? Adverse effect versus quality control of the Fuenzalida-Palacios antirabies vaccine.
“We evaluated the components of the Fuenzalida-Palacios antirabies vaccine, which is till used in most developing countries in human immunization for treatment and prophylaxis. This vaccine is prepared from newborn mouse brains at 1% concentration. Even though the vaccine is considered to have a low myelin content, it is not fully free of myelin or of other undesirable components that might trigger adverse effects after vaccination. The most severe effect is a post-vaccination neuroparalytic accident associated with Guillain-Barré syndrome. In the present study we demonstrate how the vaccines produced and distributed by different laboratories show different component patterns with different degrees of impurity and with varying protein concentrations, indicating that production processes can vary from one laboratory to another. These differences, which could be resolved using a better quality control process, may affect and impair immunization, with consequent risks and adverse effects after vaccination. We used crossed immunoelectrophoresis to evaluate and demonstrate the possibility of quality control in vaccine production, reducing the risk factors possibly involved in these immunizing products.”
[A case of Guillain-Barré syndrome following cholera vaccination (author’s transl)].
“A 45-year-old woman developed bilateral ascending flaccid paralysis after cholera vaccination, 15 days after the first and 1 day after the second injection. The clinical course resulted in nearly complete paralysis of the lower limbs, paresis of the upper limbs and partial involvement of the cranial nerves. There was only slight sensory loss. The CSF revealed no pleocytosis and a protein level of 206 mg/100 ml. Recovery began 2 weeks later and was almost complete after 2 months. Immunological investigations revealed no remarkable changes.”
? Demyelinating disease and polyvalent human papilloma virus vaccination
“Since its inception, the polyvalent vaccine against the human papilloma virus (HPV), Gardasil, has generated some controversies as a temporal relationship between the administrations of the vaccine and the development of a few autoimmune diseases, such as acute disseminated encephalomyelitis (ADEM), multiple sclerosis (MS) and Guillain–Barre syndrome have been reported.1–3 We encountered two cases whose initial presentation of CNS demyelination followed in close time relationship the administration of Gardasil vaccine and we discuss their possible association.
Case No 1
A 19-year-old woman received two doses of Gardasil, 3 months apart, and approximately 1 month after the second dose, she developed numbness to the right foot that within 1 day extended to the contralateral foot and was associated with mid-thoracic back pain. Her neurological examination was only significant for the altered perception to touch to the feet. Deep tendon reflexes were normal and plantar reflexes in flexion. MRI of cervical and thoracic spine revealed a total of three lesions with characteristic demyelinating appearance, one of those in the thoracic spine was contrast-enhancing (figure 1A–C). MRI brain demonstrated one additional white matter lesion also consistent with a demyelinating process.”
[Demyelinating disease and vaccination of the human papillomavirus].
“CASE REPORTS: We describe the cases of four young women that developed demyelinating disease after the vaccination of the HPV, with a rank of time between the administration of the dose and the development of the clinical of seven days to a month, with similar symptoms with the successive doses. We have described six episodes coinciding after the vaccination.
CONCLUSIONS: Have been described seizures, autoimmune disorders such as Guillain-Barre syndrome, transverse myelitis, or motor neuron disease, probably adverse effects following immunization by HPV vaccine. So we suggest that vaccine may trigger an immunological mechanism leading to demyelinating events, perhaps in predisposed young.”
Franklin Delano Roosevelt’s (FDR’s) (1882-1945) 1921 neurological disease revisited; the most likely diagnosis remains Guillain-Barré syndrome.
? Guillain-Barré Syndrome after H1N1 Shot in Pregnancy: Maternal and Fetal Care in the Third Trimester-Case Report.
“We presented a case of a 36-year-old pregnant woman that was immunized to H1N1 in the last trimester; 10 days later she developed shoulder and lumbar spine’s pain, limbs weakness and facial paralysis with unfavorable clinical evolution and was submitted to intensive therapy care. We described clinical and obstetrical approach, pointing out peculiarities involved in this pathology in pregnancy.”
Guillain-Barre syndrome after influenza vaccine administration: two adult cases.
“We describe two adult cases of neurologic complications occurring after the administration of the influenza vaccine. The first case described is a 68 year-old man who experienced paresthesias of the upper and lower extremities two weeks after vaccination, and the second case was a 64 year-old female who exhibited paraplegia eighteen days after vaccination. Diagnosis of acute idiopathic demyelinating polyradiculopathy (Guillain-Barré syndrome) was made for both patients, and intravenous gammaglobulin therapy was given with marked improvement of the first case, but poor response on the second case. Although the efficacy of influenza vaccination has been widely accepted, such neurologic complications might occur in the elderly and adult population. Even if Guillain-Barré syndrome was a true side effect of vaccination, the risk is substantially lower than is the risk for complications following influenza. The rare occurrence of neurological complications after influenza vaccine should not discourage against the vaccination.”
