Hepatitis B vaccine adverse events: citations
Hepatitis vaccination
[2008] Hepatitis B triple series vaccine and developmental disability in US children aged 1-9 years This study found statistically significant evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B vaccine, during the time period in which vaccines were manufactured with thimerosal, were more susceptible to developmental disability than were unvaccinated boys.
[2008 Sept] Carolyn Gallagher a; Melody Goodman a. Hepatitis B triple series vaccine and developmental disability in US children aged 1-9 years This study found statistically significant evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B vaccine, during the time period in which vaccines were manufactured with thimerosal, were more susceptible to developmental disability than were unvaccinated boys.
Allergy reactions to gelatin & neomycin (journal articles)
Allen MB, et al. Pulmonary and cutaneous vasculitis following hepatitis B vaccination. Thorax. 1993 May;48(5):580-1. No abstract available.PMID: 8322254; UI: 93310736.
Berkman N, et al. [Bilateral neuro-papillitis after hepatitis B vaccination]. Presse Med. 1996 Sep 28;25(28):1301. French. No abstract available.PMID: 8949792; UI: 97107044
Berkman
N. [A case of segmentary unilateral occlusion of the central retinal vein
following hepatitis B vaccination]. Presse Med. 1997 Apr 26;26(14):670. French. No
abstract available.PMID: 9180888; UI: 97324783.
Bentsi-Enchill
A. Adverse events following the administration of hepatitis B vaccines. Can Commun Dis
Rep. 1992 Apr 17;18(7):49-53. English; French. No abstract available.PMID: 1291014; UI:
93177423.
Biasi
D, et al. A new case of reactive arthritis after hepatitis B vaccination. Clin
Exp Rheumatol. 1993 Mar-Apr;11(2):215. No abstract available.PMID: 8508565; UI: 93284771.
Biasi
D, et al.[Rheumatological manifestations following hepatitis B vaccination. A report
of 2 clinical cases]. Recenti Prog Med. 1994 Sep;85(9):438-40. Review. Italian. PMID:
7938876; UI: 95025084.
Biacabe
B, et al. A case report of fluctuant sensorineural hearing loss after hepatitis B
vaccination. Auris Nasus Larynx. 1997 Oct;24(4):357-60. PMID: 9352826; UI: 98012875.
Bourges
JL, et al. [Multifocal placoid epitheliopathy and anti-hepatitis B
vaccination]. J Fr Ophtalmol. 1998 Nov;21(9):696-700. French. PMID: 9894208; UI:
99111579.
Bonfils
P, et al. [Fluctuant perception hearing loss after hepatitis B vaccine].
Ann Otolaryngol Chir Cervicofac. 1996;113(6):359-61. French. PMID: 9124778; UI: 97254004.
Brooks R, et al. Guillain-Barre syndrome following trivalent influenza vaccine in an elderly patient. Mt Sinai J Med. 1980 Mar-Apr;47(2):190-1. No abstract available.PMID: 6967162; UI: 80232515
Bracci M, et al. Polyarthritis associated with hepatitis B vaccination. Br J Rheumatol. 1997 Feb;36(2):300-1. No abstract available.PMID: 9133957; UI: 97279516
Brezin
A, et al. Visual loss and eosinophilia after recombinant hepatitis B
vaccine. Lancet. 1993 Aug 28;342(8870):563-4. No abstract available.PMID: 8102709; UI:
93360669.
Bui-Quang
D, et al. [Cutaneous vasculitis after hepatitis B vaccination with recombinant vaccine
in a renal transplant patient]. Presse Med. 1998 Sep 12;27(26):1321-3. French. PMID:
9779046; UI: 98452068.
Christau
B, et al. [Reactive arthritis following vaccination against hepatitis B]. Ugeskr
Laeger. 1987 Jul 6;149(28):1882. Danish. No abstract available.PMID: 3433400; UI:
88128088.
Green, C et al, "A Case of Hepatitis Related to Etretinate Therapy and Hepatitis B Vaccine", Dermatologica, 1991, 182(2):119-120.
David A Geier,
Mark R Geier MD PhD.
Chronic adverse reactions associated with hepatitis B vaccination.
The Annals of Pharmacotherapy 2002: Vol. 36,
No. 12, pp. 1970–1971.
In conclusion, our study demonstrates that
adult HBV is statistically associated not only
with acute neuropathy, neuritis, myelitis, vasculitis, thrombocytopenia,
gastrointestinal disease, multiple sclerosis, and arthritis, but some of these
patients go on to develop chronic adverse reactions that persist for at least 1
year following HBV. These types of chronic adverse reactions following
adult HBV should be discussed with patients contemplating being immunized with
HBV and should be included in the differential diagnosis of those who develop
them following adult HBV.
Geier DA, Geier MR.
A one year followup of chronic arthritis following rubella and hepatitis B
vaccination based upon analysis of the Vaccine Adverse Events Reporting System
(VAERS) database. Clin Exp Rheumatol
2002 Nov-Dec;20(6):767-71. MedCon, Inc.,
Silver Spring, Maryland, USA.
mgeier@erols.com
OBJECTIVES: This analysis examined the incidence rate of chronic arthritis
adverse reactions reported following adult rubella and hepatitis B
vaccinations. In this analysis, etiologic mechanisms for chronic arthritis
following adult rubella and hepatitis B vaccines were also explored. METHODS:
The Vaccine Adverse Events Reporting System (VAERS) database was analyzed for
the incidence rate of reported cases of chronic arthritis in comparison to
Tetanus-diphtheria (Td) and tetanus toxoid adult vaccine control groups.
RESULTS: Chronic arthritis adverse reactions following adult rubella
vaccination were primarily reported in females (female/male ratio = 3.0), at
about 45 years-old, and at a mean onset time of 10-11 days following
vaccination. Chronic arthritis adverse reactions following adult hepatitis B
vaccination were also primarily reported in females(female/male ratio = 3.5),
at about 33 years-old, and with a mean onset time of 16 days following
vaccination. The incidence rates of chronic arthritis following adult rubella
and adult hepatitis B vaccinations were statistically significantly increased,
by chi 2 analysis, in comparison to the adult vaccine control groups. The
attributable risk of chronic arthritis following adult rubella vaccine ranged
from 32 to 53 and from 5.1 to 9.0 following adult hepatitis B vaccine in
comparison to the adult vaccine control groups. CONCLUSION: This study
revealed that adult rubella and adult hepatitis B vaccines were statistically
associated with chronic arthritis which persisted for at least one year.
The etiology for these adverse reactions may involve autoimmune mechanisms.
Furthermore, potential biases in the reporting rates of adverse reactions to
VAERS were not observed. PMID: 12508767
[PubMed - in process]
Hanzawa
S, Takahashi T, Nakayama S, Ohhara K, Ebihara I, Koide H, Ohno J.[A case
of membranoproliferative glomerulonephritis associated with hepatitis B (author's transl)]Nippon Jinzo Gakkai Shi. 1980 Jan;22(1):41-9. Japanese. No abstract
available.PMID: 7382161 [PubMed - indexed for MEDLINE]
Hall A, Kane M, Roure C, Meheus A. Multiple sclerosis and hepatitis B vaccine? Pubblicato su: Vaccine 1999 Jun 4;17(20-21):2473-5
London School of Hygiene and Tropical Medicine, UK. PMID: 10418891, UI: 99345232
Halsey
NA, et al. Hepatitis B vaccine and central nervous system demyelinating
diseases. Viral Hepatitis Prevention Board. Pediatr Infect Dis J. 1999 Jan;18(1):23-4.
Review. No abstract available.PMID: 9951975; UI: 99135446.
Karaali-Savrun
F, Altintas A, Saip S, Siva A. Hepatitis B vaccine
related-myelitis?Eur J Neurol. 2001 Nov;8(6):711-5.PMID: 11784358
[PubMed - indexed for MEDLINE]
Kerleau JM, et al. [Is hepatitis B vaccination a new cause of necrotizing vasculitis]? Rev Med Interne. 1997;18(6):491-2. French. No abstract available.PMID: 9247052; UI: 97390000.
Kakar A, Sethi PK. Guillain Barre syndrome associated with hepatitis B vaccination.Indian J Pediatr. 1997 Sep-Oct;64(5):710-2. No abstract available.PMID: 10771907 [PubMed - indexed for MEDLINE]
Kear
TM, et al. Transient hepatitis B antigenemia in hemodialysis patients
following hepatitis B vaccination. ANNA J. 1996 Jun;23(3):331, 337. No abstract
available.PMID: 8716993; UI: 96356647. [See
Related Articles]
Kaplanski
G, et al. Central nervous system demyelination after vaccination against hepatitis B
and HLA haplotype. J Neurol Neurosurg Psychiatry. 1995 Jun;58(6):758-9. No abstract
available.PMID: 7608688; UI: 95332874.
Korman
SH. Thrombocytopenic purpura during the incubation of hepatitis B. Acta Paediatr
Scand. 1991 Oct;80(10):975-6. PMID: 1755310; UI:
92095079
Kerleau
JM, et al. [Is hepatitis B vaccination a new cause of necrotizing vasculitis]?
Rev Med Interne. 1997;18(6):491-2. French. No abstract available.PMID: 9247052; UI:
97390000.
Konstantinou D, Paschalis C, Maraziotis T, Dimopoulos P, Bassaris H, Skoutelis A. Two episodes of leukoencephalitis associated with recombinant hepatitis B vaccination in a single patient. Clin Infect Dis. 2001 Nov 15;33(10):1772-3.PMID: 11595974 [PubMed - indexed for MEDLINE]
Lasheras Carbajo MD, et al. [See Related Articles] [A case of intense cytolysis following the administration of a hepatitis B vaccine]. Rev Clin Esp. 1999 Jan;199(1):49-50. Review. Spanish. No abstract available.PMID: 10089783; UI: 99189653.
Le
Hello C, et al. Suspected hepatitis B vaccination related vasculitis. J
Rheumatol. 1999 Jan;26(1):191-4. Review. PMID: 9918261; UI: 99114793.
S. Laoussadi, V. Sayag-Boukris, C.-J. Menkes, André Kahan.
Department of Rheumatology A, Cochin Hospital, Paris V University, Paris,France. HBV
vaccination may induce hypersensitivity and autoimmune reactions in susceptible
individuals and healthy
Subjects. Seven patients (4 F, 3 M; mean age 35 ± 10 yrs), developed severe rheumatic
disorders after the first (4) or the third (3) injection of HBV vaccine. Before HBV
vaccination, one was a healthy subject and 6 were previously suffering from: eosinophilic
fasciitis (1), systemic lupus (1), HLA B27 positive axial ankylosing spondylitis (2),
sickle cell disease (1) and idiopathic cutaneous urticaria (1). The underlying disease was
in remission induced by treatment (4 cases), including NSAIDs (2), corticosteroids (CS;
1), sulfasalazine (SZ; 2) and hydroxychloroquine (HC; 1) and in 3 cases there was no
treatment. Fourteen days (mean) after vaccine injection, they developed rheumatic
disorders including: 3 severe symetric polyarthritis fulfilling ARA RA criteria,
associated in one case with vasculitis and 2 monoclonal IgM cryoglobulins. Two cases of
oligoarthritis (one associated with palatine and laryngeal oedema, ocular sicca syndrome,
hypereosinophilia, positive ANA, and C4 defect), 1 case of Sjögren syndrome, 1 severe
systemic flare of lupus with arthritis, pleural effusion, vasculitis and a grade IIIa
glomerulonephritis.
In all patients these disorders were controlled using prednisone therapy (0.3 to 1
mg/kg/day; 7) combined, according to the underlying rheumatic disease with HC (2), SZ (2),
cyclophosphamide (1), azathioprine (1), methotrexate (1) and IV Ig (1). Six patients met a
remission after 2 months to one year treatment, but they are still under treatment. In one
patient, with eosinophilic fasciitis, a total recovery was observed after 7 years and he
has stopped any treatment for 2 years.
Hepatitis B virus vaccination may induce severe reactions requiring the use of a long term
treatment (mean period of time of 32.5 ± 24.8 months) in healthy subjects and in patients
who suffer from autoimmune diseases and from ankylosing spondylitis or reactive arthritis,
even if a complete remission has been already obtained. Abstract: 1186 November 10, 1998
Poster Session D: Miscellaneous Rheumatic Diseases 12:30-2:00 pm, Hall B1/C
Manna
R, et al. Leukoencephalitis after recombinant hepatitis B vaccine. J Hepatol.
1996 Jun;24(6):764-5. No abstract available.PMID: 8835755; UI:
96432703.
J.F. Maillefert1, J. Sibilia2, E. Toussirot3, E. Vignon4, R. Juvin5, C. Piroth1, D.
Wendling3, J.L. Kuntz2, C. Tavernier1, P. Gaudin5 Departments of Rheumatology; 1Dijon;
2Strasbourg; 3Besançon; 4Lyon; 5Grenoble, France
Aim: to obtain an overview of rheumatic disorders occurring after
hepatitis B vaccination.
Methods: a questionnaire was sent to rheumatology departments in nine french hospitals.
Criteria for entry were rheumatic complaints of one-week duration or more, occurrence
during the 2 months following hepatitis B vaccination, no previously diagnosed rheumatic
disease, exclusion of bacterial or viral reactive arthritis.
