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[Complications after preventive mumps vaccination in West Germany (including multiple preventive vaccinations)].

Since the introduction of mumps vaccination in the Federal Republic of Germany 34 untoward vaccinal reactions were collected. In 2 cases of aseptic meningitis after mumps immunisation mumps virus was isolated from the CSF. The final investigation showed mumps virus (wild type) in one case; in the other a mumps vaccine-like strain (Jeryl-Lynn) was identified. Both patients recovered completely. These complications do not outweigh the enormous benefits of mumps immunisation.

Child↗

Polymyositis: rare complication of hepatitis B vaccination. An unusual cause of toxic shock syndrome.

Transient weakness of the legs developed in a 17 year-old male high school student three weeks after the initial injection of a hepatitis B vaccine. Seventeen days after the second injection of the vaccine, low-grade fever, a pruritic maculopapular rash appeared and weakness of the legs recurred. This was associated with elevation of the creatinine kinase to 2,406 U/L. The day after admission he became afebrile and in the subsequent four days the rash improved but leg weakness persisted. One-month later, muscle strength had returned; and the creatinine kinase had returned to normal levels. The only case of dermatomyositis associated with hepatitis B vaccination and the findings in the six reported cases of surface antigen-positive hepatitis associated with polyomyositis or dermatomyositis are briefly reviewed. Hepatitis B vaccination should be encouraged, but it is important to be aware that, rarely, dermatomyositis, polymyositis or neurovascular complications may occur. Polymyositis associated with the administration of the hepatitis B vaccine or with hepatitis B virus infection is a rare occurrence. A Medline Search performed from 1960 to January 2002 associating hepatitis B vaccine or hepatitis B virus with myopathy, myositis, polymyositis and dermatomyositis, showed only one case of dermatomyositis related to the hepatitis B vaccine, and six case reports relating polymyositis to hepatitis B virus infection. We present a case where a causal relationship between polymyositis and hepatitis B vaccination appears quite likely.

Adolescent↗

Risks of serious complications and death from smallpox vaccination: a systematic review of the United States experience, 1963-1968.

BACKGROUND: The United States (US) has re-instituted smallpox vaccinations to prepare for an intentional release of the smallpox virus into the civilian population. In an outbreak, people of all ages will be vaccinated. To prepare for the impact of large-scale ring and mass vaccinations, we conducted a systematic review of the complication and mortality risks of smallpox vaccination. We summarized these risks for post-vaccinial encephalitis, vaccinia necrosum (progressive vaccinia), eczema vaccinatum, generalized vaccinia, and accidental infection (inadvertant autoinoculation). METHODS: Using a MEDLINE search strategy, we identified 348 articles, of which seven studies met our inclusion criteria (the number of primary vaccinations and re-vaccinations were reported, sufficient data were provided to calculate complication or case-fatality risks, and comparable case definitions were used). For each complication, we estimated of the complication, death, and case-fatality risks. RESULTS: The life-threatening complications of post-vaccinial encephalitis and vaccinia necrosum were at least 3 and 1 per million primary vaccinations, respectively. Twenty-nine percent of vaccinees with post-vaccinial encephalitis died and 15% with vaccinia necrosum died. There were no deaths among vaccinees that developed eczema vaccinatum; however, 2.3% of non-vaccinated contacts with eczema vaccinatum died. Among re-vaccinees, the risk of post-vaccinial encephalitis was reduced 26-fold, the risk of generalized vaccinia was reduced 29-fold, and the risk of eczema vaccinatum was reduced 12-fold. However, the risk reductions of accidental infection and vaccinia necrosum were modest (3.8 and 1.5 fold respectively).

Bioterrorism↗

[Acute disseminated encephalomyelitis after active immunization against early summer encephalitis].

After repeated immunization against european spring-summer encephalitis, a 36-year-old patient developed recurrent retrobulbar neuritis, had a fit of grand mal epilepsy and a focal motor clonic-tonic attack status as a result of post-vaccination ADEM. Post-vaccination encephalomyelitis after TBE-vaccination is a very rare complication of vaccination and has so far only been described occasionally. We observed the clinical course of post-vaccination ADEM after TBE vaccination over 12 years.

Acute Disease↗

Development and clinical application of new polyvalent combined paediatric vaccines.

