ;164(2):157-9. PMID: 10050577

Abstract Title: 

Sudden death after typhoid and Japanese encephalitis vaccination in a young male taking pseudoephedrine.

Abstract: 

The case of a 21-year-old male taking over-the-counter pseudoephedrine for weight loss who died suddenly during exercise shortly after inoculation with Japanese encephalitis and phenol-inactivated typhoid vaccines is presented. The patient collapsed in mild weather while exercising 75 minutes after his vaccinations. He presented in asystole with a core temperature of 42.2 degrees C (108 degrees F). There was no evidence of urticaria or angioedema. It is likely that the combined pyrogenic effects of the vaccines, pseudoephedrine, exercise, and mild obesity contributed to a failure of the thermoregulatory system. Fever is still a common side effect of numerous other vaccines. Military physicians should consider administrative controls on thermogenic activities for a period after inoculations. Additionally, the dangers of ephedrine-containing compounds need to be more widely publicized.

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A case report of sudden, unexpected death 8 hours following typhoid-cholera vaccination in a previously health male.

PMID: 

Forensic Sci Int. 1984 Jan ;24(1):95-8. PMID: 6698459

Abstract Title: 

Sudden, unexpected death following typhoid-cholera vaccination.

Abstract: 

A previously healthy 33-year-old Australian male died suddenly and unexpectedly 8 h after a typhoid-cholera vaccination. Such fatalities are extreme rarities and the present case is the first in which postmortem measurement of serum immunoglobulins has been undertaken. The clinical course and necropsy findings suggest that death was the result of a slowly evolving systemic anaphylactic reaction which terminated in hypotension and right heart failure. The deceased was probably atopic. The current recommendations for the vaccination of international travellers against typhoid and cholera are discussed.

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