Results: 21 patients (18 women, 3 men; mean age = 30.7 years +/- 12.6 SD) were included.
All received recombinant hepatitis B vaccine. The time interval between the vaccination
and occurrence of complaints was one week or less for 10 patients, between one week and
one month for 8 patients, between one and two months for 3 patients. In 9 patients, the
next vaccinal dose was inoculated despite the complaints. The symptomatology worsened in 7
cases, and was not modified in one case (effects unknown for the last patient). The
observed disorders were as follows: rheumatoid arthritis for 6 patients, systemic lupus
erythematosus for 2, reactive arthritis for 5, polyarthralgia-myalgia-fatigue for 3,
suspected or biopsy-proved vasculitis for 3, miscellaneous for 2. Conclusion: hepatitis B
vaccination might be followed by various rheumatic conditions, and might trigger the onset
of underlying inflammatory and/or auto-immune rheumatic diseases. However, a causal
relation between hepatitis B vaccination and the observed rheumatic manifestations cannot
be easily established. Further epidemiological works are needed to establish whether
hepatitis B vaccination is associated or not with an incidence of rheumatic disorders
higher than normal.
Marsaudon
E, et al. [Meningeal reaction after vaccination against hepatitis
B]. Presse Med. 1996 Oct 26;25(32):1561-2. French. No abstract available.PMID: 8952667;
UI: 97110516.
Macario
F, et al. Nephrotic syndrome after recombinant hepatitis B vaccine.
Clin Nephrol. 1995 May;43(5):349. No abstract available.PMID: 7634556; UI:
95361242.
Mader
R, et al. Systemic vasculitis following influenza
vaccination--report of 3 cases and literature review. J Rheumatol. 1993 Aug;20(8):1429-31.
Review. PMID: 8230034; UI: 94046875.
Mahassin
F, et al. [Acute myelitis after vaccination against hepatitis B]. Presse Med.
1993 Dec 18;22(40):1997-8. French. PMID: 8127802; UI:
94173824.
Maillefert
JF, et al. Mental nerve neuropathy as a result of hepatitis B
vaccination. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997 Jun;83(6):663-4. PMID:
9195619; UI: 97339059.
Maillefert
JF, et al. Rheumatic disorders developed after hepatitis B vaccination. Rheumatology
(Oxford). 1999 Oct;38(10):978-83. PMID: 10534549; UI: 20006401[See
Related Articles]
Marsaudon E, et al. [Meningeal reaction after vaccination against hepatitis B]. Presse Med. 1996 Oct 26;25(32):1561-2. French. No abstract available. PMID: 8952667; UI: 97110516.
Mathieu
E, et al. Cryoglobulinemia after hepatitis B vaccination. N Engl J Med. 1996 Aug
1;335(5):355. No abstract available.PMID: 8668224; UI: 96283165.
Masse
I, et al. [Hypersensitivity vasculitis after hepatitis B vaccination].
Presse Med. 1998 Jun 6;27(20):965-6. French. No abstract available.PMID: 9767839; UI:
98440953.
Martinez
E, et al. Evans's syndrome triggered by recombinant hepatitis B vaccine. Clin
Infect Dis. 1992 Dec;15(6):1051. No abstract available.PMID: 1457642; UI: 93091042.
Meyboom
RH, et al. Thrombocytopenia reported in association with hepatitis B and A vaccines.
Lancet. 1995 Jun 24;345(8965):1638. No abstract available.PMID: 7632294; UI:
95302878.
Nagafuchi
S, et al. Eosinophilia after intradermal hepatitis B vaccination. Lancet. 1993
Oct 16;342(8877):998. No abstract available.PMID: 8105253; UI: 94018194.
Neau
D, et al. Immune thrombocytopenic purpura after recombinant hepatitis B vaccine:
retrospective study of seven cases. Scand J Infect Dis. 1998;30(2):115-8. PMID: 9730294;
UI: 98398062.
Nadler
JP. Multiple sclerosis and hepatitis B vaccination. Clin Infect Dis. 1993
Nov;17(5):928-9. No abstract available. PMID: 8286645; UI: 94114816.
Noel
I, et al. Hypersensitivity to thiomersal in hepatitis B vaccine. Lancet. 1991
Sep 14;338(8768):705. No abstract available.PMID: 1679511; UI: 91359780.
Noble
JP, et al. [Skin diseases related to hepatitis B vaccine]. Gastroenterol Clin Biol.
1997;21(1):87. French. No abstract available.PMID: 9091400; UI:
97226853.