The availability of combined vaccines containing protective antigens against the majority of (ideally all) diseases for which universal immunization is recommended in infancy would simplify the implementation, increase the acceptance, reduce the global cost of immunization programmes and improve disease control, while offering the possibility of disease elimination or even pathogen eradication. The desirability of combined vaccines is further enhanced, and made more urgent, because of the increasing number of diseases that can be prevented by vaccination. The complicated logistics of administering different vaccines that each require several inoculations is a significant barrier to successful immunization of a population. Furthermore, interest in immunization is continuously gaining momentum since it is now generally recognised that vaccines are among the safest and most cost-effective medical interventions for infectious diseases that continue, in spite of the widespread use of efficacious antimicrobial drugs, to be an important cause of morbidity and mortality. This burden is likely to increase due to the development of antimicrobial resistance. Basic research on new vaccines or improvement of existing ones such as the use of new technologies may be carried out in academic or other non-industrial laboratories but development work, including the necessary extensive clinical testing, that lead to products that can be approved for routine use is usually co-ordinated and financed by commercial companies. The decision to develop any particular combined vaccine will therefore be influenced not only by its medical desirability and technical feasibility but also the potential financial returns that the required investments in time and resources may bring to the company. All major vaccine manufacturers are currently working, either alone or through strategic alliances, towards developing more polyvalent vaccines by adding antigens such as inactivated polio virus, conjugated Haemophilus influenzae type b polysaccharide and hepatitis B surface antigen to the diphtheria-tetanus-pertussis vaccine either in its 'classical' (whole-cell) or more purified (acellular) formulations. Experience is showing that the development of combined vaccines involves much more than the simple mixing of existing antigens. Possible incompatibilities or mutual interferences between the antigens themselves, or between excipients, preservatives, adjuvants, residual contaminants, stabilisers and suspending fluids make it mandatory that each formulation be thoroughly tested for quality, stability, efficacy and safety. Furthermore the ability to produce and control it consistently must be established before it can be licensed for commercial use. The progress being made in this field is reviewed.

Child↗

Is the acute encephalopathy test in mice suited for control of pertussis vaccines?

Animal models to control the serious neurological complications after vaccination against whooping cough are not available. In a recent paper pertussis vaccine induced acute encephalopathy in certain mouse strains (1). Healthy BALB/c mice died with shock-like symptoms after immunization with bovine serum albumin (BSA) and heat-killed pertussis. Mice not sensitized with BSA survived, and mice of strains with another H-2 type than H-2d were not susceptible. The authors concluded that the susceptibility to side effects to pertussis vaccine in mice and possibly in human is linked to the MHC. We tried to repeat the experiments reported by Steinman et al. in the hope that the murine encephalopathy model would be useful to evaluate possible neurological complications. In spite of having the same H-2d genotype, the BALB/c mice of two breeding stocks did not develop shock-like symptoms with fatal consequences after the last injection with BSA. This fact corresponds possibly with the author's observation that the pertussis vaccine encephalopathy is not under the control of H-2 genes alone. As shown in our tests the sudden deaths and encephalopathy in mice are not linked to BSA-sensitization because mice who received pertussis vaccine only showed the same symptoms as mice injected with BSA and vaccine. Histology did not indicate brain damage. It seems obvious that the deaths in our experiments were caused by the pertussis toxins present in the large numbers of bacteria given.

Animals↗

A high rate of neurological complications following Semple anti-rabies vaccine.

A fatal case of encephalitis due to Semple (phenolized sheep-brain) anti-rabies vaccine prompted a search for neurological complications among 722 recipients of 2 vaccine batches administered in Bangkok, Thailand in June and July 1984. A review of all patients admitted with neurological symptoms from June through August 1984 to the 5 major teaching hospitals in Bangkok found 6 cases (0.83%), including the index case, who had received the vaccine. Rabies infection was ruled out in all 6 cases. 4 patients had meningitis, and 2 had meningo-encephalitis. Only the index case was fatal; the other patients recovered without neurological sequelae. The rate of neurological complications after receiving Semple vaccine was therefore a minimum of 8.31 cases per 1000 persons vaccinated (1:120). This complication rate was about 25 times higher than the overall complication rate of 0.33 per 1000 (1:3018) determined from 14 previous reports. The fatality rate was 1.39 per 1000 (1:722), about 15 times higher than the rate of 0.09 per 1000 (1:10805) calculated from the previous studies. It is urgent to find economically feasible alternatives to Semple vaccine.

Adolescent↗

[Differences in the quality of vaccinia viruses with normal and abnormal post-vaccination course (with neurological complications) (author's transl)].

Conventional vaccinia strains were cultured at different temperatures, because it is known that vaccinia viruses which are human pathogens grow even at higher temperatures (41 degrees C). Neither the vaccination strains nor the vaccinia viruses which were isolated from vaccination vesicles after normal (n equals 7) or abnormal primary vaccinations (n equals 2) multiplied at higher incubation temperatures; Vaccinia viruses isolated from CSF of four patients with neurological complications behaved differently. Uninhibited growth at 41 degrees C (with high infection titres) suggest that the viruses isolated from CSF were vaccinia variants with abnormal characteristics. Accordingly, these variants morphologically formed plaques in Vero-cell cultures which were two to three times larger than those of vaccinia viruses obtained from CSF of primary vaccinated cases after only moderately severe general reactions, and which on temperature test responded like the viruses used in the original vaccination.

Child↗

Smallpox and smallpox vaccination: neurological implications.

