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WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome
If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior
influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine
should be based on careful consideration of the potential benefits and risks.
5.2 Altered Immunocompetence
If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to
immunocompromised persons, including individuals receiving immunosuppressive
therapy, the expected immune response may not be obtained.
5.3 Preventing and Managing Allergic Reactions
Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent
Vaccine, the healthcare provider should review the patient’s prior immunization history
for possible adverse events, to determine the existence of any contraindication to
immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an
assessment of benefits and risks. Appropriate medical treatment and supervision must be
available to manage possible anaphylactic reactions following administration of the
5.4 Limitations of Vaccine Effectiveness
Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect