This study presents a case report of sudden hearing loss developing after rabies vaccination.

PMID: 

Balkan Med J. 2013 Sep ;30(3):327-8. Epub 2013 Sep 1. PMID: 25207131

Abstract Title: 

Sudden hearing loss after rabies vaccination.

Abstract: 

BACKGROUND: Sudden hearing loss developing after immunisation is a very rare situation. Rabies is a viral disease characterised by encephalitis and death. Treatment involves active and passive immunisation. Neurologic complications including Guillain-Barre syndrome or facial paralysis are reported in the literature as a side effect after rabies immunisation.CASE REPORT: Sudden hearing loss was detected in an 11 year-old male patient who had taken the medication for rabies immunisation.CONCLUSION: This study presents a case report of sudden hearing loss developing after rabies immunisation – no other aetiological factors were detected and clinical management is discussed in light of the literature.

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Oral polio vaccine (OPV) has failed to provide full protection to many children who have developed paralytic polio even after taking 10 or more doses of OPV. In some children, OPV has caused paralysis-vaccine associated paralytic polio.

PMID: 

Vaccine. 2004 Oct 22 ;22(31-32):4144-8. PMID: 15532129

Abstract Title: 

Polio eradication in India: some observations.

Abstract: 

In 1988, the World Health Assembly passed resolution WHA 41.28, which committed the World Health Organization (WHO) to the global eradication of poliomyelitis by the year 2000. In spite of the combined efforts by UNICEF, National Polio Surveillance Project (NPSP), Indian Academy of Pediatrics (IAP) and Rotary International, Polio Free India is still a distant dream. Though oral polio vaccine has succeeded in polio eradication from many countries but there is high incidence of vaccine failure in India. Oral polio vaccine (OPV) has failed to provide full protection to many children who have developed paralytic polio even after taking 10 or more doses of OPV. In some children, OPV has caused paralysis-vaccine associated paralytic polio (VAPP). Number of children developing polio due to vaccine is high and on increase. Reasons for this could be that even immunocompromised children are being administered OPVbecause IPV is not available. Vaccine failure has exaggerated the problem of VAPP. No efforts have been made to find the causes for high incidence of vaccine failure and VAPP.

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A case report of vaccine-associated paralytic poliomyelitis following a dose of oral polio vaccine.

PMID: 

Ann Trop Paediatr. 2001 Sep ;21(3):223-9. PMID: 11579860

Abstract Title: 

Paralytic poliomyelitis associated with the Sabin 3 revertant strain of poliovirus in Bahrain.

Abstract: 

We report a case of vaccine-associated paralytic poliomyelitis (VAPP) in Bahrain. The case occurred in an 8-week-old infant who had received a dose of oral polio vaccine (OPV) 7 days after birth. She was in contact with two vaccinees who had received OPV during the national immunisation campaign conducted 10 days before her birth. Specimens from the infant were sent to the WHO Collaborating Centre for Virus Reference and Research Laboratory for serological testing and virus detection, including genomic sequencing. Clinical and virological features are presented of a case of VAPP caused by the Sabin 3 strain of poliovirus that had reverted towards neurovirulence. The case represents one in 51,879 first doses of OPV distributed between 1995 and 1998. In order to reduce further the risk of VAPP, the dose of OPV at birth has been discontinued and a sequential schedule of inactivated polio vaccine (IPV) followed by OPV will be recommended.

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The addition of adjuvants to vaccines may cause unwanted immune responses, including facial nerve paralysis and narcolepsy, and a more accurate and comprehensive strategy must be used to develop next-generation vaccines for ensuring vaccine safety.

PMID: 

Vaccine. 2017 02 1 ;35(5):821-830. Epub 2017 Jan 4. PMID: 28063707

Abstract Title: 

A novel vaccinological evaluation of intranasal vaccine and adjuvant safety for preclinical tests.

Abstract: 

Vaccines are administered to healthy humans, including infants, so the safety and efficacy must be very high. Therefore, evaluating vaccine safety in preclinical and clinical studies, according to World Health Organization guidelines, is crucial for vaccine development and clinical use. A change in the route of administration is considered to alter a vaccine's immunogenicity. Several adjuvants have also been developed and approved for use in vaccines. However, the addition of adjuvants to vaccines may cause unwanted immune responses, including facial nerve paralysis and narcolepsy. Therefore, a more accurate and comprehensive strategy must be used to develope next-generation vaccines for ensuring vaccine safety. Previously, we have developed a system with which to evaluate vaccine safety in rats using a systematic vaccinological approach and 20 marker genes. In this study, we developed a safety evaluation system for nasally administered influenza vaccines and adjuvanted influenza vaccines using these marker genes. Expression of these genes increased dose-dependent manner when mice were intranasally administered the toxicity reference vaccine. When the adjuvant CpG K3 or a CpG-K3-combined influenza vaccine was administered intranasally, marker gene expression increased in a CpG-K3-dose-dependent way. A histopathological analysis indicated that marker gene expression correlated with vaccine- or adjuvant-induced phenotypic changes in the lung and nasal mucosa. We believe that the marker genes expression analyses will be useful in preclinical testing, adjuvant development, and selecting the appropriate dose of adjuvant in nasal administration vaccines.

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Four case reports of neurological abnormalities compatible with vaccine-related poliovirus infections following oral polio vaccine.

PMID: 

J Pediatr. 1986 Jun ;108(6):878-81. PMID: 3012055

Abstract Title: 

Neurologic complications in oral polio vaccine recipients.

Abstract: 

Between April 1982 and June 1983 four children 3 to 24 months of age were referred for evaluation of neurologic abnormalities found to be compatible with vaccine-related poliovirus infection, which had not been suspected by referring physicians. Patients were epidemiologically unrelated residents of Indiana, and none had prior symptoms suggestive of immunodeficiency. All had received poliovirus vaccine orally (first dose in three, fourth dose in one) and a diphtheria-tetanus-pertussis injection in the left anterior thigh within 30 days of symptoms. A vaccine-like strain of poliovirus was isolated from each patient, and each had symptoms (left leg paralysis in three; developmental regression, spasticity, and progressive fatal cerebral atrophy in one) persisting for at least 6 months. Immune function was normal in two with poliovirus type 3 infection, and abnormal (hypogammaglobulinemia, combined immunodeficiency) in two with type 1 and type 2 infection, respectively. The incidence of observed vaccine-related poliovirus infection in Indiana recipients of orally administered poliovirus vaccine was 0.058 per 100,000 per year, significantly greater (P less than 0.001) than predicted.

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Seven case reports of ascending polyneuritis, due to rabies vaccine treated between 1982-1986.

PMID: 

Mikrobiyol Bul. 1987 Apr ;21(2):145-50. PMID: 3447020

Abstract Title: 

[Neurologic complications due to a sample type of rabies vaccination].

Abstract: 

Neuroparalytic accidents due to sample type rabies vaccination are still an important problem in our country. We present seven patients with ascending polyneuritis, due to rabies vaccine, treated between 1982-1986, and discuss the importance of the problem.

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A case report live attenuated oral polio vaccine-related flaccid monoplegia.

PMID: 

Vaccine. 2014 Sep 22 ;32(42):5379-81. Epub 2014 Aug 12. PMID: 25131733

Abstract Title: 

The muscle findings in a pediatric patient with live attenuated oral polio vaccine-related flaccid monoplegia.

Abstract: 

A pediatric patient, who was given live-attenuated oral polio vaccine twice without distinct gait disturbance during infancy, begun to present limp at 3 years. His gait disturbance became remarkable with aging. At 7 years, he was unable to dorsiflex the left ankle, and presented flaccid monoplegia of the left lower extremity, and the left Achilles tendon reflex was diminished. Magnetic resonance imaging revealed multiple crack-lines in the left anterior tibial muscle, but was unable to detect any distinct lesion at responsible level of L4, L5 and S1 anterior horn cells' degeneration. Electromyography showed continuous fibrillation potentials, but muscle biopsy presented nearly normal in this muscle. The serum levels of polio antibody type 1 and type 2 titers were elevated 64× respectively, while the type 3 antibody titer was not elevated 4×. This patient was diagnosed as live attenuated oral polio vaccine-related flaccid monoplegia, with mild clinical course.

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A case report of an infant with vaccine-associated paralytic poliomyelitis.

PMID: 

Pediatr Radiol. 2010 Dec ;40 Suppl 1:S138-40. Epub 2010 May 4. PMID: 20440488

Abstract Title: 

MRI findings in an infant with vaccine-associated paralytic poliomyelitis.

Abstract: 

Although acute flaccid paralysis is a manifestation observed in several neurologic and muscular disorders, vaccine-associated paralytic poliomyelitis (VAPP) is an exceedingly rare etiology. In the clinical setting of acute flaccid paralysis, MRI is useful in differentiating between VAPP and other conditions. Additionally, MRI can assess the extent of lesions. However, reports on MRI findings in VAPP are scarce in the pediatric radiology literature. We report a Brazilian infant who developed VAPP 40 days after receiving the first dose of oral polio vaccine (OPV). MR images of the cervical and thoracic spinal cord showed lesions involving the anterior horn cell, with increased signal intensity on T2-weighted sequences. We would like to emphasize the importance of considering VAPP as a differential diagnosis in patients with acute flaccid paralysis and an MRI showing involvement of medulla oblongata or spinal cord, particularly in countries where OPV is extensively administered.

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Skeletal muscle injury induces retrograde axonal transport of poliovirus and thereby facilitates viral invasion of the central nervous system and spinal cord damage. Intramuscular injections may increase the likelihood of vaccine-associated polio.

PMID: 

J Virol. 1998 Jun ;72(6):5056-60. PMID: 9573275

Abstract Title: 

Mechanism of injury-provoked poliomyelitis.

Abstract: 

Skeletal muscle injury is known to predispose its sufferers to neurological complications of concurrent poliovirus infections. This phenomenon, labeled"provocation poliomyelitis,"continues to cause numerous cases of childhood paralysis due to the administration of unnecessary injections to children in areas where poliovirus is endemic. Recently, it has been reported that intramuscular injections may also increase the likelihood of vaccine-associated paralytic poliomyelitis in recipients of live attenuated poliovirus vaccines. We have studied this important risk factor for paralytic polio in an animal system for poliomyelitis and have determined the pathogenic mechanism linking intramuscular injections and provocation poliomyelitis. Skeletal muscle injury induces retrograde axonal transport of poliovirus and thereby facilitates viral invasion of the central nervous system and the progression of spinal cord damage. The pathogenic mechanism of provocation poliomyelitis may differ from that of polio acquired in the absence of predisposing factors.

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The rapid translation of the polio vaccine had serious drawbacks.

PMID: 

Clin Transl Sci. 2010 Aug ;3(4):182-5. PMID: 20718820

Abstract Title: 

Lessons from the Salk polio vaccine: methods for and risks of rapid translation.

Abstract: 

The Salk inactivated poliovirus vaccine is one of the most rapid examples of bench-to-bedside translation in medicine. In the span of 6 years, the key basic lab discoveries facilitating the development of the vaccine were made, optimization and safety testing was completed in both animals and human volunteers, the largest clinical trial in history of 1.8 million children was conducted, and the results were released to an eagerly awaiting public. Such examples of rapid translation cannot only offer clues to what factors can successfully drive and accelerate the translational process but also what mistakes can occur (and thus should be avoided) during such a swift process. In this commentary, we explore the translational path of the Salk polio vaccine from the key basic science discoveries to the 1954 Field Trials and delve into the scientific and sociopolitical factors that aided in its rapid development. Moreover, we look at the Cutter and Wyeth incidents after the vaccine's approval and the errors that led to them.

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