No
authors listed] [See
Related Artices] Report of the working group on the possible relationship between
hepatitis B vaccination and the chronic fatigue syndrome. CMAJ. 1993 Aug 1;149(3):314-9.
English; French. No abstract available.PMID: 8339178; UI: 93338559.
Orlando
MP, et al. Sudden hearing loss in childhood consequent to hepatitis B
vaccination: a case report. Ann N Y Acad Sci. 1997 Dec 29;830:319-21. No abstract
available.PMID: 9616691; UI: 98279663.
Ozdemir
S, et al. Nephrotic syndrome associated with recombinant hepatitis B vaccination: a
causal relationship or just a mere association? Nephrol Dial Transplant. 1998
Jul;13(7):1888-9. No abstract available.PMID: 9681759; U
Pemberton MN, Sloan P, Thakker NS. Oral lichenoid lesions after hepatitis B vaccination.:Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2000 Jun;89(6):717-719 PMID: 10846126
Petousis-Harris H, et al. Hepatitis B vaccination and diabetes. N Z Med J. 1999 Aug 13;112(1093):303-4. No abstract available.PMID: 10493435; UI: 99421178.
Pennesi M, Torre G, Del Santo M, Sonzogni A.Glomerulonephritis after recombinant hepatitis B vaccine.Pediatr Infect Dis J. 2002 Feb;21(2):172-3.PMID: 11840090 [PubMed - indexed for MEDLINE]
Peyriere
H, et al. [Acute pericarditis after vaccination against hepatitis B: a rare effect to
be known]. Rev Med Interne. 1997;18(8):675-6. French. No abstract available.PMID: 9365747;
UI: 98032451.
Poullin
P, et al. Thrombocytopenic purpura after recombinant hepatitis B
vaccine. Lancet. 1994 Nov 5;344(8932):1293. No abstract available.PMID: 7967998; UI:
95057573.
Pope
JE, et al. The development of rheumatoid arthritis after recombinant hepatitis B
vaccination. J Rheumatol. 1998 Sep;25(9):1687-93. PMID: 9733447; UI: 98402283.
Sindern
E, Schroder JM, Krismann M, Malin JP. Inflammatory polyradiculoneuropathy
with spinal cord involvement and lethal outcome after hepatitis B vaccination.
Neurologische Klinik, BG-Kliniken Bergmannsheil, Ruhr-Universitat, Burkle-de-la-Camp-Platz
1, 44789, Bochum, Germany
J Neurol Sci 2001 May 1;186(1-2):81-5
We report on a 36-year-old man who developed an inflammatory polyradiculoneuropathy
similar to Guillain-Barre syndrome 9 days after hepatitis B vaccination. Extensive
immunotherapy including immunoglobulins, steroids, plasmapheresis, cyclophosphamide and
methotrexate did not stop the progressive course of the disease and the patient died 4
months later due to multiorgan failure with septic shock symptoms and adult respiratory
distress syndrome (ARDS).The neuropathological investigation showed severe axonal loss
with mild demyelination of peripheral nerves and mononuclear cell infiltrates,
predominantly T-lymphocytes, in nerve roots and spinal ganglia. In addition, there were
unusual, perivascular and parenchymal lymphocytic cell infiltrates in the grey matter,
especially the anterior horns of the spinal cord. The temporal relationship to hepatitis B
vaccination, the strong increase of HBs-antibodies within 3 weeks after vaccination, and
the presumptive immune mediated pathology of this disorder suggest a possible etiologic
link with hepatitis B vaccine. ------------------------
Vanoli
M, et al. A case of Churg-Strauss vasculitis after hepatitis B vaccination. Ann
Rheum Dis. 1998 Apr;57(4):256-7. No abstract available.PMID: 9709187; UI: 98374849.
Vautier
G, et al. Acute sero-positive rheumatoid arthritis occurring after
hepatitis vaccination. Br J Rheumatol. 1994 Oct;33(10):991. No abstract available.PMID:
7921766; UI: 95006007.
Voigt U, Baum U, Behrendt W, Hegemann S, Terborg C, Strobel J. [Neuritis of the optic nerve after vaccinations against hepatitis A, hepatitis B and yellow fever] Klin Monatsbl Augenheilkd. 2001 Oct;218(10):688-90. German.PMID: 11706386 [PubMed - indexed for MEDLINE]
Waugh MA. [See Related Articles] Acute hepatitis B infection after vaccination. Lancet. 1995 Jan 28;345(8944):262; discussion 262-3. No abstract available.PMID: 7823746; UI: 95124109.
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