Guillain-Barré syndrome after vaccination in United States: data from the Centers for Disease Control and Prevention/Food and Drug Administration Vaccine Adverse Event Reporting System (1990-2005).
“There were 1000 cases (mean age, 47 years) of GBS reported after vaccination in the United States between 1990 and 2005. The onset of GBS was within 6 weeks in 774 cases, >6 weeks in 101, and unknown in 125. Death and disability after the event occurred in 32 (3.2%) and 167 (16.7%) subjects, respectively. The highest number (n = 632) of GBS cases was observed in subjects receiving influenza vaccine followed by hepatitis B vaccine (n = 94). Other vaccines or combinations of vaccines were associated with 274 cases of GBS. The incidence of GBS after influenza vaccination was marginally higher in subjects <65 years compared with those >or=65 years (P = 0.09); for hepatitis vaccine, the incidence was significantly higher (P < 0.0001) in the <65 group. Death was more frequent in subjects >or=65 years compared with those <65 years (P < 0.0001)." #Guillain #Barre #Death #Neurological #Influenza #Hepatitis B #Flu #Vaccine #MedScienceResearch https://www.ncbi.nlm.nih.gov/m/pubmed/19730016/
Guillain-Barré syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June-July 2005.
Case 1. A male aged 18 years was vaccinated with MCV4; 15 days later, he experienced tingling in his feet and hands. He had no history of major underlying illness; his mother had had GBS 5 years earlier. He reported no history of respiratory or gastrointestinal illnesses during the 6 weeks before onset of symptoms. Sixteen days after vaccination, he was hospitalized, and nerve conduction studies (NCS) of upper and lower extremities, 2 days after onset of symptoms, were consistent with GBS. He was observed for 3 days, discharged, and then readmitted 2 days later with bilateral facial weakness and increasing lower extremity weakness. Patellar, triceps, and biceps deep tendon reflexes (DTRs) were absent. NCS performed 4 days after the previous examination revealed worsening motor nerve conduction velocities consistent with GBS. Tests for mononucleosis and Lyme disease were negative. During hospitalization, he was treated with plasmapheresis. His facial palsy and gait improved, and his reflexes returned. He was discharged home.
Case 2. A male aged 17 years was vaccinated with MCV4; approximately 25 days later, he had difficulty walking, followed by difficulty moving from a standing to a seated position. Medical history included attention deficit hyperactivity disorder and Asperger syndrome; he had been taking multiple psychotropic medications. He did not report recent respiratory or gastrointestinal illness. Thirty-two days after vaccination, he was hospitalized with bilateral muscle weakness of upper and lower extremities with absent DTRs. NCS was consistent with GBS. Cerebrospinal fluid (CSF) analysis revealed 2 white blood cells (WBC)/mm3 with protein of 60 mg/dL; bacterial cultures were negative. DNA polymerase chain reaction (PCR) for adenovirus, herpes simplex virus types 1 and 2, varicella zoster virus, cytomegalovirus (CMV), and Epstein-Barr virus (EBV), and RNA PCR for West Nile virus, eastern equine encephalitis virus, St. Louis encephalitis virus, enterovirus, and California group and Cache Valley viruses, were all negative. During hospitalization, he was treated with intravenous immunoglobulin (IVIG). On discharge, his motor strength and gait were improved.
Case 3. A female aged 17 years was vaccinated with MCV4. She had a previous history of GBS at ages 2 and 5 years, both beginning 14 days after vaccination with childhood vaccines. She had not been previously vaccinated with meningococcal vaccine. Both episodes of GBS were characterized by muscle weakness, decreased reflexes, and difficulty walking. During both episodes, she was treated with intravenous immunoglobulin and completely recovered. Fourteen days after vaccination with MCV4, she reported numbness of toes and tongue and had a lump in her throat. These symptoms were followed by numbness of thighs and fingertips, arm weakness, inability to run, difficulty walking, and falling. Sixteen days after vaccination, she was hospitalized, and neurologic examination revealed decreased tone and weakness of both arms and legs and reflexes reduced or absent in ankles, knees, and arms. CSF results revealed 0 WBC/mm3 and protein 26 mg/dL. She was treated with IVIG, recovered, and discharged home.
Case 4. A female aged 18 years was vaccinated with MCV4. Six days after vaccination, she had a sore throat that lasted for 6 days, and 29 days after vaccination she reported a severe headache and was evaluated in an emergency department (ED), where she had a normal computerized tomography (CT) scan, was treated with ketorolac, and discharged on oral ibuprofen. Thirty-one days after vaccination, the patient reported numbness of legs and had trouble standing on her toes. The next morning she could not stand. The patient was admitted to the hospital, and physical examination revealed decreased muscle strength in ankles and wrists bilaterally and reduced biceps, knee, and ankle DTRs. Previous medical history included mild ulcerative colitis that had been asymptomatic off medications; she did not report having diarrhea during the 6 weeks before onset of muscle weakness. Her only outpatient medications were oral contraceptives. CSF analysis revealed 1 WBC/mm3 and a protein concentration of 30 mg/dL. NCS was consistent with GBS. She was treated with IVIG. After a 7-day hospitalization, her motor strength had improved, and she was discharged home with outpatient physical therapy. Three weeks after discharge, her weakness and gait were improved.
Case 5. A female aged 18 years was vaccinated with MCV4; 14 days later, she experienced heaviness in her legs when walking upstairs. During the next 8 days, her difficulty walking continued, and she had bilateral leg pain. Subsequently, she reported headache, back and neck pain, vomiting, and tingling in both hands. She became unable to walk and was evaluated in an ED, where an initial diagnosis of viral meningitis was made. Two days later, she was hospitalized for progressive weakness and inability to walk. Neurologic examination revealed bilateral acute flaccid weakness with decreased DTRs.”
Guillain – Barre’ syndrome following recombinant hepatitis B vaccine and literature review.
“A 17 year-old woman developed progressive quadriparesis with bilateral facial diplegia after immunization with recombinant hepatitis B vaccine 3 days prior. Cerebrospinal fluid analysis revealed acellular fluid with high protein level. The electrodiagnosis was compatible with demyelinating polyneuropathy. Other potential causes of Guillain-Barre’ syndrome (GBS) were ruled out. Her motor power gradually improved and returned to normal later. The temporal relationship between GBS and vaccination was suggestive of a vaccine-induced cause. Mechanisms of this very rare complication are proposed with a literature review.”
Guillain-Barre syndrome occurring after rabies vaccination.
“A variety of events are associated with the onset of Guillain-Barre syndrome, including vaccinations and vaccines. These are the swine influenza vaccine, oral poliovirus vaccine and rabies vaccine. Rabies is a uniformly fatal disease. It is preventable if World Health Organization (WHO) guidelines for post exposure treatment (PET) are followed. These include local treatment of wound, passive immunization with rabies immunoglobulins and administration of a efficacious vaccine. Cell culture vaccines are highly immunogenic with fewer side effects, but are costly. For that reason neurotissue vaccines are still widely used in Pakistan, although they are less immunogenic with higher incidence of neuroparalytic complications. We report a case of Guillain-Barre syndrome secondary to sheep brain anti-rabies vaccine in a young boy, who presented with lower limb weakness with total recovery after treatment.”
Recurrent Guillain-Barré syndrome following influenza vaccine.
“Two patients recovered from an attack of Guillain-Barré syndrome and then had a second attack of this disease, with a shorter latent period, following monovalent influenza vaccination. These cases suggest that an attack of Guillain-Barré syndrome may result in greater risk of future episodes of the syndrome in conjunction with exposure to influenza or other vaccinations.”
Simultaneous development of acute disseminated encephalomyelitis and Guillain-Barré syndrome associated with H1N1 09 influenza vaccination.
“A 36-year-old man was admitted to our hospital because of urinary retention and muscle weakness affecting all 4 limbs after receiving a H1N1 09 influenza vaccination. Magnetic resonance imaging demonstrated multiple lesions in his brain and spinal cord. Furthermore, nerve conduction study showed acute sensorimotor neuropathy, and anti-GM2 antibodies were detected in his serum. Based on the temporal association and exclusion of alternative etiologies, we made a diagnosis of acute disseminated encephalomyelitis (ADEM) and Guillain-Barré syndrome (GBS). To our knowledge, this is the first case of co-morbid ADEM and GBS after influenza vaccination with positive anti-ganglioside antibodies.”
Sudden hearing loss after rabies vaccination.
“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.”
Surveillance of adverse events after the first trivalent inactivated influenza vaccine produced in mammalian cell culture (Flucelvax(®)) reported to the Vaccine Adverse Event Reporting System (VAERS), United States, 2013-2015.
“Among 309 reports with an AE documented, 19 (6.1%) were serious and the most common categories were 152 (49.2%) general disorders and administration site conditions (mostly injection site and systemic reactions) and 73 (23.6%) immune system disorders with two reports of anaphylaxis. Four reports of GBS were submitted. Disproportional reporting was identified for ‘drug administered to patient of inappropriate age.'”