Compulsory vaccination was discontinued in the U.S. in 1972; the world was declared free of smallpox infection in 1980. Since that time, no new smallpox infections have been recognized, and only limited numbers of military and laboratory personnel have been vaccinated. As a result, the majority of the U.S. and the world population have no or diminished immunity to smallpox. Widespread vaccination, beginning with the military and health care workers, is now being undertaken. Public health strategies for immunizing the general population include preexposure voluntary vaccination, case surveillance with ring vaccination, and mass vaccination at the time of attack. Cutaneous complications of vaccination occur in immunosuppressed subjects and in those with atopic dermatitis. Among the most serious complications is postvaccinal encephalomyelitis (PVEM). A related condition, postvaccinial encephalopathy (PVE), may be seen in children less than two years of age. There are no markers to predict who will develop PVEM. In the past, mortality was high, ranging from 10 to 50%. The neuropathology of PVEM suggested an immune-mediated attack on the CNS, but the target of the immune response is unknown. Comprehensive programs are needed for surveillance and confirming case definitions for neurologic complications. Multi-institutional controlled trials of antiviral and immune modulating therapy of PVEM should be considered. Neurologists should be actively involved in the planning process for vaccination programs and in the treatment of neurologic complications.

Adult↗

Impact of HIV vaccination on laboratory diagnosis: case reports.

BACKGROUND: It has not been clearly demonstrated whether HIV vaccination can complicate routine HIV testing. In this report, we describe the laboratory data of two prisoners who received rgp120 vaccine in a phase III trial underway in Thailand. These data indicate that previous vaccination may complicate the interpretation of screening HIV diagnostic tests. CASE PRESENTATION: The participants were identified from a cohort study on "Health factors related to HIV-1 and other viral infections among incarcerated people" that was approved by The Ethical Committee for Research in Human Subjects, Ministry of Public Health, Thailand. HIV diagnosis was definitively established with serial specimens using multi-screening tests, Western blot and diagnostic PCR.Anti-HIV screening tests consistently exhibited either weakly reactive or inconclusive results. The band patterns of the Western blot analysis corresponded to those found in individuals who received the rgp120 vaccination. Definite results were established using diagnostic PCR, which exhibited consistently negative results with follow-up specimens. Such problems in HIV testing are not easily resolved in the routine clinical setting in Thailand. CONCLUSIONS: These data demonstrate that HIV-1 vaccination interferes with routine diagnostic tests. Similar cases will not be uncommon in Thailand, where 2,545 people have already participated in a phase III trial.

AIDS Serodiagnosis↗

[Neurological complications following whooping-cough vaccination (author's transl)].

The clinical symptoms, frequency, etiology, pathogenesis and differential diagnosis of neurological complications following immunisation against pertussis are being discussed. Guide lines are presented for the evaluation of the causal connection between the observed complications and the vaccination.

Encephalomyelitis, Acute Disseminated↗

Neurological complications of swine influenza vaccination.

The emphasis upon the remarkably large number of cases of Guillain-Barre syndrome which resulted from the 1976 National Swine Influenza immunization program in the U.S.A. has obscured the fact that other neurological complications, involving the central nervous system also occurred. The anatomical distribution of lesions is almost identical with that seen following other types of vaccination: involvement of the brain, cerebellum, optic nerve, cranial nerves and spinal cord occurred with approximately the same frequency. 5 instances of the very rare subacute or chronic, progressive, post-vaccinal encephalopathy are described, a situation which is identical to the subacute and chronic forms of polyradiculoneuropathy. In a number of cases, in particular the myelopathies, a subclinical involvement of peripheral nerves was demonstrated by means of electrodiagnostic studies, illustrating the often overlooked fact that central nervous system involvement will mask peripheral nerve lesions. The etiological significance of the swine influenza vaccination was overlooked and completely erroneous diagnoses were established in a surprisingly large number of the 26 new cases reported here.

Adolescent↗

The age-dependent risk of postvaccination complications in vaccinees with smallpox vaccine.

The use of vaccinia virus in recombinant systems may result in the occurrence of complications observed following smallpox vaccination. The results are presented of a large survey carried out in the USSR between 1968 and 1979. High complication rates are reported, particularly in older primary vaccinees; for example, there were 312.5 cases of neurological complications per million in those aged greater than or equal to 5 years. The author concludes that this factor will limit the use of vaccinia virus in recombinant technology.

Age Factors↗

[Treatment of the complications occurring in BCG vaccine immunotherapy of patients with malignant neoplasms].

The results of nonspecific immunotherapy with BCG vaccine in 98 cases of melanoma, breast cancer and other malignancies were used in evaluating the frequency and degree of side-effects and complications arising in cancer patients during this treatment. The procedure proved to be safe irrespective of patients' age. Prevention and treatment of side-effects such as fever, water-salt disorders, anorexia, interstitial hepatitis and promotion of tumor growth are discussed.

BCG Vaccine↗