Bell’s Palsy as a Possible Complication of

Hepatitis B Vaccination in A Child, 2009

Handan Alp1, Hüseyin Tan2, and Zerrin Orbak1

1Department of Pediatrics and 2Department of Pediatric Neurology, Faculty of Medicine, Atatürk

University, Erzurum, Turkey

 two-year old female patient with right peripheral facial palsy following hepatitis B vaccination.
Readers’ attention is drawn to an uncommon cause of Bell’s Palsy, as a rare complication of
hepatitis B vaccination
 Vaccination against hepatitis B virus (HBV) is important to reduce the incidence of
HBV-associated infection. Although HBV vaccine is among the safest of all vaccines, it has been
associated with adverse effects

 An estimated 850,000 individuals had received the vaccine over the time of their study. They
found three cases of brachial plexus neuropathy, four cases of transverse myelitis, five cases of
optic neuritis, five cases of lumbar radiculopathy, nine cases of Gullian-Barre Syndrome, and 10
cases of Bell’s Palsy.
 The aetiology and pathogenesis of Bell’s Palsy remains unclear. There is a concern that
reactivation of latent herpes simplex virus-associated infections of the geniculate ganglia of
facial nerves may be one of the causes of Bell’s Palsy. Auto-immune processes have also been
considered. It has been hypothesized that an immunomediated segmental demyelination may
be involved. Also, it is known that hepatitis vaccine is associated with Gullian- Barre Syndrome
and demyelinating disease, possibly through an immune response mechanism
 The prognosis in this disorder is excellent. More than 85% of cases recover spontaneously with
no residual facial weakness

 The study considered in all patients with this disease, following hepatitis B vaccination but the
present universal vaccination programme to eradicate hepatitis B should not be changed.

(BOOK )Adverse Effects of Vaccines: Evidence and Causality, 2012

Kathleen Stratton, Andrew Ford, Erin Rusch, and Ellen Wright Clayton,

BELL’S PALSY and INFLUENZA VACCINE

Epidemiologic Evidence
The committee reviewed five studies to evaluate the risk of Bell’s palsy after the administration of
influenza vaccine. Two studies (Izurieta et al., 2005; Zhou et al., 2004) were not considered in the
weight of epidemiologic evidence because they provided data from passive surveillance systems and
lacked unvaccinated comparison populations. One controlled study (Mutsch et al., 2004) investigated
the association of a vaccine product that is no longer in use and was not included in the epidemiologic
evidence. The two remaining controlled studies (Greene et al., 2010; Stowe et al., 2006) contributed to
the epidemiologic weight of evidence and are described below. Stowe et al. (2006) conducted a
self-controlled case-series study in patients (2 to 95 years of age) enrolled in the GPRD. Eligible
patients received at least one inactivated influenza vaccine and had a consultation for Bell’s palsy
from July 1992 through June 2005. Multiple consultations were counted as a single episode if the
second consultation occurred within 6 months of the first visit. Follow-up ended on the date the
patient left the practice, the date data were last obtained from the practice, date of death, or June 30,
2005, whichever occurred first. The risk period was defined as 1–91 days after vaccination, with
separate analyses for 1–30 days, 31–60 days, and 61–91 days. The authors expected a reduced number
of events 14 days prior to vaccination and an increased number of events on the day of vaccination
because of increased opportunity to record cases, so these were analyzed as separate risk periods. The
control period included all other time not attributed to the risk periods. Analyses were adjusted for age
(5-year categories), influenza season (defined as July through June), and calendar time (by quarter). A
total of 2,128 patients were included in the analysis; they experienced 2,263 Bell’s palsy episodes, and
received 8,376 doses of influenza vaccine. The relative risk of Bell’s palsy within 1–91 days of
influenza vaccination was 0.92 (95% CI, 0.78–1.08). Additionally, no significant increased risk was
observed when the risk period was separated into 30-day intervals or when the analyses were
separated into three age groups (0–44 years, 45–64 years, ≥ 65 years). The authors concluded that
influenza vaccine is not associated with an increased risk of Bell’s palsy within 3 months of
vaccination.

The study by Greene et al. (2010) was described in detail in the section on seizures. This retrospective
cohort study investigated the occurrence of adverse events after influenza vaccination in children and
adults enrolled in eight MCOs participating in the VSD. The study included cases of Bell’s palsy
reported during outpatient, inpatient, and emergency department visits after receipt of influenza
vaccine from September through April of the 2005–2006, 2006–2007, and 2007–2008 influenza
seasons. The risk period for the Bell’s palsy analysis (1 to 42 days after vaccination) of the given
season was compared to the control period (15 to 74 days before vaccination) of the same season.
Because the prevaccination period tended to always be in the earliest part of the season, residual
confounding owing to the lack of adjustment for different seasonal risks of infection was present. The
relative risk of Bell’s palsy in children within 1–42 days of influenza

Mechanistic Evidence The committee identified two publications reporting Bell’s palsy after
administration of an influenza vaccine. The publications did not provide evidence beyond temporality,
some too short based on the possible mechanisms involved (Chou et al., 2007; Philippin et al., 2002).
The publications did not contribute to the weight of mechanistic evidence.

BELL’S PALSY and TdaP vaccine

Epidemiologic Evidence
The committee reviewed one study to evaluate the risk of Bell’s palsy after the administration of
vaccines containing diphtheria toxoid, tetanus toxoid, and acellular pertussis antigens alone or in
combination. This one controlled study (Yih et al., 2009) contributed to the weight of epidemiologic
evidence and is described below. The study by Yih et al. (2009) was described in detail in the section
on encephalitis or encephalopathy. This cohort study compared the incidence of cranial nerve
disorders, including Bell’s palsy, after Tdap vaccine to a historical Td comparison population. The
observed number of cranial nerve disorders in the Tdap cohort (126 events) was greater than the
historical Td cohort (100.8 events), which resulted in a relative risk of 1.25 (confidence interval not
provided). The authors concluded that the risk of cranial nerve disorders following Tdap vaccination is
not significantly higher than the risk following Td vaccination, which only provides information on
the safety of the acellular pertussis antigen component.

Weight of Epidemiologic Evidence

The committee has limited confidence in the epidemiologic evidence, based on one study that lacked
validity and precision, to assess an association between acellular pertussis vaccine and Bell’s

palsy. The epidemiologic evidence is insufficient or absent to assess an association between diphtheria
toxoid or tetanus toxoid vaccine and Bell’s palsy.

Mechanistic Evidence
The committee did not identify literature reporting clinical, diagnostic, or experimental evidence of
Bell’s palsy after the administration of vaccines containing diphtheria toxoid, tetanus toxoid, and
acellular pertussis antigens alone or in combination.
Weight of Mechanistic Evidence

While rare, infection with Clostridium tetani or Corynebacterium diphtheria has been associated with
facial nerve palsy (MacGregor, 2010; Reddy and Bleck, 2010). The committee considers the effects of
natural infection one type of mechanistic evidence. The committee assesses the mechanistic evidence
regarding an association between diphtheria toxoid or tetanus toxoid vaccine and Bell’s palsy as weak
based on knowledge about the natural infection.

The committee assesses the mechanistic evidence regarding an association between acellular pertussis
vaccine and Bell’s palsy as lacking.

Causality Conclusion
The evidence is inadequate to accept or reject a causal relationship between diphtheria toxoid–,
tetanus toxoid–, or acellular pertussis–containing vaccine and Bell’s palsy.